FDA REGIMTION OF MEDICAL DEVICES,
INCLUDING THE STATUS OF BREAST IMPLANTS
Y4.G 74/7: M 46/13
"" Be,.utio. 0. --'"^;-'^«- • HEARING
BEFORE THE
SUBCOMMITTEE ON HUMAN RESOURCES
AND INTERGOVERNMENTAL RELATIONS
AND THE
SUBCOMMITTEE ON NATIONAL ECONOMIC GROWTH,
NATURAL RESOURCES, AND REGULATORY AFFAIRS
OP THE
COMMITTEE ON GOVERNMENT
REFORM AND OVERSIGHT
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTH CONGRESS
FIRST SESSION
AUGUST 1, 1995
"''^mi:^
Printed for the use of the Committee on Government Reform and Oversight
. ■"■if
'^f?fl
U.S. GOVERNMENT PRINTING OFFICE
For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-052222-6
IDA REGUUnON OF MEDICAL DEVICES,
INCLUDING THE STATUS OF BREAST IMPLANTS
4.G 74/7: M 46/13
"'""'"" '' ""'"irr;: HEARING
BEFORE THE
SUBCOMMITTEE ON HUMAN RESOURCES
AND INTERGOVERNMENTAL RELATIONS
AND THE
SUBCOMMITTEE ON NATIONAL ECONOMIC GROWTH,
NATURAL RESOURCES, AND REGULATORY AFFAIRS
OF THE
COMMITTEE ON GOVERNMENT
REFORM AND OVERSIGHT
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTH CONGRESS
FIRST SESSION
AUGUST 1, 1995
^'^U^K-
Printed for the use of the Committee on Government Reform and Oversi^t
'^^,
U.S. GOVERNMENT PRINTING OFFICE
For sale by the U.S. Government IMnting Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-052222-6
COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT
WILLIAM F. CLINGER, JR., Pennsylvania, Chairman
BENJAMIN A. OILMAN, New York
DAN BURTON, Indiana
J. DENNIS HASTERT, lUinoiB
CONSTANCE A. MORELLA, Maryland
CHRISTOPHER SHAYS, Connecticut
STEVEN SCHIFF, New Mexico
ILEANA ROS-LEHTINEN, Florida
WILLIAM H. ZELIFF, JR., New Hampshire
JOHN M. MCHUGH, New York
STEPHEN HORN, California
JOHN L. MICA, Florida
PETER BLUTE, Massachusetts
THOMAS M. DAVIS, Virginia
DAVID M. MCINTOSH, Indiana
JON D. FOX, Pennsylvania
RANDY TATE, Washington
DICK CHRYSLER, Michigan
GIL GUTKNECHT, Minnesota
MARK E. SOUDER, Indiana
WILLIAM J. MARTINI, New Jersey
JOE SCARBOROUGH, Florida
JOHN B. SHADEGG, Arizona
MICHAEL PATRICK FLANAGAN, Illinois
CHARLES F. BASS, New Hampshire
STEVEN C. LaTOURETTE, Ohio
MARSHALL 'TVIARK" SANFORD, South
Carolina
ROBERT L. EHRLICH, Jr., Maryland
CARDISS COLLINS, IlHnois
HENRY A. WAXMAN, California
TOM LANTOS, California
ROBERT E. WISE, JR., West Virginia
MAJOR R OWENS, New York
EDOLPHUS TOWNS, New York
JOHN M. SPRATT, JR., South Carolina
LOUISE MCINTOSH SLAUGHTER, New
York
PAUL E. KANJORSKI, Pennsylvania
GARY A. CONDIT, California
COLLIN C. PETERSON, Minnesota
KAREN L. THURMAN, Florida
CAROLYN B. MALONEY, New York
THOMAS M. BARRETT, Wisconsin
GENE TAYLOR, Mississippi
BARBARA-ROSE COLLINS, Michigan
ELEANOR HOLMES NORTON, EMstrict of
Columbia
JAMES P. MORAN, Virginia
GENE GREEN, Texas
CARRIE P. MEEK, Florida
CHAKA FATTAH, Pennsylvania
BILL BREWSTER, Oklahoma
TIM HOLDEN, Pennsylvania
BERNARD SANDERS, Vermont
(Independent)
James L. Clarke, Staff Director
Kevin Sabo, General Counsel
Judith McCoy, Chief Clerk
Biro Myers, Minority Staff Director
Subcommittee on Human Resources and Intergovernmental Relations
CHRISTOPHER SHAYS,
MARK E. SHOUDER, Indiana
STEVEN SCHIFF, New Mexico
CONSTANCE A. MORELLA, Maryland
THOMAS M. DAVIS, Virginia
DICK CHRYSLER, Michigan
WILLIAM J. MARTINI, New Jersey
JOE SCARBOROUGH, Florida
MARSHALL "MARK" SANFORD, South
Carolina
Connecticut, Chairman
EDOLPHUS TOWNS, New York
TOM LANTOS. California
BERNARD SANDERS, Vermont Gnd.)
THOMAS M. BARRETT, Wisconsin
GENE GREEN, Texas
CHAKA FATTAH, Pennsylvania
HENRY A. WAXMAN, California
Ex Officio
WILLIAM F. CLINGER, JR., Pennsylvania CARDISS COLLINS, Illinois
Lawrence J. Halloran, Staff Director
Anne Marie FINLEY, Professional Staff Member
Robert Newman, Professional Staff Member
Thomas M. Costa, Clerk
Kevin Davis, Minority Professional Staff
(11)
m
subcommitteb on national economic growth, natural resources, and
Regulatory Affairs
DAVID M. Mcintosh, Indiana, Chairman
JON D. FOX, Pennsylvania COLLIN C. PETERSON, Minnesota
J. DENNIS HASTERT, Illinois HENRY A. WAXMAN. California
JOHN M. MCHUGH, New York JOHN M. SPRATT, Jr., South Carolina
RANDY TATE, Washington LOUISE McINTOSH SLAUGHTER, New
GIL GUTKNECHT, Minnesota York
JOE SCARBOROUGH, Florida PAUL E. KANJORSKI, Pennsylvania
JOHN B. SHADEGG, Arizona GARY A. CONDIT, California
ROBERT L. EHRUCH, Jr., Maryland CARRIE P. MEEK, Florida
Ex Officio
WILLIAM F. CLINGER, Jr., Pennsylvania CARDISS COLLINS, Illinois
Mildred Webber, Staff Director
Jon Praed, Professional Staff Member
David White, Clerk
Kevin Davis, Minority Professional Staff
CONTENTS
Page
Hearing held on August 1, 1995 1
Statement of:
Hazleton, Richard A., chairman and chief executive ofilcer, Dow Coming
Corp.; James E. Benson, senior vice president, technology and regu-
latory affairs, Health Industry Manufacturers Association; and Jerome
S. Schultz, Ph.D., president, American Institute for Medical and Bio-
lo^cal Engineerinff, and director, Center for Biotechnology and
Bioengineering, Umversity of Pittsburg 168
Kessler, David, Director, Food and Drug Administration, Washington,
DC; accompanied by Donald Bruce Burlington, Director, the Center
for Devices in Radiological Health; Joseph A. Levitt, Deputy Director,
and Ruth Merkatz, Director, the Office or Women's Health 57
Lloyd, Marilyn, Hon., a former Representative in Congi^ess from the
^ate of Tennessee; Hon. James A. Traficant, a Representative in Con-
gress from the State of Ohio; Hon. Greg Ganske, a Representative
m Congress from the State of Iowa 18
Sergent, John S., M.D., Vanderbilt Universitv; Doudas R. Shanklin,
M.D., University of Tennessee, Memphis; Snerine E. Gabriel, M.D.,
Mayo Clinic; Elizabeth B. Connell, M.D., Emory University; Linda Ran-
som and Tara Ransom, Phoenix, AZ; Sybil Niden Goldrich, Command
Trust Network; Sharon Green, Y-ME; and Jama Kim Russano, Chil-
dren Afflicted by Toxic Substances 108
Letters, statements, etc., submitted for the record by:
American Society of Plastic and Reconstructive Surgeons, the Plastic
Surgeiy Educational Foundation, and the American Society for Aes-
thetic Plastic Surgery, joint prepared statement of 203
Benson, James E. Benson, senior vice president, technology and regu-
latory affairs. Health Industry Manufacturers Association, prepared
statement of 177
Burlinston, Donald Bruce, Director, the Center for Devices in Radiologi-
cal Health and David Kessler, Director, Food and Drug Administration,
Washington, DC:
Joint prepared statement of 170
Response to written questions submitted by Hon. Ed Towns 174
Clinger, Hon. William F., Jr., a Representative in Congress from the
State of Pennsylvania, prepared statement of 10
Connell, Elizabeth B., M.D., Emory University, prepared statement of 129
Leslie Lilienfeld DeHoust, Co-Founder, East Coast Connection, prepared
statement of 205
Gabriel, Sherine E., M.D., Mayo Clinic, prepared statement of 125
Gan^e, Hon. Greg, a Representative in Congress from the State of
Iowa, prepared statement of 28
Goldrich, Sybil Niden, Command Trust Network, prepared statement
of 142
Green, Hon. Gene, a Representative in Congress from the State of Texas,
prepared statement of^ 18
Green, Sharon, Y-ME, prepared statement of 146
Hazleton, Richard A., chairman and chief executive officer, Dow Coming
Corp., prepared statement of 170
Kessler, David, Director, Food and Drug Administration, Washington,
DC, and Donald Bruce Burlington, Director, the Center for Devices
in Radiological Health:
Joint prepared statement of 170
Response to written questions submitted by Hon. Ed Towns 174
(V)
VI
Page
Letters, statements, etc., submitted for the record by — Continued
Lloyd, Marilyn, a former Representative in Congress from the State
of Tennessee, prepared statement of 20
Mcintosh, Hon. David M., a Representative in Congfress from the State
of Indiana, prepared statement of 8
Morella, Hon. Constance A., a Representative in Congress from the State
of Maryland, prepared statement of 11
Pastor, Hon. E<C a Representative in Congress From the State of Arizona,
prepared statement of 201
Ransom, Linda, Phoenix, AZ, prepared statement of 136
Ransom, Tara, Phoenix, AZ, prepared statement of 139
Russano, Jama Kim, Children Afflicted by Toxic Substances, prepared
statement of 150
Schultz, Jerome S., Ph.D., president, American Institute for Medical and
Biological Engineering, and director, Center for Biotedinology and
Bioengineering, University of Pittsburg, prepared statement of 186
Sergent, John S., M.D., Vanderbilt University, prepared statement of 110
Shfmklin, Douglas R., M.D., University of Tennessee, Memphis, prepared
statement of 115
Shays, Hon. Christopher, a Representative in Congress from the State
of Connecticut, prepared statement of 3
Talcott, Thomas D., prepared statement of 202
Towns, Hon. Edolphus, a Representative in Congress from the State
of New York, prepared statement of 5
Traficant, Hon, James A., a Representative in Congress from the State
of Ohio, prepared statement oi 24
FDA REGULATION OF MEDICAL DEVICES, IN-
CLUDING THE STATUS OF BREAST IM-
PLANTS
TUESDAY, AUGUST 1, 1996
U.S. House of Representatives, Subcommittee on
Human Resources and Intergovernmental Rela-
tions, JOINT with the Subcommittee on National
Economic Growth, Natural Resources, and Regu-
latory Affairs of the Committee on Government
Reform and Oversight,
Washington, DC.
The subcommittees met, pursuant to notice at 9:45 a.m., in room
2154, Rayburn House Office Building, Hon. Christopher Shays
(chairman of the Subcommittee on Human Resources and Intergov-
ernmental Relations) presiding.
Subcommittee on Human Resources and Intergovernmental Rela-
tions present: Representatives Shays, Souder, Morella, Davis,
Chrysler, Martini, Towns, Barrett, and Fattah.
Subcommittee on National Economic Growth, Natural Resources,
and Regulatory Affairs present: Representatives Mcintosh, Fox,
Tate, Gutknecht, Shadegg, Hastert, Peterson, and Kanjorski.
Ex officio present: Representative dinger.
Staff present: Lawrence J. Halloran, staff director and counsel;
Anne Marie Finley and Robert Newman, professional staff; Thomas
M. Costa, clerk; Mildred Webber, staff director; Jon Praed, profes-
sional staff; Liz Campbell, minority staff assistant; and Kevin
Davis, minority professional staff.
Mr. Shays. I'd like to call this hearing to order and to welcome
our witnesses, our very distinguished witnesses, and our guests at
this hearing and to say from the outset that this is going to be a
long day. We have 16 witnesses and we want to make sure the wit-
nesses have a chance to tell their story.
We want to give an opportunity to Members to question our wit-
nesses. This is also a joint hearing held with Mr. Mcintosh's Sub-
committee on Regulatory Affairs. So we have really two subcommit-
tees that are participating in this hearing.
And I'm going to invite all Members who want to, to have open-
ing statements, the two chairman and the two ranking members
for the record are required to have opening statements and so we
will read these into the record and encourage other Members to
summarize their statements, but they are also welcome to g^ve
statements.
(1)
And I would like for the record to get some housekeeping out of
the way and ask unanimous consent that all members of the sub-
committee be permitted to place any opening statement in the
record and that the record remain open for 3 days for that purpose.
Without objection, so ordered.
And I also ask unanimous consent that our witnesses be per-
mitted to include their written statements. I mean, some of the
statements of our witnesses are very long and we would appreciate
a summary of the main points.
Without objection, so ordered.
This joint hearing reflects the importance all Members attach to
our oversight responsibilities, especially in matters affecting public
health. The Food and Drug Administration, FDA, has been charged
by Congress to stand as the scientific and regulatory gatekeeper
between the public and the makers of foods, drugs, medical devices,
and cosmetics. It is a complex and often controversial mission, par-
ticularly when attempting to discern the benefits and risks of medi-
cal devices.
Today, we will confront four questions generated by the unique
circumstance of silicone gel breast implsmts, but questions just as
relevant to the FDA's current approach to medical device regula-
tion in general. First, what is the agency's current view of the safe-
ty of silicones as a biomaterial, specifically silicone gel-filled breast
implants.
Second, when and on what basis will the agency be able to reach
final conclusions on the safety and efficacy of these devices? Third,
what is the impact of the FDA approach to breast implants on the
development of new medical devices and the availability of
biomaterials? And finally, what standard should guide the FDA in
the quantification and evaluation of the benefits and risks of medi-
cal devices and biomaterials.
These are important questions, important to women who deserve
the benefit of the best scientific analysis to date on the safety of
the materials they have or will put into their bodies, and important
to patients whose lives will depend on the availability of medical
devices not yet invented. For if the system intended to insure the
safety and efficacy of these devices is litigated and regulated to a
standstill, public health will suffer and lives will be lost.
There is a tragic irony to the history of breast implants. The
1976 device amendments to the Food, Drug and Cosmetic Act
brought added protections and assurances of safety to users of new
medical devices, but to patients who had or who would need breast
implants, the application of the device law froze the technology in
a regfulatory and legal limbo from which it has yet to emerge.
Now, 19 years later, 19 years later, the very regulatory process
designed to produce scientifically valid answers to questions of
safety and risk seems unable to do so with regard to breast im-
plants. We need to know when this tragic uncertainty will end.
The vacuum created by that uncertainty has sr>awned junk
science and a litigation feeding frenzy that now threatens to devour
other devices and biomaterials, even those scientifically determined
to be safe. In such a litigious environment, let it be clear that we
are not here to produce evidence for any plaintiff or defendant.
Rather, our purpose is to determine what the responsible Federal
agency, the regulated industry, and doctors are doing to resolve
outstanding questions on silicones and other biomaterials. Patients
deserve access to the information they need to make informed deci-
sions. Scientists, not lawyers, judges, not juries must be relied
upon to validate scientific conclusions.
Our goal is also to assure the public that life saving devices will
be available and that those devices have been determined to be
reasonably safe relative to the known risks. Reasonableness is the
standard that must apply, but which can also easilv elude us. We
yearn for certainty, but science yields only reasonable probability.
If we eliminate risk and punish risk taking, we will all be the
victims. If we ignore risks or overstate benefits, doctors and pa-
tients will be unable to make important health choices and people
will suffer. Between smothering paternalism and a callous reliance
on caveat emptor, let the buyer beware, stands only the reasonable
assurance that the benefits of a device or a procedure will outweigh
the risks. It is that critical balance that we explore today.
Again, I welcome the witnesses. I'm going to invite, if I might,
the ranking member of my subcommittee and then go to the chair-
man of the other subcommittee to make a statement. And so I ask
now Mr. Towns if you have a statement.
[The prepared statement of Hon. Christopher Shays follows:]
Prepared Statement of Hon. Christopher Shays, a Representative in
Ck)NGRESs From the State of Connecticut
This joint hearing reflects the importance all our members attach to our oversight
responsibilities, especially in matters affecting public health. The Food and Drug
Administration has been charged by Congress to stand as the scientiflc and regu-
latory gatekeeper between the public and the makers of foods, drugs, medical de-
vices and cosmetics. It is a complex and often controversial mission, particularly
when attempting to discern the beneflts and risks of medical devices.
Today, we will confront four questions generated by the unique circumstances of
silicone gel breast implants; but questions just as relevant to the FDA's current ap-
proach to medical device regulation in general: First, what is the agency's current
view of the safety of silicones as a biomaterial, specifically silicone gel fllled breast
implants? Secona, when and on what basis will the asencjr be able to reach flnal
conclusions on the safety and eflicacy of these devices/ Third, what is the impact
of the FDA approach to breast implants on the development of new medical devices
and the availability of biomaterials? And Anally, what standards should guide the
FDA in the qjuantincation and evaluation of the benefits and risks of new medical
devices and biomaterials?
These are important questions. Important to women who deserve the benefit of
the best scientific analysis to date on the safety of the materiab they have, or will,
put into their bodies. And important to patients whose lives will depend on the
availability of medical devices not yet invented. For if the system intended to ensure
ihe safety and eflicacy of these devices is litigated and regulated to a standstill, pub-
lic health will suffer and lives will be lost.
There is a tragic irony to the history of breast implants. The 1976 Device Amend-
ments to the F(x>d, Drug and Cosmetics Act brought added protections and assur-
ances of safety to users of new medical devices. But for patients who had, or would
need breast implants, the application of the device law froze the technology in a reg-
ulatoiy and legal limbo from which it has yet to emerge. Now, nineteen years later,
the veiy regulatory process designed to produce scientifically valid answers to ques-
tions of safety and ri^ seems unable to do so with regard to breast implants. We
need to know when this tragic uncertainty will end.
The vacuum created by that uncertainty has spawned junk science and a litiga-
tion feeding frenzy that now threatens to devour other devices and biomaterials,
even tiiose scientifically determined to be safe. In such a litigious environment, let
it be clear that we are not here to produce evidence for any plaintiff or defendant.
Rather, our purpose is to determine what the responsible federal agency, the regu-
lated industry and doctors are doing to resolve outstanding questions on silicones
and other biomaterials. Patients deserve access to the information they need to
make informed decisions. Scientists, not lawyers, judges or juries, must be relied
upon to vedidate scientific conclusions.
Our goal is also to assure the public that life-saving devices will be available, and
that those devices have been determined to be reasonably safe relative to the known
risks. Reasonableness is the standard that must apply, but which can so easily
elude us. We yearn for certainty, but science yields only reasonable probability.
If we eliminate risk, and punish risk taking, we will all be the victims. If we ig-
nore risks or overstate benefits, doctors and patients will be unable to make impor-
tant health choices, and: people will suffer. Between smothering paternalism and a
callous reliance on caveat emptor stands only the reasonable assurance that the
benefits of a device or procedure will outwei^ the risks. It is that critical balance
that we explore today.
We welcome our witnesses this morning, and I look forward to a thorough and
balanced discussion of an important public nealth issue.
Mr. Towns. Thank you very much, Mr. Chairman. Let me begin
by thanking you for convening this hearing. I think it's a very, very
important hearing and your leadership on this issue, I want to let
you know, is greatly appreciated.
The subject of today's hearing FDA's regulation of medical de-
vices and more specifically the silicone breast implants is a public
health issue of fundamental importance. Given that over 1 million
women have breast implants and a sizable portion of them have re-
ported problems, we must ensure that these devices are both safe
and effective.
When the Human Resources Subcommittee last focused its atten-
tion on this issue in 1990, we knew far less about the safety of sili-
cone breast implants than we know today. At that time few sci-
entific studies had been conducted, and speculation about the safe-
ty of the implants was rampant. As a result of scientific uncer-
tainty, suggestions that silicone breast implants lead to connective
tissue disorders such as lupus and also rheumatoid arthritis, the
FDA issued a moratorium on the use of silicone breast implants
until science could substantiate their safety.
Since that time, numerous scientific studies have been conducted
that put to rest a number of prior safety concerns. These studies
have found no significant increased risk in connective tissue dis-
orders resulting from the use of silicone breast implants. At a mini-
mum, these findings should prompt the FDA to review its position
with respect to the regulation of silicone breast implants.
These findings should not, however, be looked upon as conclusive
in this debate over safety. I think the debate over safety should
continue. There are still a number of outstanding safety issues not
addressed in these studies and I would counsel caution until these
issues have been resolved.
Beyond the issue of breast implant safety, this hearing speaks to
the much larger issue of risk assessment within the FD/L From our
previous oversight hearings, the picture has emerged of an agency
that is tremendously risk-averse. While I applaud the agency^s ef-
forts to provide an assurance of safety for products and devices it
regulates — and I think that is good — ^it is impossible, though, to ex-
pect these products to be completely and absolutely risk free.
The FDA should not keep potentially life-saving products off the
market for fear that some extremely remote hazard will be real-
ized. We cannot have an FDA whose duty is to protect public
health and safety being the primary obstacle between a patient in
need and a lifesaving device.
In addition, there is a concern that the FDA's actions in the past
with respect to siHcone implants and concerns over Habihty threat-
en to lead the withdrawal of numerous products from the market.
I have with me a list of such products, and I could iust go down
the list but the point is that I would like to ask the chairman that
we include this list in the record, dialysis and heart surgery, blood
transport. I could just go on and on naming these items. And I
would like to just sort of include it in the entire record.
Mr. Shays. Without objection.
[The information referred to follows:]
Hydrocephalus shunts (brain cavity fluid drain for children)
Cardiac pacemaker pulse generators and leads
Cardiac defibrillator pulse generators and leads
Central nervous system and peritoneal shunts
Urological catheters
Implantable drug delivery pumps
Dialysis and chemotherapy ports
Needle and vial lubricants
Ostomy systems and bags
Tracheal and feeding tubes
Intravenous drip systems
Dialysis and heart surgery blood transport tubing
Any number of other grafts, shunts and guidewires used in less invasive surgery
Ear drains
Incontinence devices
Retina and eye socket repair
Tear ducts
SmaU joint orthopedics (finger and wrist joint replacement)
Intra-aortic balloon angioplasty devices
Wound drainage sets
Norplant birth control device
Condom lubricants
Blood oj^genator defoamers
Antigas-antiflatulence preparations
Intraocular lens
Infusion (drip bag) systems
Certain heart valve designs
Interferon production process
Scar treatment
Mr. Towns. In light of these concerns, I welcome the FDA and
all of these witnesses, and I look forward to hearing their views on
the issues raised, Mr. Chairman, as you well know, I am committed
to working with you and again commend you for convening this
hearing. We have some very outstanding witnesses, some that we
served with in the Congress and of course had great respect for in
the Congress and have great respect for them now they're out of
the Congress and of course some that are still with us in the Con-
gress and it's a pleasure to have them and all the witnesses here.
So at this particular time I would yield back and look forward
to hearing from the witnesses.
[The prepared statement of Hon. Edolphus Towns follows:]
Prepared Statement of Hon. Edolphus Towns, a Representative in Congress
From the State of New York
Mr. Chairman, thank you for convening this hearing which continues the Human
Resources Subconmiittee s oversight of the Food and Drug Administration. The sub-
ject of today's hearing — FDA regulation of medical devices, and more specifically, sil-
icone breast implants — is a public health issue of fundamental importance. Given
that over 1 million wonien have breast implants, and a sizable portion of them have
reported problems, we must ensure that these devices are both safe and effective.
When the Human Resources Subcommittee last focused its attention on this issue
in 1990, we knew far less about the safety of silicone breast implants than we know
today. At that time, few scientific studies had been conducted, and speculation about
the safety of the implants was rampant.
As a result of scientific uncertainty, and amid suggestions that silicone breast im-
plants led to connective tissue disorders such as lupus or rheumatoid arthritis, the
FDA issued a moratorium on the use of silicone breast implcmts until science could
substantiate their safety.
Since that time, numerous scientific studies have been conducted that put to rest
a number of prior safety concerns. These studies have found no significant increased
risk for connective tissue disorders resulting from the use of silicone breast im-
plants.
At a minimum, these findings should prompt the FDA to review its position with
respect to the regulation of silicone breast implants. These findings should not how-
ever, be looked upon as conclusive in this debate over safety. There are still a num-
ber of outstanding safety issues not addressed in these stuaies, and I would counsel
caution until these issues have been resolved.
Beyond the issue of breast implant safety, this hearing speaks to the much larger
issue of risk assessment within the FDA. From our previous oversight hearings, the
picture has emerged of an agency that is tremendously risk-averse. While I applaud
the agency's eiTorts to provide an assurance of safety for products and devices it reg-
ulates, it is impossible to expect these products to be completely and absolutely risk-
free. The FDA should not keep pxjtentially life saving products off the market for
fear that some extremely remote hazard will be realized. We cannot have an FDA
whose duty is to protect public health and safety, being the primary obstacle be-
tween a patient in need and a life-saving device.
In addition, there is a concern that the FDA's actions in the past with respect
to silicone implants, and concerns over liability, threaten to lead to the withdrawal
of numerous products from the market. I have with me a list of such products.
I ask, is this a course that we wish to follow?
In light of these concerns, I welcome the FDA and all of the witnesses and I look
forwara to hearing their views on the issues raised. Mr. Chairman. As you well
know, I am committed to working with you, and again, I commend you for conven-
ing this hearing.
Mr. Shays. Thank you. At this time I'd like to call on the chair-
man of the National Economic Growth, Natural Resources, and
Regulatory Affairs Subcommittee, Mr. Mcintosh, and then we^l
hear from the ranking member and then we'll invite Mr. dinger,
the chairman of the committee to make a statement.
Mr. McIntosh. Thank you. Chairman Shays. And I appreciate
you holding this hearing today. I think it's of vital importance to
all Americans.
This morning we will be addressing a matter that is of vital im-
portance to all Americans, the process by which the Food and Drug
Administration approves medical devices for use by the public. Spe-
cifically, the process the FDA has used to review the safety of sili-
cone breast implants in cancer patients.
The issue today is whether FDA is killing women, specifically, is
FDA causing more women to die of breast cancer because its fail-
ure to reach a conclusion about the relative safety of artificial
breast implants for women who suffer with that disease.
Let me say at the outset this is not only a women's issue, it is
also an issue for which men must share responsibility. After all, we
all have mothers, wives, sisters, and other loved ones who may al-
ready or may someday in the future suffer from breast cancer. 'To-
day's statistics show 1 in 8 women in America are likely to suffer
from breast cancer, and the chances are getting worse every day.
Let me also say that this is a personal issue. When I started dat-
ing my wife Ruthie, who is here today, her mother Sherry
McManus was diagnosed with breast cancer. Sherry is also here
today. She is a survivor. And I'd like both of them to stand and be
recognized. [Applause.]
At the time Sherry had her surgery, which included reconstruc-
tion of her breast with an implant, Dr. Kessler scared the living
daylights out of women across America by telling them that such
procedures could be risky or even fatal. And on top of this, there
is the very real fear that the cancer may reoccur and they may be
untreatable.
My mother-in-law chose to go forward with her procedure, but I
shudder to think of the women who chose not to go forward or who
hesitated to have surgery or were even fearful to have a mammo-
fram because they didn't know the awful truth, that they might
ave breast cancer.
Reconstructive surgery has done wonders to help women who do
have breast cancer receive treatment and live with dignity. Yet
tens of thousands of women die each year because they do not act
quickly to do everything to detect and eradicate their own breast
cancer.
FDA's failure to act promptly to allay their fears about breast
implants contributes to those needless deaths. Mastectomies and
lumpectomies coupled with chemotherapy have cured millions of
women of breast cancer. The procedure can also disfigure a woman
and potentially have debilitating and life threatening side effects.
Yet every day, people elect to accept the real and high risks asso-
ciated with that treatment, because it offers them a chance to live.
Many times, however, patients and doctors are robbed of this
choice. Instead, the Federal Government specifically the FDA pro-
hibits them from accepting risk for treatments they need. The gov-
ernment should not be allowed to make such critical decisions for
American women, but the FDA does.
As a result, the FDA is depriving women from access to nec-
essary treatments which they desire to try and see whether they
will succeed in spite of the risks. This morning we will examine a
case of silicone breast implants which will allow us to study the
questions of risk assessment and the government's role in permit-
ting or denying patients' access to medical devices.
The FDA has ag^reed that scientific research performed to date
tends to show there is no connection between silicone implants and
connective tissue diseases, which has been the main medical con-
cern about silicone implants.
In fact the scientific research is much more conclusive. A June
1995 study in the New England Journal of Medicine states, "We
found no evidence of an association between silicone breast im-
plants and either connective tissue diseases defined according to a
variety of standardized criteria or signs of symptoms of connective
tissue disease."
In spite of this, the FDA has refused to go further. Afler so many
years and so many studies, I want to know why. I also want to
know if the FDA shares my concern that until we put the breast
implant controversy to rest, there will be those who choose to with-
hold or withdraw life saving products from the market and there
will be women who choose to put off mammograms and delay or
forego mastectomies and who ultimately die needlessly.
8
I want to welcome all of our witnesses, and especially Dr.
Kessler, who has done his own risk assessment and concluded that
the benefits of being here today outweigh the risks.
This hearing entails difficult and complex questions and a great
degree of emotion. I hope we will focus on the science and that we
will answer women's questions and concerns about breast implants.
But I also hope we will examine the difficult questions of how risk
is measured, what level of risk is acceptable, and who should deter-
mine if the benefits of medical treatment outweigh the risks.
Thank you very much, Mr. Chairman, for holding this hearing.
[The prepared statement of Hon. David M. Mcintosh follows:]
Prepared Statement of Hon. David M. McIntosh, a Representative in
Congress From the State of Indiana
This morning we will be addressing a matter of vital importance to all Ameri-
cans— ^the process by which the Food and Drug Administration approves drugs and
medical devices for use by the public.
Everyone in this room agrees that drugs and medical devices must be "safe." But
I'm not sure we all agree on the definition of "safe."
"Safe" should not mean that there are no risks associated with a drug or device.
We know that there are very real risks associated with some of the most important
and necessary medical products available today.
For some devices or arugs, the risks are so high that they outwei^^ the benefits —
so high that the government must prohibit them from the market. They simply are
not "safe."
But, for many devices or drugs, a high level of risk is appropriate and necessary.
Chemotherapy has cured millions of people of cancer. It also haa debilitating and
life-threatening side effects. Every day, people elect to accept the very real and high
risks associated with that therapy because it offers them a chance to live.
Many times, however, patients and doctors are robbed of this choice. Instead, the
federal government, specifically the FDA, prohibits them from accepting risks for
treatments they need. The government should not be allowed to maJce such critical
decisions for the American people, but it does. As a result, the FDA is depriving
Americans from access to necessary treatments which they desire to try in spite of
the risks.
The FDA restricts the availability of new products to patients who want and need
them. Many Americans are forced to travel abroad to access drugs and new proce-
dures that can help them. When the Subcommittee on Regulatory Affairs held a
field hearing in Pennsylvania in June, we heard testimony from David Samowitz,
a young man who has suffered from epilepsy all his life. In order to obtain the only
two medications that will curb his disease and allow him to lead a relatively normal
life, David must go to extreme lengths and have them shipped from a pharmacy in
London. If the shipment does not arrive in time, or if there is a problem with cus-
toms, David is left without the medicine he must have to survive.
This morning we will examine the case of silicone breast implants which will
allow us to study the questions of risk assessment and the government's role in per-
mitting or denying patients' access to medical devices.
The FDA has agreed that the scientific research j>erformed to date tends to show
that there is no connection between silicone implants and connective tissue dis-
eases— which has been the main medical concern about silicone implants. But it has
refused to go any further. After so many years and so many studies, I want to know
why.
I also want to know if the FDA shares my concern that until we put the breast
implant controversy to rest, there will be those who will choose to witnhold or with-
draw a life-saving product from the market.
I want to welcome all our witnesses, and especially Dr. Kessler, who has done his
own risk assessment and concluded that the benefits of being here today outweigh
the risks.
This hearing entails diflicult and complex questions and a great degree of emo-
tion. I hope we will focus on the science that will answer women's concerns about
breast implants. But, I also hope we will examine the difficult questions of how risk
is determined, what level of risK is acceptable, and who should determine if the ben-
efits of medical treatments outweigh the risks.
Mr. Shays. Thank you, Mr. Chairman. And I just want to say
that all witnesses here todav are very welcome and we appreciate
that they're here today. And at this time I ask Mr. Peterson if he
has a statement for the record.
Mr. Peterson. Well, thank you, Mr. Chairman. I appreciate your
calling this hearing and your leadership on this issue.
What I hope we can determine today are four fundamental is-
sues, what is the FDA's current view of the safety of silicone as
biomaterial and specifically silicone breast implants. Second, when
will the agency be able to reach final conclusions on the safety and
efficacy of these devices. What impact has the FDA's approach to
the regulation of silicone breast implants had on the development
of new medical devices and the availability of biomaterials, and fi-
nally, what standard should guide the FDA in risk assessment of
new medical devices and biomaterial.
So I hope that, Mr. Chairman, we can get some answers and
some insight into these four fundamental issues. I will concluded
with that, because we have a number of witnesses that we want
to hear. I again appreciate your leadership in calling this hearing
and look forward to hearing the testimony of the witnesses.
Mr. Shays. I thank the gentleman. Those are excellent questions
that need to be asked, and at this time I would ask the cnairman
of the full committee, Mr. dinger if he has a statement.
Mr. Clinger. Thank you very much, Mr. Chairman. I am very
pleased to have the opportunity to participate in this joint sub-
committee hearing today on this important issue of FDA regulation
of medical devices, and to look at the breast implant issue and the
safety concerns that swirl around this.
It is my hope that this hearing will shed light on some of the dif-
ficult issues surrounding breast implants. I am sympathetic toward
the women who are faced with these difficult decisions, those that
have breast implants, and those who must make decisions in the
future.
We're going to be hearing testimony from many different points
of view on this issue today. One of the hardest things about this
issue is, quite frankly, the lack of information. Since 1992, the FDA
has declared a moratorium on silicone implants for other than re-
constructive purposes because of insufficient information. But the
FDA has yet to assess the studies and make a judgment regarding
the safety and efficacy of the implants.
The FDA has been far too slow in helping us gain a full under-
standing of the issue of both the risks and the benefits. The sooner
the FDA can provide the necessary information to the public in
some definitive form, the better off everyone will be in terms of
making these hard decisions.
Decisions should not be based on anecdotal or piecemeal informa-
tion. Without some definitive guidance, we are simply taking a
walk in the dark down a very rugged path. The information we are
seeking includes: What are the risks? Are the risks any higher for
developing autoimmune diseases with the implants? Are the risks
so high that no one should have silicone breast implants? What are
the DKBnefits of silicone implants? Once the risk factor is known
should we allow individuals to make their own choices? Since the
moratorium has been in effect, what has the FDA done in evaluat-
10
ing the known studies and when do they plan to issue their opin-
ion?
We need to get some answers to these questions now. The an-
swers have been much too slow in coming. How much longer will
it take?
So, Mr. Chairman, I look forward to the testimony of our wit-
nesses today on this very critical issue affecting the lives of thou-
sands of women. Thank you, Mr. Chairman.
[The prepared statement of Hon. William F. dinger, Jr., follows:]
Prepared Statement of Hon. William F. Cunger, Jr., a Representative in
Congress From the State of Pennsylvania
I am pleased to have the opportunity to participate in this joint Subcommittee
hearing today on the issue of FDA regulation of medical devices, and to look at the
breast implant issue and safety concerns. It is my hope that this hearing will shed
light on some of the difficult and painful issues surrounding breast implants. I am
svmpathetic towards the women who are faced with these difficult choices, those
that have breast implants and those who must make decisions in the future. We
will be hearing testimony from many different points of view on this issue today.
One of the hardest things about this issue is the lack of information. Since 1992
the FDA has declared a moratorium on silicone implants (for other than reconstruc-
tive purposes) because of insufficient information, but the FDA has yet to assess the
studies and make a judgment regarding the safety and efficacy of the implants. The
FDA has been too slow in helping us gain a full understanding of the issue — ^both
the risks and the benefits. The sooner the FDA can provide the necessary informa-
tion to the public in some definitive form, the better off everyone will be in terms
of making these hard decisions. Decisions should not be based on anecdotal or piece-
meal information. Without some definitive guidance, we are simply taking a walk
in the dark down a very rugged path.
The information we are desperately seeking includes: What are the risks? Are the
risks any higher for developing autoimmune diseases with the implants? Are the
risks so high that no one should have silicone breast implants? What are the bene-
fits of silicone implants? Once the risk factor is known snould we allow individuals
to make their own choices? Since the moratorium has been in effect what has the
FDA done in evaluating the known studies and when do they plan to issue their
opinion?
We need to get some answers to these questions now. The answers have been
much too slow in coming. How much longer will it take?
I look forward to the testimony of our witnesses today on this critical issue affect-
ing the lives of thousands of women.
Mr. Shays. Do other Members have statements? Mr. Souder, do
you have a statement?
Mr. SouDER. No.
Mr. Shays. Mr. Fattah.
Mr. Fattah. In the interest of time, Mr. Chairman, I'll forego an
opening statement.
Mr. Shays. Thank you. It will be submitted for the record, if you
have one.
Ms. Morella.
Ms. Morella. Yes. I'd like to give just a brief statement, Mr.
Chairman. First of all, to thank you for scheduling this hearing on
FDA regulation of medical devices, specifically as we focus on
breast implants today.
In anticipation of this hearing, I've been provided with materials
from a variety of individual groups and companies, ranging from
those critical of the FDA response to the breast implant issue who
point to the data from recent studies, to those who believe that the
FDA took appropriate action and that the risks associated with sili-
cone breast implants continue to be significant.
11
I have received letters from women who have suffered from auto-
immune diseases and other health problems linked with breast im-
plants who contend that these implants were rightfully banned and
the FDA, while agreeing that recent studies are providing helpful
data, believes that the evidence of silicone breast implant safety
continues to be inadequate.
So I approach today's hearing, Mr. Chairman, with the hope that
we can learn from this experience and apply these lessons to our
efforts to improve and streamline the FDA approval process. As
many of us have discovered over the past several months, risk as-
sessment is a very tricky business.
I strongly believe that we have a responsibility to protect the
health of our citizens and to continue to provide careful analysis of
medical devices before approving them for use by the public, and
at the same time we cannot allow a cumbersome approval process
to prevent lifesaving devices from reaching the market in a timely
fashion.
So I look forward to hearing from our witnesses today. I particu-
larly want to thank and bid a strong, warm greeting to Marilyn
Lloyd, with whom I had the pleasure of serving in Congress and
on the Science Committee and our two incumbent Members of Con-
gfress, Congressman Traficant and Congressman Ganske.
Thank you very much, Mr. Chairman.
[The prepared statement of Hon, Constance A. Morella follows:]
Prepared Statement of Hon. Constance A. Morella, a Representative in
Congress From the State of Maryland
Mr. Chairman, thank you for scheduling this hearing on FDA regulation of medi-
cal devices, speciiically focusing on breast implants.
In anticipation of this hearing, I have been provided with materials from a variety
of individuals, groups, and companies, ranging from those critical of the FDA re-
sponse to the breast implant issue who point to the data from recent studies to
those who believe that the FDA took appropriate action and that the risks associ-
ated with silicone breast implants continue to be significant.
I have received letters from women who have suffered from autoimmune diseases
and other health problems linked with breast implants, who contend that these im-
plants were rightiully banned. And the FDA, while agreeing that recent studies are
providing helpful data, believes that the evidence of silicone breast implant safety
continues to be inadequate.
I approach today's hearing with the hope that we can learn from this experience
and apply these lessons to our efforts to improve and streamline the FDA approval
process. As many of us have discovered over the past several months, risk assess-
ment is a verv tricky business.
I strongly believe that we have a responsibility to protect the health of our citi-
zens and to continue to provide careful analysis of medical devices before approving
them for use by the public. At the same time, we cannot allow a cumbersome ap-
ftroval process to prevent lifesaving devices from reaching the market in a timely
ashion.
I look forward to hearing from our witnesses today as we ponder these issues.
Thank you, Mr. Chairman.
Mr. Shays. I thank the gentlelady.
Mr. Martini, do you have a statement? Mr. Fox.
Mr. Martini. Yes. Thank you, Mr. Chairman. And just briefly,
I would also like to thank you, Mr. Chairman, and Mr. Mcintosh
for holding these hearings this morning.
In the context of this discussion, I'd like to just address my con-
cerns, really, Mr. Chairman, the medical device manufacturing
community in my opinion is currently standing at a crossroads. The
12
access for millions of Americans to lifesaving implantable medical
devices such as pacemakers, heart valves, hip and knee joints, and
artificial blood vessels are in serious jeopardy.
The litigation that arose from the breast implants scare has
forced the Nation's raw materials suppliers to restrict their sales
to medical device manufacturers. Recently, DuPont, Dow Chemical
and Dow Corning have announced that they would no longer sup-
ply biomaterials to medical implant manufacturers.
Medical device manufacturers represent about 1 percent of the
business for these large corporations but about 80 percent of the
litigation exposure. As we all know, Dow Coming has recently filed
for Chapter 11. Dow Corning is the Nation's leading supplier of sili-
cones for medical use, and silicone, as we know, is used in many
critical medical devices.
Without an adequate supply of this material, we will be severely
threatening the American peoples' access to vital medical devices.
If Congress fails to act swiftly and certainly, we are going to drive
the domestic medical device manufacturing industry out of the
United States.
Mr. Chairman, I believe this committee should commit itself to
exploring the full ramifications of the biological materials shortage.
And before I conclude my remarks, I would like to submit for tne
record a list of medical devices whose supply may be in jeopardy.
And I would urge my colleagues on the committee to examine this
list so that they may fully understand how serious a problem we
are facing.
And I would just like to submit for the record, Mr. Chairman, a
comprehensive list of many of the medical devices that are im-
pacted by today's hearings. Thank you, sir.
Mr. Shays. Without objection. Any testimony that the Members
wish to submit will be submitted for the record without objection.
[The information referred to follows:]
Potentially* Affected Temporary Implants
litit than 30 dayt)
Product BuRiaterial (Ganeric Polymer)
Auto Transfusion:
Chest Drainage Unit urethane
Other polyester, sABS, polycarlwnate
Balloons:
Intra-aortic silicone
Other polyester, urethane, polycartxmate
Blood Filters polyethylene, nylon, polyvinylchloride, polyester
Blood Pumps polyester, silicone
Bl^ Pressure Transducer Attch polycartwnate
Blood Temperature Monitors acrylic
Bone Growth Stimulator (Implantable) silicone
Breathing Circuit Connectors polypropylene
Cannulac:
Coronary silicone
Femoral polyurethane
Inducer polypropylene, polycarbonate, polyethylene, ABS
Other polyvinylchloride
Cardiac Insulation Pads polyethylene
Cardiac Jackets polyurethane
Catheter:
Angioplastic polyester, polyethylene, nylon, polyurethane
Cardiovascular silicone, polyvinylchloride, urethane, polyamidc, ABS
13
Potentially* Affected Temporary Implants — Continued
[Lm tb«« 30 days]
Product
Biomatwial (GtMric PolyMtr)
Chotongiography silicone
Coronary Laser PTFE, polyurethane, epoxy
Diagnostic polyester, polyethylene, nylon, polyurethane
Dilatation polyethylene
Epidural PT7E, nylon
Epistaxis silicone
External CFS Drainage silicone, polypropylene
Foley silicone, polyurethane, PTFE-coated
Gastrointestinal silicone, polyester elastomer, polyvinyichloride
Guiding polyester elastomer. PTTE, polyamide. urethane, aramid fitwr,
ABS
Nephrostomy silicone
PCTA Balloon polyester
Peripheral Laser PTFE, polyurethane, epoxy
Vascular PTFE, polyvinyichloride, polyurethane
Venous PTFE, silicone, polyurethane, polycartxMiate, PVDF, polymethyl
pentaene, polyphenyleneoxide
Other PTFE, polyester, polyurethane, silicone, polyvinyichloride,
polyacetal, polycartionate
Catheter Introducer Kits polypropylene, FEP, polyamide
Catheter Shafts polyester, polyethylene
Covers:
Blood Filter polyester yam
Sterile PETG, polyethylene
Dialators polyethylene
Dialyzers polyurethane, polyethylene, polyurethane, polysulfone
Disposal)le Temperature ProtMS polyvinyichloride
Drainage Products:
Drainage Tulws polyurethane, polyethylene
External CFS Drainage & Monitoring System polyethylene
Wound Drainage Set polyvinyichloride, silicone
Drapes polyethylene
Ear Wicks merocel, polyurethane
Electrodes:
Fetal Scalp polyethylene
Vaginal silicone
Embolic Device n-Butyl cyanoacrylate
Esophageal Stethoscopes polyvinyichloride
Fracture Fixation Device polyethylene
Gloves polyvinyichloride
Guide Wires PTFE, silicone
Hemofiltration Device polysulfone, polycartwnate, polypropylene, polyurethane, sty-
rene aciylonitrile
Hubs polyurethane, polyethylene, polyvinyichloride
Intra-Arterial Blood Gas Sensor silicone, polycarbonate, urethane, PTFE, urethane adhesives
Intracardiac Suction Device polyester, polyvinyichloride
Intrauterine Pressure Device:
Ruid Filled polyethylene
Transducer Tipped polypropylene, silicone, polyurethane, polycarbonate
Leads:
fteuro (& aaessories) silicone, PTFE, polyurethane, polyacetal, nylon, sunoprene
Pacing polyethylene, silicone, polypropylene
Lead Inducers:
Cardio PTFE
Lead/Catheter polyethylene, PTFE, polypropylene, polystyrene
Nasal Septal Splints silicone
Nasal Tampons polyurethane
Needles silicone coated
Ophthalmic:
Glider polyethylene
Lacrimal (DCR) silicone
Sealant n-Butyl cyanoacrylate
Orthopedic Implant Si2e Testers acetal
14
Potentially* Affected Temporary Implants — Continued
(IMS tkan 30 days]
Prodyd Bmnatehal (GMtric Potymar)
Oxygenators:
Dialyttr polycartwnate. polyurethane, polyethytene
Long Term silicone
Surgical Membrane silicone
Other polyester, silicone defoamer, polypropylene
PAP Brush polyvinylchloride, nylon
Patient ID Bands homopolymer acetal, polyethylene, polyester, vinyl, poly-
styrene, tyvek
Periodontal ?\ba Adhesives 2-octyl cyanoactylafe
Pessary polyurethane, polyvinylchloride
Prosthesis;
Hip polyethylene
Knee polyethylene
Retention Cuffs (Enema Tip) silicone elastomer
Sets:
Electrolyte Testing polyvinylchloride, ABS, PCS
Infusion polyvinylchioride, PCB
Peresis polyvinylchloride, silicone, nylon, polyethylene, ABS
Reinfusion polyvinylchloride, ABS
Thoracostomy polyvinylchloride
Sheeting silicone
Staples/Clips PTFE, silicone coating
Stomach Ports silicone
Surgical Instruments PTTE, silicone, polyacetal, FEP, polyethylene, polypropylene,
polysulfone, nylon, polyester foam
Transducer Protectors PTFE
Tubes:
Blood Line silicone, polyvinylchloride
Gastrointestinal polyvinylchloride
Reservoir Bags silicone
Stomach Feeding silicone, polyurethane
Tipptnostopy (Ear Implant) silicone
Tracheal polyvinylchloride, polyurethane
Other silicone
Ureteral Stents silicone, polyethylene, polyurethane
Vaginal Contraceptives silicone
Valves:
Holder polyacetal
Sizer polysulfone
Other silicone
Vascular Vessel Clamps acetal homopolymer, nylon
Vessel Loops silicone
Water and Saline Bottles polyethylene
*At tkis tima tha poientlal Impact of a biomaterials ambarjo on temporary implants is uncertain.
Biomaterials Embargo: Potentially Affected Permanent Implants
[More than or equal to 30 days]
Product Blomaterial (Generic Potymer)
Acetabular Cups polyethylene
Annuloplasty Ring polyester, PTTE
Aortic/Coronary Locators silicone
Artificial Pancreas PTFE, acrylic
Batteries: >
Defibrillator PTFE
Pacemaker PTFE, polyimides, ETTE, FEP
Bone Cement PMMA, n-Butyl Cyanocrylate
Breast Implants silicone
Cardiac Materials:
Fabrics polyester
Felts polyester. PTFE
15
Biomaterials Embargo: Potentially Affected Permanent Implants — Continued
[Mora thtii or equal to 30 dtys)
Product
Biom«tari«l (GtMrk PolyMtr)
Mesh polyester
Patches (vascular repair) polyester, PTFE
Catheters:
CAPO silicone
Central Venous polyester, polyurethane
Chest silicone
Intra-Skomal Corneal Ring PMMA
Peritonea) Dialysis silicone, polyester
Other polyester, silicone, polyethylene terepthalate
Catheter Introducer Kits polypropylene, FEP, polyamide
Cement Spacers PMMA
aips:
Aneurysm polyester
Ligation polyacetal
Vena Cava polyester, PTFE
Cochlear Implant silicone
Contraceptive silicone
Defibrillators PTFE, polyester, ETFE, silicone, polyimide, polyurethane
Embolic Device n-Butyl Cyanoacrylate
Frekote Lubricant (general) PTFE
Generators: >
Defibrillator pulse PTFE, nylon
Pacemalier pulse silicone, polyurethane, parylene C
Other epoxy, silicone
Grafts:
A-V Access silicone, polyester
Intra-aortic polyester
Valve polyester, PTFE
Vascular polyester, PTFE, silicone
Implantable Pumps silicone, nylon, polyacetal, polyimide, polypropylene, PTFE,
polyester, polyvinyl idene fluoride
Impotence Implant silicone, PTFE, polyacetal
Incontinence Implant silicone, PTFE, polyacetal
Intraocular Lens PMMA
Leads:
Cardio PTFE, polyester, FEP, silicone
Defibrillator polyester, silicone, polyurethane
Pacemaker polyester, silicone, polyurethane
Vagus Nerve polyester, silicone
Lead Adapters silicone, polyurethane
Lead Connectors silicone, polyurethane
Mokled Components (Catheters, etc.) silicone
flasal Button silicone
Ort)(tal Implant silicone
Orthopedics:
Finger Prosthesis silicone elastomer
Fracture Fixation Device polyethylene
Hip Joint polyethylene, PMMA
Knee Joint polyethylene, PMMA
Partial/Total Ossicular Replacement polyethylene, silicone, PTFE
Plug (hip fracture stem) silicone
Shoulder Joint polyethylene, PMMA
Spinal Systems polyethylene
Tibia Insert polyethylene
Pacemakers polyimide, PTFE, FEP, ETFE, silicone, nylon
Patellar Buttons polyethylene
Penile Implant silicone
Pledgets PTFE
Ports:
Infuswn silicone, polyethylene, polyurethane
Injection acetal
Osteoport silicone
Vascular access silicone, polyacetal, polypropylene, polysulfone
16
Biomaterials Embargo: Potentially Affected Permanent Implants — Continued
[More than or tqual to 30 days]
Product Bjoaiattrial (G«Mric Polyi«*r)
Other silicone, polyurethane, PVDF
Prosthetic Heart Valves polyurethane, polyester, silicone, polysulfone, polyacetal, PTFE
Sheeting (Scar tissue prevention lininj) silicone, PTFE
Shunts:
CNS silicone, polypropylene
Dialysis PTTE, silicone
Hydrocephalus silicone, polypropylene
Peritoneal silicone, PTFE. polypropylene
Other silicone, polyester
Stimulators:
Bone Growth Implant silicone
Functional Electrical silicone elastomers, polyester, epoxy, PTFE
Neuro (& Accessories) PTFE, polyacetal, silicone, polyurethane, hysol epoxy, parylene
C
Sutures polybutester, polyester. PTFE. nylon, polypropylene, silicone
Tutws:
Myringotomy silicone, PTFE, polyethylene
Otological Ventilation silicone
Vent silicone
Umtxlical Tape polyester
Valved Conduits polyester, PTFE
Vascular Access Device silicone elastomer, polyester mesh, polysulfone, acetals
Vascular Stents polyester
Liitiiif wdadM dcvicM that ara ioipacted, will be impadad, mIiM or niiM Ml U inpaciad.
PMMA potywatliytiiiethaciylata
FEP — tluorwatad «lhy<m< propyletw
ETFE — athylaaa-talrafluroelliylene copolymar
ABS — acrilonllrila butadieM styreae
sABS— stabHoad ABS
PVDF — potyviiylldena fluoride
PCB — piolyckloriaatad biphenyl
■ — polyacetal/acetal
PTFE— -polytttraflvoraathyieRe
PET— potyatMMe terephthalate(poVa(ter)
PFTG — PET with (lycol additwe
> CoitaiMd ia device: *«t directly exposed to skia.
Mr. Shays. Mr. Fox or Mr. Tate, do you have a statement? Mr.
Fox.
Mr. Fox. Mr. Chairman, thank you. And I thank vou and Mr.
Mcintosh for your efforts today and in organizing toaay's hearing
on the Food and Drug Administration's regulation of medical de-
vices, including the status of breast implants.
We all know that the Food, Drug and Cosmetic Act authorized
the FDA to regulate the safety and effectiveness of medical devices
before, during, and after marketing. The FDA is therefore respon-
sible for evaluating the safety and the effectiveness of medical de-
vices prior to marketing and sale.
Americans want safe medical devices, they want a strong FDA
that will keep unsafe products off the market, but I believe they
want to see more emphasis on the value of giving patients a choice
and access to accept risks for the treatments they so desperately
need.
By illustration, let me speak of the 20 million diabetics in the
United States many of whom need to take insulin injections to sur-
vive. In effect, diabetics are supposed to measure their blood sugar
levels several times a day to determine the amount of insulin they
need at a given time. Currently, Mr. Chairman, the only approved
method is to stick the finger and apply blood to a test strip several
times a day. Because the pain associated with the frequency of this
17
procedure, many diabetics refuse to test themselves, thus leading
to medical problems which include diminished eye sight, organ de-
generation, and wounds which often lead to amputations.
The knowledge exists now, Mr. Chairman, which would allow
diabetics to test themselves without experiencing the pain associ-
ated with the needle-stick method. Research in this noninvasive
medical device has been going on since 1986, and there are 20 dif-
ferent companies trying to get devices on the market. However, no
one has been successful because the FDA continues to require addi-
tional testing. Meanwhile, people continue to live in pain without
being given the choice to take advantage of a necessary product.
Through my illustration this morning we explore the case of sili-
cone breast implants which will allow us to study the questions as-
sociated with risk assessment and the government's role in permit-
ting or denying patients' access to medical devices.
We have impressive panels of witnesses, Mr. Chairman, before
us today. The issue of today's hearing will invoke a strong degree
of emotion; however, we look forward to hearing from each witness
as we seek a balanced discussion on such an important health care
issue.
Thank you.
Mr. Shays. I thank the gentleman. Mr. Tate.
Mr. Tate. Thank you, Mr. Chairman. I'd like to thank the chair-
man as well as the chairman of the other subcommittee, Mr.
Mcintosh, for their interest in this issue. I'll keep my remarks
brief, because I think it's more important that we hear from the
witnesses today than myself.
I'm here to find out the answers. Women deserve the right to
know the effects, the benefits, the costs of these sort of procedures,
and that's the hope that I have from these committees, is just to
find the answers. I'm here to learn, to listen and to find out, and
that's the hope of the people of my district and the hope of the peo-
ple of this country.
And I look forward to getting started with the debate.
Mr. Shays. I thank the gentleman and, again, I want to thank
the witnesses. To be helpful to panel 3, it's my judgment we will
probably not come to you until somewhere between 12:30 and 1:30.
So I would just say to panel 3, if you need to do something else
in the meantime, you have our permission certainly.
At this time I will swear in our witnesses and thank Marilyn
Lloyd, a former Member of Congress, and James Traficant and
Greg Granske, Dr. Greg Ganske. All three of you, we swear in all
our other witnesses, so we feel it's appropriate to swear in Mem-
bers and former Members as well.
[Witnesses sworn.]
Mr. Shays. For the record our witnesses have answered in the
affirmative. All three of you have very important statements to
make and this isn't going to be pro forma where we get you in and
out. You're free to make your statements and make your points,
and we welcome all three of you here today. Thank you for coming.
We're going to go in the order that you're seated and we'll start
with you, Congresswoman Lloyd and it s nice to have you back.
[The prepared statement of Hon. Gene Green follows:]
18
Prepared Statement of Hon. Gene Green, a Representative in Congress
From the State of Texas
Mr. Chairman, I would first of all like to express my appreciation to you for hold-
ing these hearings on such an important subject. It is of vital importance that we
provide ourselves and the American people with the necessary information on the
approval of all medical devices especially silicone-gel breast implants. Thousands of
women have experienced a variety of medical problems as a result of these implants
and we owe it to them as our wives, mothers, sisters and daughters to assure these
problems will cease to be overlooked. Every person in this country should feel a cer-
tainty and confidence in their doctor and tneir judgement. This hearing will help
to bring this assurance to our constituents. With the testimonies of our panels today
we can hopefully bring to light where improvements can be made in our approval
process of medical devices and in effect reauce, and hopefully eliminate, future med-
ical problems caused by any device or implant.
STATEMENT OF HON. MARILYN LLOYD, A FORMER REP-
RESENTATIVE IN CONGRESS FROM THE STATE OF TEN-
NESSEE; HON. JAMES A. TRAFICANT, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OHIO; HON. GREG GANSKE,
A REPRESENTATIVE IN CONGRESS FROM THE STATE OF
IOWA
Ms. Lloyd. Thank you. Thank you very much, Chairman Shays,
Chairman Mcintosh, Chairman dinger, Mr. Towns, Mr. Peterson,
Connie Morella, all my good friends. It's good to be here, and be-
lieve me, it's good to sit on this side of the table.
I speak to you today as a former Member of this House, as a
former chair with oversight responsibilities and jurisdiction of the
FDA, and I come to you as a woman, a 4-year survivor of breast
cancer and after 2-years the recipient of a gel implant.
I don't suppose there is anyone here with a greater personal or
professional interest in this hearing than I have, so thank you so
very much for inviting me today.
I suppose my personal story began in June 11, 1991, when I par-
ticipated with other women in front of the Capitol on the Breast
Cancer 2000 Rally. The purpose of the rally was to educate more
women about this deadly epidemic, to bring it to our Nation's con-
science, to educate more women on the reality of disease, and at
the same time to create a greater awareness of the need for more
funding to find a cure for breast cancer.
But in all reality, Mr. Chairman, that rally saved my life, be-
cause I was determined that week, when I went back home to Ten-
nessee, to have a mammogram, which I did on the following Fri-
day. This mammogram revealed a very suspicious lump. The fol-
lowing morning, Saturday, I had surgery for a biopsy, and I in-
formed my surgeon that if he found a malignancy, not to awaken
me but to go ahead and do a mastectomy.
When I awakened the malignancy was gone and so was one
breast. This shock was beyond description, out I was resolved to
get on with my life. My plans were to have chemotherapy and radi-
ation followed by my reconstruction. And in surgery through
chemo, I only missed 2 weeks away from Washington. I worked
very hard for recovery.
But I was looking forward to the day that I wouldn't have to get
up in the morning and look at my disfigured body and I would not
have to wear an uncomfortable prosthesis. Silicone gel implants
19
were my choice. To me and for other women, they might mark the
final stage of recovery from breast cancer.
Cancer was not my choice. Implants were. But before my sched-
uled reconstruction surgery, the FDA under Dr. David Kessler's di-
rection restricted my access to a product that my personal physi-
cian and I agreed was right for my full recovery. And the tragic
part of this story is the FDA acted without adequate data to war-
rant this very unnecessary decision.
The decision was based on fantasy and not science. There is no
scientific evidence to support the decision to withdraw silicone im-
plants. This is a quote from Dr. John E. Woods, vice chair of the
Department of Surgery at Mayo Clinic, "So instead of protecting
the health and concerns of women, this moratorium caused undue
stress and anxiety for women with implants and women who want-
ed them around tne world."
But the point I want to make to you all this morning is that real
women, mothers, daughters and wives died because of this tragic
decision and the FDA knows this. Since my surgery, I have tried
to help women who have been diagnosed with the disease and I try
to speak out on awareness. And I know it is a fact that there is
a fear among women to have an exam when they know that they
might find a problem.
And because of the work that I've done and other women who are
survivors, many women say that they have found the courage to go
ahead and to act responsible. And I can tell you that without the
prospect of reconstruction and the thought of facing life disfigured
and wearing an uncomfortable prothesis such as this for the rest
of their lives, many women are going to put off a check-up imtil
it is too late.
Remember, time is all we have. We don't have a cure.
I'd like to look at some numbers. Last year there were 182,000
new cases of breast cancer in women. Two years ago it was
170,000. But if 1 in 100 victims finds the prospect of going through
life disfigured too dismal to bear, and they wait an extra 6 months
before they see a physician, that's 1,820 women that will go unde-
tected. If it's 1 in 1,000, that's 182 women that will die needlessly.
We don't know the exact numbers, but the numbers are there
and we know that they're real, and we know that a lot more
women died because of this mandate than could ever be killed by
silicone.
Dr. Kessler, in defending his imdefensible decision, repeatedly
said that his first obligation as a physician was to do no harm.
Well, Dr. Kessler has done harm, considerable harm to thousands
of women around this world.
I try to make it my business both professionally and personally
to be as infor..ied as possible and not to have a biased attitude. Mr.
Chairman, these are the facts as I see them today. The moratorium
did more harm than an implant. There was not then, nor is there
now any scientific evidence that implants are imsafe for women.
The decision was based on unsubstantiated claims and not good
science.
Two, women who had implants were terrified, and even though
the FDA said they didn't need to, they had them removed unneces-
20
sarily. Three, other women sadly did not have a breast exam in
time because of fear and many of them died as a result.
The United States lost it's biomedical silicone industries. Bio-
medical research which depends upon silicone has declined. Four,
health costs have increased, and six, lawsuits have been filed by
the thousands.
Well, this is history and we can't change the past, so you say,
well, why are you here this morning. Well, I'm here this morning
because I care. I care about the women and families who must
make the tough decisions that I had to make. They should have the
most advanced care and treatment that we as a Nation can provide
for them. And the choices should be theirs alone, with the very best
scientific information available and not the opinion of junk sci-
entists.
And I care about our research community. We should do all we
can as a Nation to foster the finest research facilities and medi-
cines that can be produced. We should encourage our good doctors
and scientists and not continue to put these unnecessary controls
and restrictions on their efforts to develop new products and medi-
cines.
So I hope that by being here today that I have done a very small
part in helping to rein in a misguided and inept FDA, who, in my
opinion, is more interested in promoting itself as a regulatory agen-
cy than listening to the respected medical community and protect-
ingthe lives of women.
Thank you, Mr. Chairman.
[The prepared statement of Ms. Lloyd follows:]
Prepared Statement of Hon. Marilyn Lloyd, a Former Representative in
Congress From the State of Tennessee
I speak to you today as a former member of this House, a former chair of a sub-
committee with jurisdiction and oversight responsibilities for the FDA, and I come
to you as a woman who is now a four-year survivor of breast cancer and, after two
years, a recipient of a silicone breast implant. I doubt anyone here has a greater
personal and professional interest in this hearing. I deeply appreciate the invitation
to testify this morning.
I suppose my personal stoiy began June 11, 1991 when I participated in a Breast
Cancer 2000 rally in front of the Capitol. I was there that day with other women
Members of Congress and women from every state in the Union as a means to bring
the breast cancer epidemic to our nation's conscience — to educate more women on
the reality of the disease and to create a greater awareness of the need to provide
more funding for research for a cure. Perhaps this rally saved my life. I decided to
schedule a manomogram for myself for the following Friday in Tennessee. The mam-
mogram revealed a suspicious lump. The next morning, Saturday, I had surgery for
a biopsy. I instructed my surgeon not to awaken me if he found a malignancy, but
to do a mastectomy. When I awakened, the malignancy has been removed and so
was one breast. The shock was beyond description. But I resolved to get on with
my life. My plans were to have chemotherapy and radiation followed by reconstruc-
tion. From surgery through chemo I missed only two weeks awav from Washington
and worked hard for recovery. I looked forward to the day I would not have to Took
at my disfigured body each morning and would not have to wear an uncomfortable
prostnesis. Silicone gel implants were my choice — to me, they marked the final stage
of my recovery from cancer. Cancer was not my choice, but implants were.
But before my scheduled reconstruction surgery, the FDA, under Dr. David
Kessler's direction, restricted my access to a product that my personal physician and
I agreed was right for me for a full recovery. The tragic point of this story is that
the FDA acted without adequate data to warrant this unnecessary and senseless de-
cision. The decision was based on fantasy — not science. There was not scientific data
supporting the decision to withdraw silicone implants. This is a quote from Dr. John
E. Woods, Vice Chair, Department of Surgery, Mayo Clinic.
21
So instead of protecting the health and concerns of women, this moratorium
caused undue stress and anxiety for women with implants and woman who wanted
them around the world. But the point I want to make this morning is that real
women (mothers, wives, and daughters) died because of this tragic decision, and the
FDA knows this. Since my surgery, I've tried to help women who are diagnosed with
the disease and speak out on awareness. There is a fear among many women to
have an exam ana to find a problem. Because of my work, many woman said they
found the courage to be responsible. I can tell you that without the possibility of
reconstruction, and the thought of facing life disfigured, many women will put off
their check-up until it is too late.
Let's look at some numbers. In 1995 there were 182,000 new cases of breast can-
cer in women. If one in 100 victims finds the prospect of going through life dis-
figured too dismal to bear and waits an extra six months betore seeing a physician,
that's 1,820 women who go undetected. If it's one in 1,000, that's 182 women who
die needlessly. We don't know the exact numbers but the numbers are there and
we know that a lot more women died because of the mandate thein could ever be
killed by silicone.
Dr. Kessler, in defending his indefensible decision, repeatedly stated that his first
obligation as a physician was to do no harm. Dr. Kessler has done harm — consider-
able harm to the well being of hundreds of thousand of women around the world.
I made it my business both professionally and personally to be as informed as pos-
sible and not have a biased attitude. Here are the facts as I see them today.
1. The moratorium did more harm than an implant. There was not then, nor is
there now any scientific evidence that implants are unsafe for women. The decision
was based on unsubstantiated claims and not good science.
2. Women who had implants were terrified and even thou^ the FDA said they
didnt need to— had them removed unnecessarily.
3. Other women, sadly, did not have a breast exam because of fear, and many
died as a result.
4. The U.S. lost biomedical silicone industries. Biomedical research which depends
upon silicone has declined
5. Health costs increased.
6. Lawsuits have been filed by the thousands.
This is history — it has happened and we can't change the past. So you ask, why
am I here today at this hearing? I'm here because I care about women and their
families who must continue to make the tough decision I made. They should have
the most advanced treatment and care we can provide. These choices should be
theirs alone with the best scientific information available — not the opinion of junk
scientists.
I care about our research community. We should do all we can as a nation to fos-
ter the finest research facilities and medicines that can be produced. We should en-
courage our good doctors and scientists and not continue to put unnecessary controls
and restrictions on their efforts to develop new products and medicines.
I hope that by being here today I have done a small part in reining in a misguided
and inept FDA who, in my opinion, was more interested in promoting itseu as a
regulatory agency than listening to the respected medical community and protecting
the lives of women.
Mr. Shays. I thank you, Congresswoman Lloyd. And I now I call
on our very articulate and distinguished Member from Ohio, Mr.
Traficant. You have the floor, Mr. Traficant.
Mr. Traficant. Thank you, chairman. Thank you for holding
these hearings, I'm glad to be here with former Member Marilyn
Llovd and Dr. Ganske.
Im not a scientist, I'm still trying to figure out the tax code. I
have 260 women in my congressional district that have had prob-
lems health related, that all have one thing in common, they had
a silicone breast implant.
Frankly, I'm not trying to chase away American jobs, nor do I
want to export the silicone industry, and I can't accept that many
of the devices that are in fact in use are not only useful but in most
cases as you had stated, their benefits probably outweigh the risks.
But in looking at this issue it takes me back to another concern,
and if the Congress of the United States would have allowed to-
22
bacco companies to make a decision whether or not they would put
warning labels on the side of those packs of cigarettes, I do not be-
lieve we would have warning labels on those packages.
And Congress has a responsibility, a responsibility to at least in-
form the American citizens, the taxpayers, of possible risks associ-
ated with important medical procedures. I am not a doctor, but I
do know this, there is much more document and evidence available
than what we the consuming public have been lead to believe and
what the FDA and this Congress in fact has received.
In fact, as clear back as the 1950's, Dow Chemical and Dow Cor-
ning knew of such medical studies that indicated there was a po-
tential threat to human health. I'd like to submit for the record a
number of documents and studies, much of it never having been
submitted to the Congress.
And when we get to my testimony, in 1990, Mr. Rylee, a vice
president of Dow Coming, testified that there were in fact no prob-
lems with silicone breast implants and silicone gel. Yet, I have here
a document dated December 20, 1990, 2 days after his testimony,
submitted from the corporate medical director of Dow Coming,
Chuck Dillon, that said that in fact Mr. Rylee had sent down one
of his attorneys and asked that a scientist for the company,
Marianne Woodbury, destroy all copies of a memo she circulated 2
days previously.
This scientist felt that it would compromise the intejpp^ty of in
fact their company and her professional capacity and remsed to do
that. Now, much of the most recent claims of safety come from the
Harvard Nurses Study of 1994. What very few people realize, in
1993, there was a nurses study as well at Harvard. I don't know
if it was known as a Harvard Nurses Study, but I will just read
to you Table 6 of this study that never was made known to the
American people.
Table 6 indicates that women with breast implants did not ap-
pear to be at increased risk of developing breast cancer, significant
arthritis or arthritis other than rheumatoid arthritis. However,
these women might be at a 45 to 59 percent increased risk of devel-
oping rheumatoid arthritis.
You have 400,000 that are claiming a health-related problem.
You have one side saying it is overzealous attorneys trying to make
a buck. You have now another side saying that a company with
clear documentation withheld that documentation because of the
perceived, at least, risk from the documents that they held in their
possession.
Now, what were these studies? In 1955, V.K. Rowe, a Dow Chem-
ical scientist, indicated in an internal memo that Dow Corning sili-
ca is capable of causing diffuse cellular infiltration and fibrotic
changes in the lungs and other organs. That was relative to certain
types of animals studied at that time by Dr. Rowe.
In 1956, scientists for Dow Chemical and Dow Corning found
that silicone migrates to other parts of the body. In 1961, a Dow
Chemical study reported liver, kidney and lung abnormalities in
rats exposed to silicone. A 1975 study by Dow Corning found that
a particular type of silicone gel called D-4 is highly toxic to the
human immune system. This study was only revealed to the public
in 1994, and through a court order.
23
According to recent court documents, between 1950 and 1960,
Dow Chemical conducted hundreds of tests on Dow Corning sili-
cones which proved silicone could cause adverse health effects. In
a July 1994 article by Dr. Kossovsky, reviews a number of signifi-
cant medical studies which indicate a link between silicone breast
implants and autoimmune disease.
What bothers me, though, is this same subcommittee in 1990
held a hearing. Chairman Weiss from New York and Robert T.
Rylee, the vice president for health care businesses testified before
that subcommittee. And I'm going to quote some of his testimony.
"Dow Coming has not and would not keep important evidence of
a health risk from the FDA and surgeons who have the profes-
sional responsibility to discuss all risks with their patients. Our
ethics and our code of business conduct as employees of this cor-
poration would demand that we report evidence of a health risk
should one ever be discovered from our research." December 18,
1990.
December 20th there is an internal ethics inquiry from a sci-
entist who states she was asked to destroy copies of a memo that
lead to and in fact exchange certain information relative to haz-
ards. If someone is going to be swearing in imder oath here, you
better swear in Dow Coming people.
I don't want to lose another American job, but I have 260 women
in my district, 400,000 in the United States of America, and these
are not like many of these devices. These are in the hardened total
form, and I'm not a scientist and I don't know what a difference
is between the different composition and the chemical make-up of
the silicone gel.
And I don't want one woman to be denied silicone gel if it is safe.
I do not want to damage one bit of research, but for Members of
Congress, one woman seated at the Congress, here at the table, 90
to 95 percent of all Federal research dollars go to mens' diseases.
That is a shame. The bill we passed last year at least opens up a
health research facility for women.
But let me say this to the Members of Congress, if 90 to 95 per-
cent of all Federal research dollars are going toward men, who is
in fact financing the women's research here? It's the private sector.
Am I saying Dow Corning lied? No, I'm not. But Hershey's choco-
late wouldn't be researching silicone breast implants, neither would
AT&T, neither would IBM. What is the vested interest?
I'm saying, look, the last statement that I'll make here is that
after Robert Rylee's testimony before this same subcommittee,
here's the report language, the report clearly notes, "That Dow Cor-
ning subsequently refused to provide all the documents," any docu-
ments. That, my friends, is a direct violation of Federal statutes in-
cluding 2 U.S.C. 192.
Now, I want to know — I'm not a scientist, but I would not be
overrun by all these jobs issues and job claims and not get to those
facts. I appreciate that and all my information is here. I ask that
it be included in the record.
[The prepared statement of Hon. James A. Traficant follows:]
24
Prepared Statement of Hon. James A. Traficant, Jr., a Representative in
Congress From the State of Orao
Chairman Shays, Chairman Mcintosh, and members of the committee, I am
pleased that you have given me the opportunity to speak at this hearing on the risk
assessment standards used by the FDA in evaluating medical devices, including sili-
cone breast implants.
The manner in which Congress and the FDA interact with companies that
produce medical devices is vitally important in ensuring public health and safety.
That's why I am here today.
For the past several months I have been reviewing a wealth of data concerning
Dow Chemical, Dow Coming and silicone breast implants. The more I look into this
issue, the more concerned I become.
The subcommittee will hear a lot of testimony this morning about how safe and
effective silicone breast implants are — how they have dramatically improved the
lives of thousands of women.
You will hear how important silicone is in the development of other life-saving
medical devices.
You will hear that there is no scientiiic evidence that silicone breast implants are
connected to immune diseases.
Yes, thousands of women have had extremely positive experiences with silicone
breast implants. But thousands more have become seriously ill.
Yes, there may be legitimate and important medical uses for silicone products.
But dont let this testimony cloud the real issues and get in the way of the facts.
There is clear evidence that, as far back as the 19508, Dow Chemical and Dow
Coming knew of medical studies which indicated that silicone ;>oses a threat to
human health.
Dow Chemical and Dow Coming withheld this information from the general pub-
lic, from the FDA and from the United States Congress.
At this time, Mr. Chairman, I would like to submit for the record a number of
documents which outline the findings of some of these studies.
Let's look at some of these studies:
• In 1955, V.K. Rowe, a Dow Chemical scientist, indicated in an internal memo
that Dow Coming silica is capable of causing "diffuse cellular infiltration and ii-
brotic changes in the lungs and other organs of certain types of animals." (This
memo was only recently made public through a court order.)
• In 1956, scientists for Dow Chemical and Dow Coming found that silicone mi-
grates to other parts of the body.
• A 1961, Dow Chemical study reported liver, kidney and lung abnormalities in
rats exposed to silicone.
• A 1975 study by Dow Coming found that a particular type of silicone gel called
"04," is highly toxic to the human immune system. This study was only revealed
to the public in 1994 through a court order.
• According to recent court documents, between 1950 and 1960, Dow Chemical
conducted hundreds of tests on Dow Coming silicones which proved silicone was not
inert and could cause adverse health effects.
• A July 1994 article by Dr. Nir Kossovsky reviews a number of significant medi-
cal studies which indicate a link between silicone breast implants and auto-immune
disease.
Let me talk a little about the impact these independent studies have had in re-
cent months.
In May of this year, Chairman Shays, you wrote to the FDA and indicated that
the French and British Governments have issued statements declaring that sci-
entific studies show no casual relationship between connective tissue disease and
silicone breast implants.
On May 17, 1995 the French Government withdrew silicone breast implants from
France and banned the importation, manufacture, sale or use of these medical de-
vices.
In announcing the ban, the French Minister of Health noted that silicone breast
implants expose women to the risk of rupture with spread of silicone and that sili-
cone can be associated with local and systemic complications.
It is interesting to note that the French Government banned silicone breast im-
plants just one week after Dow Coming claimed in ads placed in major U.S. news-
papers that silicone breast implants were safe because France permitted them.
Chairman Shays, I'd like to say a few things'about Dow Coming's testimony be-
fore your subcommittee in 1990.
25
On December 18, 1990, Robert T. Rylee, II, Dow Coming's vice president for
health care businesses testifled before your subcommittee. The chairman at the time
was the late Ted Weiss.
I would like to submit for the record a copy of Mr. Rylee's 1990 testimony and
excerpts from the subcommittee's report. Let me read part of Mr. Rylee's testimony:
"Dow Coming has not and would not keep important evidence of a health risk
from FDA and surgeons who have the professional responsibility to discuss all
risk with their patients . . . our ethics, and our code of business conduct as
employees of this corporation, would demand that we report evidence of a
health risk, should one ever be discovered from our research."
On page 202 of the committee report on the hearing, it is noted that Chairman
Weiss specifically asked Mr. Rylee to provide to the subcommittee certain docu-
ments regarding Dow Coming's research on silicone breast implants.
The report clearly notes that "Dow Coming subsequently refused to provide the
documents." This is a direct violation of Federal statutes, including 2 U.S.C. 192.
rd like to touch on the Harvard nurses study, which was published last June in
the New England Journal of Medicine.
Dow Coming would have the public believe that this study conclusively shows
that silicone breast implants are safe. A few facts about the study:
• The study's authors excluded from their study aU women who developed diseases
after May of 1990, thereby excluding many women who developed symptoms years
aft«r receiving implants.
• There are women included in the study who had implants in place for as little
as one month. (Many other studies report that symptoms of auto-immune disease
do not manifest themselves until 8 to 15 years after implantation.)
• The study did not look for the atypical diseases reported by thousands of women
across the country who have received breast implants.
• The study group was so small that it would not have found an association be-
tween cigarette smoking and cancer!
• Three of the stud/s authors. Dr. Jorge Sanchez-Guerrero, Dr. Graham Colditz
and Dr. Matthew Liang, were either personally receiving monies from breast im-
plant manufacturers or had agreed to act as a paid consultant for a breast implant
manufacturer while they were conducting the study — ^yet they failed to disclose this
conilict of interest at the time.
• Dr. Liang later resigned from another study due to this conflict of interest.
• While Dow Coming had no direct involvement in the study, it was provided with
a copy of the questionnaire before it was sent to the study's participants.
• Dow Coming contributed $7 million to Brigham & Women's Hospital, the insti-
tution conducting the study, while the study was in progress.
• Even the study's authors admit the study does not prove that silicone breast im-
plants are safe.
K the FDA and Congress are to effectively review and assess the safety of medical
devices, they need to have all the facts.
The main manufacturer of silicone breast implants — Dow Coming and its parent
company Dow Chemical — withheld key information and medical studies which indi-
cated that their medical devices pose a threat to human health.
Up until the time the French Government banned silicone breast implants on May
17, 1995, Dow Coming continually pointed to the French Government's approval of
silicone breast implants as proof that their product was safe.
Can't the reverse now be true? At the very least, the French Government's action
should be taken very seriously by Congress.
I ui^e the committee to examine the facts I have presented. I would also respect-
fuUy urge the committee to conduct a full and separate inquiry into this matter.
With that I conclude my statement, and woula be happy to answer any questions
you mi^t have.
ATTACHMENTS
ATTACHMENT 1: V.K. Rowe intemal Dow Coming memo marked "Not For Out-
aide Distribution" concerning the harmful effects of silica when inhaled (1955).
ATTACHMENT 2: "The Physiological Assimilation of Dow Coming 200 Fluid"
which found silicone throughout the bodies of dogs and rats (1956).
ATTACHMENT 3: "The Toxicity To Rats of Vapor Resulting From Heating of Sili-
con Containing Fluids" which reported liver, kidney, and lung abnormalities in rats
exposed to silicone (1961).
26
ATTACHMENT 4: "Action of Polydimeth^lsiloxanes on the Reticuloendothelial
System of Mice" indicated D4 silicone gel is highly toxic to the immune system
(1975).
ATTACHMENT 5: "Silicone Breast Implant Pathology" by Dr. Nir Kossovsky re-
views significant medical studies indicating link between silicone breast implants
and auto-inmiune diseases (1994).
ATTACHMENT 6: Excerpt from The New York Times regarding the French gov-
ernment's decision to withoraw silicone breast implants from the maricet (June 21,
1995).
ATTACHMENT 7: Excerpts from Robert T. Rylee's testimony before the House of
Representatives Human Resources and Intergovernmental Relations Subcommittee
(December 18, 1990).
ATTACHMENT 8: Memo to Dow Comings Ethics Committee regarding an em-
ployee's refusal to shred memos containing mformation regarding problems silicone
Dreast implants (1990).
ATTACHMENT 9: Questions and answers regarding the 1995 Harvard Nurses'
Study and the 1993 Mayo Clinic Study.
ATTACHMENT 10: Unpublished Preliminary Interim Report from the Harvard
Women's Health Study showing an increased risk of rheumatoid arthritis in women
with breast implants Q993)
ATTACHMENT 11: "The Physiological Activity of Dow Coming 200 Fluid" found
silicone in the organs of ir^ected rabbits (1957).
ATTACHMENT 12: "Report Prepared for the Dow Coming Corporation, Midland,
Michigan on Six Silicone Materials" which indicated deleterious effects in the livers
of injected rats (1957).
ATTACHMENT 13: Report on the "Histopathologic Examination of Livers, Dow
Coming Z-4141". Indicated silicone globules may be present in the livers of iiyected
rats (1957).
ATTACHMENT 14: Excerpts from "Dow Coming News" indicating Dow Coming's
concern over the toxicity of lJ4 (October 1963).
ATTAC]!HMENT 15: Memo from H.C. Spencer regarding Dow Coming hydrophobic
silica and toxicity from dust inhalation, and corresponding tests (1954).
ATTACHMEOT 16: Compilation of published scientific articles on silicone and sil-
icone implants.
[Note: The 16 attachments referenced above have been retained
in the Subcommittee on Human Resources and Intergovernmental
Relations files.]
Mr. Shays. I thank the gentleman and it will be part of the
record. Dr. Ganske, Congfressman Ganske, we have a visit from a
Senator who wants to introduce some constituents. Do you mind if
he does? I'm not used to Senators having time like this.
Mr. Kyl. No. No.
Mr. Shays. Mr. Ganske, it's wonderful to have you as a Member
of Congress. You're a wonderful addition to Congress and I wel-
come your statement.
Dr. Ganske. Thank you, Mr. Chairman.
I must admit that I debated with myself whether to appear be-
fore you today. As you may know, prior to the November election,
I was a practicing plastic and reconstructive surgeon, and I won-
dered whether I was too close to this issue.
However, I believe that it is important for Congress to take ad-
vantage of the experiences and diverse backgrounds of its Mem-
bers. I have 130 boxes of patient charts in my basement. My prac-
tice is closed. I have never been involved in implant litigation, or
any lawsuits for that matter, but for some personal reasons which
I will tell you about, I am very interested in the problem of avail-
ability of tnese medical devices.
In 10 years of private medical practice, I cared for many pa-
tients, both cosmetic and reconstructive, with silicone gel and sili-
cone saline breast implants. Part of the pre-op consent always in-
cluded discussions of possible complications of both the surgery,
27
such as infection or bleeding, and the implant, such as hardening
of the implant which is actually tightness of scar tissue around the
implant.
I have always been concerned about my patients' safety and I
know my colleagues are, too. And I've read most of the scientific
literature on this issue. Let me summarize what I think the sci-
entific literature shows to date. And I have a number of points in —
the paper that you received. I'm only going to talk about two — ^be-
cause of the time constraint.
First, I believe that there is strong evidence that implants do not
cause cancer, and I would like to submit this study from the New
England Journal of Medicine of 11,676 women in Canada who un-
derwent cosmetic breast augmentation. That study found that im-
plants do not increase the risk of cancer.
Second, there is no concrete evidence that silicone implants cause
any form of autoimmune disease or rheumatologic disorder. Mr.
Traficant has been very eloquent, but you're going to hear testi-
mony^ today from some of the real experts on this issue, allergists
and immunologists, and I would ask that you listen to them very
carefully. There are now 17 such studies from three different coun-
tries that find no relationship.
And I would like to submit for the record a June 22, 1995, article
from the New England Journal of Medicine which reported that in
a large, 87,000 women, cohort study there was no, let me repeat,
no association between silicone implants and connective tissue dis-
eases.
Mr. Chairman, this is about much more than breast implants.
Silicone has hundreds of uses, both inside and outside the body.
The administration of drugs and perineal fluids as well as
hemodialysis and cardiac bypass technology depend on liquid sili-
cone. Droplets of silicone coat plastic syringes and over time dia-
betics accumulate substantial amounts of silicone. An infant get-
ting one dropper full of pediatric mylacon approved by the FDA, I
might point out, has iust ingested more silicone than it could ever
get from mother's milk.
Now, we are talking about whether there will be available other
medical devices to treat other diseases. Mr. Chairman, I am also
submitting a partial list of medical products that depend on the
supply of raw materials.
Now, I would like to briefly tell you about three people who have
needed silicone products. These photos show you a young man who
had a severe head injury in an automobile accident prior to and
after bone-grafl reconstructed his skull.
He is functional, but has a paralyzed right arm. And the story
of his rehabilitation is heroic, but my point in showing this is that
he needed a silicone silastic cerebral spinal fluid shunt, just like
this, to protect his remaining brain. Thanks to this medical device
and good medical care from a number of people who took care of
him in the emergency room, Tim is doing just nne today.
I wish I could say the same thing about my wife's sister. In the
early 1950's, Cathy was born with spinabifida and developed hydro-
cephalus. She did not have the benefit of this CFS shunt, and she
developed severe hydrocephalus with a head like a pumpkin and
she passed away when she was 4.
20-998 O - 96 - 2
28
I am pleased you will have testimony today from live, happy chil-
dren who can benefit from silicone silastic products like this.
And when my mother was 21 years old, she developed breast
cancer and she had a radical mastectomy tnat saved her life. But
when I was a kid, I remember mom's external prosthesis as she
called it, her falsie, slipping in her swimming suit at the beach.
Only years later did I learn how that constant deformity, as Mrs.
Llovd has pointed out, can always remind a woman of her cancer
and the fear that that causes her and her spouse.
Nine years ago my mother had a breast reconstruction with a sil-
icone gel prosthesis, and I'm happy to report she is very happy
with it. And if I ever thought that this implant was causing her
problems, I'd recommend its removal in a second.
Now, I know that my friend Jim Traficant here, somebody I have
grown to really enjoy and like in my brief stay here in Congress,
has a heart as big as this room, and my heart too goes out to those
small percentage of women who have had implants and have had
problems. But we can't legislate on compassion alone. We must be
right or else in being compassionate to some, we will end up being
mean to others.
Thank you.
[The prepared statement of Hon. Greg Ganske follows:]
Prepared Statement of Hon. Greg Ganske, a Representative in Congress
From the State of Iowa
Thank you, Mr. Chairman, for the opportunity to testify today. I must admit that
I debated with myself whether to appear before you today. As you may know, prior
to the November election, I was a practicing plastic and reconstructive surgeon and
I wondered whether I was too close to this issue. However, I believe that it is impor-
tant that Congress does take advantage of the diverse backgrounds of its members.
I have 130 boxes of charts in my basement and my practice is closed. I have never
been involved in implant litigation, or any lawsuits for that matter. For personal
reasons which I will explain, I am very interested in the problem of availability of
medical devices.
In ten years of private medical practice I cared for many patients, both cosmetic
and reconstructive, with silicone-gel and silicone-saline breast implants. Part of pre-
operative consent always included discussions of possible complications of both the
sui^ery such as infection or bleeding, and the implant such as "hardening" implant
which is actually tightness of scar tissue around the implant. Fve always been con-
cerned about my patient's safety and have read most oi the scientific literature on
this issue.
Let me summarize what I think the scientific literature shows to date:
• There is strong evidence that implants do NOT cause cancer. I would like to sub-
mit this study from The New England Journal of Medicine of 11,676 women in Can-
ada who underwent cosmetic breast augmentation which found that implants do not
increase the risk of cancer.
• There is also theoretic concern that breast implants can delay cancer detection.
Several recent studies have shown that this appears to be only a theoretic risk since
the stage of detection of breast cancer in women with implants appears to be iden-
tical or better than that of the overall population.
• There is NO concrete evidence that silicone implants cause any form of auto-im-
mune disease or rheumatologic disorder. There are now seventeen such studies from
three different countries that find no relationship. I would like to submit for the
record a June 22, 1995 article from The New England Journal of Medicine which
reported that in a large (87,501 women) cohort study, there was NO association be-
tween silicone breast implants and connective tissue diseases.
• The evidence that surgical removal will reverse any systemic disorder allegedly
caused by these devices is ambiguous and mostly unconvincing.
• There are no lab tests that can determine silicone spread, immunogenicity or
toxicity.
• There are no laboratory tests that are useful in determining an association be-
tween implants and any known disease.
29
• There is no evidence that silicone is a teratogen.
• 'Riere is no evidence that silicone is found in breast milk.
• The silicone gel of an implant does not spread diffusely throughout the body in
any detectable amount even if the implant is oroken.
Mr. Chairman, this is about much more than breast implants. Silicone has hun-
dreds of uses both inside and outside the body. The administration of drugs and par-
enteral fluids, as well as hemodialysis and cardiac-bypass technology, depend on liq-
uid sUicone. Droplets of silicone coat plastic sjrringes, and, over time, diabetics accu-
mulate substantial exposure to silicone. An infant getting a dropper full of pediatric
Mylicon to treat infant gas with FDA approval has just mgested more silicone than
it could ever get from mother's milk.
We are talking about whether there will be available other medical devices to
treat other diseases. Mr. Chairman, I am also submitting a partial list of silicone
medical products that depend on a supply of raw materials.
I want to tell you about three people who have needed silicone products. The
photos show you a young man who had a severe head injury in an auto accident
f)rior to, and after, I bonegraft reconstructed his skull. He is functional with a para-
yzed right arm and the story of his rehabilitation is heroic.
But my point of showing this is that he needed a silicone silastic cerebral spinal
fluid (CSF) shunt like this to protect his remaining brain. Thanks to that medical
device and good medical care, Tim is doing iust fine.
I wish I could say the same about my wife's sister. In the early 1950's, Kathy was
bom with a spina bifida and developed hydrocephalus. Without this CSF shunt that
was available to Tim, she developed severe hydrocephalus and a head like a
pumpkin . . . and passed away when she was 4. I am pleased that you will have
testimony before you today from live and happy children with CSF shunts.
And when my mother was 21 years old she developed breast cancer and had a
radical mastectomy that saved her life. But when I was a kid I remember Mom's
external breast prosthesis (she called it her "falsie") slipping in her swimming suit
at the beach. Only years later did I learn how that constant deformity can always
remind a woman of her cancer and the fear that causes for her and ner husband.
Nine years ago, my mother had a breast reconstruction with a silicone-gel prosthesis
and is very happy with it. And if I ever thought that it might cause her any prob-
lems, I'd recommend its removal in a second.
I know that my friend Jim Traflicant has a heart as big as this room, and my
heart, too, goes out to those women who have had problems with their implants.
But we cant legislate on compassion alone, we must oe right ... or else in being
compeissionate to some, we will be mean to others.
30
The New England
Journal of Medicine
©Copynghl. 1992. by the Massachusetts Medical Society
Volume 326
JUNE 18, 1992
Number 25
BREAST AUGMENTATION: A RISK FACTOR FOR BREAST CANCER?
Hans Berkel, M.D,, Ph.D., Dale C. Birdsell, M.D., and Heather Jenkins
Abstract Background. A relation between breast aug-
mentation and the subsequent risk of breast cancer has
, been postulated. Since an estimated 2 million women in
'^ the United States alone have received breast implants,
even a small increase in the risk of breast cancer could
have considerable public health consequences.
Methods. We performed a population-based noncon-
current cohort-linkage study. All women in Alberta, Can-
ada, who underwent cosmetic breast augmentation from
1973 through 1986 were included in the implant cohort
(n = 1 1 ,676). This cohort was compared with the cohort of
all women in Alberta in whom a first primary breast cancer
was diagnosed (n = 13,557). The expected number of
breast-cancer cases in the Implant cohort was estimated
by applying age-specific and calendar year-specific inci-
dence rates of breast cancer (obtained from the Alberta
Cancer Registry) to the implant cohort. Standardized inci-
dence ratios were calculated by dividing the observed by
the expected number of breast-cancer cases in the im-
plant cohort. *^
Results. Forty-one patients with implants were subse-
quently found to have breast cancer. The expected num-
ber was 86.2. The standardized incidence ratio was thus
47.6 percent, significantly lower than expected (P<0.01).
The average length of follow-up in the implant cohort was
10.2 years, and the average length of time from breast
augmentation to the diagnosis of breast cancer was 7.5
years.
Conclusions. Women who undergo breast augmenta-
tion with silicone implants have a lower nsk of breast can-
cer than the general population. This finding suggests that
these women are drawn from a population already at low
nsk and that the implants do not substantially increase the
risk. (N Engl J Med 1992;326;1649-53.)
PROSTHETIC breast augmentation and recon-
struction have been practiced for several decades
and have been considered to be safe and accepted
surgical procedures. Smooth-vifalled silicone implants
(filled with silicone gel or saline) have been the most
common type of prosthesis used. Scar encapsulation
of these implants frequently leads to compression and
undesirable firmness. To overcome these complica-
tions, implants covered with polyurethane sponge
were reintroduced in the 1980s in the United States
and Canada. Recently, however, concern has been
raised about the carcinogenic potential of the break-
down products of polyurethane. The breakdown
products (i.e., toluene 2,4-diisocyanate and toluene
2,6-diisocyanate diamines) were reportedly found in
the urine of a patient with polyurethane-sponge-
covered implants.' These substances are known to
cause sarcomas in rats.^'"" An expert panel of the
Canadian Medical Association concluded, howev-
er, that "surgical removal of polyurethane-foam-
covered breast implants solely for reasons of poten-
tial risk of cancer does not appear to be indicated."'
Despite this statement there has been considerable
From (he Division of Epidemiology and Prrvenlivc Oncology. Aliwna Cancer
Board. Edmonlon. Alta iH B.. HJ l. and the Division ot Plastic and Recon-
structive Surgery, Depanment of Surgery. Foottiills Hospital. University of Cal-
gary .Medical Sciiool. Calgary. Alta (D C B I Address reprint requests to Dr
Berkel at the Division of Epidemiology and Preventive Oncology. Albena Cancer
Board. 9707 1 10 St . 5th Fl . Edmonton. AB T5K 2L9. Canada
public concern about the potentially increased risk
of breast cancer after cosmetic breast augmenta-
tion."'" In the scientific literature few studies have
addressed the issue. To our knowledge only four stud-
ies have been reported to date, and three of these
consisted of surveys mailed to plastic surgeons.""'^
.Although no excess risk was found, the strength of the
evidence in this type of study is limited because of
the great potential for ascertainment and recall bias.
In one epidemiologic study, no increased risk was
found."
It is estimated that 2 million women in the United
States have received breast implants. Thus, from a
public health perspective it is important to determine
the extent of any increase in risk in these women, even
if it is only a small one. To evaluate the potential
difference in the risk of breast cancer among women
who have undergone breast augmentation, we decided
to perform a nonconcurrent cohort-linkage study.
Methods
Albena. Canada, has had a comprehensive, compulsory, govern-
ment-sponsored health care insurance prot^ram since 1966. Physi-
cians submit claims for payment of approved procedures to the
.Mberta Department of Health, vxhich keeps computerized records
of these claims. From 1969 through 1986 breast augmentation was
an apprtjved procedure for which surgeons could submit claims.
L'nfortunatelv, records for the \'ears before 1973 were not accessible
at the lime of our study. The .Mberta Department of Health pro-
vided us with data on all women who had undergone breast aug-
31
1650
THE NEW ENGLAND JOURNAL OF MEDICLNE
June 18, 1992
mentation from 1973 through 1986, All women who had received
implants as reconstructive surgery were then excluded from further
analvses. The remainmg women constitute the implant cohort. The
data obtained from the .Alberta Department of Health were checked
for validity and coding errors.
The Alberta Cancer Registry was initiated in the early 1940s and
became a comprehensive population-based registry in the early
1960s, Data on all patients with cancer in Alberta are entered in the
cancer-registn data base, which is maintained by the .Mberta Can-
cer Board's Division of Epidemiology and Preventive Oncolog\-
The completeness of the registry has been estimated to exceed 95
percent-'' Data on all patients with first prtmarv- breast cancers,
diagnosed from 1973 through 1990, were selected from this popula-
tion-based cancer registry. These patients constitute the breast-can-
cer cohort.
The study design is shown in Figure 1, In short, the two cohorts
(implant cohort and breast-cancer cohort) were linked to determine
which women had both breast cancer and implants. The linkage
was performed with each patient's full name (surname, maiden
name, and first initial), date of birth, and .Mberta Health Care
Insurance Plan number as matching variables, .Mlowance was
made for logical errors in data entry, such as spelling mistakes and
reversal of the order of month and day in the date of birth. For each
positive match the patient's clinical charts were reviewed The end
points for the studv were the diagnosis of breast cancer, death (from
anv cause), or the end of the study (January 1, 1991), whichever
was earliest. In order to calculate the number of person-years at risk
in the total cohort of women with cosmetic implants, we determined
the vital status of the women by linking the implant data base with
the .Mberta X'ital Statistics file. For women who died, the date and
cause of death were obtained.
Statistical Analysis
The observed number of cases (the number of patients who re-
ceived implants and subsequently were given a diagnosis of breast
cancer) was determined through the linkage of the two data bases.
The expected number of cases was calculated by applying age-
specific and calendar year-specific incidence rates for breast cancer
prevailing in the general population in .\lberta to the implant co-
hort. The incidence rales were obtained from the .Mberta Cancer
Registry"* and were calculated with the use of data only on women
with first primary malignant tumors of the breast. The standard-
ized incidence ratio was then determined with the formula (ob-
served cases/expected cases) x 100 percent, in which the observed
number of breast-cancer cases is expressed as a percentage of the
expected number." Thus, a value of more than 100 indicates an
incidence that is higher than expected. The significance of the
standardized incidence ratio was estimated with Hailar's method for
estimating significance factors for the ratio of a Poisson variable to
its expectation.'"
Results
The original implant cohort consisted of 14.545 pa-
tients, A total of 2869 were excluded from further
analysis for the reasons given in Table 1 , The majority
(60 percent) were excluded because they had dupli-
cate records. In these cases the first year (and the
records pertaining to that date) were retained in the
data base. These women were included in further
analyses. Also excluded from the implant cohort were
315 women who had received implants as part of re-
constructive surgery after mastectomy for breast can-
cer. After these exclusions, the implant cohort consist-
ed of 11,676 women. From the cancer registry data
base we selected all the patients with first primary-
breast cancers diagnosed from 1973 through 1990.
During these 18 years a total of 13,557 women in Al-
berta were given such a diagnosis. These women con-
stituted the breast-cancer cohort. The cancer registry
has a continuous quality-control monitoring program
in place; therefore, we are confident that the data on
breast-cancer cases from the registry are complete and
valid.
Table 2 shows the age distribution of the two co-
horts. As expected, the implant cohort was much
younger: 86.0 percent of the women in this cohort
were less than 40 years of age, whereas 91.6 per-
cent of the women in the breast-cancer cohort were
Exclusion of ineligible ' '
patients
Original data set of all
patients with implants
\
Clean data set
r
Implantation after
cancer diagnosis
(reconstructive surgery)
Alberta Cancer Registry
Linkage
Matches
All patients with 1 st primary
breast cancers
(breast-cancer cohort)
Implantation before
cancer diagnosis
Chart review
Observed cases
Figure 1 Design of the Study.
32
Vol 326 No. 25
BREAST AUGMENTATION AND BREAST CANCER— BERKEL ET AL.
1651
Table 1 , Reasons for Exclusion from the
Implant Cohort of 14,545 Patients.
Reason for Excilsion
No Of Patients
Male sex
218
Treated outside study pcnod
102
Exceeded aec limit
512
Duplicate record
1.722
ReconstTiJCiive surgery
315
Total
2.869
Total alter exclusions
1 1 .676
at least 40 years of age at the time of diagnosis.
The two cohorts were hnked. and a total of 47
matching women were identified in whom breast aug-
mentation preceded the diagnosis of breast cancer.
The hospital charts of these women were reviewed,
and in six of them no evidence of an implant proce-
dure was found. Neither the medical history of the
patient nor the mammograms revealed any evidence
of breast augmentation. These si.x women were ex-
cluded from further analyses. The 41 women con-
firmed to have had implant procedures before cancer
was diagnosed had bilateral augmentation. These 41
women constituted 0.4 percent of the original cohort
of 1 1,670 women with implants.
The total number of person-years at risk for the
women in the study was 124,494. The average follow-
up was 10.2 years (range, I to 18); 58.1 percent of the
cohort had at least 10 years of follow-up (Table 3).
Only 29 of the women in the implant cohort (0.2 per-
cent) were followed for less than five years.
A total of 86.2 cases of breast cancer were expected,
and only 41 were observed. The standardized inci-
dence ratio was thus 47.6 percent — significantly less
than expected (P<0.0l). The age-specific standard-
ized incidence ratios are shown in Table 4. In all age
groups the standardized incidence ratios were signifi-
cantly lower than expected; in fact, the ratios were
remarkably constant across the age groups.
A short interval between the date of implantation
and the date of diagnosis of the cancer could indi-
cate that a tumor was present subclinically at the time
of augmentation. We therefore detei- r.ed the length
of this interval for the 41 women; the average was
7.5 years. In 80 percent of the women (33 of 41),
the implant procedure was performed at least five
years before the diagnosis of the cancer. The in-
terval between implantation and the diagnosis of
breast cancer was at least 10 years in II cases (27
percent).
The mean age at implantation of the 41 women in
whom breast cancer later developed was 38.3 years
(range, 20 to 64); the mean age at diagnosis was 45.7
years (range, 30 to 68).
Discussion
Using the same design as in our study, Deapen et
al.'* reported a standardized incidence ratio of 57 in a
cohort of 31 1 1 women who were followed for an aver-
age of 6.2 years. The average length of follow-up in
our study was almost twice as long (10.2 years), and
more than half of our cohort were followed for at least
10 years. The question arises, however, whether even
this length of follow-up is adequate to allow a plausi-
ble lead time between exposure (implantation) and
outcome (the diagnosis of breast cancer). To evaluate
this problem, we excluded all women from the implant
cohort for whom fewer than 10 years of follow-up data
were available. This adjustment resulted in the exclu-
sion of 4892 women (Table 3). .Applying the same
methods as described earlier, we found that the ex-
pected number of cancer cases in the remaining 6778
women was 67.8. Eleven cases of breast cancer were
observed. The standardized incidence ratio in this
subcohort with a long follow-up was 16.2. Thus, in
women with long-term follow-up after implantation
(the average number of years of follow-up in this
group was 13.3 years; range, 10 to 18), no increased
risk of breast cancer was found.
The size of the cohort in our study was nearly four
times that of the study by Deapen and colleagues
(11,670 vs. 3111). In the latter the implant cohort
consisted of patients treated by 35 plastic surgeons in
Los Angeles; therefore, it was not a population-based
study — a factor that could give rise to ascertainment
bias. In our study all women who had breast augmen-
tation in Alberta from 1973 through 1986 were includ-
ed in the study and matched with patients from the
population-based cancer registry We believe that this
makes ascertainment bias an unlikely explanation of
our results.
Our study yielded a result similar to that of the
study by Deapen et al.'*: there was no increased risk of
breast cancer after breast augmentation. In addition
to these two cohort studies, the results of three surveys
among plastic surgeons, inquiring about the frequency
of cancers in women with implants, have been report-
ed."'^ Although the evidence in this type of study is
not strong, these studies also did not indicate an in-
Table 2. Age Distribution of the Women with
Breast Implants and the Women with Breast
Cancer.
Breast Cancer
ACE Group
Implant Cohort"
Cohort
V,
numhef
'•*!
20-24
1.997(17 II
12 (0 11
25-29
3.287 128 2)
114 (0,8)
30-34
3.048(26,11
351 (2.6)
35-39
1.711 (14.61
662 (4.9)
40-44
824 17.1)
1.079(8.0)
45-49
436(3.71
1.502(11.1)
50-54
232 (2.01
1.531 (11 3)
55-59
94 (0 8)
1.613(11 9)
60-64
41 (0.4)
1.580(11.6)
365
—
5.113(37 7)
Tolal
1 1 .670
13.557
'Six women in the impluni cuhon were exclu^icd because there
was na evidence ut bre;ui jugmemaiion
33
1552
THE NEW ENGLAND J(irRNAL OF MEDICINE
June 18. 1992
creased frequency of breasi cancer. Case reporls'"*"
do not allow an evaluation of the question of a differ-
ence in risk.
Could the result of our study be explained by (he
influence of biases? .As mentioned, ascertainment bias
is unlikely to explain the absence of an increased
risk. The very nature of the nonconcurrent cohort-
study design eliminates recall bias as a potential ex-
planation. From the data on radiation risk, it appears
that younger women are more sensitive to a radiation
effect than older women. The question thus arises
whether the age of women at implantation could be a
confounding factor in the determination of the sub-
sequent risk of breast cancer. By using age-specific
and calendar year-specific incidence rates in cal-
culating the expected number of cases of breast
cancer, however, we have controlled for a potential
age effect.
In the study by Deapen et al," a large number of
patients were lost to follow-up (approximately 14 per-
cent) because of the mobility of the California popula-
tion and the difficulty of gaining access to out-of-state
records. A study in .Alberta of women with cer\ical
cancer found that approximately 10 percent of the
cohort moved out of the province (Woodhead SE:
personal communication). Nevertheless, women who
were living in .\lberta but whose cancers were diag-
nosed or treated in another province would also
have been reported to the .Alberta Cancer Registry.
We believe that the loss to follow-up cannot explain
the low standardized incidence ratios found in our
study.
We found six false positive matches. In these cases,
the wrong fee code was probablv used or entered in the
-Alberta Department of Health data base. It is possible
that there were also false negative "matches," result-
ing in a lower observed number and therefore in an
artificially low standardized incidence ratio. However,
since we allowed for logical errors in data entry during
the linkage procedure, we do not believe that under-
matching is a plausible explanation of the low number
of breast cancers observed. To eliminate this possibil-
ity, we randomly selected a 1 percent sample of pa-
tients with breast cancer in the registrs' and reviewed
their charts to evaluate whether there was any evi-
dence of implantation. In all cases there was no indi-
cation of implantation either in the medical history or
Table 4 Age-Spedtic Standardized
Incidence Ratios.
Table 3. Characteristics of the Implant
Cohort.
Chabacteristic
No OF Women
•S OF T0T*L
Date of implant
1973- 1975
1318
130
1976-1979
3221
27.6
1980-1983
4085
35 0
1984-1986
2846
24.4
Years of follow-up
<5
29
0.2
5-9
4863
41.7
10-14
4581
393
315
2197
18 8
Person. tft
ACE nal
AT Risk
No Of
OBSERVED
Cases
expected
SIR*
<30
24,033
0
1.2
0
30-39
58.358
10
21.2
47.2
40-49
30.846
20
.386
51 8
50-59
8.889
8
18 3
43 7
360
2.368
3
69
435
ToTdl
I24.4U4
41
86 :
47.6
'SIR dcr)Otc> Mdndaniized incidence ntliu
on the mammograms. We believe there is no possibil-
ity that false negative matches explain the results of
our study.
-Another possible explanation of the low standard-
ized incidence ratio found in our study could be that
cancer in women with implants is diagnosed at a later
stage (i.e., it has not yet been discovered, thus lower-
ing the number of observed cases) . Preliminary results
of a survival analysis of the group of women with
implants who had cancer showed no difference in sur-
vival between these women and women without breast
implants who had cancer. We therefore do not think
that there is a substantially longer latency period in
women with breast implants before a tumor is diag-
nosed.
Finally, one could hypothesize that women who un-
dergo augmentation mammoplasty have a much lower
a priori risk of breast cancer, which may or may not be
aflfected by the presence of the implants. No informa-
tion about the base-line risk of breast cancer or the
prevalence of risk factors among women who have
implants is available. Theoretically, therefore, one
could argue that the results of our study do not permit
the conclusion that implants do not increase the risk of
breast cancer (because of the unknown base-line risk),
despite the fact that any such risk does not reach that
in the general population of women of comparable age
during the same period. Strictly speaking, then, we
have not ruled out the possibility that implants in-
crease the risk of breast cancer in a highly selected
group of women with a very low base-line risk. Wom-
en who undergo breast augmentation are in general of
higher socioeconomic status (a factor that increases
the risk of breast cancer). On the other hand, aug-
mentation for cosmetic reasons is usually done in
slim women with small breasts, and small breasts
have been considered a favorable factor, lowering the
risk."'^ "'■' The relation between breast size and the risk
of cancer is controversial, however.-^"''
This study focuses on women who had silicone im-
plants for cosmetic breast augmentation. Approxi-
mately 85 percent of the women received smooth-
walled implants filled with silicone gel. whereas the
remainder received smooth-walled implants filled
with saline. During the study period, prophylactic
mastectomy followed by reconstructive surgery was
34
Vol. 326 No. 25
BREAST AUGMENTATION AND BREAST CANCER— BERKEL ET AL.
1633
^
very rarely done. Polyurethane-sponge-covered im-
plants were not used in Alberta during the study
period. It probably will not be possible to evalu-
ate the elTects of such implants for 5 to 10 years, at
which time a sufficient number of person-years at risk
will have been accumulated in women with this type
of implant.
In summary, our study did not find an increased
risk of cancer among women who had received breast
implants, although the length of follow-up, the com-
pleteness of follow-up, and the size of the cohort
would have allowed the detection of such a risk. Ques-
tions that remain to be answered include what the risk
estimates are for other cancers and what the survival
experience is of women who had breast cancer after
cosmetic breast augmentation.
References
1. Chan SC. Birdsell DC. Gradcen CY. Delection of loluenediamines in Ihe
unne of a patient with polyurethanc-covered brea;.! implants. Clin Chem
1991.37:756-8,
2. Ito N. Hiasa Y. Konishi Y. Marugami M- The development of carcinoma in
liver of rats treated with m-loluylencdiamine and the synergistic and antago-
nistic effects v«iih other chemicals Cancer Res I969.29JI37-15
3. Umeda M Production of rat sarcoma by injections of propylene glycol
solution of m-toluylenediamme GANN i955.-16:597-603.
4 Giles AL Jr. Chung CW Dermal carcinogenicity study by mousc-skin
painting with 2.4-ioIuenediamine alone or in representative hair dye formu-
lations J Toxicol Environ Health 1976.1 433-40,
5 Cardy RH Carcinogenicity and chronic toxicity of 2.4-toluenediamine in
F344rats J Natl Cancer Inst 1979:62:1 107-16
6. Sonlag JM. Carcinogenicity of substituted-bcnzenediamines Iphenylenedia-
minesl in rats and mice J Natl Cancer Inst 1981.66:591-602
7- Expen Panel on the Safety of Polyurethane-covercd Breast Implants, Safety
of polyurethane-covered breast implants. Can Med Assoc J 1991.145:1 125-
32
8 Berkman L, Implant furor: health warning or hyslena' Los Angeles Times
December 10. 1990
9 Blakeslee S The true story behind breast implants Glamour August
1991
10, Rohlting C, Is there a time bomb ticking in women's breasts? Longevity
July 1991
1 1 Snyderman RK. Lizardo JG, Statistical study of malignancies found before,
dunng, or after routine breast plastic operations Plast Reconstr Surg
1960;25:253-6
12, Harris HI Survey of breast implants from [he point of view of carcinogene-
sis Plast Reconstr Surg 1961:28:81-3
13, De Cholnoky T, Augmentation mammaplasty: survey of complications in
10.941 patients by 265 surgeons Plast Reconstr Surg 1970:45:573-7
14 Deapen DM. Pike MC. Casagrande JT. Brody GS The relationship be-
tween brtast cancer and augmentation mammaplasty: an epidemiologic
study Plast Reconstr Surg 1986,77:361-8
15. Koch M. Clarke EA, Ediger J. Hayles P. Robson D Western Canada
Cancer Registries comparability Chronic Dis Can 1985.5,74-5,
16 Berkel J. Anderson WA, Hanson J. et al Incidence, •:urvival and dis-
tribution of cancer in Alberta. 1964.1988 Edmonton, Alta Divi-
sion of Epidemiology and Preventive Oncology. Albena Cancer Board.
1990
17 Lilienfeld AM, Foundations of epidemiology New York: Oxford Universi-
ty Press. 1976
18 Bailar JC III. Ederer F Significance factors for the ratio of a Poisson
vanable to Its expectation Biometncs 1964.20:639-43
19, Hoopes JE, Edgenon MT Jr. Shelley W Organic synthetics for augmenta-
tion mammaplasty their relation to breast cancer Plast Reconstr Surg 1967.
39 263-70
20 Bower DG Jr. Radlauer CB Btrast cancer after prophylactic suf)cutaneous
mastectomies and reconstruction with silastic prostheses Plast Reconstr
Surg 1969.44:541-4
21 Benavent WJ Treatment of bilateral breast carcinomas in a patient with
siliconc-gel breast implants: case repon Plast Reconstr Surg 1973.51:588-
9.
22 Bingham HG. Copeland EM. Hackelt R. Caffec HH. Breast cancer in a
patient with silicone breast implants after 13 years, Ann Plast Surg 1988:
20:236-7
23 Wvnder EL, Identification of women at high nsk for breast cancer Cancer
1969.24 1235-40
24 Hsieh C-C. Tnchopoulos D Breast size, handedness and breast cancer nsk,
Eur J Cancer 1991.27:131-5
25, Valaoras VG. iMacMalom B. Tnchopoulos D. Polychronopoulou A, l.acta-
tion and reproductive histones of breast cancer patients in greater Athens.
1965-67 Int J Cancer 1969:4:350-63
26 Hirohata T. Nomura AMY, Kolonel LN Breast size and cancer BMJ
1977:2:641
Massachusetts .\letjical Society
Registry on Continuing .Medical Education
Ti) obtain information on continuing medical education courses in the New England area,
call between 9:00 a.m. and 12:00 noon, .Monday through Friday, (617) 893-4510 or in
Massachusetts 1-800-322-2303, ext. 1342.
35
1666
THE NEW ENGLAND JOURNAL OF MEDICINE
June 22, 1995
SILICONE BREAST IMPLANTS AND THE RISK OF CONNECTIVE-TISSUE DISEASES AND
SYMPTOMS
Jorge Sanchez-Guerrero, M.D., GR,^HAM A. Colditz, M.B., B.S., Dr.P.H., Elizabeth W. IC\rlso.\, M.D.
David J. Hu.nter, MB., B.S., Sc.D., Frank E. Speizer, M.D., and Matthew H. Liang, M.D., M.P.H.
Abstract Background. Silicone breast implants have
been linked to a variety of illnesses, the most controver-
sial of which are connective-tissue diseases and symp-
toms. To study this relation, we analyzed data from 14
years of follow-up of the Nurses' Health Study cohort.
Methods. Women who were free from connective-tis-
sue disease in June 1 976 were followed through May 31 ,
1990, before there was widespread media coverage of
the possible association of breast implants and connec-
tive-tissue diseases. Information was collected through
biennial and supplementary mailed questionnaires and
blinded reviews of medical records with the use of stand-
ardized criteria. Relative risk, the measure of association,
was defined as the incidence rate of connective-tissue
disease among women with breast implants divided by
the corresponding incidence rate among women without
breast implants.
Results. Among 87,501 women who were eligible for
follow-up, 516 were confirmed as having definite connec-
tive-tissue diseases and 1183 as having breast implants
(of which 876 were silicone-gel-filled, 170 saline-filled,
67 double-lumen, 14 polyurethane-coated, and 56 of un-
known type). The mean (±SD) period of follow-up after
surgery was 9.9±6.4 years (range, 1 month to 40.5
years). Three of the patients with definite connective-tis-
sue disease — all had rheumatoid arthritis — had implants
(one silicone-gel-filled, one saline-filled, and one double-
lumen). The age-adjusted relative risk of a definite con-
nective-tissue disease among women with any type of im-
plant was 0.6 (95 percent confidence interval, 0.2 to 2.0),
as compared with women without implants. For women
with silicone-gel-filled implants, the comparable relative
risk was 0.3 (95 percent confidence interval, 0 to 1 .9). The
relative risk of self-reported signs or symptoms of connec-
tive-tissue disease for women with implants was 1 .5 (95
percent confidence interval, 0.9 to 2.4); the risk of having
any 1 of 41 signs, symptoms, or laboratory features of con-
nective-tissue disease was 0.7 (95 percent confidence in-
terval, 0.3 to 1 .6).
Conclusions. In a large cohort study, we did not find
an association between silicone breast implants and con-
nective-tissue diseases, defined according to a variety of
standardized criteria, or signs and symptoms of these dis-
eases. (N Engl J Med 1995;332; 1666-70.)
SINCE 1962, approximately 1 million to 2.2 million
women in the United States and Canada have re-
ceived silicone breast implants as part of reconstruc-
tion following surgery for breast cancer or prophylactic
mastectomy or for cosmetic reasons.'-^ Silicone breast
implants have been linked to a variety of illnesses, the
most controversial of which are connective-tissue dis-
eases and symptoms.''^ Since 1982, at least 293 pa-
tients with connective-tissue diseases or rheumatic
illnesses and silicone breast implants have been de-
scribed in the English literature; many additional cases
From the Departments of Rheumatology and Immunology (J.S -G.. E W.K..
M.H.L ) and Medicine (GA C. D J.H . F.E.S.. M.H.L). Harvard Medical School;
the Robert B Bngham Multipurpose Arthnlis and Musculoskeletal Diseases Cen-
ter (JS-G., EW.K. MHD») and the Channmg Laboratory (G A C . DJH.
F.E.S-l. Bnghafn and Women's Hospital; and the Department of Epidemiology.
Harvard School of Public Health (G A.C.. D.J H.l — all in Boston Address re-
pnnt requests to Dr. Liang at Bngham and Women's Hospital, DepI of Rheuma-
tology and Immunology, 75 Francis St. Boston. MA 021 15.
Supponed by grants from the National Instinites of Health (CA40356-O8S1, for
the Supplement-respective Study of Diet and Cancer in Women. AR36308. for
the Multipurpose Arthritis and Musculoskeletal Diseases Center, and AR42630.
for the Effects of Silicone on the Immune Response Study). Dr Sanchez-Guerrero
was supponed by a Research Fellowship Award from the Fogany International
Center (NIH 5F05 TWO4573-021
The Bngham and Women's Hospital has received grants from Dow Coming to
study silicone breast implants in a separate study, the breast-implant substudy of
the Women's Health Cohon Study, being conducted by the Division of Preventive
Medicine From these grants. Dr. Sdnchez-Guerrcro received $7,500 toward tu-
ition at the Harvard School of Public Health in September 1992 and Dr, Karlson
received $25,800 in salary and fringe-benefit suppon between February 1. 1994.
and June 30. 1994. Dr Liang received $2,525 from four legal firms representing
Dow Coming or McGhan for 8,5 hour, of consulting between June 16. 1993. and
August 26. 1994. TTie other authors have not received compensation from com-
panies that manufacture breast implants or from lawyers involved in breasl-
implant litigation
Editor's note This disclosure statement is in accord with our usual policy but
is somewhat more detailed because of the intense public controversy over the
health effects of breast implants
have been reported in abstract form.^ On April 16,
1992, the Food and Drug Administration banned fur-
ther use of these devices, except for limited use in re-
search settings.'
To study the relation between silicone breast im-
plants and connective-tissue diseases, we analyzed data
from 14 years of follow-up of the Nurses' Health Study
cohort with respect to connective-tissue diseases that
were diagnosed before June 1, 1990. Widespread media
coverage in the United States of a possible association
began in December 1990, after a program on the sub-
ject was aired on national television.*
\>
Methods
The Nurses* Health Study Cohort
The Nurses' Health Sludy cohort was assembled in June 1976.
Questionnaires were mailed to all registered nurses who were female,
married, 30 to 55 years of age, and living in California, Connecticut,
Florida, Maryland, Massachusetts, Michigan, Newjersey, New York,
Ohio, Pennsylvania, or Texas. Seventy percent of the women invited
to participate returned the base-line questionnaire. Information was
sought on a variety of heahh conditions and practices. Subsequently,
biennial questionnaires have been sent. The overall response rate to
follow-up questionnaires has been more than 90 percent. The study
protocol has been approved by the Human Research Committee of
Brigham and Women's Hospital in Boston. All subjects have given in-
formed consent.
Ascertainment of Exposure to Silicone Breast Implants
By 1992, the number of women still alive and participating in the
study was 109,750. Among many other topics on the 1992 biennial
questionnaire were questions about whether participants had ever
had breasi-implant surger>- or silicone, paraffin, or collagen mjec-
tions. .\fier three mailings, 89,376 women (81.4 percent) returned
the questionnaire, including 88,153 who answered the questions re-
lated to breast implants and injections. A supplementary question-
36
Vol. 332 No. 25
SILICONE BREAST IMPLANTS AND THE RISK OF CONNECTIVE-TISSUE DISEASES
1667
najrc was sent to ihc 1861 women who reported having received
breast implants of any sort or silicone, paraffin, or collagen injec-
tions. The supplementary questions were intended to confirm the
breast-implant surgery and to ascertain whether it was unilateral or
bilateral, the side of the implant, the reason for the surgery (cancer
treatment, prophylaxis, cosmetic reasons, or other), type of implant,
date (or dates) of surgery, and complications, if any. Although all
breast implants are contamed m silicone envelopes, there are dificr-
cnces in structure and filling. The implant types were categorized
as silicone-gel-filled. saline-filled. double-Uimen (a siliconc-gel-filled
envelope within a saline-filled envelope), poK-urethane-coatcd (a sil-
icone-gel- filled implant coated with polyurethane foam), other, or
unknown.
Overall, 1809 of the 1861 women (97.2 percent) responded to the
supplementary questionnaire; 330 without breast implants reported
silicone, paraffin, or collagen injections; 1 17 reported breasl-implant
surgery after May 1990; 22 had received implants after the date of
diagnosis of a connective-tissue disease; and 157 provided incom-
plete information about the breast-implant surger\'. The remaining
1 183 women with confirmed breast implants in Mav 1990 or earlier
were included in the analysis. Researchers who entered data on im-
plant history were blinded to information about the medical histories
,)f the women.
Validation of Breast-Implant Information
A validation studv of self-reported information on breast implants
was conducted for a random sample of 1 00 women. Permission was
requested to review their medical records. Sixteen women did not
give permission, the medical records for 1 1 were not available after
multiple mailings, and the medical records for 6 were not received
from the surgeon or hospital. For the 67 women whose medical rec-
ords were obtained, we confirmed that surgery had been performed
and ascertained which side the implant was on, the reason for the
surgery, the type of implant (or implants), and the date (or dates) of
surgery. Medical records were abstracted bv physicians using a ques-
tionnaire identical to that completed by the subjects. Self-reports
agreed with blinded record reviews at the following rates: surgerv —
99 percent; side of the implant — left 91 percent, right 100 percent,
and bilateral 99 percent; reason for the surgery — cancer 93 percent,
prophylaxis 91 percent, and cosmetic reasons 95 percent; type of im-
plant — silicone-gel~filled 100 percent, and saline-filled 89 percent;
and date (or dates) of surgery — same date 78 percent, within one
year 84 percent, and within two years 95 percent.
Case Identification of Connective-Tissue Disease
Questions regarding rheumatic conditions that had occurred since
1976 were included on all questionnaires after 1980. There were
specific questions about diagnosis by a physician of systemic lupus
erythematosus in the 1982, 1984, 1986, and 1992 questionnaires;
about rheumatoid arthritis in 1982 through 1992; about scleroderma,
polymyositis, dermatomyositis, and Sjogren's syndrome in 1992; and
about "other major illness diagnosed" on every biennial question-
naire.
In 1992, we mailed a screening questionnaire on connective-tissue
disease*" to participants who had reported any rheumatic, musculo-
skeletal, or connective-tissue disease before June 1, 1990, and had an-
swered the 1992 questionnaire. These diseases included rheumatoid
arthritis, scleroderma, morphea, systemic lupus erythematosus, der-
matomyositis or polymyositis, Sjogren's s\ ndrome, "connective tissue
disease not further specified." or "any other arthritis (excluding os-
teoarthritis and fibromyalgia)." Those who did not respond inmailv
were sent second and third mailings. Those who still did not respond
were sent a shorter quesiionnaire, once or twice, asking specifically
about the occurrence of these conditions, or were telephoned by
trained interviewers who asked the same questions and sought per-
mission to obtain further details regarding the diagnosis. Of the 50H6
participants who were sent the screening questionnaire, 4598 (90
percent) responded to the mailings or telephone calls.
The screening questionnaire on connective-tissue disease" con-
tained 30 questions about symptoms or signs of connective-tissue dis-
eases ever experienced by the subject, based on the classification cri-
teria of the American College of Rheumatology for rheumatoid
arthritis,' systemic lupus ei^thematosus," and systemic sclerosis";
A larcon -Segovia and Cardiel's criteria for mixed connective-tissue
disease'"; Bohan and Peter's criteria for inHammatory myositis"; and
Fox et al.'s criteria for Sjogren's syndrome.'* Validation of question-
naire data on 253 subjects with connective-tissue disease and 340
control subjects showed a sensitivity ranging from 83 to 96 percent
and a specificity of 83 to 93 percent for detecting any of these six con-
nective-tissue diseases.^
For this study, we used a more conservative screening rule to max-
imize sensitivity. A positive questionnaire was defined as one indicat-
ing at least two swollen joints for more than six weeks or at least
three positive answers to questions about connective-tissue disease
symptoms. Medical records were requested to validate the diagnoses
for all subjects who had reported connective-tissue diseases and had
positive questionnaires. Exposure information was separated from
the medical records by a research assistant, and the records were
then reviewed independently by two rheumatologisis blinded to ex-
posure. Definite connective-tissue disease was identified according to
the standardized classification criteria on which the questionnaire
was based. When the rheumatologists disagreed, the complete med-
ical information was reviewed by a third independent rheumatologist
and a final judgment was made by consensus of all three rheumatol-
ogists. The date of onset of the connective-tissue disease was the date
of diagnosis indicated in the medical record. The analysis was based
on records received through May 1994.
Population for Analysis
Women for whom information on breast implants was missing or
whose connective-tissue disease was diagnosed before 1976 or after
May 1990 were excluded, leaving 87.501 women eligible for follow-
up. The period from June 1976, the start of the study, through May
31, 1990, was chosen to a\'oid potential bias from the widespread
news-media attention to this topic, which began in December 1990.
During the 14-year period, we accrued 1.181,244 person-years of fol-
low-up.
Since the classification criteria for connective-tissue diseases ex-
cluded patients with milder or atypical cases and those who did not
fulfill the criteria early in their disease, the true incidence of the dis-
eases could have been underestimated. We performed three addition-
al analyses using less stringent case definitions that included (1) pa-
tients who reported a rheumatic disease on any biennial questionnaire;
(2) patients who had a positive screening, as defined on the connec-
tive-tissue disease screening questionnaire; and (3) patients who had
any I of 41 signs, symptoms, or laboratory features of a connective-
tissue disease that were included in the six classification-criteria sets
that were abstracted from the medical record.
We performed analyses according to type of implant: silicone-gel-
filled, saline-filled, double-lumen, or polvairethane-coated.
Statistical Analysis
For each participant, the number of person-years was assigned to
the appropriate breast-implant category. Once a subject had surgery
for a silicone breast implant, she was defined as having been exposed
to silicone, regardless of whether an implant was subsequently re-
moved. The number of person-years was calculated from 1976 until
Ma\ 31.1 990, or until the date of diagnosis of any connective-tissue
disease, whichever came first.
The analysis was based on incidence rates. Relative risk, the
measure of association, was defined as the incidence rate of connec-
tive-tissue disease among women with breast implants divided bv the
corresponding incidence rate among women without breast implants.
Age-specific rates were calculated in five-year categories of age and
used to compute age-adjusted relati\e risks, with 95 percent confi-
dence internals. '^ When fewer than five cases involving exposure
were observed, we calculated exact confidence intervals."
Results
During the 1,181,244 person-years of follow-up, con-
nective-tissue diseases were confirmed in 516 subjects.
Among the 87,501 women in the analysis, 1183 (1.4
percent) reported having had some type of breast im-
37
1668
THE NEW ENGLAND JOURNAL OF MEDICINE
June 22, 1995
plant between 1976 and May 31, 1990; gave complete
information; and were free from connective-tissue dis-
ease before the implantation. Women with breast im-
plants accounted for 11,170 person-years of follow-up.
Information about the breast-implant surgery is sum-
marized in Table I.
The mean (±SD) period during which any kind of
breast implant was in place was 9.9 ±6.4 years (range,
I month to 40.5 years). Among women with silicone-
gel-filled implants, the mean period was 10.0 ±6.2
years (range, 1 month to 37.5 years) (Table 2).
Definite Connective-Tissue Disease
Among the 516 women who met the criteria for con-
nective-tissue disease, the observed incidence rate per
100,000 women was within the ranges reported in other
studies (Table 3). Three of the patients with definite
connective-tissue disease had breast implants (silicone-
gel-filled in one, double-lumen in another, and saline-
filled in the third). All had rheumatoid arthritis; their
cases had no unusual features. The age-adjusted rela-
tive risk of any definite connective-tissue disease among
the women with any type of breast implant, as com-
pared with the women without breast implants, was 0.6
(95 percent confidence interval, 0.2 to 2.0) (Table 2).
We also examined risk according to the type of
breast implant, specifically the silicone-gel-filled im-
plants. One woman with a definite connective-tissue
disease had silicone-gel-filled implants. The age-adjust-
ed relative risk among women with such implants was
0.3 (95 percent confidence interval, 0.0 to 2.0) (Table
2). No patient with poKoirethane-coated breast im-
plants had any of the connective-tissue diseases studied.
The age-adjusted relative risk of rheumatoid arthri-
tis was 0.9 (95 percent confidence interval, 0.3 to 2.6)
with any breast implant, 0.4 (95 percent confidence in-
terval, 0.1 to 2.4) with silicone-gel-filled breast im-
Table 2. Age-Adjusted Relative Risl< of Connective-Tissue Dis-
ease among Women with Breast Implants as Compared witii
■ Women without Implants.
No Implant
Case Type
(N = 86.318)
Breast Implant
SIUCONE-
ANY TYPE
GEL-nLLED*
(N- 11831
{N-876)
disease
No. of cases
5054
32
21
Age-adjusted relative risk
1.0
07
0.6
95% Confidence interval
0.5-1.0
04-09
Self-reported signs or symptoms
of connective-tissue
diseaset
No of cases
1277
17
11
Age-adjusted relative nsk
1.0
1.5
1,2
95% Confidence interval
0.9-2.4
0.7-2.2
Documented signs or symptoms
of connecuve-tissue
disease}
No of cases
898
6
4
Age-adjusted relative risk
1.0
0.7
0,6
95% Confidence interval
0.3-1.6
0.2-1.6
Definite connective-tissue
disease
No. of cases
513
3
1
Age-adjusted relative risk
1.0
0.6
0.3
95% Confidence interval
0.2-2.0
0.0-1.9
Durauon of implant
Mean (±SD) yr
9.9±64
10,0±6.2
Range
1 mo-40.5 yr
1 mo-37.5 yr
This category is a subgroup of "any type" of implant.
tThc signs and symptoms are tho&e included in the screening questionnaire on connecuve-
tissue disease '
jDala were denved from the medical -record review Documented signs and symptoms in-
cluded proximal weakness, a high creatine kinase concentraiion. posiuve eleciromyogram.
positive muscle biopsy, proximal scleroderma, sclcrodaclyly. digital scars, bibasitar lung fi-
brosis, malar or discoid rash, photosensitivity, nasopharyngeal ulcers, nonerosive anhritis,
pleuntis. pericarditis, proteinuria, renal casts, seizures, psychosis, hemolytic anemia, leuko-
penia, lymphopenia, thrombocytopenia, positive test for lupus cryUiemaiosus. antibodies 10
double -stranded DNA. biologic false positive serologic test for syphilis, positive lesi for anti-
cardiolipin antibody, positive anti nuclear- antibody icsi, Raynaud's phenomenon, morning
stiffness for more than one hour, arthntis m three or more joini areas, anhntis in hand joints,
rheumatoid nodules, positive rheumatoid -factor tests, radiographic changes charactcnstic of
rheumatoid arthntis. keratoconjuncuvitis. xerostomia, salivary-gland biopsy positive for Sjo-
gren's syndrome, and anii-Ro, ami-La. arti-extracublc-nuclear-anligen. and anti-Ul-RJ^P
antibodies.
Table 1. Breast-Implant Surgery in 1183
Women from the Nurses' Health Study.
Variable
No OF Women (%)
Indication
Cosmetic reasons
587 (501
Cancer
387 (33)
Prophylaxis
138(12)
Unknown
71(6)
Type
Silicone-gcl-filled
876 (74)
Saline-filled
170X14)
Double-lumen
67(6)
Polyurethanc -coaled
14(1)
Unknown
56(5)
No. of opcrauons*
1
911
2
191
3
52
4
29
Side
Unilateral
224(19)
Right
112
Left
112
Bilateral
937 (79)
Unknown
22(2)
-E^ch otxralion wu counled as one, inespecuve of wtiether
• blUteraJ operauon was performed
plants, and 1.4 (95 percent confidence interval, 0.2 to
9.7) with saline-filled implants, as compared witK no
breast implants. No patients with scleroderma, systerfi-
ic lupus er)'thematosus, inflammatory myositis, mixed
connective-tissue disease, or Sjogren's syndrome had
any type of breast implant.
Risk of Connective-Tissue Disease or Symptoms Based on
Less Stringent Diagnostic Criteria
We studied women with possible early, milder, or
atypical forms of connective-tissue disease or with any
sign or symptom of a connective-tissue disease who
did not meet standard classification criteria (Table 2).
These groups were not mutually exclusive.
Since 1976, 5087 women have reported having a con-
nective-tissue disease or rheumatic disorder on the bi-
ennial questionnaires. Thirty-two had some type of
breast implant, including 21 with silicone-gel-filled im-
plants. The age-adjusted relative risk of any connec-
tive-tissue disease was 0.7 (95 percent confidence in-
terval, 0.5 to 1.0) for those with breast implants as
compared with those without breast implants. For worn-
38
Vol. 332 No. 25
SILICONE BREAST IMPLANTS AND THE RISK OF CONNECTIVE-TISSUE DISEASES
1669
Table 3- Incidence Rates of Connective-Tissue Diseases in the
Nurses' Health Study (1976 to 1990).
Incidence
Range in
Disease
Nurses"
Health Study
OTMEU STUDIESt
INCI0Er4Ce
NO, Of CASES
•ATE'
Rheumaioid ajlhnlis
392
332
24-50
Systcmii: lupus erythematosus
96
8.1
1.8-7,6
Sclct<»ienna
14
12
0 4-1.9
Polyniyosius or demulomyositis
12
1,0
05-1.1
Sjogren's syndrome
2
—
—
Mixed conneclive-tjssue disease
0
—
—
Any connective-tissue dis«as«
516
43,68
—
'Rjles aie per l(X}.000 person-year^
tRange of incidence rales reported in 10 other studies. "^'*
en with silicone-gel-filled implants, the age-adjusted
relative risk viras 0.6 (95 percent confidence interval, 0.4
to 0.9).
Signs or symptoms of connective-tissue disease v/ere
reported on the screening questionnaire by 1294 wom-
en, including 17 with some type of breast implant and
11 with silicone-gel-filled implants. Of these 17 pa-
tients, 3 fulfilled the classification criteria for rheuma-
toid arthritis on review of the medical records. Two pa-
tients, one with symptoms of arthritis and Raynaud's
phenomenon and another with Raynaud's phenomenon
alone, could not be classified as representing definite
cases. Nine patients had other rheumatic or musculo-
skeletal conditions (five had osteoarthritis, one chon-
drocalcinosis, one trochanteric bursitis, one cervical
strain, and one familial Mediterranean fever). In three
patients, no evidence of rheumatic disease or symptoms
could be found. The age-adjusted relative risk of self-
reported signs or symptoms of connective-tissue dis-
ease was 1.5 (95 percent confidence interval, 0.9 to 2.4)
among the women with any type of breast implant as
compared with those without implants (Table 2). For
the women with silicone-gel-filled breast implants, the
age-adjusted relative risk was 1.2 (95 percent confi-
dence interval, 0.7 to 2.2).
We also studied 904 participants with any of 41
signs, symptoms, or laboratory findings seen in connec-
tive-tissue diseases that were validated by review of the
medical records (Table 2). Six of these women had
some type of breast implant, including four with sili-
cone-gel-filled breast implants. As compared with the
group without breast implants, their age-adjusted rela-
tive risk of having the signs or symptoms of connective-
tissue disease was 0.7 (95 percent confidence interval,
0.3 to 1.6) with any breast implant and 0.6 (95 percent
confidence interval, 0.2 to 1.6) with silicone-gel-filled
breast implants. The analyses for other implant types
had similar results (data not shown).
Discussion
In this large cohort study, we did not find an in-
creased risk of any connective-tissue disease or of 41
signs or symptoms of connective-tissue disease among
women with any breast implant or with specific types
of breast implants. Connective-tissue diseases occur in-
frequently. For this and other reasons, our study cannot
be considered definitively negative. The upper bound of
the 95 percent confidence interval for the relative risk
of definite connective-tissue disease (2.0), for example,
does not exclude minor associations that would still be
of public health importance. Since information on ex-
posure was based on self-report, there may have been
some misclassification of breast-implant surgery. How-
ever, we found high rates of agreement between self-
reports and medical records in our validation study of
self-reported breast implants.
In all epidemiologic studies of rheumatic diseases,
diagnosis is a major problem. We identified and con-
firmed cases through a multistep procedure and blind-
ed medical-record review. Sixtv-five percent of the 904
subjects who had any signs or symptoms of connective-
tissue disease as determined by chart review had seen
physicians who were active members of the American
College of Rheumatology. The observed incidence of
connective-tissue diseases was within ranges previous-
ly reported in population-based studies. '^^* The appli-
cation of strict criteria for any connective-tissue dis-
ease may exclude some true cases or milder cases and
hence underestimate the true incidence of disease.
With a rare disease, a slight underestimation of the in-
cidence rate is less important in a study of etiology
than is the misclassification of participants without
disease as having disease.-^ In this situation, misclassi-
fication adds a small number of true cases to the very
large number of true non-cases and has a negligible in-
fluence on estimates of the exposure among the non-
cases. Less specific criteria might add non-cases. Since
the number of cases is relatively small, the non-cases
could make up an appreciable proportion of the total
cases. Thus, the distribution of exposure among cases
might be inaccurate. If the misclassification is ran-
dom, the risk estimate will be driven toward the null
value.
We found no association between breast implants
and previously reported signs and symptoms,''^" such
as Raynaud's phenomenon, photosensitivity, arthritis,
morning stiffness, xerostomia, dry eyes, sclerodactyly,
positive antinuclear-antibody tests, and positive rheu-
matoid-factor tests. We could not study subjective and
largely unverifiable symptoms, such as fatigue, de-
creased ability to sleep, frequent sore throats, cognitive
deficits, arthralgias, lymphadenopathy, or dizziness, or
diseases such as fibromyalgia.
The 5514 women who died during the 14-year study
period could not be studied because information about
breast-implant surgery was not available for them. It is
unlikely that this potential limitation biased the results,
unless women with breast implants and connective-
tissue disease died at a higher rate than women with
connective-tissue disease who did not have breast im-
plants.
Our results are based on data about registered nurs-
es, about 95 percent of whom were white. Whether
39
1670
THE NEW ENGLANDJOURNAL OF MEDICINE
June 22, 1995
these results can be generalized to include other wom-
en may be questioned. In 1989, a national survey of
40,000 households in the United States found that ap-
proximately 60 percent of breast implantations were
performed for cosmetic reasons and that 95 percent of
women with implants were white.'" The prevalence of
breast implants was higher in the South and West than
in other regions of the country and increased with
household income. Furthermore, the breast-implant rate
in our cohort, 1.4 percent, is within the range of 0.7 to
2.0 percent estimated for U.S. women. For these rea-
sons, the women m our study are likely to be represen-
tative of women in the United States who have breast
implants.
Our results are consistent with the findings of pub-
lished epidemiologic studies of breast implants and
rheumatic diseases""'^' and reports in abstract form.""''"
In a population-based retrospective cohort study,'' 749
women in Olmsted County, Minnesota, who received
breast implants between January 1964 and December
31, 1991, were followed for a mean of 7.8 years and
compared with 1 498 control women of similar age with-
out implants. In 5 case subjects, as compared with 10
in the control group, one of the specified connective-tis-
sue diseases was diagnosed (relative risk, 1.06; 95 per-
cent confidence interval, 0.34 to 2.97).
In conclusion, we found no evidence of an associa-
tion between silicone breast implants and either con-
nective-tissue diseases defined according to a variety of
standardized criteria or signs or symptoms of connec-
tive-tissue disease.
Wc are indebted to the nurses in this study for their continuing
participation; to Barbara Egan, Karen Corsano, and Mary Scamtnan
for expert assistance; and to Dr Peter H. Schur for reviewing this
manuscript.
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stract
40
Medical Procedures/Patients Affected by a Biomaterials Shortage (April 1994)
Number of
Madical Sp*aalty and AHedtd ProMd«re P»i!^m$ '(fa(- *"'*^'*' °*'**
nually)
CARDIOLOGY & THORACIC SURGERY (Source: American College of Cardiology and Society of Thoracic Surgeons)
Angioplasty 331,000 angioplasty catheter 2
Diagnostic Cardiac Catheterization 1,057,000 cardiac catheter 2
Implantable Cardiac Defibrillator 35,000 cardiac defibrillators
Open Heart Surgery 342,500 blood filters,^ cardiotomy reservoir.^ heart/lung
oxygenator 2
Pacemaker Implantation 140,000 pacemakers
Valve Implantation 35,000 mechanical valves, tissue valves, annuloplasty rings
Vascular Graft Related 330,000 polyester grafts, other grafts
Number of Patients Affected 2,270,600
ORTHOPEDICS (Source: American Academy of Orthopedic Surgeons)
Arthroplasty 617,000 hand and finger prothesis, hip prothesis, knee proth-
esis, shoulder joint orthopedic
Other Orthopedic Related data not bone gro«yth stimulator, fracture fixation device
available
Number of Patients Affected 617,000
OPHTHALMOLOGY (Source: American Academy of Ophthalmology)
Cataract Surgeiy 1,500,000 phacoemulsification unit,^ foldable silicone intra-
ocular lens
Glaucoma Shunts 3,000 eye valve implants
Punctum Plug Related data not silicone punctum plug
available
NEUROLOGY (Source: American Association of Neurological Surgeons)
Ventricular Shunt 75,000 CNS shunt
Number of Patients Affected 75,000
UROLOGY (Source: American Urological Association)
Anti-incontinence Operations 2,500 urinary sphincters
Diagnostic Ureteroscopy/Cystoscopy 500,000 endourology devices ^
Laser Prostetectomy 250,000 laser hbers^
Multiple Urology 100,000 section drains 2
Penile Prothesis Procedure 50,000 penile prothesis
Prostetectomy/Reconstructive 250,000 silicone urinary catheter 2
Multiple Urological & Other 1,000,000 ureteral catheter/stents 2
Stone Manipulation 500,000 basket graspers 2
Testicular Prothesis Procedure 1,000 testicular protheses
Number of Patients Affected 2,653,500
RECONSTRUCTIVE SURGERY (Source: American Society of Plastic & Reconstructive Surgeons)
Breast Augmentation 29,607 saline-filled breast implant, silicone gel-filled breast
implant
Breast Lift 7,963 saline-filled breast implant, silicone gel-filled breast
implant
Breast Reconstruction 32,607 saline-filled breast implant, silicone gel-filled breast
implant
Other Reconstructive/Plastic Surgery data not cheek implants, chin implants, tissue expanders
available
Hand Surgery ' 138.233 no device data available
Number of Patients Affected 208.410
Total Number of Patients Impacted by a 7.406,210
Biomaterials Shortage.
'Dm totti number of hand syrieries is listed; however the percentaje ot these which will be attected is sail uncertain.
41
*At tkis tim*. tke impact of a biomatcrials skortaje on (or the unavailability of) twnporafy implants or dwicas whick temporarily come in
CO«tact witk tke body is not as certain as tkat on permanent implants.
Note-. Estlmatas compiled from Medicare/Medicaid records, federal records (wkere available), and input from physicians, manufacturers, and
rtfulatory representatwes Current prwate sector statistics are generally not tracked and are difficult to obtain. Figures may be understated.
Mr, Shays. I thank all three of our witnesses. We will proceed
with some questions, but I'll ask a witness who was not sworn in,
Mr. Kyi, evidently you have some individuals you would like to in-
troduce. Do you have a statement as well that you want to make?
Mr. Kyl. Mr. Chairman, I don't have a statement. I simply want-
ed to make brief comments in the way of an introduction of the wit-
nesses youll hear this afternoon.
Mr. Shays. That would be very nice. We welcome you.
Mr. Kyl. Would you like for me to be sworn to give the introduc-
tion?
Mr. Shays. No, not for that.
Mr. Kyl. Well, Mr. Chairman, if I could proceed at this time,
then, I appreciate your courtesies. Two of you — well, about four of
you know that this was a committee on which I sat when I was
in the House of Representatives, and it's a pleasure for me to be
back at this committee today, and also to be with Marilyn Lloyd.
I worked with Marilyn on issues relating to breast cancer when
I was in the House with Jim Traficant, who has been aptly de-
scribed as a friend and someone who is very courageous. And Dr.
Ganske who has just presented, I think, some extraordinarily im-
portant testimony. My comments will bear on what he has just
said.
I very much appreciate the opportunity to appear at this hearing
this morning. And as I noted, I'm not here as a witness, but to in-
troduce two remarkable women from my State of Arizona. The first
is Tara Ann Ransom. She's a very young woman, just 8 years old.
She's an exceptionally bright and active third grader. She jumps
rope, roller skates, and is the top student in her class at the Mag-
net Traditional School in Phoenix.
She reads on the sixth grade level and has recently finished all
14 books of the Wizard of Oz series. She scores in the — and she'll
talk to you more about that. She scores in the 99th percentile on
national academic achievement tests.
Tara is a hydrocephalic child. She can do all the things that a
normal 8-year old can do and more with the help of a little piece
of plastic silicone very much like this. It's a little smaller, but it
looks almost exactly like this. And I think she'll show that to you
this afternoon.
This plastic tube is called a shimt, and it drains excess fluid from
her brain. Without the shunt the pressure on her brain would in-
crease, causing severe disability and ultimately death. She wants
us to make sure that when she outgrows her current shunt she will
be able to get a new one.
Unfortunately, there is a real danger that the companies that
produce the raw material for shunts will stop supplying it because
of product liability concerns and FDA regulatory overreach. I
learned about Tara from her mother Linda, a devoted mother who
is fighting for her daughter's life. She's also fighting for the lives
of all of the approximately 50,000 citizens in Arizona and all over
this country who depend on silicone plastic shunts.
42
It is important to note that more than 7 million Americans have
some kind of implants made of silicone. She has my support and
the support of the senior Senator from Arizona Senator McCain,
and I hope she'll have yours. In May, the Senate passed S. 565 the
Product Liability Fairness Act. This bill contains a provision that
would limit the liability of suppliers of the raw materials that are
manufactured into medical implant devices.
The House passed Product Liability Bill H.R. 956 as a similar
provision. But regulatory reform is also needed. That is the pur-
pose of this hearing, to determine whether the FDA has gone so far
in trying to protect some Americans that it has in fact jeopardized
the lives of others like Tara.
Mrs. Ransom and Tara will testify this afternoon, but I'd like
just to read one paragraph from a letter that Tara wrote to me,
"Some issues, like the life of a child — " excuse me, Mrs. Ransom
wrote this letter to me. "Some issues like the life of a child seem
so basic, but as you know all too well they are anonymous statistics
to many bureaucrats. There has to be a solution to this problem.
Tara will die without a shunt. What more can be said?"
And Mr. Chairman, members of the committee, I hope that you
will be moved by the testimony of Tara and Linda Ransom this
afternoon. I believe that they have entered the hearing room this
morning, and if they are here I wonder if they would at least stand
and be recognized.
Mr. Shays. It's very nice to have both of you here, you bless our
company with your presence and we look forward to both of your
testimonies. And I thank you, Senator, for taking the time to come
and introduce them.
Mr. Kyl. Thank you again for your courtesies, Mr. Chairman.
With your leave, I will absent myself now, unless there are any
questions.
Mr. Shays. Well, you're very kind to come here to introduce two
people and thank you very much. It's very important you did that.
I open now — our witnesses are invited to respond to some ques-
tions and I would ask Mr. dinger if he has a question or two for
the witness.
Mr. Clinger. Thank you, Mr. Chairman. I just have one com-
ment and a question. I just want to commend all three of the wit-
nesses for very compelling testimony and delighted to see our
former colleague Ms. Lloyd here today and hear her testimony and
Jim Traficant our good friend and Dr. Ganske. I think you have all
done yourselves very well in this testimony.
I have one question I wanted to ask you, Jim, and it has to do
with the French study which you referred to, the French morato-
rium which you referred to. My question is, that study or that mor-
atorium or taking it off the market was not precipitated by any
study that showed that there was a chemical problem or a causa-
tive problem with cancer or any sort of tissue-related diseases; is
that your understanding?
Mr. Traficant. Yes. My understanding, though, and the reason
why I brought up that whole incident -regarding the French deci-
sion is Dow Coming used extensively in their advertisements as
documentation and further support for the safety of their silicone
43
gel breast implants that France and Britain had in fact accepted
those products and found them to be safe.
Some 2 weeks after a lot of that extensive advertising campaign,
France in fact banned totally the manufacture or sale of all of those
products.
Mr. Clinger. But I believe that there is a moratorium pending
further study, not a permanent condition, as I understand it.
Mt. Traficant. Yeah. The French Minister of Health noted that
silicone breast implants — this is their exact statements — "Expose
women to the risk of rupture with spread of silicone and that sili-
cone can be associated with local and systemic complications."
Let me just say sitting here between these two, a great former
Member and certainly a dynamite young Member, Im not here
today totally about the safety of this issue. I think Congress must
get to it. What I am here putting on the record was there documen-
tary evidence withheld, knowingly and with intent, by Dow Cor-
ning.
Did Dow Corning in 1990 knowingly and willingly within intent
to deceive the Congress of the United States withhold certain par-
ticular salient points from the Congress. Did thev lie to Congress.
Did they ever comply with the 1990 request of Cnairman Weiss to
give us all the documentation of the claim that they made that
their product was risk-free.
So I'm not talking about this device. I support them. I'm not talk-
ing about all these other devices. I'm not a scientist, but I'm talk-
ing about the silicone breast implants and did in fact our govern-
ment get all the information it could have from the private sector
driven research, much of it conducted by those with vested interest
in such research.
Mr. Cljnger. In reference to the study that was done as a result
of Congressman Weiss's inquiry. There was a report put out at that
time, it was controversial because it was not— it was never ap-
proved by the committee, it was actually issued by the staff and
never had the imprimatur, as you would say, of the committee it-
self. So I think it has some basis to question that.
Mr. Traficant. Well, I believe then that we could check the re-
port of that language. My language basically — the information that
I have says that the report clearly notes, "That Dow Coming subse-
quently refused to provide the documents."
Now, I'm sure we could look at the report language and the re-
port of that subcommittee process.
Mr. Clinger. Thank you.
Mr. Shays. I thank the gentleman.
Mr. Towns.
Mr. Towns. Thank you very much, Mr. Chairman. Let me begin
by thanking all the witnesses for their testimony and of course Mr.
TVaficant and of course Dr. Ganske and Congresswoman Lloyd.
What I would like to do is just basically ask you, Congresswoman
Lloyd, what action would you encourage the FDA to take in the
near future with respect to the regulation of silicone breast im-
plants. What would you suggest?
Ms. Lloyd. I think they should do as I called for when I was a
Member of Congress, to allow women to make — and I cosponsored
44
legislation to this and I believe Mrs. Morella did also — to allow
women to make an informed consent decision.
It should be her decision alone, and I think that this is the way
that we should have moved ahead instead of providing this terrible,
terrible moratorium. As I said, it's cost the lives of many women.
You know, I think it's very important. Congressman Towns, that
we listen to the respected medical community. And that's really all
I ask of this committee today.
If you're interested in why the French Government made the de-
cision they did, I think you should ask the French Government. I
think if you want to know if there is any problem with implants,
I think it should come from the medical community, and to the in-
formation available to me at the present time, there is no informa-
tion from the respected medical community, the New England
Journal of Medicine reports here on the table, that indicates in any
way that silicone gel implants are unsafe to women if they are han-
dled properly.
This is my opinion. You know that science can never prove nega-
tive propositions entirely, but I do think that we've harmed many,
many women with the decision to move ahead as we have. And I
hope that this committee will shed further light on it and review
the harm that has been done. Thank vou.
Mr. Towns. Thank you very mucn. Let me just conclude, Mr.
Chairman, by saying I think that when we have people in the Con-
gress like Dr. Ganske who has had a tremendous amount of prac-
tical experience in terms of dealing with many issues, to come and
to testify, I think that that is very, very important in terms of what
we have to do in terms of documenting and making a decision in
terms of the future.
Also, good for you, Mr. Traficant, in terms of the fact that you
want to make certain that if there is any information out there
that we need to have, we need to — we 'want to make certain that
we do have it.
Let me just say that in terms of 1990, as I remember what hap-
pened, some of the things that happened was that Congressman
Weiss became ill and someone else was actually filling in as the
chair of the committee, so — and I understand tnere was a break-
down there in terms of information sort of flowing the way it
should have. So I think that was also part of the problem.
So the 1990 situation is something that was not clear, because
of the fact that the chairman became very ill and was not able to
follow through on many of the issues that were raised during that
time.
Thank you very much. I yield back the balance of my time.
Mr, Shays. I thank the gentleman.
Mr. Mcintosh.
Mr. McIntosh. Thank you, Mr. Chairman. I've got essentially
two questions. First, Con^esswoman Lloyd, thank you for coming
today. I remember very vividly your testimony around the time of
your treatment in which you were in between having had the mas-
tectomy and having had the opportunity to have an implant.
I remember it very vividly and it was very moving at the time
and I appreciate your willingness to put your personal story into
the public record that way about a very emotional and trying issue.
45
Let me ask you this. It's my understanding that all sorts of orga-
nizations, including the National Cancer Institute, the Society of
Surgical Oncology, and prominent physicians have all indicated
that they believe that women will be less likely to either submit
themselves to mammography or other procedures for detection of
breast cancer because of the fear that they will not be able to take
care of the disfigurement that may occur should they have that dis-
ease.
Ms. Lloyd. That's the point that I was trying to make. You
know, the only thing we have in the fight in breast cancer is time.
That's the reason I had my surgery done immediately. All you have
is time. And if you wait 6 months, many times it can be fatal.
So we must do more to educate women and to let them know —
you don't have to go through life wearing an uncomfortable pros-
thesis, you don't have to go through life lopsided, that we do care
as a country and we are going to have the treatment that you need.
Mr. McIntosh. And isn't it true that women often will find ex-
cuses to put off going in for a mammography? My mother, when
I asked her whether she had received one recently said, "No,
they're terribly uncomfortable. I don't want to do that." And don't
we need to do everything possible to encourage that type of screen-
ing?
Ms. Lloyd. This really, in a woman's mind, marks the final stage
of her recovery. You go through chemo, you go through radiation,
you go through the wig bit, but you're always looking forward to
that day when you can say it's behind me.
Mr. McIntosh. Which is 5 years?
Ms. Lloyd. That's right.
Mr. McIntosh. Let me also turn to Mr. Ganske, and I appreciate
you coming and sharing your expertise as a doctor who has treated
patients. I wanted to know, was it your experience when you were
practicing as a physician that your patients did try to avoid either
detection of breast cancer or treatment and that you often had to
work hard to persuade them to move forward with those two proce-
dures?
Dr. Ganske. I was not infrequently referred patients who had a
diagnosed breast cancer who had told their general surgeon that
they would not proceed with a mastectomy, which for their particu-
lar circumstances was probably the best treatment, unless they
could have a breast reconstruction.
Mr. McIntosh. So the ability to have a reconstruction was criti-
cal for their decision to be treated?
Dr. Ganske. Absolutely.
Mr. McIntosh. And let me ask you a hypothetical question, Dr.
Ganske, and that is to put yourself in the position of Dr. Kessler
as head of FDA, given the 17 studies that you're aware of, would
you be able to approve finally with certainty the use of silicone
breast implants in the cases of women who had breast cancer?
Dr. Ganske. I want to answer in a little bit more detail. I believe
that Dr. Kessler's first decision in which he ignored the advice of
the first advisory panel was ill-advised. His first advisory panel ba-
sically said there is no substantial proof that there is a problem
with implants.
46
Yes, let's proceed with some additional studies, but I believe that
he overreacted. And I believe on the basis of the subsequent science
that has come out, that breast implants either saline filled or gel
filled are safe.
Now, I want to say one thing. There is no medical device that
is 100 percent free of'^any complications. Hip prostheses will break.
Finger prostheses made of silicone can break. They need to be re-
placed occasionally. There is no surgical procedure that you can do
that is 100 percent free of complications.
Any time you place a knife to the skin, there is a small chance
of infection, there is a small chance of bleeding, there is a small
chance of excess scar formation, but those are things that are dis-
tinct from a medical device in relationship to the complications of
surgery. And if we're going to use any medical devices at all, we
have to weigh the benefits versus the small acceptable risks of com-
plication. That is a cost benefit analysis that I think this Congress
needs to be involved in.
Mr. McIntosh. Thank you. Dr. Ganske. And specifically, the tes-
timony that Dr. Kessler will give us later in written testimony indi-
cates that there is not a general risk of the autoimmune disease
but there is a small and perhaps significant risk that they mav in-
crease certain types of diseases, mainly because it's never been
disproven.
Dr. Ganske. You cannot prove the negative.
Mr. McIntosh. In all of this. Would you be willing to advise your
patients that those small risks are worth the potential benefits of
having an implant?
Dr. Ganske. When I, as a physician, talked to a patient, I do as
Congresswoman Lloyd has suggested, you lay out what the possible
complications are, and then the patient should have the right to
make an informed decision.
Mr. McIntosh. Thank you. Dr. Ganske. I have no further ques-
tions for this panel.
Mr. Shays. Mr. Peterson.
Mr. Peterson. Thank you, Mr. Chairman. I want to thank the
panel for their testimony.
Congressman Traficant, I'm aware that you've sent several let-
ters to Attorney General Janet Reno requesting that the Justice
Department investigate whether Dow Corning knowingly mislead
Congress and withheld information on the sa^ty of silicone breast
implants.
What has been the Justice Department's response to your re-
quests?
Mr. Traficant. We have not had a specific response, but we
have cited the circumstances why we believe that it should at least
be looked into.
And I think that is part and parcel of what we're discussing here
today. I am not in disag^reement with many of the things that Dr.
Ganske has stated and testified to, nor Marilyn Lloyd, but I think
the record is quite clear that there has been an awful lot of with-
holding of information and what I consider to be worthy of inves-
tigation, lying to Congress.
But everybody is predicating what is we're hearing on this 1994
study. And one of the reasons why I've asked for such an informa-
47
tion is that I want to know if three of the studies authors were ei-
ther personally receiving moneys from breast implant manufactur-
ers or had already agreed to act as paid consultants for a breast
implant manufacturer while they were conducting that study.
I also want to know if Dow Coming contributed $7 million to
Brigham and Women's Hospital, the institution conducting this
study while this study was in progress. Let me say this, I don't
want to see any of these devices withheld.
Mr. McIntosh. Excuse me. Would the gentleman yield? I have
a question for the witness. Are you impugning the integp*ity of that
university?
Mr. Traficant. No, I'm not.
Mr. McIntosh. What was the purpose of pointing out the fact
that they received a contribution?
Mr. Traficant, I want to know if Dow Corning made a $7 mil-
lion contribution.
Mr. McIntosh. But are you stating that that would affect the
University in their scientific study?
Mr. Traficant. Whether or not it would have, I know this, if
they received $7 million at about the time they were in fact per-
forming that study, from a company that had concerns about the
study wiey were performing, I just want to know if in fact that is
the case. Those are reports that I have had.
Mr. McIntosh. But it may be an irrelevant fact.
Mr. Traficant. If it is, then they can certainly explain that. Con-
gressman.
Mr. McIntosh. Unless you're implying that they've been influ-
enced by that?
Mr. TIlAFlCANT. If it is, they could certainly explain that.
Mr. McIntosh. I don't think that Dow Coming would be able to
explain that. I think the University whose integrity is at stake here
would be the one that you would question about that.
Mr. Traficant. Then let me rephrase my answer to you. If in
fact the research is coming out of an institution, and a company
with a tremendous problem at stake has made a sizable contribu-
tion to that institution, I'm not saying that it in fact impacted the
decision, but that seems to be a very timely donation of sig^nificant
amounts and I want to know.
Let me also say to this Congress, you have an industry that has
agreed to the largest settlement in American history of over $4 bil-
lion. Now, I'm just a regular lay taxpayer here. I'm not a doctor.
I haven't had one of these devices. But I'll tell you this, if I was
a major corporation that had a completely safe product, I'm not so
sure that I would have in fact agreed to such a settlement then
filed bankruptcy.
Was the filing of the bankruptcy — did Dow Corning and Dow
Chemical in fact collude to in fact make a settlement then file the
bankruptcy? The only final point I'm making to you is this, I am
not necessarily here to stop silicone breast implants, but my God,
if there is a safety risk associated with it, it shouldn't be the advice
of a good conscientious doctor that says there mav be a risk.
Congress took upon themselves to warn people the health haz-
ards of tobacco, and if there is a potential health risk, my Grod, let's
get all the facts in. Did they keep those facts from us?
48
Mr. Shays. Let me just say for the record Mr. Peterson has the
floor, and I didn't hear you say yes, and I didn't jump in soon
enough. I apologize to the gentleman.
Mr. Peterson. Oh. That's fine. I think we are all learning from
these exchanges.
One final thing. I was just wondering if you're aware of any of
the documents that support your claim that Dow Coming know-
ingly mislead Congress, whether they have been introduced into
evidence in any of the cases that are currently pending against
Dow Coming?
Mr. Traficant. I don't know if they've been submitted into evi-
dence. I'm sure they probably have, but I have submitted all the
documents that I was able to uncover, and I placed them before you
and your committee. And in such a short period of time, I did not
go into many of them. I'd advise that somebody be assigned to go
through and distill and digest all of those reports. That's the only
advice I'll make to the committee.
Mr. Peterson. Thank you. Thank you, Mr. Chairman.
Mr. Shays. I thank the gentleman.
Ms. Morella, you have the floor, and you've been very patient.
Ms. Morella. Thank you very much. I want to thank our three
witnesses' very eloquent testimony given very passionately, because
you all in your own areas of expertise believe strongly, and I appre-
ciate that very much.
I just have one question, perhaps to Congresswoman Lloyd, and
I think it will be the kind of question I'll probably direct to Dr.
Kessler on the next panel, because what I'm curious about is, is it
true that breast cancer survivors do have access under certain cir-
cumstances to silicone breast implants? I mean, it seemed to me
that there was some element of choice, maybe it isn't very clear,
if they are involved with a clinical trial or — I think there was some
stages — are you aware of that?
Was anyone telling you about that, Congresswoman Lloyd, or do
you think it's not adequate? I wanted to get your response.
Ms. Lloyd. No. When I received mine, I had to take part in a
clinical study, and there is a certain element of fear in this. Connie,
I think it would have been much better, as I stated earlier, if we
would allow women when the issue came up after the Connie
Chung story, if we could have had an informed consent decree for
women.
But I would just like to remind you one more time, that more
women died because of this moratorium than could ever be killed
with silicone gel implants.
Ms. Morella. Because of the anxiety, the concern?
Ms. Lloyd. We went about it in the wrong way.
Ms. Morella. So you think of course informed consent, but at
this point, we'll find out from Dr. Kessler whether there is a way
that women can still get the silicone gel implant.
You think it's too complicated?
Ms. Lloyd. Is silicone only harmful in women's breasts? Why did
we pick women's breasts as a topic for use of silicone? Why didn't
we pick up some of these other medical devices made of silicone?
49
Mr. Shays. Excuse me, Marilyn. Could you make sure you're
talking into the mike. When you look this way we don't pick you
up as well.
Ms. Lloyd. It seems to me that if we're talking about the safety
of silicone gel, why could it be bad only for women's breasts, why
not some of these other devices that we have listed here.
Ms. MoRELLA. I guess what I'm trying to get at is, can we have
these silicone gel implants now under certain — can anybody have —
if they get into a trial?
Ms. Lloyd. I can have them, but as far as I know, women cannot
have them that want to have cosmetic surgery. And there again,
I think this is a real put-down for women that other people can de-
cide whether — they need or should have an implant.
Ms. MoRELLA. Well, that it is part of choice, I would agree with
you in that regard. Thank you. Thank you, Mr. Chairman. I really
have no other questions.
Mr. Shays. I thank the gentlelady.
Mr. Fattah, you have the floor.
Mr. Fattah. Thank you, Mr. Chairman. And let me ask former
Congresswoman Lloyd a question, since you served in this body
and were involved in this issue in a number of different ways. We
seem to be having a debate about the validity of research con-
ducted by the private sector. Have there been, and what is your
view point about. Federal efforts to do research on this issue so
that we could find some objective information on which to base,
say, informed consent or some further ruling by the FDA in this
matter?
Ms. Lloyd. Congressman, I think we should listen to the advice
of our knowledgeable medical community, from our scientists and
our doctors. I don't think that the opinion of junk scientists should
come into play.
Mr. Fattah. But my question is whether there has been feder-
ally sponsored research on this question?
Ms. Lloyd. Oh, yes. A lot of very fine doctors and scientists work
for the Federal Government. As you know, when I was a Member
of Congress, I worked very hard to increase the funding for more
research, and certainly I hope the Federal Government will con-
tinue fiinding needed research and I hope the FDA will act respon-
sibly.
What we need is more research, but until we do find a cure, all
we have is time.
Mr. Fattah. It seems though that this phenomena related to im-
plants seems to leave out, at least most of the research that I've
seen, any real reference to minority women. And I note that breast
cancer has a disastrous effect in terms of its impact upon minority
women in this country.
Ms. Lloyd. I'm glad you bring out this point, because there are
more minority women — especially Hispanics — that develop breast
cancer and die because they did not receive timely treatment. And,
again, all we have is time, and all we can do is try to educate more
women to take control of their body, to do their monthly exams and
have check-ups. It's one of the reasons that the Congressional
Women's Caucus has called for having mammograms paid for by
50
Medicaid. We must have our mammograms for at-risk women fi-
nanced annually.
So I would hope you would continue as a Member of this Con-
gress to fight for Federal research dollars for women's health, with
special attention to needs of minorities.
Mr. Fattah. Well, I intend to, and thank you very much for your
very compelling story. I'm glad that the chairman arranged for you
to De here.
Let me move now to Congressman Traficant. I think it's fascinat-
ing that we could have Members of the Congress now be concerned
al^ut making statements that could impede the integrity of institu-
tions, given all of the statements that have been made in this Con-
gress over the last several months that are absolutely irrespon-
sible.
But I think that your point, having served on a number of uni-
versity boards and particularly related to our health care institu-
tions in Pennsylvania, it is not irrelevant, that a major grant would
be made at the time that supposedly objective research was being
conducted. And any university or ooard thereof should be con-
cerned if such an offer were made of such a significant amount.
I'm glad that you've raised it, and we need to find out whether
it's true, because I do think that it does rise to the level of signifi-
cant questions about what the impact of such research would be.
Mr. Traficant. Yeah. Just let me Just respond, because I think
you've touched that point very well. But I think more importantly,
everybody is overlooking the fact is we're talking about more re-
search. I m not so sure the Congress of the United States has seen
all of the research on this issue.
That's what my goal is. What was withheld from the Congress
of the United States. What documents were not submitted. Was
there in fact scientists who performed certain studies that also had
a monetary link to those with vested interests.
We have — I don't think anybody more than the chairman there,
Mr. Shays, has looked at an issue relative to tobacco where for
years tobacco was completely safe and much of the research was
generated from that industry. And you'll get still scientists today
on the payroll of those tobacco companies tell you how safe they
are.
BotJi my parents died of complications directly attributed to
smoking. They were always wondering good, bad, indifferent, like
many Americans. Much of the study performed in that 1994 Har-
vard Study, none of it dealt with women who had had breast im-
plants after 1990. Much of it was done on women that had a short
experience with breast implants.
Now, if we looked at a 25-year old sample of American people
and looked for health-related issues from tobacco and health, I
don't think we'd find that many. But you start looking at 55, 60-
year-olds and what I'm saying is that is something I believe Dow
Coming has, in my heart, they haven't shared with us.
I'd like Congress to say, look, give us the truth, give us the facts.
Mr. Fattah. Let me just ask the final member of the panel a
quick question. Congressman, is there' any medical reason why —
and I'm going back to the question that was asked by former Con-
gresswoman Lloyd — one would be concerned about this material in
51
a breast implant but not concerned about it in these other — ^in the
shunts or in other ways that this material is used?
Dr. Ganske, Well, the silicone gel material has been used in
penile implants and in testicular implants, but hasn't generated as
much interest as this.
But let me, if you would, respond to Mr. Traficant's statement
about this recent study that has come out from Harvard on silicone
breast implants and the risk of connective tissue disease.
In an effort to be up front, the authors noted at the beginning
that in a prior study they had received grant money from Dow, but
this study was funded by the NIH. And furthermore, if you read
how the methodology of this study was done, specifically it says
that researchers who entered data on implant history were blinded
to information about medical histories of the women.
So, in other words, there were proper precautions taken to avoid
bias in this study, and furthermore, the reason the study was done
with a cutoff in 1990, was to eliminate bias in a study related to
all the publicity that has surrounded this subject. And the follow-
up in fact on the average was 9 to 10 years plus minus 3 to 4
years. So it's a pretty good study and I think it is unbiased.
Mr. Fattah. Are you satisfied that there is enough research on
this issue that an informed opinion can now be made on this ques-
tion?
Dr. Ganske. Yes. I believe that the American College of
Rheumatology for instance has looked at all of this, and they are
much more expert in rheumatology than I am by any means. They
have looked at all of the evidence to date on this, and have basi-
cally said that they see no connection between silicone gel implants
and connective tissue diseases. And so I think that informed con-
sent should be sufficient to allow these implants to be used.
Mr. Fattah. Thank you very much, Mr. Chairman.
Mr. Shays. I thank the gentleman.
Mr. Fox.
Mr. Fox. Thank you. Chairman Shays. Congresswoman Lloyd,
we do appreciate your testimony today and you're coming here with
your very poignant account of what has happened in your life and
now it affects many women across the country. We're very hopeful
that as a result of your testimony and your support and leadership,
that we can make some changes in the country which are beneficial
to all women and we in Congress are certainly appreciative of your
efforts. I'm sorry I didn't get a chance to serve with you, but we
certainly are continuing by working together here at this stage.
In your opinion, how should the FDA have weighed the fact that
many women avoid or delay cancer detection screening due to the
fear of a disfigurement in the agency's assessment of the risks and
benefits of silicone gel breast implants?
Ms. Lloyd. Well, certainly, it's my opinion as I stated earlier,
that the moratorium did more harm than implant could have done.
As Dr. Ganske stated we don't have any evidence that the implants
have done any harm.
But I truly believe that if we had just moved ahead as the first
FDA advisory panel had suggested to the FDA, and they had al-
lowed women to look at all the evidence and then make the deci-
sion for themselves, I think it would have been a much wiser
52
course of action. And I think that should still be the woman's deci-
sion, and I think that she has the information available to her that
she should make this for herself and her family. It's a tough choice.
Mr. Fox. Well, women do have access to the implants, but it is
a special exception, this creates an uncertainty about safety. Was
the uncertainty because the FDA has failed to act to discourage
women from seeking treatment, in your opinion?
Ms. Lloyd. Well, Congressman, frankly, I think the whole thing
for the past 4 years has been so blown out of proportion that at
the present time, most women that go in to have a mammogram
are scared to death, and they aren't having the regular screenings
that they should have.
And look at the women who have had them removed unneces-
sarily, they spent thousands of dollars having them removed. So,
yes, I think great harm has been done, and I think that we should
move ahead and put the facts before the women of this countiy and
let them make their decision with their doctor on what is rignt for
them.
Mr. Fox. This question would probably be for you and Congress-
man, Dr. Ganske, and what I've learned from testimony from Sher-
ry McManus who is with us today is that there has been a great
deal of paperwork required in order to get the excejption, and I
wondered whether you found in your studies and the involvement
that it might take a physician as much as 1 day or more to fill out
the paperwork that's connected with this procedure. Doctor?
Dr. Ganske. Well, I think there is a lot of paperwork, but that
doesn't particularly bother me. I mean, I personally used three or
four forms, including ones that have been, of course, put out by the
FDA. And that to me is just part of informed consent and I don't
mind. I didn't mind going through that. If you had to go through
it two or three different times, it was all right.
Mr. Fox. Did that cause a burden for you, Congresswoman?
Ms. Lloyd. I felt informed consent when I received my implant,
yes.
Mr. Fox. What would you have the FDA do now at this point?
Ms. Lloyd. What?
Mr. Fox. What would be your course of action if your words
today could be a single message to the FDA, what would they be?
Ms. Lloyd. I would allow all women who want to have an im-
plant to have them with an informed consent. She and her physi-
cian would have all the valid information before her, that it would
be her decision based on sound research. I think it's very patroniz-
ing for women that the FDA can decide whether or not they de-
serve an implant.
Mr. Fox. Very good. Thank you, Mr. Chairman. Thank you
panel.
Mr. Shays. I thank the gentleman.
Mr. Barrett, welcome to the committee. You've been here for a
while and I appreciate your patience.
Mr. Barrett. Thank you, Mr. Chairman. Maybe, Mr. Traficant,
I C£m follow-up on the question that was just asked of Congress-
woman Lloyd who it's nice to see back here. You heard her say
that she would like to see the FDA have a policy of just informed
consent. What is your response to that?
53
Mr. Traficant. Well, I think, No. 1, that we should get all the
facts out, review it veiy carefully. And I believe, if in fact, what we
have found in some of the studies, that neither has talked about,
that it usually takes 8 to 15 years before you can really define
whether or not there has been £iny damage to the autoimmune sys-
tem, that at least there should be a warning.
That, if in fact, the Grovemment of the United States, after re-
viewing all these documents in evidence believes that it is the
woman s choice, that there could be certain risks related, cite what
those risks are purported at least to be, and let the woman have
enough information so that she could make a decision.
I certainly don't want any woman to die from cancer because
they were afraid that they would be disfigured by going in and
frnding out the truth. But on the second hand, let me say this, if
there are related health risks, that Congress can at least come with
a policy that says, OK, there are certain risks. Whether or not this
side is right amd this side is right, there is enough smoke here to
say, there is a possible risk, here is what the risks are, and in fact,
mandate that those risks be known to women.
And if women are then going to go forward, that would be their
choice. So I am not here trying to stop Marilyn that opportunity,
I really mean that. I am here about lying, withholding, shredding
documents on or about the time where an individual, a vice presi-
dent testified before this same subcommittee in 1990, in 1990, Mr.
Chairman.
And if I could just maybe close with this, Mr. Barrett, the spe-
cific incident occurred on Friday, December 14, at 5:15 p.m., Greg
Tyse a senior litigation attorney in the corporate legal department
approached Marianne Woodbury a research scientist of my staff in
her office. He asked that she destroy all copies of a memo she cir-
culated 2 days previously.
The memo contained a data analysis of a recent National Center
for Health Statistics survev of surgical device, et cetera. This was
submitted bv the company s corporate medical director to the com-
pany's ethic s committee that felt that their whole operation would
be compromised by some executive coming down and asking them
to destroy documents.
Now, I don't know what the truth is here. I'm not trying to stop
women from breast implants. But I want women to know the truth
of this issue, and I'm not satisfied from what I've seen that they're
getting that truth.
Mr. Barrett. Congressman Ganske, how satisfied are you?
Dr. Ganske. I think that with informed consent, with the studies
that have been done, not just in the last couple of years, but have
been ongoing for 20 years, showing that implants are safe, that no
medical device is without some risk of complication, that when you
balance the benefits, I believe that it comes down in favor of being
able to utilize these devices.
And I must say that gel implants were used as opposed to saline,
because many people thought that they were better implants. And
practically speaking, at this point in time, gel implants aren't avail-
able because of the litigation problem.
Mr. Barrett. You referred to the litigation problem, how con-
cerned are you with their safety when you look at the lawsuits that
54
have been settled? How does that factor into your analysis? In
other words, as a person who is not a medical person at all, if I
saw that there were billions or millions or whatever the figure is
in lawsuits, I would think, well, maybe it's not just a spurious law-
suit.
Dr. Ganske. I think there are a lot of examples of litigation in
the past where over the years the science has proven that there
was minimal to no risk. We can go into the instances of anti-nau-
sea medicine for women in pregnancy and so whether the science
is valid or not Euid that the risk is exceedingly small, that doesn't
necessarily mean that you're going to ignore a litigation problem in
terms of whether you use or do not use a medical device.
I think it really does affect whether these devices are available
or not.
Mr. Barrett. And I understand that in terms of the wide array
of different procedures and devices on the market, but specifically
with respect to this one, are you comfortable enough with the liti-
gation to say, OK, there's no problems?
Dr. Ganske. I am personally comfortable enough with my review
of the literature that these devices are safe.
Mr. Barrett. Congresswoman Lloyd.
Ms. Lloyd. I believe the scientific information supports my belief
that they are safe, and as I stated earlier, we must do all we can
to encourage women to see their physicians and have regular
checkups. They should have their self-examinations and do all they
can to be knowledgeable. And we should never forget there is no
cure for breast cancer. All we have is time.
Mr. Barrett. Let me ask you if I could to make sure, because
I'm new on this issue. With the moratorium, if a woman has had
a mastectomy, can she have the implant following that? What is
the FDA rule on that? Does that fall into cosmetic or not? I hon-
estly don't know. Do any of you know?
Dr. Ganske. Let me answer that. A woman can use, obviously,
silicone saline implants are available, but this is a matter that is
coming up for additional FDA review. The silicone gel implants are
available, but you need to get — enter a patient into a registry and
go through a number of things, and I think that as I said before,
practically speaking, because of the litigation situation, just a lot
of plastic surgeons just will no longer use them.
Mr. Barrett. OK. Thank you very much.
Mr. Shays. Mr. Gutknecht, do you intend to ask questions?
You're welcome to do so.
Mr. Gutknecht. I'd like to, Mr. Chairman, if I could, ask one
quick question of Representative Traficant. Do you have any con-
cern— and one of the things that I've heard, and we have a lot of
research and medical technology companies up where I come
from — and one of the big concerns that I hear from many of the re-
searchers and the companies is that because of the litigation and
some of the things that have gone on, many of the maior compa-
nies— particularly the major chemical companies— don t want to
offer things like Dacron and simple component products that would
go into some of these new technologies.
Does that concern you at all?
55
Mr. Traficant. Absolutely. I think that there has been litigation
in the past, it was designed in fact to cause problems. It has. I
have great concern over a fine, large company that employs an
awfiil lot of Americans where a technology is being, many times,
from what I hear now, exported overseas. And I'm the No. 1 guy
in the Congress probably to oppose those types of phenomenons.
But I don't see that as the crux of this issue. I see full disclosure
and that's my purpose here. I think you should be able to make a
decision predicated on all the facts not just that that has been
force-fed to you. And I have doubts, and I believe I have submitted
in documents evidence now that will prove that those doubts really
exist.
Let's get it all on the table. I am most likely in agreement with
both of my co-panelists here. But I believe there is more of a risk
than what has been stated and the reason why we're not getting
all that risk is because of the tremendous amount of litigation that
is there and what are the costs implications.
Now, that's unfortunate because I'm not concerned about the
costs in the litigation process, but what is the valid health situa-
tion of the American women. Do they have all those facts as a 30-
year and say, look, when you're 40, 55 years old, there is a possible
link to rheumatoid arthritis, et cetera, and do they have all those
facts.
And so I think that is more or less what my purpose is here. Did
they withhold documents? Did they lie to us? Did they shred docu-
ments that spoke to salient points that could give us the truth of
this issue? Are they in fact driving the litigation process by denying
facts? We've only seen the studies that support their positions.
That's all I'm saying. I'm saying, get all of the facts.
When we get all the facts, I'm sure we will make a good decision.
Mr. GUTKNECHT. Thank you, Mr. Chairman, I yield back.
Mr. Shays. I thank the gentleman. All three of you have been
excellent witnesses.
Mr. Towns. Mr. Chairman, excuse me. Let me ask one question
just before you close out.
And I just sort of really — something you said is sort of — ^it's on
my mind. Congressman Traficant, are you suggesting that Con-
gress should require manufacturers of silicone implants to issue
warnings similar to those issued on cigarette packaging?
If so, unlike the case of with cigarettes, most women receiving
the implant would never see the packaging. How could Congress
act to ensure that women are adequately informed of safety con-
cerns? Am I understanding you correctly?
Mr. Traficant. Mr. Towns, I used the tobacco issue as a co-rel-
ative issue that has spoken to years of research driven by vested
interests. And it took the Congn'ess years to come to some position
where the Congress mandated certain warnings for cause.
Now, I'm not saying that every breast implant should have a tag
put on it and say the Congress of the United States warns every-
body this could be dangerous to your health. But I think in some
process — I'm first saying, get all of the facts, afler we do, I believe
that women should be — ^have the total truth objectively fi-om all
parties.
56
Maybe Dr. Ganske is right. Maybe the industry is right. Maybe
there are no complications here, no safety risks. But I have some
real doubts when people shred documents withhold evidence, do
not submit reports, and then we find things in files. I'm saying get
that and then we construct a policy. I'm not trying to withhold any-
thing, but so that women would know the truth.
I question the truth at this point on this whole issue, and I think
it's driven by the industiy, and I think Congress is incumbent upon
us to get to the bottom of it and get all the facts.
Mr. Towns. Thank you very much, Mr. Chairman, I yield back.
Mr. Shays. I'd like to again thank all three witnesses. You have
been extraordinarily helpful in serving the ball into play and giving
us — I tJiink a very balanced view of the differences. We really ap-
preciate you being here and in terms of your point, Mr. Traficant,
all of the facts won't be heard today and we're not going to be get-
ting into some of the facts.
In deference to corporate funding of studies, I just make the
point to you that in some cases the FDA requires corporations to
do studies, ask institutions to do them, and ask them to fund it.
And so I just want to provide that information as well.
Dr. Ganske, Mr. Traficant, and Congresswoman Lloyd, thank
you.
We call on our second panel. It is comprised of Dr. Kessler and
he brings with him Bruce Burlington, and if you have anyone else
that you choose to come and assist you in answering questions. Dr.
Kessler, we'll swear them in as well.
Let me just say that if there is anyone else that you may call to
answer a question, even if thev are sitting behind you, I would
want them to be sworn in. So if anyone who might assist you and
so on, and we welcome as well. So any of those who will be, in fact,
testifying, if they would rise at this time to be sworn in.
[Witnesses sworn.]
Mr. Shays. I will affirm that everyone has answered in the af-
firmative. If we could, Dr. Kessler, just those who have stood up,
if they could introduce themselves and we'll start with you, Joseph
Levitt and if you would just explain who you are and vour job.
We'll just go through the introductions so we know who is here.
Mr. Levitt. My name is Joseph A. Levitt. I am the Deputy Direc-
tor for Regulations and Policy in FDA's Center for Devices in Radi-
ological Health.
Mr. Shays. Thank you. Bruce Burlington, if you would introduce
yourself.
Dr. Burlington. I'm Donald Bruce Burlington. I'm a physician,
and for 2 V2 years I have been the Director for the Center of Devices
in Radiological Health at FDA.
Dr. Merkatz. My name is Ruth Merkatz. I am a nurse and I am
the Director of the new Office of Women's Health at FDA.
Mr. Shays. What we'll do is if we call on someone who is sitting
behind you we'll have them introduce themselves at that time. Dr.
Kessler, let me just say that in your business you have to have
thick skin, and I know you are a dedicated public servant. I know
there is going to be lots of disagreement on what you say, and
you're aware of that.
57
We're p^oing to try to stay on topic and deal with this extraor-
dinarily important issue. I am happy you were here for the testi-
mony of the three Members of Congpress, because I think it is a
good introduction to this issue and I appreciate your willingness to
listen to their testimony as well.
And so what I'm goin^ to suggest is that you give your statement
as you choose. I thmk it woula be good to summarize, but you've
heard the testimony before, you know the issue, and I think it's im-
portant for you to put everything on the record that you feel needs
to be put on the record.
We're going to go through and ask questions of the Members and
we'll do the 5-minute rule. If a Member needs to pursue a question,
we might give them a little more than 5 minutes and we will then
do a second pass with the Members that are here.
So, Dr. Kessler, welcome and thank you for being here.
STATEMENT OF DAVID KESSLER, DIRECTOR, FOOD AND DRUG
ADMINISTRATION, WASfflNGTON, DC; ACCOMPANIED BY
DONALD BRUCE BURLINGTON, DIRECTOR, THE CENTER FOR
DEVICES IN RADIOLOGICAL HEALTH; JOSEPH A. LEVITT,
DEPUTY DIRECTOR; AND RUTH MERKATZ, DIRECTOR, THE
OFFICE OF WOMEN'S HEALTH
Dr. Kessler. Thank you very much, Mr. Chairman. My prepared
testimony provides considerable detail about silicone gel-filled
breast implants and broader questions about medical grade silicone
used in medical devices. And Dr. Burlington will comment after I
am done on the broader questions.
Since that statement has been submitted for the record, I would
like to focus on its most important points. Although the scientific
and regulatory issues raised by silicone gel breast implants are in-
deed complex, the task of the FDA can oe simply stated. It is the
job of the FDA to ensure that breast implants are safe and effec-
tive.
The role of manufacturers is to provide evidence of safety and ef-
fectiveness. This is an affirmative duty. Simply put, manufacturers
must show that their products are safe. Because breast implants
were marketed for some 30 years because they were grandfathered
under the medical device law, there has been some confusion about
that point.
In April 1991, FDA called for the safety and effectiveness data
for these medical devices. That November, at a 3-day meeting, an
FDA advisory panel of outside experts agreed that the manufactur-
ers' data were insufficient to establish the safety and efficacy of
breast implants.
Nevertheless, the panel recommended continued availability of
the implants imder certain conditions while manufacturers col-
lected additional data under a strict time table set by the FDA,
After that meeting, FDA received a large volume of documents that
suggested that adequate quality control procedures were not in
place to prevent safety problems, that animal safety studies were
not consistently completed or even undertaken before the products
were promoted for use in women, and that indications of problems
including implant rupture, gel bleed and migration and contracture
had been evident years earlier.
58
This new information convinced us of two things. The advisory
panel needed to revisit the issue and women mi^t be at greater
risk than had been realized. On January 6, 1992, I requested a vol-
untary moratorium on the distribution and implantation of silicone
gel-filled breast implants.
The advisory panel met in February, reviewed the newly avail-
able data about implants and connective tissue diseases and the re-
lationship between implants and rupture and expressed greater
concern about implants than it had in November. The panel rec-
ommended that further use of implants be restricted to women par-
ticipating in clinical trials.
After 30 years of use, after this device had been implanted in an
estimated 1 million women, we still did not know how long it lasts
in the bodv? How often it ruptures? How frequently it had to be
replaced? And what are the consequences of that rupture?
To answer these questions and to preserve the option of access
for patients with breast cancer, on April 16, 1992, FDA lifted the
voluntary moratorium and announced that silicone gel breast im-
plants would be available with informed consent and under clinical
trials.
In the 3 years since 1992, important research has been under-
taken on some of the critical scientific questions concerning these
products. In these and other areas more research is still needed.
Let me take a moment to summarize the current state of knowl-
edge. Safety concerns fall into two categories, local complications
and systemic disease. Examples of local complications are implant
rupture, capsular contracture, infection and surgical complications.
Althougn my formal testimony cites several studies on the rupture
rate of silicone gel breast implants, the bottom line is that we still
do not know what that rate is or how it changes over time.
Several published studies suggest that the rupture rate may be
much higher than the 0.3 to 1.1 percent rate manufacturers origi-
nally estimated, and that the rate may increase as the implant
ages. In a 1992 published study, that analyzed the screening mam-
mograms of 350 women, there was a 5 percent rupture rate in
asymptomatic women who did not suspect a rupture nad occurred.
It was referred to as silent rupture.
In a 1995 study, investigators found frank ruptures in 51 percent
of patients and either frank rupture, severe silicone gel bleed or
botn in as high as 71 percent of^the patients. Published studies to
date suggest a rupture rate between 5 and 51 percent, an enor-
mous range, and unfortunately we do not know with any confidence
where within that range the real rupture rate lies.
While local complications are clearly related to the presence of
the breast implant, possible links between systemic disease and im-
plants are much more difficult to prove or disprove. We are talking
about a type of autoimmune disease called connective tissue dis-
ease including the very rare conditions such as scleroderma and
more common conditions such as rheumatoid arthritis. It is only
within the past year and a half that several epidemiological studies
of this possible connection have been published.
There are two important conclusions to be drawn from that. We
now have reasonable assurance that silicone gel implants do not
cause a large increase in traditional connective tissue disease.
59
These studies, however, cannot rule out either a small but signifi-
cant increased risk in traditional connective tissue disease or the
risk of atypical disease.
If 1 million women have silicone gel implants, even 1 percent
translates to 10,000 women. So for some women we still do not
have all the answers. In the end, Mr. Chairman, this is about get-
ting the important data FDA needs to protect and inform consum-
ers.
Dr. Burlington.
Dr. Burlington. Thank you, Mr. Chairman. If I may brieflv
touch on a couple of issues that Dr. Kessler has asked me to ad-
dress for him.
I'd like to make three points. First, silicone is not one product
but in fact a wide array of chemicals used in many different prod-
ucts. Second, that in the concern about the availability of silicone
materials, the agency and industry have worked closely together to
allow new silicone manufacturers to be used as material suppliers
by existing device manufacturers.
Third, the risk benefit assessment provided in the statutory
fi-amework is flexible. It's categorized according to the level of risk,
and it's appropriate given the broad array of products that we reg-
ulate as medical devices.
In addressing the question of biomaterials, if youll look to the
chart on my left, your right, you can see silicone products that are
in fact pol3aners. We have a drawing of a monomer that is one
building-block of these polymers. It has silicone and oxygen in the
center and carbon atoms going off the top and bottom.
These monomers are strung together in long chains and some-
times in circles in a wide array of ways. You can see in the second
line that they can be oils which are usually linear polymers with-
out a lot of substitutions and without a lot of cross-linking.
In the middle we have an illustration of gels where there is lim-
ited cross-linking, but usually not fillers. And these gels have a
semi-solid consistency. And at the bottom we have a drawing to il-
lustrate silicone elastomers which are highly cross-linked and con-
tain fillers and other substances in order to give them a rubberlike
consistency.
I assure you the chemistry of these products is almost as complex
as that which we know as organic chemistry. What we need to un-
derstand fi*om this is that there are a wide array of properties,
oft;en valuable properties in interactions with the human body that
are potentially attributable to these different chemicals.
They are not one — they are not all the same. The concerns have
been gfreatly less for the elastomers and for the oils. We have a
large number of approved products in these categories. In fact,
we've gone through and counted over 155 classes of products, either
approved or under investigation, including products that you have
illustrated on the exhibit table in front of us here and that we've
heard previously testified about.
The issue of materials availability, as this committee knows,
came to a head when Dow Corning in December 1992, annoimced
the discontinuation of implant-grade silicones to be effective in
March 1993, at least on the open market.
60
Subsequently, new companies have entered into the market place
and the agency and the industry have worked together to define
that minimal set of testing which would be appropriate to allow
substitution of materials from these new companies in the many
valuable applications. Where necessary, we have looked beyond
that minimal core set of testing and there is one particular product
previously at issue here, the hydrocephalus shunt, where because
of direct exposure to brain tissue, there is a particular concern
about the various chemicals used in manufacture of the elastomer
to make sure there is not a toxicity to brain tissue.
A second aspect of concern about that shunt is it contains a flap
valve, a valve to make sure that fluid drains out of the brain but
doesn't reflux back into the brain. That flap valve has got to open
at the right pressure. If it becomes sticky, as rubber is wont to do
over time, and doesn't open right, then the shunt won't function
right.
For that specific instance in a critical application we are working
with manufacturers to accelerate the testing and assure the contin-
ued availability of these critical products.
Beyond looking at substitute sources biomaterials, it's important
to understand that we don't look at the materials in the abstract.
We look at the materials in the context of a product in which they
are used, because the risk varies tremendously whether they are
used outside the body, on the surface of the body, for a temporary
implant or for a tube going through the body wall or for a perma-
nent implant. And that requires a different level of assessment of
what is the level of scientific data needed to assess safety and effi-
cacy.
The assessment is based on the standard of valid scientific data,
not conjecture. However, where there are risks because of areas
that are simply not known, where we did not have data to address
the risks, we must also take that into consideration in classifying
products into class 1, 2 or 3 and in terms of interpreting the stand-
ard for entering the market.
I believe this structure provides flexibility appropriate to the di-
versity of products that we regulate. Some are used for life or
death situations, like implantable cardiac defibrillators or hydro-
cephalus shunts. Others are as straight forward as tongue depres-
sors and clearly need a lesser level of data and scrutiny.
In summary, I would like to reiterate silicones are many mate-
rials, not one. The agency looks at these materials in the context
of the products in which they are used and the specific risks attrib-
utable and benefits attributable to those products. We have had a
lower level of concern about elastomers and oils than has been
raised about gel over the last few years, and the agency and indus-
try have continued to work together to assure availability of sili-
cones and silicone made products so that the health needs of the
American public can be met. Thank you, Mr. Chairman.
[The prepared joint statement of Dr. Kessler and Dr. Burlington
follows:]
61
Joint Prepared Statement of David A. Kessler, M.D., Commissioner, Food and
Drug Administration and D, Bruce Burlington, M.D., Director, Center for
Devices and Radiological Health, Public Health Service, Department of
Health and Human Services
Thank vou, Mr. Chairman. My neime is David Kessler, Commissioner of Food and
Drugs. With me this morning on the panel are Dr. Bruce Burlington, Director of
FD/Ts Center for Devices and Radiolocical Health (CDRH): Mr. Joseph A. Levitt,
Deputy Director for Regulations and Policy, CDRH; and Dr. Ruth B. Merkatz, Direc-
tor of our Office of Women's Health. I am pleased to be here this morning to discuss
the issues surrounding silicone gel-illled oreast implants and the implications for
other medical devicesuiat utilize medical grade silicone.
BACKGROUND ON SIUCONE BREAST IMPLANTS
Silicone breast implants came onto the market in the 1960s. They pre-date the
1976 amendments to the Federal Food, Drug, and Cosmetic Act (the Act), which re-
auires FDA to review and approve the safety and effectiveness of manj[ new medical
evices. Tliose amendments also require FDA to establish a systematic way to col-
lect and evaluate data relevant to devices on the market before 1976. Manufacturers
of these devices, when called to do so by FDA, are required by law to provide safety
and effectiveness data for devices, like breast implants, that had been marketed for
many years.
In January 1982, FDA published a proposed rule to classify silicone gel-fllled
breast implants into class III. The final rule was published on June 24, 1988. Under
the law, manufacturers have a minimum of 30 months following final classification
to submit the data on safety and effectiveness. On January 6, 1989, FDA aimounced
that silicone gel-filled breast implants were one of 31 class III devices with the high-
est priority for requiring the submission of safety and effectiveness data. FDA pub-
lished a proposed rule to require safety and effectiveness data on May 17, 1990.
FDA called for the safety and effectiveness data for silicone gel-filled breast im-
plants in a final rule on April 10, 1991. Premaiket Approval Applications (PMAs)
were due to FDA by July 9, 1991. Once submitted, the law gives FDA 180 days to
reach a final decision. Let me emphasize that the law reqruires manufacturers to
prove afHrmatively, with valid scientific data evaluated by FDA, that their devices
are safe and effective. Several manufacturers submitted data in the form of PMAs.
The applications from four of these manufacturers did include some clinical data.
The applications also contained, however, major scientific deficiencies. In the Agen-
cy's opinion, none of the applications provided sufficient data to assure safety and
effectiveness.
FDA brought to its General tmd Plastic Surgery Devices Panel the applications
from these four manufacturers. Despite their major deficiencies, FDA believed these
applications warranted public evaluation by the advisory panel. The purpose of the
panel was to advise FDA as to what we could tell the puolic about the safety and
effectiveness of these medical devices based on those data.
This advisory panel was composed of a broad range of experts, including rep-
resentatives from the fields of plastic surgery, oncology, epidemiology, internal medi-
cine, immunology, radiology, pathology, gynecology, toxicology, sociology,
biomaterials, and psydiology, as well as industry and consumer groups.
The panel spent three days, November 12, 13 and 14, 1991, hstening to informa-
tion regarding the PMAs, and hearing from physicians and pa.tients, advocacy
groups and others. Significant concerns were discussed regarding implant rupture*
bleea; and potential carcinogenicity of implant materials. Questions were raised
about the possibility that an inaplant might interfere with the detection of breast
cancer through mammography. On the otner hand, many individuals who testified
before the advisory panel presented information about the psychological benefits of
implants. The panel heard from those who strongly supported continued availability
of these implants, as well as from those who felt the devices were unsafe and urged
FDA to remove them from the market.
The panel's deliberations resulted in a series of conclusions and recommendations.
First and foremost, they concluded there were not sufficient data about the risks
and benefits of these devices. Basic questions were unanswered regarding the chem-
ical properties of the silicone gel, the physical properties of the implants, including
the uiefl, and the possible acK^erse effects of implants. The panel agreed with the
assessment of FDA scientists that the clinical data provided in the applications were
not adequate to allay safety concerns. Panel members expressed the view, however,
that the devices appeared to serve what could be viewed as a public health need.
They recommended, therefore, that silicone gel-filled breast implants continue to be
available under specified conditions, and that a patient registry be established while
62
manufacturers collect additional data. They also urged FDA to hold manufacturers
accountable to collect the additional data without delay.
After the meeting concluded, FDA became aware of information about the im-
plants that was not available for presentation to the panel.
First, FDA received a large volume of documents that suggested that adequate
quality control procedures were not in place to prevent ssSeiy problems, that animal
safety studies were not consistently completed or even undertaken before the prod-
ucts were promoted for use in women, and that indications of problems — including
implant rupture, gel bleed and migration, and contracture — ^haa been evident years
eariier. In addition, FDA was advised that some physicians and researchers were
suggesting an association between connective tissue disorders and breast implants.
The Agency contacted a large number of physicians who specialize in diseases of the
immune system. These individuals confirmed that there was a concern regarding a
possible link between silicone gel implants and the development of one of these ous-
eases.
We became convinced of two things. First, consumers might be at greater risk
than we had anticipated earlier. Second, the advisory panel needed to revisit its rec-
ommendations in light of this new information. On January 6, 1992, therefore, I re-
quested a voluntary moratorium on the distribution or implantation of silicone gel-
filled breast implants until FDA and the advisory panel had an opportunity to con-
sider the newly-available information. The manufacturers agreed to comply with the
voluntary moratorium.
Shortly afler the moratorium began, another issue of significant concern came to
light: the phenomenon of "silent rupture." These were situations where implant rup-
tures were undetected by the patient. In the case of rupture, the gel has the poten-
tial to spread through neighboring tissues. When rupture occurs, the standard prac-
tice is to have the device surgically removed and replaced.
We re-convened the advisory panel for a second meeting on February 18, 19 and
20 1992, to review this new information and reach a decision regarding the future
availability of silicone gel-filled implants. The committee was asked to look at the
incidence and hazards of rupture and bleed, the possible link to autoimmune dis-
ease, and the industry's record on testing, reporting and marketing of these im-
plants over the last thirty years. The members expressed heightened concern re-
garding the safety of the implants. The panel recommended:
• That further use of implants be restricted to women participating in scientific
protocols. Women who need breast reconstruction should be allowed unrestricted ac-
cess to the protocols. The number of augmentation patients, however, should be lim-
ited to that needed to answer specific safety Questions about the implants.
• That epidemiological studies be conducted to assess the risk of autoimmune dis-
ease, though concluding that no causal link had been established between auto-
immune disease and silicone gel-filled breast implants.
• Women with breast implants, even if asymptomatic, should be checked regularly
by their physicians. Women should not be routinely x-rayed to check their implants
ii they are not having problems. If a woman with implants is in the age eroup
where regular mammograms are recommended, she should be sure to have them.
Special mammography techniques are necessary in order to detect breast cancer in
women with implants.
• Manufacturers must provide adequate preclinical data on the implants, such as
the chemical and physical characterization of the implant materials and their resist-
ance to stress and rupture.
At this point, the Agency had three options on how to proceed under the statute.
It could: (1) approve the applications; (2) deny the applications; or, (3) if there was
a public health need, allow continued availability of the products while the manufac-
turers supplemented their applications with additional scientific data.
Approval was not justified given the absence of data to support a finding of safety
and efficacy. Complete denial of the PMAs would have resulted in removal of the
products from the market, making them unavailable even to women who required
reconstructive surgery. A compelling case had been made that a public health need
existed for women seeking reconstructive surgery. The Agency, therefore, decided on
a combination of the second and third options, based on the indications for use.
The PMAs for implants used in breast reconstruction were held open to allow con-
tinued availability while the needed data were collected. Consistent with the panel's
recommendations, we required that women seeking breast reconstruction with these
implants enroll in scientific protocols so that the needed scientific information would
be obtained. The deadline for completing the submission of data and the Agency's
subsequent review, as defined in the medical device law, has been extended indefi-
nitely Dased on public health need. The data required to complete the review must
63
be collected by the manufacturers and submitted to FDA. To date, those data have
only been partially collected.
tne PN^s for breast implants used in augmentation were oflicially denied by
FDA. These devices may be used for augmentation only with an Investigational De-
vice Exemption (IDE) in an FDA-approved research study.
In either case, for breast reconstruction or augmentation, silicone gel-filled breast
implants are available only through clinical studies conducted under a protocol. This
is the way to answer the questions of women, doctors, and FDA, and those of our
advisory panel of outside experts, regarding the safety and eflectiveness of these im-
Klants. With these actions on the PMAs on April 16 1992, the moratorium ended,
lanufacturers can fulfill their legal, affirmative obligation to demonstrate the safe-
ty and effectiveness of silicone gel-filled breast implants by conducting the required
clinical studies.
CURRENT INFORMATION REGARDING THE SAFETY OF SILICONE GEL
Today I would like to give you an update on the safety of silicone gel breast im-
plants based on the published literature and respond to some of your questions
about silicone in general. The good news is that in the three years since 1992, im-
portant research on these products has been undertaken, some by FDA staff, on
some of the critical scientific questions. In these and other areas, more research is
still needed. FDA has worked with the industry and academic community to encour-
age needed research and to establish a research agenda.
Let me take you back more than three years, to review with you the kinds of
ouestions facing the Agency in early 1992. At that time, very little was known about
tiie safety of silicone gel implants.
The questions included:
• How frequently do these devices rupture or cause other local complications?
• What do we know about the relationship between silicone gel implants and auto-
immune (connective tissue) disease?
• What are the possible mechanisms of silicone gel-mediated immunological reac-
tions?
These questions are very important, and they are not easily answered. But we do
have much more information about some of them than we did three years ago. Vig-
orous research has been conducted over the last three and a half years that has pro-
vided a lai^r body of epidemiological, laboratory and clinical studies than pre-
viously existed. We now are begirming to get the kinds of studies that were unavail-
able in our earlier review of these products.
ITie safety issues that concern us fall into two categories: local complications
which, when they occur, we know are directly attributable to the breast implants.
Examples of local complications are implant rupture, capsular contracture, infection,
and surgical complications. With the second category oi safety issues — systemic dis-
ease— ^the association between breast implants and disease is more difficult to estab-
lish. Systemic diseases include auto-immune diseases, particularly connective tissue
diseases, such as scleroderma, lupus, and rheumatoid arthritis.
Let me first review what we now know about local complications.
DEVICE FAILURE AND LOCAL COMPLICATIONS
I am going to cite several studies that examine the rupture rate of breast im-
plants. FDAnas to be concerned about the durability of any kind of implant — ^how
long it lasts in the body, how often it fails, how frequently it has to be replaced,
and what are the consequences of failure.
I want to begin with an important point about rupture rate: today we still do not
know what the rupture rate is in women with silicone gel implants, or how that
rate changes over time. Several studies, however, suggest that the rate may be
much higher than the one percent rate manufacturers originally suggested, and that
the rate may increase as the implant ages.
The study that first elevated our concern on the rupture rate issue was conducted
by Dr. Ju<iy Destouet and her colleagues and published in 1992 in the American
Journal of Radiology.^ They retrospectively analyzed screening mammograms of 350
women with breast implants. In sixteen of the women — five percent — there was evi-
dence of implant rupture. It is very important to keep in mind that women in whom
^Destouet JM, Monseea BS, Oser RF, Nemecek JR, Young VL, Pilgram TK. Screening nrvam-
mography in 350 women with breast implants: Prevalence and findings of implant complica-
tions. AJR 1992; 159: 973-978.
64
rupture was suspected were specifically excluded from this study — ^the 5% percent
rate, then, was in asymptomatic women who did not suspect a rupture had occurred.
A more recent study was performed by Dr. O. Gordon Robinson, Jr. and others
and published in the Annals of Plastic Surgery in 1995.^ Of 495 women who con-
sulted with Dr. Robinson on their silicone breast implants, 300 women decided to
have them removed. The study focuses on these 300 women. In some cases the
women made the decision because they suspected an implant-related problem, and
in other cases the decision was made on the basis of a general concern about silicone
gel-filed implants. The investigators found frank ruptures in 154 or 51% of these
patients. In a total of 71% of the patients, they found either frank rupture, severe
silicone gel bleed, or both. They concluded that the likelihood of rupture increases
as the implant ages. As a result, Dr. Robinson recommends to his patients that they
have their implants removed prophylactically, preferably within eight years of im-
plantation— prior to rupture.
In another study of 31 women who had 51 implants removed, whether the im-
plant was ruptured was clearly related to the age of the implant.* Of those implants
aged 1-9 years, 35.7% were ruptured; of those aged 10-17 years, 95.7% had either
ruptured or were leaking silicone gel. In a similar study of 57 women who had 102
implants removed, of the implants aged 2-10 years, 25.6% were ruptured; of the im-
plants 11-26 years old, 53.6% were ruptured.'* These two studies are not representa-
tive of the rupture rate in all women with implants, but rather in women who are
going to their doctor because they are having problems with their implants. They
indicate, however, that the risk of implant rupture increases as the implants age.
Published studies to date suggest a rupture rate between 5 and 51% — an enor-
mous range — and unfortunately, we do not know with any confidence where within
that range the real rupture rate lies.
In addition to rupture rates, I want to mention one other complication that may
afiect the majority of women with implants: capsular contracture. This occurs when
the scar around the implant contracts. In its severest form, it may cause painful,
rock hard breasts. The frequency of this complication is unknown. Like rupture, re-
ports in the medical literature vary considerably but suggest that some degree of
capsular contracture may occur in the majority of women with implants.**
There are other local complications, including infection and surgical complications.
While some of these are of greater concern than others, we simply have no solid in-
formation at this time about their frequency.
SYSTEMIC DISEASES
Unlike local complications, which are clearly related to the presence of the im-
plant, there are a constellation of diseases that some suspect silicone gel breast im-
plants also cause. It is more difficult, however, to prove or disprove such a link. It
is only within the past year and a half that several epidemiologic studies addressing
this issue have been published.
The diseeises in question are a type of autoimmune disease called connective tis-
sue disease. Included in this category are very rare diseases, such as scleroderma
and lupus, and relatively more common conditions such as rheumatoid arthritis.
The two types of published epidemiologic studies on this subject are cohort studies
and case control studies. Cohort studies compare groups with the exposure of inter-
est— in this case breast implants — with an unexposed group, and assess whether the
rate of disease is different in the two groups. In contrast, case control studies take
patients who have the disease of interest and then compare the rate of exposure —
breast implants — to those who do not have the disease.
Each of these study types has its limitations. Cohort studies are most useful when
studying common diseases and are of limited use when the outcome or disease is
rare. Case control studies are used when the disease of interest is rare but the expo-
sure may be more common.
'Robinson OG, Bradley EL, Wilson DS. Analysis of explanted silicone implants: A report of
300 patients. Ann Plast Surg 1995;34: 1-7.
^deCamera D.L., Sheridan J.M., Kammer B.A. Rupture and aging of silicone gel breast im-
plants. Plast and Reconstr Surg. 1993:91;828-834.
* Peters W., Keystone E, Smith. Factors afTecting the rupture of silicone-gel breast implants.
Ann Plast Surg 1994;32:449-^i5I.
"Burkhardt BR. Capsular contracture: Hard breasts, soft data. Clinic Plast Surg 1988;16:521-
632.
65
The two largest cohort studies published to date are the Mayo Clinic study per-
formed by Dr. Sherine Gabriel and her colleagues^ and the Nurses Health Study
from Dr. Jorge Sanchez-Guerrero and his colleagues at Harvard.''
Dr. Gabriel's study was a population-based study of all women in Olmsted Coun-
ty, Minnesota who received a breast implant between 1964 and 1991 — a total of 749
women. These women were compared to similar women without breast implants.
The study found no association between breast implants and those connective tissue
diseases studied.
Dr Sanchez-Guerrero's study was based on a large survey of nurses that began
in 1976. It included 876 women with silicone gel breast implants. It also found no
increased risk of conunon connective tissue diseases in women with silicone gel im-
plants.
Neither of these studies, however, could rule out a small but significant increase
in risk for rare connective tissue disease nor could they fully answer the question
of whether the implants might lead to atypical symptoms related to the immune
system in some women.
The only published case-control study we are aware of that examines the associa-
tion between breast implants and scleroderma is by Dr. Helen Englert and her col-
leagues in Sydney, Australia.* It was published in the Australian / New Zealand
Journal of Medicine in 1994. This study involved women in Sydney who had
scleroderma or a related ailment. These women were compared to similar women
without the disease. The authors concluded that they had failed to demonstrate "an
association between silicone gel breast implantation and the subsequent develop-
ment of scleroderma, to a risk level as low as 4.5 with 90% power." This means that
this study was large enough to detect whether women with breast implants were
4.5 times more likely to have scleroderma than women in the population. But the
study was too small to document any smaller increase in risk. So while ruling out
a large increase in scleroderma, this study also was unable to rule out a small, but
signincant, risk of disease.
There are two important conclusions to draw from these studies. Based on the
published studies to date, we now have, for the first time, a reasonable assurance
that silicone gel implants do not cause a large increase in traditional connective tis-
sue disease in women who have those implants. This is particularly important for
those women who already have implants and have suffered from an absence of sci-
entific information on this subject. The second conclusion, however, is that these
published studies simply cannot rule out either a small but statistically significant
increased risk in traditional connective tissue disease or the risk of atypical disease.
Given the fact that an estimated one million women (an estimate still in question)
have received these implants, even one percent translates to 10,000 women. Thus,
for some women, we still do not have all the answers.
THE BIOLOGICAL ACTIVITY OF SILICOhfE GEL
It also is important to review the basic science related to the biological activity
of silicone gel. Recently published laboratory studies have focused on the potential
molecular mechanisms that might be a basis for autoimmune reaction triggered by
the silicone gel material in breast implants.
Let me briefly summarize some recent reports.
/. Antibodies to Silicone Gel
Development of an assay for antibodies to silicone gel is a difficult technical chal-
lenge, and there is still disagreement over assay reliability. Given this caveat, a sig-
nificant increase in anti-silicone antibodies has been reported in women with im-
plants compared with groups of women without implants.* There was no discussion,
however, of health problems in these women or a possible association between ad-
verse reactions ana anti-silicone antibodies. In another study, anti-silicone anti-
bodies were reported in two children who experienced an inflammatory reaction
•Gabriel SE, OTallon WM, Kurland LT, Beard CM, Woods JE, Melton LM. Risk of connective
tissue diseases and other disorders after breast implantation. NEJM 1994;330:1697-702.
^Sanchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE Liang MH. Silicone
Breast implants and the risk of connective tissue diseases and symptoms. NEJM 1995,332:1666-
70.
'Englert HJ, Brooks P. Scleroderma and augmentation mammoplasty — a causal relationship?
Aust NZ J Med 1994;24:74-80.
*Wolf, LE. Lappe, M. Peterson, RD et al. Human inrunune response to polydimethylsilaxane
(silicone): acreenmg studies in a breast implant population. FASEB J 1994; 7:1265-1268.
66
around implanted silicone tubing.^^ It was concluded, however, that antibodies like-
ly were not involved in the inflammatory reaction.
Neither these nor other studies, ^^ provide convincing evidence that anti-silicone
antibodies, if present, are responsible lor adverse effects.
2. Auto-antibodies to Connective Tissue and Other Proteins
With assays speciilcally designed to detect auto-antibodies to altered proteins, sev-
eral reports have provided evidence consistent with the hypothesis that proteins ad-
sorbed to gel can induce auto-antibodies to connective tissue and other proteins in
women with breast implants.^^ The question remains, however, whether these or
other auto-antibodies can induce clinical manifestations of disease. A recent study
on the relationship between auto-antibodies and silicone gel implants concluded that
'^ere is no conclusive evidence that silicone-gel implants are related to the develop-
ment of connective tissue disease." ^^
Mudi recent attention has been paid to auto-antibodies; less to other potential
mechanisms of autoimmunity involving the cellular immune response, cytokines
(soluble inmiune mediators), and effects of chronic inflanmiation. Although progress
has been made, additional well-controlled studies are needed to understand silicone
gel's biological activitv.
Let me also note that although most reports have focused on silicone gel, other
silicones — including low molecular weirfit contaminants and silicone oil that bleeds
through the elastomer shell — also are oeing studied in experimental animals. One
compound of particular interest, D4, was able to enhance the antibody response to
a foreign protein in experimental animals, but onl^ at levels exceeding those found
in implants.^* Gel bleed did not have detectable adjuvant activity.^*
Reaching a Final Conclusion on Safety and Efficacy
A second general topic of interest to the subcommittee involves when FDA will
be able to reach a final conclusion on the safety and efficacy of these devices.
Mr. Chairman, the short answer is: when the manufacturers submit data support-
ing their PMAs. That is quite simply because sponsors of medical devices, not the
FDA, generate data to support product approval. Until such time as a sponsor has
submitted a complete appbcation for marketing approval of a breast implant, and
there are adequate data to support the safety oi the implant, FDA cannot under the
law allow the general marketmg of silicone gel-filled breast implants. I also should
say that any marketing application needs to be product-specific. As part of our eval-
uation, we would need to examine the implant's specific design characteristics and
the way it is to be manufactured.
But that is hardly the entire answer. The FDA has stated publicly the kinds of
data we will be looking for in a maiketing application for breast implants. We have
done this specifically in a written guidance document for breast implants that con-
tain silicone gel. We also are developing guidance for implants that might be filled
with alternative materials, based on a major workshop on non-silicone gel implants
we held last October. It is fair to say that the data needs are well-known, involving:
chemistry, materials science, toxicology, and the clinical data on local complications
and systemic diseases, as described above, as well as the product's benefits. We need
sufficient data to evaluate the product's safety and prepare informative labelling for
surgeons and patients. The manufacturer also must be able to establish adequate
quality systems in its manufacturing of the product and pass an on-site FDA inspec-
tion. We have been working closely with manufacturers and with the academic com-
munity to encourage studies that will provide the information needed on the safety
of these products.
OUTREACH TO WOMEN
The uncertainty about the safety of breast implants is alarming, naturally, to
women who have or may consider implants. The FDA, as a consumer protection
agency, takes their concerns very seriously and has undertaken the following initia-
"Goldblum, RM. Pelley, RP, O Donell, AO. et al. Antibodies to silicone elastomerB and reac-
tions to ventriculoperitoneal shunts Lancet 1994z: 340;510-513.
iiVqjdani, A. Brautbat, N. Campbell, AW. Antibody to silicone and native macTomolecules in
women with breast implanU. Immunopharmacology and Immunotoxicology 1994;16(4): 497-523.
"Kossovsky, N. Teuber, SS. Rowley, MJ. Yoehida, SH. Anti-collagen autoantibodies are found
in women with silicone breast implants J Autoimmunity 1993; 6:367-377.
"Peters, W. Keystone, E. Snow, K. Rubin, L. SmTth D. Is there a relationship between
autoantibodies and silicone-gel implants? Ann Plast Surg 1994: 32;l-7.
"Mykken, PC, White, KL Jr. The adjuvancy of silicones: Dependency on
compartmentalization. Current topics in micro & immun 1^5: In press.
67
lives to both educate consumers with the latest information about implants and en-
sure their participation in the debate.
• In September 1991, FDA published a notice in the Federal Register requiring
manufacturers to relay to physicians information on the risks of breast implants.
Physicians then would be better able to advise their patients before having implant
surgery. I met with consumer groups, health professional groups and manufacturers
to (uscuss this notice.
• Over sixty consumers and consumer rejpresentatives testiiied at the 1991 and
1992 panel meetings on breast implants. Each panel had two members who rep-
resented diflerent perspectives from women with implants.
• Following the panel meetings, the Agency established an 800 telephone line
dedicated to questions about breast implants. Between February and June 1992,
over 40,000 women used this line. Our Oflice of Consumer Affairs still maintains
it and receives approximately 75 calls per week.
• In 1992, the Agency developed Breast Implants: An Information Update, which
contains current findings about known and possible risks of implants, information
about their availability, advice for women with implants, and resources for further
information. It has been distributed to over 30,000 women. We have brought copies
of our July 1996 update for distribution at this hearing. It includes information on
the new published epidemiological studies on the question of connective tissue dis-
ease, as described above, as well as the new Patient Information Sheet for Women
Considering Saline-Filled Breast Implants, which physicians are to provide to
women considering them.
• The Agency reached out to approximately 350 consumer groups for a public (Part
15) hearing on saline breast implants held in July 1994. Twenty-seven consumers
and consumer representatives testified.
Throughout this controversy, the Agency has met repeatedly with representatives
of patient groups to share information and improve our awareness of the needs and
concerns of these women. In addition, we have written articles for newspapers, pro-
fessional journals, women's magazines and the FDA Consumer to provide farther in-
formation to women and their physicians. We have issued press releases,
badcgrounders and talk papers. We will continue to use these and other vehicles to
communicate to the public the most current information about breast implants.
Mr. Chairman, that brings me to the other areas of interest to you and your col-
leagues: the development and availability of new biomaterials — and of new medical
devices. Let me turn to my colleague. Dr. Bruce Burlington, who is in charge of
FDA's medical device program.
SAFETY OF SILICONE BIOMATERIALS
The next question we would like to address is the safety for biomaterial use of
the broad class of materials known as silicones. Silicones are a large family of poly-
mers. What thev have in common, as you can see from the attached chart, is that
they are all made from a monomer building block called siloxane. They can be sub-
stituted with a wide variety of side chains, they can be linked in different ways,
and they can have a lot of different elements like phosphorus or nitrogen, attached
to the side chains.
Their chemistry is almost as complex as the carbon-based chemistry we call or-
ganic diemistry. These many silicones are very versatile materials.
In our discussions of silicone materials and devices, keep in mind there are three
broad families of these materials— oils, gels, and elastomers. The lower molecular
wei^t products are called oils. The mid-molecular weight products with some cross-
links are called gels because they have the consistency of gel at room temperature.
More highly cross-linked products are called elastomers. An elastomer is the so
called "silicone rubber" we see used in lots of ways, such as the pads in the
nosepieces of eyeglasses.
The different silicones have been found to be very valuable in medicine. There are
over 165 types of devices in which one or another silicone is used. These products
vary from silicone rubber eyeglass pads to urinary catheters to waterproof coverings
for pacemakers and pacemaker wires, to shunts used to treat hydrocephalus.
Silicone oil is used to lubricate essentially all disposable sjrringes, including insu-
lin and vaccine sjringes. Other oils are used to treat potential blindness from ret-
inal detachment by being injected into the eye to help nold the retina in place. Sili-
cone oils, gels and/or elastomers are used in plastic surgery implants for chins,
small joints of the hand, and of course, for breast implants. Silicone elastomers and
oils predominate in approved medical product use; silicone gel is used in a very
small number of products.
68
The breast implants which Dr. Kessler has discussed are composed of a silicone
elastomer envelope flUed with either silicone gel or saline.
Do we have the same level of concern about all silicone materials? The answer
is no. In fact, we have drawn a clear distinction between the use of approved sili-
cone oils and elastomers in medical devices, on the one hand, as compared to the
use of silicone gel, on the other. Our policy, as well as our practice, is based on our
conclusion that there have been far fewer concerns raised about the potential risks
associated with the use of approved silicone oils and elastomers than with silicone
gel. We continue to clear for marketing many medical products containing silicone
elastomers or oil, consistent with our higher level of scientific confidence in them.
Our level of confidence or concern is dependent on where experience or research
has raised questions and on the information we have about the answers to these
questions. For example, with approved silicone oU, we have data from prospective
safety and effectiveness studies for retinal tamponade. These data provide a reason-
able assurance of the safety of approved silicone oils, reasonable in the context of
its use and its benefits in that use. We also have looked at extractable chemicals
and data from animal studies and human experience with implants filled with sili-
cone gel as opposed to the implants which are a silicone envelope filled with salt
water. These studies show there are distinct differences in the total amount of key
chemicals that get into the body and, hence, to which patients are exposed. For ex-
ample, one of the silicone chemicals, D4, which has been identified as
immunologically active in animals, is 500-fold lower in the saline-filled silicone elas-
tomer envelope than in the silicone gel-filled implant. Thus, the different degrees
of exposure and different types of silicone pose different levels of risk.
One specific area where biological effects have been assessed is with the contra-
ceptive implant, Norplant. This product is a piece of closed tubing of silicone elas-
tomer filled with crystals of drug that delivers the drug over a 5-vear period. The
biological safety of the tubing has been studied in laboratory and. animal toxicity
tests. The silicone materials caused the expected local reactions but tests to detect
immunologic reactions were negative. In audition, reported cases of autoimmune or
potentially immune-related disorders among women using Norplant are consistent
with the expected rate in this population. With this product, however, there are
local complications that can arise and these are described in the patient package
insert.
BIOMATERIAL AVAILABILITY
Let me turn to a discussion of product availability and potential shortages of
these useful products. FDA has publically expressed concern about the potential for
shortage of raw materials which might result if materials suppliers no longer sell
to this industry. Dow Coming announced in December 1992 that, efTective March
31, 1993, it would no longer sell certain silicone materials to medical device manu-
facturers. The list of materials to be withdrawn has slowly expanded since that
date.
The Agency and the device industry, and particularly Health Industry Manufac-
turers Association (HEMA), met several times in the winter of 1993 and have
worked closely together to develop a policy on alternative materials suppliers. For
most materials, where description of tne materials specifications are clear, the com-
pany can ascertain on their own authority that alternate suppliers meet their needs.
For more complex materials, such as silicone, FDA needs to look at the data. With
silicone, we looked at data submitted in master files allowing us to review the data
quickly, yet avoid requiring individual 510(k) submissions.
For silicone materials, because of the concerns discussed earlier in the presen-
tation, FDA and the industry developed a policy, announced in the Federal Kegister
in June 1993, to facilitate access to alternative suppliers. This policy is based on
core but minimal testing by the industry, and expedited review by FDA.
While Dow Coming continued to market to a limited number of manufacturers
under special arrangements, the marketplace has changed. Two new companies,
Nusil and Applied Silicone, have come forward as alternative suppliers of silicone
raw materials. A great number of substitutions of materials suppliers has taken
place with the resmt that we have not had a shortage or withdrawal of critical prod-
ucts.
In particular, we have only a single group of products where we have needed to
go beyond this minimal level of testing. Shunts for hydrocephalus, plastic tubes im-
planted into the ventricles of the brain to drain excess fluid and so prevent the com-
plications of hydrocephalus, are an application where silicone elastomers have clear
advantages. But we need to be especially careful of the accelerating agents and
other chemicals used in silicone manufacture because brain tissue is directly ex-
69
posed to the silicone. These shunts use valves to have the fluid drain out only and
to prevent reflux back into the brain. But, silicone elastomer, like other rubbers, can
get "stickjr" and can self-anneal dver time. We also need to be sure that the flap
valve has the right opening pressure and that the opening pressure does not change
during the storage life of the product or during the time tne product is implanted.
In this instance as well, we are working with manufacturers to accelerate testing
and to ensure an uninterrupted flow of products for this critical use.
I also would like to address the more generalized questions about the relationship
between our review of silicone breast implants and the other products we review.
Fortunately, breast implants are an atypical product example. Most products do not
have a histoid of use by a million patients oefore we flrst look at the marketing
application. Most do not raise questions of rupture, bleed and systemic disease, and
most have beneflts describable in clearer health-related terms.
The general structure for evaluation of the risk/beneflt of products are derived
from the statute. We look for beneflts that are greater than risks. When we evaluate
beneflts and risks, that evaluation is based ujpon valid scientiflc evidence. We also
need to take implicit risks into account when there is not data to address them. This
structure proviaes the Agency with the necessary flexibility to deal with the huge
array of products we regmate. They cover the entire spectrum of risks from products
used with life and death risks, such as implantable deflbrillators, to uiose as
straightforward as tongue depressors.
In summary, silicone is not one thing, it is many. The silicones used in a wide
array of medical products are oils, gels and elastomers, although use of oils and
elastomers predominate. We have good reason to have confldence in the continued
marketing of he many products containing silicone elastomers or oils. The Agency
and the industry are working together to assure the continued, timely supply oi crit-
ical medical products while addressing the potential health consequences of looking
at new manufacturers for these materials.
Mr. Shays. In a hearing like this I try to ask myself, what is the
bottom line? And I have come to the conclusion as it relates to
FDA, Dr. Kessler, that the bottom line is that nothing gets re-
solved, whether it's food additives or this issue. And when I read
through your entire testimony, I was still left with the feeling when
are we going to have a decision, when is there going to be some
resolution.
Now, in fairness to your department, breast implants were on
the market and then we passed a law in 1976, that says you have
to regulate them, it was absurd in a sense to have a premarket re-
view when the device is already on the market. But in both your
testimony, I am very unclear as to what is in vour mind-set in
terms of how this gets resolved and when? And I d like you to ad-
dress that.
Dr. Kessler. Mr. Chairman, let me— can I just ask one clarifying
question, so I understand?
Mr. Shays. You can ask any question.
Dr. Kessler. When you say when will it get resolved, there are
several questions for women today who have the implants, for
women today who want the implants, what is the regulatory, as far
as marketing decision, those are different questions. And I just
want to make sure I'm answering exactly what you are asking,
when you say when will it get resolved?
Mr. Shays. It's a very fair question. The challenge that I have
in general is that with food additives we go back 20 years and deci-
sions haven't been made, even though the statute says they should
be made within 180-days. In this instance how do you see it play-
ing out as it relates to breast implants? Are you waiting for appli-
cations? Are you acting on applications? Are you governed by Fed-
eral requirements to make a decision in 180 days? In your own
mind, what brings this to a conclusion?
70
Dr. Kessler. The regulatory legal status, as you mentioned, is
complex, in part because these were pre-amendment devices.
Mr. Chairman, this is very different than a food additive petition
where there is an application with all the data where the manufac-
turer has submitted all the data and then is awaiting FDA ap-
proval.
It is the responsibility of the manufacturers or the sponsor to
submit data. We in 1992, issued guidance to manufacturers of what
we would require after we lifted the moratorium, aft<er we allowed
these devices to be used with informed consent in clinical trials,
after the initial questions of the panels had been raised. We looked
at it again in 1994, and reviewed it again in 1995.
That guidance sets out the kind oi information that is necessary
to answer basic questions, such as how long these devices last,
what percent rupture, what are the consequences of those rupture.
It is incumbent upon the manufacturer to submit that data.
Technically the PMA's submitted in 1992 — because these were
pre-amendment devices — were left open for breast cancer. Cosmetic
use requires an IDE. In essence, the bottom line is it's the respon-
sibility of the manufacturer to submit data.
We do not have, if I'm correct. Dr. Burlington, any supplemental
data that has been submitted to the agency today.
Mr. Shays. Is the bottom line, that the ball is in the manufactur-
er's court?
Dr. Burlington. Mr, Chairman, the manufacturers need to pro-
vide us with product specific information as well as general infor-
mation. The general information which we have heard earlier testi-
mony about is certainly part of the answer.
Mr. Shays. Let me cut through this. Do you have an application
and do you need an application from a manufacturer?
Dr. kkssLER. We need the data from manufacturers.
Mr. Shays. OK. Do you have an application from the manufac-
turers?
Dr. Kessler. There are applications pending that were left open
to provide women access to the devices. Those applications need to
have the data.
Mr. Shays. Whose applications would those be?
Mr. Levitt. When we acted on the applications there were two
companies' applications that were denied, in part, for argumenta-
tion purposes.
Mr. Shays. What companies were those?
Mr. Levitt. And in part extended for reconstruction. The two
companies are No. 1, Mentor Corp. and. No. 2, McGann Medical
Corp.
Mr. Shays. So you have two companies technically that have ap-
plications pending. The other companies do not have applications.
Was that because they were already in the business or were they
withdrawn?
Mr. Levitt. The other companies* applications were withdrawn.
Mr. Shays. OK. Now, do you have any requirement to act on
these applications in a specific time?
Mr. Levitt. No. The statute provides that the review period may
be extended to provide availability of the implants while additional
data is being conducted.
71
Mr. Shays. Is it being conducted?
Dr. Kessler. There is one prospective study that I have knowl-
edge is being conducted b^ one company. I think some 12,000
women have been enrolled m that study. I think the study started
around 1992 or 1993, again, by one company.
Mr. Shays. I get the sense from your testimony that you're less
concerned about the bleeding of silicone than you are about the
rupture, and you put more emphasis on the severity of a rupture,
and that you're putting more of your focus and concern on the rup-
ture; is that accurate?
Dr. Kessler. There's two — there's always — the questions that we
asked the panel in 1992.
Mr. Shays. Dr. Kessler, could you iust answer the question more
simply. Are you more concerned about the rupture or are you
equally concerned? What's the answer?
Dr. KESSLER. I am concerned about rupture.
Mr. Shays. The reason I ask the question is you seem to point
out that the failure rate of this device is quite significant.
Dr. Kessler. May be, Mr. Chairman. I don't have good data. I
have several published studies that I cited. None of them in my es-
timation are good studies. They certainly raise concerns.
Mr. Shays. Is it the obligation of the manufacturer to provide
you with those studies?
Dr. Kessler. If they want an approved application, the answer
is yes.
Mr. Shays. So should I draw any inference from Mr. Traficant
that if a company wants a study and they ask for it to be done that
they pay for the study?
Dr. I^SSLER. Yes.
Mr. Shays. Yes, what? That's their requirement to do that?
Dr. Kessler. We have a private system of device development in
this country. Yes, the companies do the studies and then we go in
and audit those studies.
Mr. Shays. So if you have a university that is conducting a study
and you have the manufacturer that is providing the funding, that
is a common practice accepted and in fact encouraged by FDA?
Dr. Kessler. That's the way we study devices and drugs in this
country.
Mr. Shays. My time has ended right now, but I'm going to come
back to the issue of when you believe this issue will be resolved.
Because I believe the FDA and the manufacturers have gotten very
used to a situation whereby if they don't think an application is
going to be approved, they just ask you to slow down and whether
it's food additives or whether it's breast implants. I bet 10, 15 years
from now, you could be the witness and you'd be saying almost the
same thing. That's my concern.
And at this time I would ask the ranking member of my sub-
committee and then we'll go to you, Mr. Mcintosh.
Mr. Towns. Thank you very much, Mr. Chairman.
Dr. Kessler, let me again thank you for coming. Would it be un-
reasonable to ask the FDA to allow use of silicone breast implants
outside of clinical trials, making the product available to patients
who have given their informed consent? Would that be unreason-
able?
72
Dr. Kessler. ConCTessman, we are making them available to
women with informed consent. There is open availability so women
can get them. I mean, these are not controlled trials where the
women are randomized. These are open availability studies. Be-
cause of that there is access for these women with informed con-
sent.
The advantage of doing it that way is that it does get the data.
Now, I'm talking about women with breast cancer.
Mr. Towns. Right. Let me ask you a question which is — I want
to make sure I understood it correctly. I tnink a witness before you
this morning indicated that the advisory panel indicated one thing
and that you made the decision to do something else. I'm talking
about the moratorium, that the advisory panel actually made a rec-
ommendation and you ignored their recommendation and called for
a moratorium; is that correct?
Dr. Kessler. Let me be very clear what the November 1991 rec-
ommendation was. That first panel said the manufacturer's data
were insufficient to establish the safety and effectiveness of breast
implants. It did go on to say because there is a public health need
for these devices exception, that we should use that public health
need exception to continue to make these devices available and
that information about them should be gathered. But the first
panel concluded the manufacturers had not in fact established the
safety and effectiveness of these devices.
It then went on to say they should be available under the public
health need. Then the now-infamous Dow documents become avail-
able. We reconvened the panel, the panel again said there was in-
sufficient data and said at this point the devices should be avail-
able in controlled trials so we get the data.
Mr. Towns. Let me ask you this, let me put it this way. How
many times, Dr. Kessler, have you gone against the advisory panel
on any issue? You've been around now how many years?
Dr. Kessler. I'd have to submit that for the record. I had an ad-
visory panel several months ago recommend that I release blood
knowing that people who had Creutzfeldt-Jackob disease had in
fact donated blood. They said the blood should be released. I had
certain questions about that. I contacted the CDC and, they raised
certain questions as well. I convened another panel.
But the exact percentage. Congressman, I can't tell you off the
top of my head.
Mr. Towns. Does it happen a lot?
Dr. Kessler. It doesn't happen a lot, but I have in fact in certain
instances convened second panels.
Mr. Towns. But you have no idea until — ^you really don't know
how many times you've done that?
Dr. Kessler. I can't give you an exact number. We would have
to look at it. Sometimes it takes a number of panel meetings on an
issue before we resolve it.
Mr. Towns. Maybe I'm not asking the question correctly. What
I'm saying is this, is that if you have a panel and a recommenda-
tion is made by the panel, do you ignore the recommendation that's
made by the panel and decide in terms of what you want to do or
do you — they did not say what you want them to say, then you go
out and get another panel? I mean, that's the question. Dr. Kessler.
73
Dr. Kessler. The issue, Congressman, is if you have new evi-
dence or there are new concerns. For example, with respect to the
incident I mentioned the CDC raised significant concerns and I
convened a second panel. So new information certainly convene sec-
ond panels.
Mr. Towns. I don't want to just sort of keep pushing that point,
but I think that it is something that I would like to, Mr. Chairman,
to ask that we hold the record open to receive that information. I
think it's very valuable in terms to this discussion.
Mr. Shays. Are you clear as to exactly what is being asked?
Dr. Kessler. Right.
Mr. Shays. Because we will make sure we follow up on it.
Dr. Kessler. Sure. I'd be happy to submit that for the record.
But the first panel concluded that the evidence was not sufficient
and said there should be availability under the public health need.
Mr. Towns. I'm talking about a situation wherein if the panel
states, this is what we recommend, how many times have you ig-
nored what they have recommended?
Dr. Kessler. And, again, I would be happy to submit that num-
ber for the record.
[The information referred to follows:]
Under no circumstances has the Agency "ignored" the recommendation of one of
its advisory panels. There are many instances in which final Agency action does not
conform to official panel recommendations. In most such instances, however, prior
to taking final action, the Agency addressed the concerns expressed by the panel.
The following information, covering panel meetings that occurred within the last
five years, are instances in which final Agency action did not conform to the advi-
sory panel recommendation. This includes instances in which the panel's concerns
in making the reconmiendation were addressed by the Agency.
This list cannot be considered exhaustive because there is no system of record-
keeping in place specifically linking final Agency actions to the recommendations.
The information was compiled from the institutional memories and limited records
of the panel Executive Secretaries.
To put this information in perspective, over 450 panel meetings have occurred in
the last five years,
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
Blood Products Advisory Committee
• 12/94 — FDA presented to the BPAC data regarding cases of blood donors infected
with Creutzfeld-Jakob Disease (CJD). Panel members recommended the retrieval of
in-date blood components and notification of recipients, but recommended against
retrieval of plasma derivatives or notification oi recipients of those derivatives,
based on a remote risk of transmission. Due to concerns expressed by the hemo-
philia community, FDA convened a Special Advisory Committee on CJD that met
in June, 1995. Inat panel recommended that all blood products be withdrawn and
all recipients notifiea. FDA subsequently issued guidance to the industry reflecting
the recommendations of the Special Advisory Committee.
• 6/95 — Nine of fifteen members present were of the opinion that donor screening
for HIV-1 antigen is not likely to provide a significant public health benefit which
outwei^s the potential risks. FDA recommended that blood establishments should
implement donor screening for HIV-1 antigen screening because of the benefit that
it will provide to a small number of blood product recioients, as a partial preventive
measure against the possibility of any increase in HIV-1 "window period" donations
and to decrease the virus burden in plasma pools for fractionation.
CENTER FOR DRUG EVALUATION AND RESEARCH
Nonprescription Drugs Advisory Committee
• 6/1/93 — At a joint meeting with the Arthritis Committee, the panels rec-
ommended against over-the-counter (OTC) status for naproxen sodium. Based on
comments from the members, changes were made in the labeling of the product and
FDA approved it for OTC marketing.
74
• 7/29/94 — At a joint meeting with the Gastrointestinal Drugs Advisory Commit-
tee, the panels recommended against OTC status for famotidine for heartburn until
certain questions were resolved. Ailer resolving the questions, the Agency gave its
approval.
Cardiovascular and Renal Drugs Advisory Committee
• 3/25/94 — The panel recommended approval of Rythmos (propafenone), condi-
tional on further review of a major clinical trial. The study failed under subsequent
review and the Agency did not approve the drug.
Gastrointestinal Drugs Advisory Committee
• 7/28/94 — The panel reviewed an NDA supplement for Actigall for primary biliary
cirrhosis. They recommended approval if a reanalysis of certain aspects of the data
supported it. On reanalysis the results did not support approval ana the Agency did
not approve the supplement.
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Gastroenterology and Urology Devices Advisory Committee
• 4/5/90 — The panel reviewed a PMA supplement for a Teflon paste used for treat-
ment of urinary incontinence in adults sixty or older, recommending conditional ap-
proval. Based on a re-review of the data, performed in development of the Final Re-
Krt of the Committee for Clinical Review Based on a Review of Selected Medical
ivice Applications, FDA determined that the data submitted in the PMA did not
meet the standard of valid scientific evidence. This was because the data came from
only one investigator who had been using the product in his practice for this new
indication. The Agency issued a not approvable letter stating that a more controlled
trial would be necessary to support approval.
General Hospital and Personal Use Devices Advisory Committee
• 3/5/91 — The panel deliberated on a PMA for an Infiisaid programmable,
implantable infusion pump indicated for the treatment of liver cancer. The panel
recommended approval with conditions. FDA later determined that there were sig-
nificant deficiencies in the variation of the pump's flow rate, which could adversefy
affect safety and effectiveness. This information had not been presented to the
panel. FDA, therefore, did not approve the PMA.
• 3/5/91 — The panel deliberated on a PMA for an infusion pump by Therex, Inc.
for specific indications and recommended approval with conditions. Upon closer ex-
amination of the data, FDA identified some significant deficiencies in the design of
the pump that resulted in catastrophic failures of the device. FDA did not approve
the PMA.
Clinical Chemistry and Toxicology Devices Advisory Committee
• 11/4/91— The panel recommended approval for the PMA for the AWARE OTC
urine specimen collection container witn mailing tube and laboratory screening for
drugs of abuse. The decision was subsequently reviewed by staff within the Office
of the Conmiissioner, who overruled OTC distribution. It was their opinion that the
panel meeting was not adequately represented by advocates of children's rights,
consumer groups and drug treatment professionals. A new panel meeting was pro-
posed whereby these additional concerns could be addressed. The sponsor declined
to invest the additional resources that would be required for a meeting of this scope.
The Agency issued an approval restricted for professional use.
Ophthalmic Devices Advisory Committee
• 4/19/90 — ^The panel reviewed a PMA for a posterior chamber intraocular lens and
recommended approval with a condition for a post-approval contrast sensitivity/
glare study. The Agency did not concur with the panel's reconunendations because
we believed the data were necessary before a final decision on the application could
be made. The Agency issued a non-approvable letter stating this.
• 4/19/90 — The panel reviewed, for the second time, a PMA for a silicone posterior
chamber intraocular lens and recommended approval with conditions. FDA believed
there was not adequate scientifically valid evidence to support the approval rec-
ommendation. We were concerned about a high lost-to-followup rate in the data pre-
sented to support safety, a lack of information on the effect of YAG capsulotomy on
lens dislocation, and inadequate data to be presented in the package insert. The
Agency issued a non-approvable letter.
• 1/23/92 — The panel recommended approval of a PMA for a posterior chamber
intraocular lens with multifocal optic. FDA believed the application lacked safety
and effectiveness information regarding contrast sensitivity. "The panel did not thor-
75
ou^ly review and discuss all the issues related to the contrast sensitivity. FDA is-
sued a not approvable letter to the sponsor.
Hematology I Pathology Devices Advisory Committee
• 6/7/93 — The panel reviewed a PMA for the Cytyc Corp. Thin Prep Processor and
recommended approval. After a subsequent inspection, the company withdrew the
PMA.
Dental Products Advisory Committee
• 10/13/94 — The panel met to discuss several issues, including classiflcation of
muscle monitoring devices. During the deliberations, the panel discussion expanded
to include sonographic muscle monitoring devices. The panel unanimously rec-
ommended the devices be placed in class III. Two manufacturers of sonographic
muscle monitoring devices claimed harm because of: 1) inadequacy of public notice
regarding the classiiication of the devices; 2) biased selection of consultants to the
panel; 3) the unbalanced views of the speakers; and 4) a conflict of interest on the
part of the Chairperson. The Agency decided to set aside the recommendations of
the panel and re-examine the classification of muscle monitoring devices at a future
meeting of the panel.
Clinical Laboratory Devices Advisory Committee
• 5/1/95 — The panel voted (five to four) to require, as a condition of PMA approval,
that the sponsor for the ChemoResponse assay conduct additional reproducibility
tests at five to seven sites or reanalyze the data. The DCLD PMA Team asked the
sponsor to conduct inter-site reproducibility tests at three sites.
Device Good Manufacturing Practices Advisory Committee
• 5/29/91 — The panel recommended the Agency adopt verbatim ISO 9001 as the
standard for GMP compliance, adding elements FDA believed were important but
not addressed bv the standard. The Agency later determined it could not adopt ISO
9001 verbatim because a review of me language revealed potential enforcement
Sroblems. In addition, it is a copyrighted document. FDA deaded to revise its own
rMP regulation, incorporating provisions contained in ISO 9001.
NATIONAL CENTER FOR TOXICOLOCICAL RESEARCH
Science Advisory Board
• 11/16/93 — The full Board approved a draft report on the Nutritional Modulation
of Risk and Toxicity Program, which recommended that we separate and manage
the Program as two individual activities. After a review by NCTR management,
FDA decided to continue managing the two activities as a single program due to
the uncertainty of funding for one oT them, the Project on Caloric Restriction.
FDA ADVISORY COMMITTEES BY CENTER
Center for Bioloncs Evaluation and Research — 4
Center for Drug Evaluation and Research — 17
Center for Devices and Radiological Health — 19
National Center for Toxicolo^cal Research — 2
Center for Veterinary Medicme — 1
Center for Food Safety and Applied Nutrition — 1
Mr. Towns. That's clear. Mr. Chairman.
Mr. Shays. Yes. That's very clear. And, also, if you would state
what they are.
Dr. Kessler. Sure. I'd be happy to.
Mr. Towns. Let me just ask one more question, very quickly be-
fore I move on.
Dr. Kessler, in your testimony you suggest that the FDA will
only be able to make a final conclusion on the safety of silicone
breast implants when manufacturers submit additional data to
support their pre-market approval application. The problem I have
with that is many companies have no interest in financing further
studies because liability concerns have scared them out of the mar-
ketplace. Do you have any suggestions as to how you might encour-
age research? I think that that has to be a concern.
76
Dr. Kessler. Congressman, I think that is a very important
question that you asked. When there are important public health
questions and there isn't a company whose interested in doing the
research or producing a product, I think that there is a responsibil-
ity on the Federal Government, if it's an important public health
question, to get the answers.
For example, the NCI is doing a large study now on breast im-
plants, but the Federal Grovemment can always do more. I found
myself in a situation a year or two ago where no company was in-
terested in making certain drugs for tuberculosis, and we have an
increase in drug-resistant tuberculosis. There wasn't the incentive
to do that. We stepped in, we had to find somebody.
I don't manufacture drugs. I don't manufacture devices. I don't
test them myself. We do a little research, but we're really not pri-
marily a research organization, but we do work with our sister
agencies, the NIH, for example, and there certainly can be more
Federal research into important public health questions.
Mr. Towns. Well, you know, in closing out, what would you advo-
cate that we do. Let's switch the roles for a moment.
Dr. KESSLER. Just help me understand this. Specifically, get
more information and more data.
Mr. Towns. And encouraging research.
Dr. Kessler. Encouraging research into silicone. I think that
with the litigation environment, the research is not being pursued
in quite the way that many people would like, I think it s reason-
able to ask for more of a Federal presence in doing that research.
You need to understand, Congpressman, there has been a lot of
research, in the last couple of years. We know a lot more now than
we knew in 1991 and 1992, and a lot of the research that's been
done has been good. But there is certainly — there is no question
that more research certainly would be very helpful and very helpful
to us.
I would like very much to be able to answer the chairman's ques-
tion of when would I have the answers, but the problem is, I don't
do the major research myself, so I don't control that.
Mr. Towns. Thank you very much, Mr. Chairman.
Mr. Shays. With leave of the committee, I just want to just fol-
low up that point. That's where I have a problem with the FDA,
because I think it's incumbent on you to suggest exactly what you
need. I mean, we're really in this catch-22 situation as pointed out
by the gentleman here.
You have helped stimulate concern about what's happening.
There are court cases that are in process. You are not going to have
manufacturers seeking to get into this business. They're not going
to want to do the studies, but you're saying they have to do the
studies. So when I come back to my questions, I want to know spe-
cifically what you need in order to make a decision, and if there
are others around you who can get that answer in that time.
Mr. Mcintosh.
Mr. McIntosh. Thank you, Mr. Chairman. Let me start out by
saying that I don't think our concern here is whether manufactur-
ers can manufacture this product so much as whether women will
be able to have the product available to them when they need it.
/
77
And I did a quick count of the room and noticed that there were
about 86 women here presenL I may have miscounted one or two
so it could be off. If they are correct that 1 in 8 has an expectation
of getting breast cancer, that means that potentially 10 people here
to<my will suffer from breast cancer.
Now, if any one of them is reluctant to go and get a mammogram
or reluctant to get a surgery as Dr. Ganske and Mrs. Lloyd men-
tioned was possible, then I think we've done a terrible disservice
to them and every woman around the country. I think it's impor-
tant for us to note what this question, about it's the responsibility
of the manufacturers to do research, is really all about.
I mean, I think it's a dodge of the responsibility that all of us
have as government officials of reassuring people about the safety
of this particular procedure. And we heard from Dr. Ganske that
local complications are inherent in any surgical procedure. We
heard from Dr. Ganske that the studies, 17 studies, show that
there wasn't £iny connection between systemic diseases and breast
implants. And as far as I can tell, the record shows there aren't
any studies that ever indicate there is a serious connection between
those.
It looks to me like we're being asked to study this, literally, to
death in order to prove something that is perhaps statistically
unprovable. And I think the chairman's question is a good one, how
many more studies will we need all of which conclude that there
is not a connection before the agency is willing to make that state-
ment and go forward with the product approval?
Dr. Kessler. Congressman, you didn't ask Dr. Ganske, or no one
asked Dr. Ganske, how long these devices last, what percent fails
what are the consequences of that. You focused on autoimmune dis-
ease, and there has been good research on that, but the guidance
that we issued in 1992, on what we needed to know to be able to
answer the very important questions for women who have these de-
vices in them today, involves research on all those questions.
Mr. McIntosh. Let me interrupt you for a second, Dr. Kessler.
I think that is a red herring. I think that if you've got a chance
that somebody is going to avoid treatment for breast cancer, we
ought to let them know we don't know how long this will last. We
don't know whether there is a chance that a certain percentage of
them will disintegrate, but we do know that it is available today
and that there are women out there who have had this implant in
the past £ind they have lived perfectly healthy lives.
And we do know that all of the studies to date show that there
is no connection between some other disease.
Dr. Kessler. Congressman, we have worked very hard to encour-
age over the last year — ^you gave us responsibility for ensuring the
quality of mammography facilities and mammography awareness.
Every woman, certainly, who is in the appropriate age gproup and
younger women who have the risk factors should have a mammo-
gram. There are a lot of reasons why somebody doesn't want to go
for a mammogram; it's scary.
Mr. McIntosh. Why hasn't the agency articulated that factor in
this whole issue? Why haven't we lookea at the relative benefits of
going forward in approving this product?
78
Dr. Kessler. In 1991 and 1992, clearly the risks and the benefits
were weighed. The manufacturer has to submit data both on the
risks and the benefits. The availability of these devices, especially
for women with breast cancer, is very important. And that's why
we've continued to make these available through informed consent,
but I've also insisted that as we do that we also get the data so
we can answer the questions.
Mr. McIntosh. But, I guess, let me turn back to my original
question. How many more studies will we need that show that
there is no connection between the diseases in order to have a
product approval?
Dr. Kessler. The number of studies that it takes to answer a
basic question of how long do these devices last, what percent rup-
ture, what are the complications of that rupture. That's what it's
going to take.
Mr. McIntosh. And how many is that, in your estimation?
Dr. Kessler. A few good studies could be sufficient to do that.
But today I'm sitting before you and I can't tell you with any de-
gree of confidence what the rupture rate is or how long these de-
vices last.
Mr. McIntosh. Why do you need to know that before you can
allow a woman to make that choice that is potentially lifesaving?
Dr. Kessler. How does someone make a choice if you don't have
information. In informed consent, at least you give some informa-
tion.
Mr. McIntosh. Now, Dr. Ganske tells us that all devices eventu-
ally wear out and break and that it is standard procedure to re-
place them when that happens.
Dr. Kessler. That certainly wasn't the impression back in 1991,
where the rupture rate was generally viewed at about 1 percent.
Women deserve to have that information as part of an informed
choice and we need to get that information.
Mr. McIntosh. My problem is that until then, we're not going
to send them a clear signal that it's safe to go forward with this
and that some women will choose not to go forward with the proce-
dure and that on a cost benefit analysis, we're doing more harm
than good.
Dr. Kessler. Which procedure?
Mr. McIntosh. To have reconstructive surgery or to have a bi-
opsy?
Dr. Kessler. But again, I just want to emphasize as strongly as
I can the need for early detection. I agree with you. There are a
lot of reasons why people are scared to go in for a mammogram or
a biopsy, and I am very sympathetic to that. But that doesn't mean
that one should allow a device on the market if you have questions
for which — and for which there aren't answers. I am not aware of
a decrease in the number — ^perhaps you are — who didn't go for
mammograms during the 3 months when we said there was a vol-
untary moratorium.
Mr. McIntosh. But what we did hear earlier today is that
women delayed going forward with the process to correct the prob-
lem and that they continue to do so if there is a fear that the de-
vice will not be available, it will be unsafe.
79
Dr. Kessler. Dr. Merkatz perhaps can answer this question
much better than I can, Congressman. But my understanding is
women don't go in for mammograms for a lot of different reasons.
Dr. Merkatz. Well, I think one of the most important reasons is
that women need to be assured that the mammogram that they
will have will be a quality mammogram, and that is one of the rea-
sons why many women came to Congress to testify, for improved
quality in mamographies.
Mr. McIntosh. But is it your opinion that one of the reasons
that they may delay detection or treatment is the uncertainty
about reconstructive surgery?
Dr. Merkatz. We asked that question at our advisory panel
meetings in November and in February in 1992, and we're not able
to obtain any data to substantiate that claim.
Mr. McIntosh. Have you seen any data since then?
Dr. Merkatz. No.
Mr. McIntosh. And were you listening to the testimony earlier
today by Dr. Ganske?
Dr. Merkatz. Yes, I was.
Mr. McIntosh. Is that not persuasive?
Dr. Merkatz. I believe that there are many reasons. Women are
more afraid of breast cancer than almost any other disease — and
women need to be encouraged in order to have this procedure done,
and we are doing everything that we can at FDA. For example,
we've just opened up a new hotline to help women find certified fa-
cilities in their geographic areas.
Mr. McIntosh. Were you persuaded by Dr. Ganske?
Dr. Merkatz. It is hard to be persuaded based upon my own
clinical practice of over 30 years in terms of why women choose to
have a mammogram or not to have a mammogram. It's a very com-
plicated issue.
Mr. McIntosh. I think he was saying that some patients decline
or are reluctant to have surgery to treat them, after the disease
has been detected.
Dr. Merkatz. I think women will ask questions about whether
they need to have a mastectomy versus a lumpectomy, which is a
very important question for women to ask and that decision should
be given every consideration because even with reconstructive sur-
gery, I think most women, if possible, would prefer the
lumpectomy.
Again, the testimony was very compelling. I do not deny that,
but I do feel it's a very complicated issue.
Dr. Kessler. Congressman, can I just add one point, if I may.
Mr. McIntosh. Sure.
Dr. Kessler. Your concern and our concern is one of the reasons
why we allowed — again, with considerable controversy— continued
open availability of silicone implants for women for reconstructive
surgery with informed consent and data collection. That's why I
was persuaded to allow open availability.
Mr, McIntosh. I'll defer to later for other questions.
Mr. Shays. I thank the gentlemen, because we will have a second
round.
And at this time, Mr. Barrett, you have the floor.
80
Mr. Barrett. Thank you, Mr. Chairman. You talked about the
woman who could get it for reconstructive surgery. Under the cur-
rent FDA regulations, which women or when would women not be
able to have the open opportunity to do so?
Dr. Kessler. Let me let Dr. Merkatz talk about the eligibility
criteria under the protocol.
Dr. Merkatz. There are two types of breast implants currently
available for women with breast cancer. The silicone gel, which is
available through clinical trials. If a woman is in the clinical trial —
and this is open across the United States, the sites where clinical
trials are being conducted for silicone gel — so a woman with breast
cancer may have a silicone gel implant provided she is enrolled in
the trial; otherwise, she may have a saline-filled breast implant.
Mr. Barrett. What is the purpose for requiring her to be en-
rolled in the trial?
Dr. Merkatz. So that we can get the data that we have tried for
so long to obtain. And the trial also guarantees that she will have
an informed consent procedure used as part of having her recon-
struction done, that there would be a frank discussion about the
risks and benefits.
Mr. Barrett. Does that slow her down in getting the implant?
Dr. Merkatz. We do not think it slows her down. The kind of
discussion that is required in informed consent really is the kind
of discussion that should go forward when a woman is confronting
either type of implant surgery. It is not our impression that an in-
formed consent procedure would slow down the process.
Mr. Barrett. OK For the woman who wants a saline-filled
breast implant, she could get it if she's in a trial?
Dr. Merkatz. Exactly.
Mr. Barrett. OK. Let's go on. Go on to which women can't get
them. Who is being stopped right now?
Dr. Merkatz. Women who are — who would like to have aug-
mentation, cosmetic augmentation, surgery for other reasons, rea-
sons other than breast cancer are currently not being enrolled into
gel trials, but they may have saline implants.
Mr. Barrett. OK. Dr. Burlington, if your mother or your wife or
your sister said she wanted to have an implant, what would you
say to her?
Dr. Burlington. It would be my frank advice that we would
need to look at the reasons promoting that request. If it was a
question of reconstruction following mastectomy, I think that the
benefits attributable to that are different, that we've heard those
discussed earlier. I think there has been a strong feeling through-
out the community from our advisory panel and firom the agency.
Those benefits make sense to enroll in the trial through the reg-
istry, through informed consent. It's not a complex or lengthy pro-
cedure.
If on the other hand the issue is augmentation, the risk benefit
ratio is different, and in that case I would counsel that we wait and
find out when we have more evidence on specific products and
what their rupture rate is. After all, a woman contemplating ana-
tomic change through augmentation needs to knov^r how long is
that anatomic change going to last. When is she going to have to
81
be reoperated. What is the risk of scarring. Is she going to get the
anatomic change she's looking for.
Mr. Shays. Would the gentleman yield for a second?
Mr. Barrett. Yes.
Mr. Shays. He will definitely have his time. What I find interest-
ing is you talk about new products. We have a system right now
designed not to create new products. So if you're going to wait to
see what new products are going to come on the line, tell me, what
new products are you aware of that are going to come on the line?
Dr. Burlington. Mr. Chairman, we have a million women im-
planted, very large numbers with products quite similar to those
made bv the two companies that have applications still held open
but back with the companies.
Mr. Shays. That's not my question.
Dr. Burlington. These specific products don't have the sorts of
information I was just addressing.
Mr. Shays. That's not my question. You said that you would
counsel your wife or your daughter that you should see what new
products would come on line?
Dr. Burlington. What new information needs to be available, if
I may correct myself, Mr. Chairman.
Mr. Shays. OK. But are you aware of any new products that are
coming on line?
Dr. Burlington. Yes, Mr. Chairman, there is one company with
a current clinical investigation in this country.
Mr. Shays. And what company is that?
Dr. Burlington. We generally need to protect commercial con-
fidential information.
Mr. Shays. Have they taken out an application?
Dr. Burlington. Yes, for investigation Mr. Chairman.
Mr. Shays. So we have two companies that have taken out appli-
cations. Am I to infer that there is a third company that has taken
out an application?
Dr. Burlington. For a different type of product, Mr. Chairman.
Mr. Shays. OK I thank the gentleman for yielding.
Mr. Barrett. Dr. Kessler, what would you tell your mother if
she said she wanted to have an implant?
Dr. Kessler. I ag^ee with Dr. Burlington. I would just add that
I think you need to look at all the available procedures and the
risks and benefits of all tvpes of reconstruction.
Mr. Barrett. But you re talking to your mother. What are you
going to tell your mom? Your mom calls and says, what should I
do, David, you're a sharp guy, what do I do?
Dr. Kessler. Mr. Barrett, I'm a pediatrician.
Mr. Barrett. All right. Your daughter.
Dr. Kessler. I would certainly ask her to talk to her surgeon,
but I do think that there are a number of reconstructive options,
and you need to look at all those reconstructive options and look
at the risks and benefits. But it is not unreasonable to enroll in the
clinical trial and get information as long as you do it with your
eyes wide open.
Mr. Barrett. OK Let me ask, would you have one? I'm sorry,
I can't see your name there, I apologize.
82
Dr. Merkatz. You're talking to someone who doesn't even take
vitamins. I probably would msike a decision against any type of im-
plant, but that's my own personal feeling.
Mr. Barrett. OK. If I can now draw the distinction between the
breast augmentation and reconstructive surgery and I apologize if
I'm oflfendine anybody, but I may be showing my ignorance here.
I would think that many times when a woman wants to have it
after breast cancer, that she wants it — obviously, I think, in part
for cosmetic reasons. And it seems to me that we're drawing a dis-
tinction between cancer and if it's just pure vanity, it's just pure
vanity. But I don't know that that is necessarily a valid distinction.
Why is that a valid distinction?
Dr. Kessler. Congn^essman, it's one of the hardest questions that
we've gn'appled with. I think that the use in breast cancer is not
exactly the same as its use in cosmetics. I think that it's fair to
state that its use — reconstruction is an integral part, I mean, of
breast cancer therapy and as I said earlier, getting on with one's
life.
I think in the end it's very different.
Mr. Barrett. OK I don't disagree that for breast cancer it's very
important and it's part of therapy, which is the word vou used. My
question is, couldn't it be therapy in another situation?
Dr. Kessler. Sure. I mean, there are other conditions: colon
anomaly, certain congenital deformities, trauma, for which I be-
lieve we have also allowed access under the protocol. So it's not just
breast cancer.
Mr. Barrett. OK, you were talking about the procedure before
and the burden being on the company to come forth with the infor-
mation— and, I'm sorry, the gentleman to the left — ^maybe you
could tell me again the procedure as to how much more information
is going to be necessary, and the timeframe here. I think that you
were talking about the procedure that is used.
Mr. Levitt. As Dr. Kessler stated, we have tried to describe for
the companies, as we do with a wide range of products, the range
of testing that's needed, some of which has already been done, and
some of which hasn't. It's really out of our control now long it takes
the companies to perform those tests. It is at their option. We can-
not require them to do tests quicker than they have the resources
or will to do.
Mr. Barrett. OK. One final question for you. Dr. Kessler: Do
you agree with Mr. Traficant that Dow did not supply all the infor-
mation?
Dr. Kessler. When I agreed to come here. Congressman, I spoke
with the chairman and I had one request, and that is, if I could
stay on the public health and scientific issues and not get involved
in other issues. I apologize, but I would rather stay on the sci-
entific/public health questions.
Mr. Barrett. I understand. Maybe I can ask a followup question,
and maybe you don't want to answer this one either. If you do have
a situation where a company does not provide you with informa-
tion, in a generic sense, and you find out about that, what is the
response of your agency?
Dr. Kessler. There are regulations that do require data to be
submitted. If, in fact, there's a violation of those laws, then we
83
make referrals and work with our colleagues in the Department of
Justice. If, in fact, the documents — and let me just make sure coun-
sel will shake her head behind me — are "material" to our deter-
mination.
Mr. Barrett. OK Thank you very much.
I yield back the balance of my time.
Mr. Shays. Thank you.
We would now like to call on Mrs. Morella, and note for the
record, she is the only woman on this panel right now. You're going
to have a little more than an extra 5 minutes for your patience ana
your perspective.
Mrs. Morella. Thank you, Mr. Chairman. I may not need it, be-
cause I've been listening to this testimony.
First of all, mothers know best, dependeth not what sons — chil-
dren— say. Mothers know best. So let the record show.
I just want to clarify what I have heard, because it seems to me,
if you're talking about reconstructive surgery with the silicone gel-
filled implant, that it is obtainable after a mastectomy if you are
involved in a clinical trial. Will those clinical trials deny anybody
the opportunity to have it? I mean, is there enough range for some-
body in Oklahoma to say, "I want the implant?" Are we denying
anybody the opportunity who falls into that category?
Dr. Kessler. Let me let Dr. Merkatz answer that question.
Dr. Merkatz. The answer, first of all, is, the trials are open
around the country. The problem, however, I believe relates to the
feeling that many of us may have about going into a clinical trial.
I know, for example, that the Women's Health Initiative, which is
going on right now across the country in 45 centers, which is the
largest trial ever to be conducted in women, their biggest challenge
is recruitment of women into the trials.
I think that we are going through a period where we're trying
to do a g^eat deal to educate people about the importance of being
in trials and what a trial really is all about. So I would say that,
yes, it is available, but we have to make more people aware of the
fact that it is available through clinical trials and do everything
that we can, which is what we are trying to do at the Food and
Drug Administration about the availability.
Mrs. Morella. The clinical trial, does it involve checking in
every week?
Dr. Merkatz. No.
Mrs. Morella. What kind of an impediment is it?
Dr. Merkatz. No, it's a followup schedule, but there are no
invasive procedures that would be involved. Its really getting the
kind of follow-up very similar to what we have recommended that
women follow in any case. And it is not a randomized trial where
some women will be chosen to have the procedure and others will
not.
All women who choose to be in the trial will have the gel im-
planted, and they must have followup visits to make certain that
the data is being collected on how they are doing with their im-
plant.
Mr. Levitt. If I may just amplify or add on a little bit. Currently,
for the Mentor study, Mentor being the company whose study is
open now for women seeking reconstruction, there are over 1,400 —
84
over 1,400 — surgeons now participating in that study. This is, I
think, quite a large number.
I'm not aware of any complaints or concerns we've had about geo-
graphic availability. I think it is pretty diverse across the country,
through, probably, virtually all the major medical centers, and cer-
tainly all the major cities having that procedure available. And,
again, so far over 12,000 women nave enrolled, and we've tried to
make it simple.
Mrs. MORELLA. It seems to me that one of the things we also
need is an education program to make sure that women are availed
of the fact that informed consent with a clinical trial, which is just
follow-up — did you want to comment?
Dr. Merkatz. Yes. I agree we need education. One of the things
that we have done is, first of all, we have an 800 number at the
FDA for women who want current information. And we have a
booklet that we continually update, that we will mail out upon re-
quest, that gives a full description of the availability of the trials,
resource lists of groups around the country where women can get
more information, as well as a discussion of risks and benefits.
Mrs. MoRELLA. Also, you mentioned. Dr. Kessler, the NCI study
that's going to be done next week. We've had a lot of discussions
about ftiis study, that one, 17 more going on, who pays for them,
et cetera. What is that going to point out? Is it going to be some-
thing about rupture, et cetera, and how valuable do you think it's
going to be?
Dr. Kessler. Again, Congresswoman, we worked very hard in
1992 with our colleagues in other agencies to get a number of stud-
ies up and running. This one was set up primarily to look at the
incidence of breast cancer, but it was expanded to look at a whole
host of other questions.
I think it will be an important study. But there have been, in the
last couple years, some other important studies that have been
published, and I think they will contribute significantly to our in-
formation.
Mrs. Morella. From what I have heard, am I correct in saying
that you feel that, in general — well, the link between whether
women are concerned about seeking mammograms or treatment of
breast cancer because they are concerned about the fact that they
might have a problem with the breast implant, the silicone gel-
filled implant.
Dr. Kessler. I think we need to do everything possible. You've
worked very hard with us, Congresswoman, to make sure that we
encourage all women, when appropriate, to get mammograms. Dr.
Merkatz has worked tirelessly. We have inspected now and accred-
ited 10,000 mammography facilities, and mammograms do save
lives.
Now, there are a lot of reasons why people don't go for mammo-
frams, but we need to encourage women to get mammograms. The
irst Lady has worked very hard to do that. We need to encourage
all women to take advantage, really, of that life-saving technique.
Mrs. Morella. I think it's very important that we all become
aware of that. I remember when 2.6 million petitions were brought
to the White House of survivors of breast cancer. The fact that we
have the race for the cure, the fact that in Medicare, now, there
85
is coverage every other year, the fact that we're moving toward also
giving free coverage for mammograms in communities, I just ques-
tion whether there was a part that the implantation played in
whether women would have mammograms.
Dr. Kessler, I'm not aware of any data.
Dr. Merkatz, are you aware of any data?
Dr. Merkatz. No. We tried to get that data, and we looked
through the literature, because we have heard that many, many
times. And I believe, even without data, it's a very important con-
sideration for us to consider, which is why we want very much to
know more about breast implants so that we can do everything
that we can, from many different angles, to encourage women
about early determination and breast cancer.
Mrs. MORELLA. I think we have to encourage our biomedical
firms to continue working in that area. Again, educate the public
about the need for the examination, the quality mammogram,
again, which is legislatively mandated, as well as coming to a con-
clusion with regard to the need for informed consent and offering
people the opportunity to make a choice. Thank you.
Thank you, Mr. Chairman.
Mr. Shays. I thank the gentlelady.
Mr. Kanjorski, you have the floor.
Mr. Kanjorski. Thank you very much, Mr. Chairman.
Dr. Merkatz, you said something about vitamins, and I'm par-
ticularly interested, you don't take vitamins. Do you know some-
thing that we don't know about vitamins?
Dr. Merkatz. No. That may have been a slip, but I'm just some-
one who — has been fortunate. I've been healthy and haven't had to
make those though choices.
If I could just add one more thing, perhaps, to the statement I
made. Not having been in the situation, if I were, I would ask a
lot of hard questions, and I would want information before I would
feel comfortable making a decision.
I think that's basically what we're after, the kind of information
so people who would like the answers, whether they are people who
ask hard questions or maybe they are a little bit afraid to ask the
questions, which often is the case, I just think we all would like
to have a few more answers.
Mr. Kanjorski. Dr. Kessler, I know you don't wish to get into
the legal aspects, but because of the sophistication of modem tech-
nology and the reliance on large corporations in a litigating society
such as ours, is there something that the Congress should be doing
to establish, perhaps, an information trust with immunity to en-
courage companies like Dow to make a deposit of all their studies
and all their information, pro and con, just to protect prior sci-
entific study, or even indications which may subject them to liabil-
ity if used in a court of law, so that we don't have a selected release
of information and a withholding, from the public or from the Fed-
eral agency, of information?
Dr. Kessler. Congressman, you raise a very important point. As
I told the chairman, one of my reluctances of late is to be very care-
fill not to, in any way — I mean, there are a lot of plaintiffs and de-
fendants at war with each other, and we try very hard not to get
involved in that.
86
But you raise a point that, even though with my reluctance not
to get involved in liability, I think really is the key. In the end,
we're never going to know everything about a device even when it's
approved, and especially if it's an implant. In some ways, drugs are
easy. You take a drug for 2 weeks. It has a half-life of 6 hours, 12
hours. You take it for 2 weeks. We know how to study that.
How do you study an implant that's not just in there for 2 weeks
or 6 months or 1 year but may be in for 5 years, 10 years, 30
years? How do you study that? And there is no way to be able to
get all the information up front before FDA makes a decision. So
we're going to need postmarket surveillance, and we're going to
need the willingness to continue to follow patients and get the an-
swers.
My biggest concern is that these devices were used for 30 years
without good procedures to follow and monitor patients. We're sit-
ting here 30 years later and still don't have the answers. If we real-
ly knew how to monitor and monitored carefully, we would b^ in
a much better position.
One of the hard parts for any company, once it puts a device on
the market and it monitors that device, is that if a company finds
a problem after it's device is on the market, that company is put
in a very difficult situation. If it admits a problem, all the lawyers
descend. Yet, what we need at the FDA is, we need that informa-
tion. And what patients need is to know if there are problems.
In fact, we're going to put a device on the market and we're going
to approve it, and there may be problems down the road. We need
a company to feel comfortable that it can step up to the plate with-
out its survival being jeopardized and say, "Hey, you know, there
are some problems," and we can talk openly and honestly about
those problems.
That's very important for medical devices, especially implants,
because you need to be able to follow those devices over 30 years.
Mr. Kanjorski. Are there some recommendations? I mean, it
seems to me that this Congress, in reevaluating legal reform, have
been willing to put a cap on punitive damages, certainly have
talked about limitations on compensatory damages.
It seems to me that, if we're getting into that area where we're
starting to reduce potential size of verdicts, we ought to look at the
other side that, concomitantly, we could find some way to g^ant im-
munity or establish a public trust, if you will, that information
could be relayed or that a company isn't encouraged to destroy
prior studies that may have raised the issue.
Dr. Kessler. I tnink there should be an incentive to do
postmarket surveillance, especially on implants. We're not going to
know everything up front. We need to create incentives for compa-
nies to be able to monitor and do that postmarket surveillance.
Mr. Kanjorski. To come forward.
Dr. Kessler. And to be able to step up to the plate and say,
"Gee, you know, there may be certain problems," and not to feel
that, if it does that, it's survival is in jeopardy.
Mr. Kanjorski. Is there some thought process at your agency
that could aid the Congress in legislating some national archives
of scientific information?
87
Dr. Kessler. Again, we really don't have expertise in the whole
issue of tort liability, and I try to stay out of it. As far as the ar-
chives is concerned, you know, manufacturers submit a lot of data
to us, but under the law that data is protected with extreme con-
fidentiality, in most instances, because they contain trade secrets,
because they contain competitive advantage.
So we are, in some ways, very limited as to how we make infor-
mation available. I leave it to you and to the Congress as to wheth-
er that's a wise policy. I don't have any expertise in that.
Mr. Kanjorski. Thank you, Mr. Chairman.
Mr. Shays. I thank the gentleman.
Mr. Gutknecht.
Mr. Gutknecht. Thank you, Mr. Chairman.
I would hope that at some point. Dr. Kessler, you would go back
and maybe play back the tape of this meeting to you and some of
your senior staff, because I think it expresses sort of the frustration
that we have. And I know that Chairman Shavs, in his line of
questioning, said a lot of the things that I think a lot of us feel
about this whole area.
In fact, there was in the Union Pacific railroad engineers manual
an expression that said, "If two trains should approach each other
on the same track, both shall come to a complete stop. Neither
shall advance till the other has passed." Sometimes when we hear
from some of our constituents about the FDA, and particularly in
the medical technology industry, it seems that way.
In fact, in the hearing, in the questioning and so forth, what we
have heard so much of is, "Well, the answer to that question is, we
need more studies; we need more data." At some point, I think, you
have to say, "Based on what we know — " in fact, even on the ques-
tion about your own mother, you equivocated. I mean, I think
there's sort of this culture that has developed that, we're never
going to get to an answer, a yes or a no. That's sort of an observa-
tion.
I think I would pursue the line of questioning at least that Mr.
Kanjorski finished with, and that is, can you offer some advice? Is
there a way that we can break this?
Because one of the concerns I have — and you see some of the de-
vices on the table up here, several of them were designed and/or
built in my home State — ^it concerns me that many of those compa-
nies are moving to Europe, and they are moving to Japan, and they
are taking their technology and the research other places, in part
because of litigation, but also because it is so very difficult to get
FDA approval for anything.
Does that cause you any concern?
Dr. Kessler. Sure, it concerns me. I think it's very important
today that we be clear where our concerns lie. Dr. Burlington put
that chart up there. I know there are a lot of squiggles and a lot
of science on the chart. But what's very important is, we're talking
about a silicone gel and the incidence of rupture and the con-
sequences of that gel migrating and what that does.
"rhat is a whole different level of concern than with something
like the CFS shunt. We don't have concerns about the CFS shunt.
I mean, that shunt should be used; it should be manufactured.
We're working with companies to make sure that it continues to be
88
made available. There are some tricky aspects to that shunt, and
we have to make sure that it works well, but it's very important
not to generalize.
I read stories in the media that, well, there are concerns about
silicone gel, so there are concerns about Norplant. Norplant is a
solid silicone elastomer. Now, there are some problems when you
take them out, and there are some issues, but it's a whole different
world as far as a medical device.
We've tried to make it clear, but we need to continue to repeat
that not all silicones are the same, and certainly not all types of
silicones present the same kinds of questions.
Mr. GuTKNECHT. Well, let me pursue one other point that was
raised earlier about some of the issues that Representative Trafi-
cant made.
Are you satisfied — I want to say this correctly — do you have the
power to go after some of those documents, if you believe a com-
pany has withheld documents?
Dr. Kessler. I did go after documents. We took a very unusual
step in late 1991.
Maybe counsel can join us at the table.
There was a report of a finding about certain documents, and
they raised certain concerns. They were under seal, and we took
the very unusual step — I just want to make sure I'm correct— of
going into court to ask the court to lift that seal so that we could
look at those documents.
Now, I think, in the end, if I'm correct, the company made those
documents available, but we did go into court first doing that. So,
yes. We don't have subpoena power. Lifting protective orders is dif-
ficult and requires us going into court, but perhaps counsel would
like to answer that a little more fully.
Ms. Reidy. I think Dr. Kessler has answered that question. In
addition, there were other documents that were under protective
order, and they have all been made available to the FDA.
Mr. GuTKNECHT. Could we get your niame?
Ms. REffiY. Arlene Reidy. I'm with the Office of General Counsel.
Mr. GuTKNECHT. OK. Another question that I'm interested in,
and that is, a number of the major chemical companies, there are
some concerns that they are not going to produce some of the com-
Eonent parts, simple component parts like Dacron thread and fi-
ers and so forth. Do you have that concern, and do you have a
plan of how to deal with it?
Dr. Kessler. It is very important for us to continue to have
these biomaterials available. Don Marlowe, who is our Acting Di-
rector of Science and Technology in our Devices Center, is an ex-
pert on that question.
Mr. GuTKNECHT. For the record, could you give your name?
Mr. Marlowe. Mr. Congressman, my name is Don Marlowe,
from the Center for Devices and Rad Health, Office of Science and
Technology.
We have worked very hard with the industry, particularly the
silicone industry, to ensure that the devices made out of silicone
continue to be available. We've worked in public meetings with the
manufacturers of those devices, and they know our concerns. And
we've put in place a specific set of written documents, and an-
89
nounced them in the Federal Register, to describe exactly the type
of exemption that firms who wish to change from one supplier of
silicone to another would have to go through to make sure that
their product stayed on the market.
Mr. GuTKNECHT. My time has expired, but I want to pursue this.
What about some of the other materials, stainless steel, other plas-
tics, Dacron?
Mr. Marlowe. There's a general policy for the availability of ma-
terials. It's probably not common knowledge, but it's certainly
known to the manufacturers in the industry that they are allowed
to change from one material supplier to another. As long as they
do not change the purchase specification for their raw material,
they are allowed to change from one supplier of that raw material
to another, without even notifying the FDA that they are doing so.
And that is commonly done in the industry.
Mr. GuTKNECHT. So you're satisfied, from the FDA's perspective,
that's not a problem.
Mr. Marlowe. Yes, sir. We live in fear, of course, that a material
would vanish. That would be the worst-case situation, from our
perspective.
Mr. GuTKNECHT. But what about from their perspective, as it re-
lates to litigation? That's really not your — that's not your problem.
Mr. Marlowe. I'm not even knowledgeable to speak to that, sir.
Mr. GuTKNECHT. Thank you, Mr. Chairman. I yield back.
Mr. Shays. I thank the gentleman.
Mr. Peterson, you have the floor.
Mr. Peterson. Thank you, Mr. Chairman.
Dr. Kessler, we keep hearing about how we need to know more
information and we need to study things more. If the Harvard
study and these other recent studies are so inconclusive, if we don't
know enough from them to decide these things.
I'm told that plaintiffs' attorneys and their allies are going out
of their way to discredit them, so I'm interested in knowing why
that's happening and why they try to have them declared inadmis-
sible in court, as I'm told that they do, why they are attempting
to harass and intimidate scientists who conducted these studies,
which I have been told they have, and why they question or even
lie about sources of funding.
My bottom line question is, why do these attorneys involved in
this behave as if they believe these studies are more conclusive
than you do?
Dr. Kessler. The Harvard Nurses Study is a good study. It an-
swers certain questions. I can't comment about lawyers on either
side going afler studies. But the Harvard Nurses Study is a good
study, as I said this morning. It does provide with the Mayo Clinic
study — ^reasonable assurance, from an epidemiological point of
view, it provides reasonable assurance that there is not a large in-
creased risk of typical connective tissue disease.
Because of the limitations of the study, because of the methodol-
ogy, I also said that it doesn't rule out a small but significant in-
creased risk. It also doesn't look for other atypical forms of connec-
tive tissue disease. But there are a lot of other questions. The Har-
vard Nurses Study, the Harvard Nurses Study doesn't tell me how
90
long these devices last, what percent rupture, or what the con-
sequences of rupture are.
So the Harvard Nurses Study is an important study.
Mr. GuTKNECHT. So you're not sure why these attorneys, then,
are more excited about this?
Dr. Kessler. Are more?
Mr. GuTKNECHT. Well, there apparently has been a lot.
Dr. Kessler. There have been ads about this study in the media.
There have been ads run by both sides. And it's one of the reasons
why I have tried very much to, in part, be very prudent, because
I don't want this agency used by either side in litigation.
I think it is very important for the women who have these de-
vices. That's what I care about. The women who have these devices
and women who may need these devices need information. And
that's why I'm here today. But I'm very reluctant to get involved
in the war between the trial attorneys and the defense counsel.
Mr. GUTKNECHT. But a lot of these women's groups have im-
plored FDA and yourself to reassure the many hundreds of thou-
sands of women that have been scared over this, to come up with
some way to alleviate the scare that I think, to some extent, you
folks have helped to create out there.
Don't you think that you have some obligation to reassure these
women rather than just say, "We've got to study this some more?"
Dr. Kessler. Congressman, that was not my testimony today. I
think I try to call it with the current state of knowledge in the pub-
lished literature. I'm not sure.
Mr. GuTKNECHT. That's still not reassuring.
Dr. Kessler. We've looked very hard at all the research, and I
tiy to call it the way that research says, and call it straight on
what that research says.
Look, as a doctor, I d love to be reassuring. You always want to
be reassuring. You always want to tell patients, "Don't worry." The
chairman asked us to come and talk about the state of the science.
My testimony is a very detailed analysis of the state of the science.
I think it answers some questions; it doesn't answer others. It al-
lays some concerns, but it raises other concerns.
Mr. GuTKNECHT. How long is it going to be, do you think, before
we can know, definitively, and we will be able to reassure these
folks?
Dr. Kessler. It's the one thing I regret, because it's the one
thing about which I feel I'm not answering the committee's ques-
tions, and I'm not trying to be difficult. But we're not a research
agency. Without being a research agency, I can't do that kind of re-
search and do the kinds of trials that really are necessary.
We can work with people to get them done, but we really have
a private system of device development in this country. And if a
company is not willing to do those studies, then maybe the NIH
should do those studies or another sister agency should do those
studies.
I know that I'm not being helpful.
Mr. Shays. If the gentleman would yield.
Mr. GuTKNECHT. Yes, I would yield.
Mr. Shays. Let me just say to you that that's heartfelt on your
part, but it's not acceptable. And we have to find a way to resolve
91
this. We're going to go a second round here, but I just want to say,
I just don't want the record to lay open with your basic comment
that you don't know and it's, in a sense, not your responsibility to
know. Because that's what's coming across.
Dr. Kessler. We set out we need the answers to certain ques-
tions. We've looked at the research to date. It allays concerns in
certain areas; it doesn't allay concerns in other areas. That data
has not been submitted by any sponsor to the agency to date. We're
even relying on published reports.
Mr. Shays. You know, with all due respect, we may end up with
no sponsors, and we may end up with no manufacturers, with that
kind of attitude. So it's almost a self-fulfilling prophecy. I think
your agency needs to help sort this out. I'd like to get this issue
in the second round. I appreciate the gentleman for vielding.
Mr. GUTKNECHT. I appreciate your comments, and I look forward
to hearing more.
Mr. Shays. Let me just say, to give everyone an update on where
we're at, we're going to get you out of here. Dr. Kessler, by 1:30.
And we're talking aoout a half-hour more. We are going to start
the next panel by 1:30, possibly sooner, but we will definitely start
it by 1:30.
We have two Members who haven't gone the first round, then
we're going to get into this issue, I think, in more depth in the sec-
ond round, with those Members who are here.
Dr. Kessler. Absolutely.
Mr. Shays. Mr. Fox.
Mr. Fox. Thank you, Mr. Chairman.
Doctor, since the 1992 moratorium, more than a dozen epidemio-
logical studies have been reported, in either complete or abstract
form, on the reported relationship between implants and connective
tissue disease, and no link has been found in any of them.
How could the FDA say, in its June 22 statement on the study,
that research is only beginning to emerge on this issue?
Dr. Kessler. Mr. Fox, Congressman, again, there are a number
of questions about breast implants: How long do they last? What
percent rupture? What are the consequences of those ruptures? The
epidemiological studies you refer to talk about the link between
breast implants and certain connective tissue diseases. That's why,
I believe, we made that statement.
Mr. Fox. But I'm saying, from your position, is there a causal
link between the silicone breast implant and any connective tissue
disease?
Dr. Kessler. The advisory committee, in 1992, stated there was
no evidence that supports a causal link between breast implants
and typical connective tissue disease. And I maintain that that
statement was the best science in 1992, and I think that statement
is also appropriate today. And I think there is much more evidence
today to back up that statement.
Mr. Fox. You say additional research is needed into ruptures and
autoimmune diseases. How long should it take to complete that re-
search to a degree that satisfies FDA
Dr. Kessler. If I know what the rupture rate is over a reason-
able period of time, using both retrospective and prospective stud-
92
ies, and that data is submitted, we will act very quickly on that
data.
Mr. Fox. Would it take months? Would it take years? Do you
know how long?
Dr. Kessler. For us to act on that data? Once that data is sub-
mitted to the agency, I think we can act within months.
Mr. Fox. What do you say to women with implants in the mean-
time?
Dr. Kessler. That's very important. And I think that is what I
said in our testimony today, that the evidence to date provides rea-
sonable assurance that there is not a large increase in risk in con-
nective tissue disease. I can't tell you that it rules out a small but
statistically significant increase. It doesn't rule out atypical forms
of disease.
And I don't know today how long these devices last and what
percent rupture, although I have some very significant concerns
based on the published reports. But those published reports on rup-
ture rate are not satisfactory. I think the patient selection and the
size of those studies are not very adequate.
Mr. Fox. I think the concern that the chairman and the commit-
tee have today with FDA saying, "We need to study it more and
study it more," is not acceptable, I think, to the American public.
I mean, in my opinion, if the FDA launched Apollo 13, it would still
be orbiting the moon because you want absolute certainty.
Dr. Kessler. Congressman, I think before you put an implant in
somebody, you should be willing and understand the consequences.
You should know what percent rupture, how long they last. There
is an affirmative duty on the manufacturer — ^beating up on the
FDA and holding FDA responsible for evervthing may be in vogue.
Mr. Fox. I think that Congress is seriously pursuing this because
we want to jointly make sure that we're protecting the public.
Dr. Kessler. I understand that, and I welcome that.
Mr. Fox. I think there still has to be an end point, Doctor, by
which the public can expect some definitive answers so we can
move forward.
Dr. Kessler. And what I said, Congressman, is that, when the
data is submitted to this agency that answers those questions, we
are committed to reviewing that data within months.
Mr. Fox. Well, don't you think the FDA needs to take a proactive
approach in making sure that the data, either independently re-
ceived or that which is already in good science, comes to some reso-
lution in the near term? Because I think that, while no one is try-
ing to bash FDA, I think the fact is, we need to work together to
make sure there's an end point to which the FDA comes to conclu-
sions, so that women who have to face this issue can do so with
as much available knowledge that you give them, as much as in-
dustry can give them.
Dr. Kessler. Congressman, you are correct. But my only point
is that we need certain partners in order to do that. We need in-
dustry and our sister agencies who are going to work together with
us to be able to get the answers to those questions.
Mr. Fox. Well, as a result of the silicone scare in 1992, which
was set off by FDA, don't you think there has been a spill-off effect
to development of new medical devices because of the fear by in-
93
dustry to offer them, because of the concerns that may be long-term
and time-consuming, whfle they may be life-saving or life-extend-
ing, they aren't offering them because of the concerns that have
happened as a result of what happened with the FDA scare on
breast implants?
Dr. Kessler. Let me ask, again, Mr. Marlowe to — ^you know,
there has been a lot of discussion about whether there is a crisis
in a lack of availability of silicone that has delayed or impeded the
development of new products and other products. I would like Mr.
Marlowe, who is an expert, to answer that.
Mr. Marlowe. Mr. Congressman, I think that it's fair to say that
there is a slowdown, if you will, in the development of brand new
medical device materials in this coimtry. There is perhaps a reluc-
tance to introduce some of these currently available materials in
areas where there is apparently a high risk associated with those
devices.
But I think that the materials remain available today. A manu-
facturer who wished to find a material to make a medical device
could find one today available in the marketplace.
Mr. Fox. Thank you, Mr. Marlowe, but my concern is, if we have
FDA not acting fast enough to get information with certainty to
women who need to have it, then we could have the ripple effect
that other medical devices that are needed by the public are not
going to be introduced in this country but rather in other countries
because we have been too slow to move ahead the approval process,
to get the scientific data, and to get the information back to a pub-
lic that is waiting for it. That's my concern with FDA.
Dr. Burlington. Mr. Congressman, we are seriously concerned
about that, as well, and the agency did, in fact, fall far behind on
its time schedule for review of devices. Over the last couple of
years, we have moved arduously to correct that.
We put in place a number of new policies. We have very substan-
tially shortened the time to review for the abbreviated applications.
We are working now with manufacturers to shorten time for the
comprehensive applications, PMA's, because we also believe that
having a vigorous industry, having new products is important to
the American public health.
Mr. Fox. We share that, obviously, with you to try to move
ahead, because the speed with which our constituents and your pa-
tients and our citizens can get it is very important, because we
want to have life-extending and life-saving devices available, and
we want to make sure we do it as quickly as we can.
Thank you, Mr. Chairman.
Mr. Shays. I thank the gentleman.
Mr. Chrysler, you have me floor.
Mr. Chrysler. Thank you.
Actually, I had the opportunity to communicate with Dr. Kessler
this year, in May, and he gave me a very good response by the end
of May. I had my questions answered, and I appreciate your
promptness in those replies. Maybe I would just have one quick
question.
You mentioned about the large study from the National Cancer
Institute, can you give me any further progress on that study?
94
Dr. Kessler. Sure. Let me ask Dr. Lori Brown to talk a little
about that study. She's our epidemiologist within this area.
Dr. Brown. I m Lori Brown. I'm from the Center of Devices and
Radiological Health also.
The study that you're talking about is one which is being con-
ducted at the National Cancer Institute by Dr. Louise Briton and
is subcontracted out to a company which is doing it. It will include
14,000 women who have breast implants and a control of 4,000, so
the total study population will be 18,000 women.
They are currently collecting the first phase of the data, which
is looking through doctors* records of women who have had breast
implants. "They have started now to contact women, and they are
getting information from these women. The third phase of the
study will be to examine the medical records of other doctors other
than the implanting surgeons who were involved. So you can see
this is a very large and complex study.
They are funded through 1996, and after 1996 they may seek
more mnding, but it's not clear whether they will or not. They have
completed some of the data collection, but data collection is ongo-
ing. The original intent of the study was to examine cancer — ^it's at
the National Cancer Institute — but they also will be studying con-
nective tissue disease and local complications.
That's the information that we have on that study. I am in con-
tact with Dr. Briton probably every couple months and so am keep-
ing up with the progress of their study.
Mr. Chrysler. Thank you very much. I yield back my time, Mr.
Chairman.
Mr. Shays. I thank the gentleman.
We're going to go through a second round of questioning, Dr.
Kessler. When I started out, I asked you if you were more con-
cerned with ruptures or autoimmune issues dealing with silicone
safety. And I didn't think you were very forthcoming, because, as
I listened to your response, you kept coming back to your concern,
and it was always on rupture, almost every time.
So I'm struck with the fact — I'd like to give you an opportunity —
are you concerned about silicone safety, or do you feel that there
have been enough studies done on this issue?
Dr. Kessler. I think that the studies on connective tissue dis-
ease, the Mayo Clinic study and the Harvard Nurses Study, as I
said before, I think those are good studies. I think that those allay
significant concerns on autoimmune disease. I don't see the same
good studies on rupture. I see some numbers that I see as high in
rupture; I don't see good studies.
Mr. Shays. I think that's helpful information. And I have to tell
you, as I read your testimony, it was clear that you were very con-
cerned about ruptures. After reading some of the testimony of wit-
nesses, I have a concern about that, as well. So describe for me the
study that would give the data on ruptures that would answer your
concerns.
Dr. Kessler. The first question you would have to answer is,
how long do you need to monitor that? When is there a suspicion
that these devices may fail, when they may fall apart, and over
what period of time? I think, if you look at the science to date,
there's reason to suspect that you're dealing, maybe, with a bath-
95
tub curve, where you see failure initially and then failure after a
period of time.
But that's only a hypothesis. So you need to be able to get rup-
ture rates over a period of time, and you may not be able to do that
and be able to wait, prospectively. There s a prospective study
under way by one company that has enrolled 12.000 patients. Now,
that's planned to go on for some period of time, but how do you ^et
the information at 7, 8 years where there may be a significant in-
crease? So you may have to go back and use a prospective study
as well as retrospective. It's tne totality of the evidence. There are
always going to be, Mr. Chairman, certain weaknesses.
Mr. Shays. No, I understand. I want to just kind of nail down
some of these key points. You've provided helpful information to me
to say that rupture is a bigger concern.
Dr. Kessler. It's a real concern.
Mr. Shays. In one sense, we have an advantage, because we
have people who for years had these devices, and we can go back
and look.
Dr. Kessler. Some of the science is a little difficult on that.
Mr. Shays. One of my concerns is, basically, we have 1980 tech-
nology, because I don't see a lot of manufacturers trying to incre-
mentally improve these devices.
My colleague gave this wonderful description, which I share, of
two trains coming and hitting each other, and you're basically de-
scribing in graphic detail what's happening, as if you're not a play-
er in this process, like maybe you can, you know, stop one trmn
and maybe we can get one train off the track.
I almost view it differently, that they are going parallel, and they
are never going to meet. And they've got to meet eventually, and
they are never going to get on the same track. That's why I believe
we can go on indefinitely.
You say manufacturers have an affirmative duty to provide and
submit data. So have you specifically outlined to manufacturers
what kind of data you want on ruptures, because that is your con-
cern?
Dr. Kessler. Again, I just want to be specific. The guidance that
we put out in 1992 covers a number of areas. Rupture is certainly
a very significant part of that. Let me let Dr. Burlington comment.
Dr. Burlington. Mr. Chairman, the guidance that Dr. Kessler
refers to provides a great deal of information on what we would
look to a manufacturer to tell us about the way the product is
made, about what its laboratory, what its animal testing, and tis-
sue culture testing might be.
Mr. Shays. I'm talking in regard to rupture right now.
Dr. Burlington. It is. however, somewhat vague regarding
what — ^it says what we're looking for; it doesn't get down to specif-
ics about how long, how many patients, that sort of thing.
Mr. Shays. Let me iust interrupt you, sir, if I could. Wouldn't it
be helpful, if you could nail down exactly what you need, to specifi-
cally spell it out to the manufacturers and get this process moving?
Dr. Burlington. Because of concern that manufacturers would
think that this was an insurmountable goal, either for this product
or for alternatives, I asked the staff to put together a workshop
which we held last fall, for alternatives, in part to address this.
96
with outside input from our external advisors. I believe that was
fruitful.
We now have one manufacturer who we're sitting down and talk-
ing with very specifically about what is appropriate, in terms of a
data package, to move forward with their product. I would welcome
the opportunitv to do that with one of the silicone gel manufactur-
ers. That would require a manufacturer coming forward and say-
ing, "We're serious about doing this. We're ready to do these trials."
Mr. Shays. Hold up a second. Hold on a second.
Dr. Burlington. Yes, sir.
Mr. Shays. I asked if you had any applications. You said you had
applications from two manufacturers. We know some manufactur-
ers have gotten out of the business. Are you saying that they are
not sincere in their applications? So, in a sense, is my question a
meaningless question? Do we have anyone who wants to get in this
business? Do we have serious applications?
Dr. Burlington. For silicone gel breast implants, we have two
applications which, as discussed earlier, are technically open, Mr.
Cnairman.
Mr. Shays. Do you view them as serious applications?
Dr. Burlington. I would welcome an opportunity for those com-
panies to come in and sit down and say thev are serious about this,
and move forward as rapidly as we can. I have not seen that hap-
pen.
Mr. Shays. Mr. Burlington, I don't mean to be disrespectful, but
they probably don't think you're serious either. Because, in my
judgment, this is a very serious issue Dr. Kessler — I feel like you
all are on the sidelines just waiting for somebody else to do some-
thing. And I would encourage you to be very proactive on this
issue.
We have nailed down, in my judgment, one issue: you are more
concerned by ruptures. So let's deal with rupture.
Dr. Burlington. Mr. Chairman, with due respect, I believe we
have made efforts to be proactive, specifically in putting out the
g^dances, specifically in putting out those offers to meet with com-
panies, and would welcome the opportunity to move forward on
that issue.
Mr. Shays. But you did state to me, Mr. Burlington, that you
weren't very specific as it related to rupture issues, that you were
very vague. I mean, I just heard you say it.
Dr. BURUNGTON. The guidance put out 6 months before I arrived
was, in fact, vague on the rupture. It addressed the generalities;
it did not address the specifics.
Mr. Shays. How long have you been there?
Dr. Burlington. Two and one-half years, sir.
Mr. Shays. So what prevents you, in 2V2 years, from being spe-
cific?
Dr. Burlington. We have moved forward, last fall, with an addi-
tional discussion. If a manufacturer is forthcoming, we will indeed
sit down.
Mr. Shays. I just want to say that that kind of attitude just con-
firms to me that we're going to get nowhere, that we will be in this
limbo. And I have some experience now, having had the second
hearing with FDA where we have this 180-day requirement on food
97
additives, and applications have been pending for 20 years. Obvi-
ously, that is not your fault, but the sense that the law doesn't
even have to be abided by.
Dr. Kessler. Congressman.
Mr. Shays. Yes, sir.
Dr. Kessler. I became Commissioner in December 1990.
Mr. Shays. Right.
Dr. Kessler. I wish the data was collected and submitted to the
agency to answer the questions at least, you know, a decade before.
Mr. Shays. OK They weren't.
Dr. Kessler. We need to get that data. We will work with com-
panies to get that data. Once that data comes in, we will review
that data. But let me make sure that I don't misspeak.
An application contains information on a lot of areas. It will con-
tain information on autoimmune disease. It will contain informa-
tion on tensile strength. It will contain information on chemistry.
I've not yet reviewed or audited like we do the published studies
that we've talked about; I've talked about them based on the lit-
erature.
We will look at the entire application. There will be weaknesses
in certain areas; there will be strengths in another. In the end, the
question is whether the data submitted to the agency allows the
agency to make a reasonable scientific judgment that the risks are
acceptable in light of the benefits.
I just don't want to say that the only data that needs to come
into the agency is rupture. We need to look at all the data.
Mr. Shays. Dr. Kessler, I don't disagree with the general thrust
of your comments, but all you do is confirm to me this issue will
never be resolved. It is a mind-set and an attitude on your part and
the departments's part that troubles me.
Let me just ask you, as it relates to the Food, Drug, and Cos-
metic Act, it says, The Secretary may not enter — ' mav not
enter — "into an agreement to extend the period in which to take ac-
tion with respect to an application submitted for a device subject
to a regulation promulgated under Subsection (b), unless he finds
that the continued availability of the device is necessary for the
public health."
So are you functioning under the "unless"?
Mr. Levitt. Yes.
Mr. Shays. OK Now, where is the agreement?
Mr. Levitt. At the time of that decision, we entered into written
agreements with each company which outlined all of the relevant
provisions. We set forth, concurrent at that time, a three-stage pro-
cedure, which was outlined in the Commissioner's statements at
that time.
Mr. Shays. We only have two companies; right?
Mr. Levitt. One company progressed to the second stage and
never pursued the third stage. The second company was never able
to satisfy existing regulations on good manufacturing practices:
meaning how you make the product, what its quality is, and what
is consistently between products. So that company never started
the prospective clinical trial stage.
In contrast, Mr. Chairman, if I might say — ^because you have a
clear concern about us being proactive.
98
Mr. Shays. I think you're proactive, but sometimes I think you're
proactive in the wrong way. And I don't mean that disrespectfully.
I think you can be very active and very determined, but I don't feel
this kind of determination to resolve this issue.
Mr. Levitt, If I may just say, in the area of saline breast im-
plants, we have been working with these very same companies. We
have set forth a research agenda and schedule, and those compa-
nies are pursuing that. One thing I derive from that is that we do
understand when the companies are seeking to perform the studies
and when the companies, for whatever of their own reasons, are
not.
Mr. Shays. I understand that companies — and I w£int to let other
Members ask questions — I understand that companies sometimes,
if they don't think they are going to like your answer, they aren't
eager to get the answer and may not encourage you to give them
the answer.
But it is your sworn testimony that there are agreements. Now,
have these agreements been modified, and are they in writing?
Dr. Kessler. I'd be happy to
Mr. Shays. I know. But are those — I thought your testimony was
that, basically, they couldn't abide by the agreement; they couldn't
meet what you wanted. We have only two people in this business,
probably we will soon have one, and maybe we will have none, and
you will still be waiting for some company to take an affirmative
action.
My point to you is this: You have both told me they have not met
the agreement.
Mr. Levitt. No, no, no. That's not what we said.
Dr. Kessler. I don't think I've said that. I'm not an expert in the
agreement at all.
Mr. Shays. You didn't answer the question, Dr. Kessler.
Dr. Kessler. I'm sorry.
Mr. Levitt. There are written agreements.
Mr. Shays. It is in writing.
Mr. Levitt. It is in writing. I honestly can't recall if it was modi-
fied along the way; it may have been.
Mr. Shays. We will have a second followup hearing, and we're
going to get into more depth here.
Mr. Levitt. Right. The agreement sets forth, as I recall it — it
will speak for itself.
Mr. Shays. Well, you know, since you don't really remember it,
we're not going to talk about it right now.
Mr. Levitt. All right.
Mr. Shays. The point, for the record, is, there is an agreement.
We will be able to get it, and we will be able to get you back here
and question you on it.
I will just say, for the record, before I turn to my colleague, that
I'm absolutely convinced that whether the trains are headed in the
same direction and they are going to crash, or whether they are on
separate tracks, never to meet, either scenario, it's a no-brainer; it's
never going to happen. We're never going to resolve this issue. It
is going to be in continued limbo, just like the 20-year pending food
additives applications.
99
And Dr. Kessler, I think you — I'm not asking you to do it — but
you need to delegate to someone to find a solution. It seems to me
you need to map out, in very specific terms, what you need, and
I don't think that agreement is going to be doing that.
Mr. McIntosh. Mr. Chairman, thank you. Let me also say, if you
feel you need to have more questions to get to the bottom of this,
I'm 100 percent behind your line of questioning there.
My question is — and I think that the chairman is onto something
here — that we're not seeing a rush of companies come forward to
want to do these studies to allay the fears about rupture or any of
the other issues that are there. And I think we have to be honest
with ourselves that part of the reason for that is the context of ex-
treme liability risks in the world, and that any business who has
a general counsel is going to say, "We'd better look at this very
closely before we decide to pursue this further."
But I think we may be able to make a breakthrough here in an
area that affects that fairly significantly by parsing a little more
carefullv the different concerns that. Dr. Kessler, you raised in
some 01 my questions earlier. I was talking with you a great deal
about the studies on autoimmime deficiencies, and I think you cor-
rectly indicated your concern about rupture and that there weren't
sufficient studies there.
Turning back to the question of autoimmune disease, given that
there are these 17 studies that Dr. Ganske mentioned and that
there is a good record in that area, can't we have the agency, at
this point, make a statement that we don't think there's a risk of
autoimmune disease; we still want to get the data on rupture, and
we're still waiting for the National Cancer Institute study on can-
cer to nail that down for sure — although I have the impression that
people are a lot less concerned about that risk than they were in
the early 1990's.
Dr. I^SSLER. Mr. Mcintosh, let me let you hear from an expert,
Dr. Brown. First of all, when you say 17 studies, there is — I as-
sume, Dr. Brown — a range of different quality within those 17
studies.
But from an epidemiological, scientific point of view, you ask me
to make a statement that there is no risk associated.
Mr. McIntosh. Let me rephrase that. No relative risk, given the
fact that there are women who, this hearing has indicated, are
being discouraged from receiving treatment.
Dr. Kessler. With regard to typical connective tissue disease,
Fve tried to be clear today — and, again. Dr. Brown can correct my
words— but I think, based on a scientific analysis of those studies,
what those studies provide is a reasonable assurance that there is
not a large increased risk of typical connective tissue disease. They
don't rule out a small, but significant risk of typical connective tis-
sue disease, and don't really address this question about atypical
connective tissue disease.
Dr. Brown is the expert, and she can correct me.
Dr. Brown. We review these studies as they are published, and
we have reviewed the studies that have been mentioned this morn-
ing, the Mayo study, the nurses study; there's another study which
is on scleroderma. Connective tissue disease is not a single entity.
There are connective tissue diseases which are extremely rare, like
100
scleroderma, and there are other connective tissue diseases which
are more common, Hke rheumatoid arthritis.
So the studies that have been done by Mayo CHnic and the Har-
vard Nurses Study have ruled out a large increase in connective
tissue diseases, in general, but they have not ruled out specifically
such diseases as scleroderma, which are very, very rare.
The types of studies that were done by Mayo and the Harvard
Nurses Study are cohort studies, and these studies typically are
very good for finding out relationships between the outcome and
something that may be causing it, when it's very common, but they
are not as good at detecting rare outcomes.
Mr. McIntosh. Did the Harvard Nurses Study have a single in-
cidence of scleroderma that was in the woman who had breast can-
cer?
Dr. Brown. I don't recall whether there was a single incident or
not. There may have been.
Mr. McIntosh. My recollection, upon reading it, is that there
wasn't.
Dr. Brown. OK Scleroderma is an extremely rare disease, and
so the Harvard Nurses Study had, roughly, I think it was 83,000
women in it. You would not expect to find many women, in 83,000
women, who had scleroderma. The Harvard Nurses is a study
which is better prepared to detect more common diseases such as,
perhaps, rheumatoid arthritis, but it is not as well equipped to de-
tect scleroderma.
The type of study which is used in order to detect very rare dis-
eases is a case-controll study. In this type of study what they do
is, they find many women who have the disease and they look for
the exposure, in this case, breast implant. In the single published
study, which is by Dr. Engler in Australia, they were able to rule
out a large increase in risk, along the lines of fivefold, for
scleroderma, but they were not able to rule out a smaller risk,
which may be significant, for women who have breast implants.
So these are all pieces of the puzzle.
Mr. McIntosh. So the Australian study did address scleroderma
and it ruled out a large risk, but there might be a small risk associ-
ated with it.
Dr. Brown. Yes, that's correct.
Mr. McIntosh. Let me turn now to Dr. Kessler on this question.
As head of the agency, are you going to require them to do that
type of study for every single one of these rare connective tissue
disorders, or when is enough enough on connective tissue disorders
and autoimmune deficiency?
Dr. Kessler. Let me let Dr. Burlington answer that question.
Mr. McIntosh. You're going to defer to her in making that deci-
sion?
Dr. Kessler. Dr. Burlington.
Mr. McIntosh. Sorry. To him.
Dr. Kessler. Yes, I defer.
Mr. McIntosh. So if he says enough is enough, you're going to
say, "OK. Fine. We're going to say we're satisfied."
Dr. Kessler. Dr. Burlington makes the decision of whether — I
mean, every day he has final sign-off on whether a device is ap-
proved or not today.
101
Dr. Burlington. Mr. Chairman, thank you.
On this issue, it's very hard, because there are, as we all know,
a number of questions that have been raised about atypical
rheumatologic disorders, about poorly defined rheumatologic dis-
orders, about something that has been tentatively labeled "silicone
disease," which is a collection of symptoms which is not even itself
well-defined. Those are questions we would have to consider.
I think we do have a substantial bodv of evidence that is useful
in providing information to women on classic connective tissue dis-
eases. In contemplating moving forward on an application, what we
would do is go back to an advisory committee to get a broad input
from the biomedical community and say, "What about all the rest
of this? If we don't have specific studies on it, nonetheless, are we
at a point where it makes sense to label the product describes that
which we do not know and put it out in the market for regular
marketing?"
Now, in order to get there — and I think this is one of the ques-
tions that Chairman Shays has been asking — we would certainly
anticipate looking at additional information on rupture rate and
other local reactions, and then we will be prepared to report.
Mr. McIntosh. Dr. Burlington, let me interrupt you for just 1
second. How long would that process take? And my question is,
can't you take a step short of issuing a product approval and make
a very clear statement by the agency that there isn't a safety risk
here, so that businesses would come forward and provide you with
the data on rupture?
Dr. Burlington. Mr. Chairman, we have disseminated to the
Members, we have disseminated to the companies involved, as well
as to consumers, information on the agency's assessment that sub-
stantial reassurance is offered by the emerging epidemiologic data.
We recognize that some of it is yet to come, the Cancer Institute
study that Dr. Briton is doing. But, to date, we do have that sub-
stantial reassurance, and we have tried to make that as clear as
we can.
Mr. McIntosh. Well, apparently, it's not clear enough, because
there's a great deal of uncertainty out there about what the agen-
cy's views are.
Do you think the cancer study will provide additional data in this
area that will be satisfactory to make a categorical statement that
the relative risks are acceptable?
Dr. Burlington. We look at the risks of products in their total-
ity. It certainly will address things within the scope of the study.
It, I expect, will augment the existing body of evidence on classic
connective tissue diseases, which tells me that we have excluded a
hi^ level of increased risk, but we will never get to perfection. We
can't prove a negative, as the Congpressman testified earlier, and we
woul(m't seek to.
Mr. McIntosh. After the cancer study, even if it came back with
a conclusion that there are no significant risks, you would not, at
that point, say, "We're satisfied that we can say there's not a risk
of autoimmune disease caused by this product that is significant
enough that we're going to keep it out of women who have breast
cancer?"
102
Dr. Burlington. Mr. Chairman, I appreciate your having quali-
fied the start of your sentence with — this basically gets to the ques-
tion of, are we satisfied that we have enough information that we
can adequately label these products we can say there is a residual,
unknown risk, and that that's information that we communicate to
women contemplating having one of these products.
That seems an appropriate position. It, however, has to be looked
at in the totality. It has to be accompanied by reasonable informa-
tion on what the durability of the product is. When something is
knowable, through readily available techniques — a million women
have these products — ^fin(fing out what the rupture rates are should
be doable.
Mr. McIntosh. So you're sajdng you're not willing to address the
safety issue until you're satisfied about the rupture question, which
to me is a disservice to American women.
Dr. Burlington. Mr. Chairman, I believe we have substantially
addressed the safety issue to the extent that data is available to
us today.
Dr. I&SSLER. We will address the question when the data is sub-
mitted to the agency and we can review it in the marketing con-
text. We have an obligation to women who have these devices in
them today to keep them informed. That's very important, because
they want the answers.
Mr. McIntosh. Dr. Kessler, let me say, I think you're failing on
the safety issue by moving the ball, first from cancer to auto-
immune disease, now to rupture, and saying, "We can't give you a
categorical statement." It reminds me of Charlie Brown and Lucy,
where every time he comes up and he tries to kick the football,
she's going to move it down the goal post.
Dr. Kessler. Mr. Chairman, can I just disagree?
Mr. Shays. If I could just interrupt a second. I think this is im-
portant to follow. I'm going to apologize to you as the panelists. We
will be going for another 10 minutes. I just want to make sure Mr.
Gutknecht and Mr. Fox get to ask — and I'm the guilty party here;
I asked too many questions. So, at any rate, were going to go a
little longer.
Dr. Kessler. Can I just answer this?
Mr. Shays. You have time to answer the question. We don't want
to put words in your mouth.
Dr. Kessler. If I can just answer the chairman's question. If you
look, in 1992, the three questions that we asked the panel on Feb-
ruary 7, 1992, "Does the newly available information — " and that's
the information from the Dow documents that we presented, as
well as other information — "does the newly available information
on the incidence and hazards of rupture and bleed increase your
concern and/or uncertainty about these products?" That was the
first question.
The second question: "Is the evidence of a possible link between
silicone gel-filled implants and autoimmune disorders strong
enough to increase your concern and/or uncertainty about these
products?" That was the second question.
The third question: "Does the industry's record in testing, report-
ing, and marketing these implants over the last 30 years — " in ref-
103
erence to the documents before it — ^"increase your concerns and/or
uncertainty about these products?"
Those were good questions back in 1992; they are the same ques-
tions I'm asking today in 1995.
Mr. McIntosh. And my position is, that second question could be
answered today and it's not, and that is a disservice to the Amer-
ican public.
Dr. Kessler. Mr. Chairman, if you're asking me to answer that
question beyond what the science allows me to answer, I can't.
Mr. McIntosh. I'm asking you to take an honest and fair look
at the science.
Dr. Kessler. And we have, and I think I've stated it. I've said,
on that question, based on the published studies — and I've not
looked behind those studies at the data; we normally do that. I
think I've made it very clear how we view those published studies
to date.
You may not agree with my statement, but I said there is reason-
able assurance that there is not a large increase in typical connec-
tive tissue disease. I've also said they don't rule out a small but
statistically significant increase in typical and it doesn't address
aWpical.
Now, other scientists are free to disagree. That's the best judg-
ment. When I talk to our scientists, that's what they tell me the
current state of the science allows us to conclude. I'm not sure
what more I can do than tell you how we read the published stud-
ies to date.
Mr. McIntosh. I will defer to the chairman.
Mr. Shays. I thank the gentleman.
Mr. Gutknecht and Mr. Fox, you both have questions.
Mr. Gutknecht. Yes, Mr. Chairman, I will try to be brief, be-
cause there are some other witnesses, and one, in particular, that
I want to hear from.
The chairman liked my story of the railroads, and I will share
another story, because I think it fits what we're talking about here.
I think it was President Harry Truman who said what he wanted
more than anything else was a one-armed economist, because he
s£ud they would go through these long presentations about what
was going to happen with the economy, and when they would fi-
nally reach what he thought was a conclusion, they would say,
"But on the other hand."
And I think that's sort of the fi-ustration that we have up here,
and I think a lot of the people in the industry have, is that once
they think they have satisfied all of your questions, then it's like,
"Oh, but on the other hand," there's this whole new set.
We don't want an adversarial relationship. I think the Congress
wants to work with you. I think we have the same goals. But there
is a high degree of frustration, and it's not just with this particular
issue, but I think it's with a lot of the new medical technologies
and new products.
This really isn't a question as much as just an invitation to try
and work with you. Because, I must tell you, I hear from an awful
lot of folks who are incredibly fi'ustrated. In fact, one of the most
troubling things that I've heard is from a venture capitalist in my
district — or in my State — who does a lot of investment in things
104
like this, but he won't invest now in any product or procedure or
new technology that requires FDA approval. He says it's just not
worth it. The return is way down the road, the costs are too great,
and it's just not worth it.
That is a very troubling thing for me. Somehow, I think we've
got to work together to get the trains running on time, rather than
having them all sitting there looking at each other. So, basically,
1 would just offer this invitation to you and your department: We
want to work with you to come up with some ways that we can get
the trains ninning, get the technology happening here in the Unit-
ed States, to get the investment back in the United States, to get
the jobs back in the United States.
And I think we have to look at that whole big picture, because
right now I'm afraid the system is not working the way it's sup-
posed to, and it's almost a dysfunctional system as it relates to new
technologies coming on line.
I would yield back to the Chair.
Mr. Shays. I thank the gentleman.
Mr. Fox.
Mr. Fox. Thank you, Mr. Chairman.
As a follow-up to what Congressman Gutknecht was talking
about, in trying to get an end point to where we are on research
and the conclusions of the agency, if I were to give you a check
today, Dr. Kessler — I'm sure you'd like to have that from Congress,
because we're not quick on giving checks — but assume it came from
me personally, how long would it take you to design, implement,
and conclude a study to determine the rupture rate and under-
stand the associated complications? Can you give me a timeframe?
Dr. Kessler. If you gave us the resources to do it and we had
the research capability to do that?
Dr. Burlington.
Mr. Fox. Is there a time?
Dr. Kessler. Having all the research capability and having the
fiinds to do it?
Dr. Burlington. Mr. Congressman, we would attempt to look at
that in two ways: In one way, we would say, "Let's find out what
the general experience with similar products is out there among
the many women who have received these."
That would be an epidemiological study that would probably take
several months to get up and ready to run, a period of data collec-
tion, and then a period of data analysis, perhaps IV2 years, maybe
2 years for a typical epidemiological study on a substantial scale.
With sufficient resources, that can be accelerated.
The other side of it is, we would look and say, "Is there a prod-
uct-specific issue?" And if it were, for instance, the Mentor product,
which, as we have heard, has been under prospective data collec-
tion for a couple years already, it may be that that data could be
similarly collected from the existing experience of women who have
today received implants. If it's a company that has to start from
today moving forward with new implants, we would be looking at
early experience to say, "Is there a manufacturing problem inher-
ent in that?"
105
So, taken together, I would say it depends on the company, but
that realistically that could easily be done in IV2 years, and with
sufficient interest and resources tnat could be accelerated.
Mr. Fox. Well, I appreciate your agency answer, but the fact is,
I think that some would say that the information already exists
upon which you can make such conclusions. I think the problem
that the Congress is haying, whether it be silicone breast implants
or drug approyal or disapproyal, we need to speed up the process
for prompt resolution, for the public's purpose.
Let me just get, if I can, to Dr. Kessler about one more question.
You said you're reluctant to get inyolyed in certain ways that
would cause more litigation. I would submit to you — and you may
have a different point of view — ^that the fact that you have not con-
cluded, with regard to the silicone breast implant, some of these
concluding statements that the women in the United States are
looking for, that we are actually helping some of the litigation at-
torneys move forward because of the lack of action by the FDA.
Dr. Kessler. I would certainly let other people who are more ex-
pert than me comment on what influences litigation. Again, I see
ads run in the paper. I see a lot of things going on, and I certainly
would leave it to other experts to know what influences litigation.
I've been reluctant to get dragged in over the last several
months. There is a lot at stake for all sides in this, and that's one
of the reasons I try to be prudent. Congressman. It's not easy.
Mr. Fox. I understand that. What we're trying to have you look
at, as we move forward from this hearing to try and help the pub-
lic, is that we try to do, with all resolute dispatch, the concluding
information that women need in order to make intelligent decisions
with informed choices.
Dr. Kessler. Congressman, you're 100 percent correct. That is
our mutual goal.
Mr. Fox. Thank you, Mr. Chairman.
Mr. Shays. Dr. Kessler, you have been a very agreeable witness
and spent a great deal of time, as have your assistants, and we ap-
preciate it. I think this has been a helpful dialog back and forth.
We would like to work with you on helping you understand a little
more clearly how we think your providing more specific guidance,
and even trying to work on some timetable, would be helpful to pa-
tients around the country.
We just have one basic technical question I would like my coun-
sel to ask. It relates to the agreements. First, the agreements with
these two companies, Mentor and McCann, they are both the appli-
cants, have they signed these agreements?
Dr. Kessler. I'm not an expert myself in these agreements.
Mr. Shays. They agreed to these agreements?
Mr. Levitt. Yes.
Mr. Shays. OK
Mr. Halloran. For the record, my question is: The documents
that you provided — and we will copy them and give you back the
originals — in the Mentor agreement, at Section 5, there's a provi-
sion that says, "In a letter to the applicant, dated — " blank — "the
agency denied approval of the applications for use of the device for
augmentation."
106
Similarly, in the guidance document, which is marked "Draft" —
is that a final, by the way? The guidance document issued in 1992
on studies, is that final?
Mr. Levitt. I believe that's the existing guidance.
Mr. Halloran. OK In the guidance document you say, "On
April 16, 1992, the Commissioner announced all PMA's had been
denied and protocols were being formulated." So, again, we need to
clarify for the record the legal status under which these agree-
ments operated, if indeed PMA's have been, in some sense, denied.
Mr. Levitt. Again, I believe that the chairman read the provi-
sion under which those agreements operate. The PMA's were de-
nied insofar as they relate to the augmentation use. They were ex-
tended under that particular provision of the statute, by agreement
with the companies, for purposes of breast reconstruction following
mastectomy and some other very specific uses, such as afler trau-
ma from an accident, and so forth, and revision for a women who
has an implant rupture.
Mr. Halloran. So these agreements are in force, and they are
the basis of the Commissioner s statement that the companies have
a legal obligation to conduct further studies?
Dr. I^SSLER. My statement is based on the general provisions in
the statute.
Ms. RoTHSTEiN. Yes, that is the legal basis.
I'm Beverly Rothstein. I'm with the Greneral Counsel's Office of
FDA,
We also have, if you would also like us to provide to you, the let-
ters dated April 16 to the two sponsors.
Mr. Halloran. That would be helpful, yes.
Ms. Rothstein. I don't have those with me.
Mr. Halloran. There's also an appendix to the Mentor agree-
ment reference, which I think is the list of studies, or there's an
Appendix F reference in the agreement which is not here. Would
you provide that, as well, please?
Ms. Rothstein. Yes. There were, I think, eight attachments to
the agreement. We could get you that.
Mr. Halloran. Thank you.
Mr. Shays. Dr. Kessler, I mean this sincerely, I thank you very
much for being here. You have helped this hearing tremendously,
as Dr. Burlington and the others who have testified. And thank
you, as well, Mr. Levitt.
Dr. Kessler. Thank you very much, Mr. Chairman. We look for-
ward to working with you.
Mr. Shays. Likewise.
Dr. Kessler. Thank you.
Mr. Shays. Thank you. And I mean that sincerely. We do look
forward to working with you.
We have a very patient third panel. It is comprised of basically
nine members; I will call them. We will proceed in this order: John
Sergent, Douglas Shanklin, Sherine Gabriel, Elizabeth Connell,
Linda Ransom and Tara Ransom, Sybil Goldrich, Sharon Green,
and Jama Russano.
If you would all — if they are still here; if they survived — I would
love to have you come ana take the witness stand.
107
Before I swear the witnesses in, let me just give you a sense of
how we're going to proceed through this panel. We have four physi-
cians, and they will give their testimony. Then we have four pa-
tients who will proceed to give their statements, as well.
Are we missing one of the panelists? Who are we missing? Dr.
Connell is not here. I would like to make sure we have a chair for
her. I will swear all of you in at the same time.
Let me just say that we have Mr. Shadegg here who, like Sen-
ator Kyi, is from Arizona, and would like to take the opportunity
to welcome one of our witnesses.
Tara, that happens to be you. It's very rare when you get a Sen-
ator and a Congressman both who want to welcome you, but I don't
blame them.
Mr. Shadegg, you have the floor.
Mr. Shadegg. Mr. Chairman, thank you very much.
I appreciate this opportunity and express my appreciation to
both you and the other chair of the joint subcommittees. I do serve
as a member of the other subcommittee, though I have missed
these proceedings this morning because I'm in tne concluding day
of the Waco hearings, which I'm pleased are concluding.
Mr. Shays. Thank you for your work there.
Mr. Shadegg. It is a privilege to introduce both Tara Ransom,
who is 8 years old and who will be testifying before this panel
today, as well as her mother, Linda Ransom. Both are residents of
Phoenix, AZ, which is a part of my district, though they are not my
constituents; they are constituents of Congressman Ed Pastor.
Linda, Tara's mother, is a patient advocate on behalf of families
who have been affected by hydrocephalus shunts, including her
daughter Tara. Tara is 8 years old, and she received a hydro-
cephalus shunt shortly afler her premature birth. She requires this
shunt for the balance of her life, in order to drain fluid from her
brain.
Linda Ransom and, of course, Tara are deeply concerned that the
controversy, and it is an important controversy that you are look-
ing into today, will somehow, and already has to some degree — and
you will hear this in their testimony — reduced the availability of
other implants made from silicone.
Materials such as silicone, teflon, and the plastics that are used
in sutures, pacemakers, artificial valves and joints, and many other
applications are key to the survival of patients all across America.
Makers of those products, in many instances, have either stopped
or are contemplating stopping the production of the materials used
in the manufacture of those oiomaterials because of their concern
about possible liabilitv implications.
Whenever we legislate, Mr. Chairman, we deal very much with
the law, which never gets discussed, of imintended consequences.
That is the issue here. In our efforts to deal with the direct prob-
lem that is before us, we need to be certain that we do not, through
an unintended consequence, place people like Tara, whose life is
truly dependent upon these materials, in jeopardy.
I simply would also further like to mention that Senator John
McCain has introduced legislation on this issue, trying to make
sure that there will be a continuing availability of materials for
these types of medical devices, including the type of brain shunt
108
that Tara wears. His legislation is, hopefully, moving through the
Senate and making progress.
I would call upon my colleagues on this committee to, please, as
you would all witnesses, listen carefully to the testimony of Tara.
1 think you will find it compelling. She has written it herself and
edited it herself I urge you to listen to both Tara and Linda.
I welcome, Tara, you and your mother, Linda, to this committee.
Thank you very much, Mr. Chairman.
Mr. Shays. Thank you for your comments.
Now, I would like all the witnesses to stand.
Tara, we're going to swear in all the witnesses. Legally, we can't
swear you in, out we're more than happy to have you participate
in this process, and then I'm going to be asking you a question
afterwards.
If all the witnesses would stand up and raise their right hands.
Tara, we're giving an oath of office about speaking the truth.
[Witnesses sworn.]
Mr. Shays, I note for the record, everyone has answered in the
affirmative.
The one thing I am absolutely certain of, Tara, is that you know
the difference between the truth and something that's not true.
That's why we don't need to swear you in.
We're just going to go right down. We're going to ask vou to keep
your words fairlv concise. We don't have as many Members asking
questions, but there will be a number of questions. So feel free to
use your 5 minutes, and then we will have some good questions
and answers, hopefully. We will certainly have some good answers.
STATEMENT OF JOHN S. SERGENT, M.D^ VANDERBILT UNI-
VERSITY; DOUGLAS R. SHANKLIN, M.D., UNIVERSITY OF TEN-
NESSEE, MEMPHIS; SHERINE E. GABRIEL, M.D., MAYO CLIN-
IC; ELIZABETH B. CONNELL, M.D., EMORY UNIVERSITY;
LINDA RANSOM AND TARA RANSOM, PHOENIX, AZ; SYBIL
NIDEN GOLDRICH, COMMAND TRUST NETWORK; SHARON
GREEN, Y-ME; AND JAMA KIM RUSSANO, CHILDREN AF-
FLICTED BY TOXIC SUBSTANCES
Dr. Sergent. Thank you, Mr. Chairman.
I'm John Sergent, chief of medicine at St. Thomas Hospital and
professor of medicine at Vanderbilt University in Nashville. In
1992-93, 1 was president of the American College of Rheumatology.
When Dr. Kessler called for the voluntary moratorium on silicone
gel breast implants and reconvened the FDA panel in 1992, I was
one of two rheumatologists asked to be on that expanded panel.
Like most rheumatologists, I was familiar with the reports of
rheumatic diseases following breast implantation, and when Dr.
Kessler called for the moratorium, I assumed that we were going
to hear new and convincing evidence that there truly was some re-
lationship between breast implants and rheumatic diseases. How-
ever, the only clinical reports we heard were anecdotal series by
rheumatologists and others whose views were well-known and
whose patient referrals included large numbers of women referred
by lawyers. There was no epidemiologically sound evidence pre-
sented.
109
The reason that good epidemiology was required to answer this
question is that out of the million or so women that the FDA esti-
mates had breast implants, one would expect to see 10,000 to
20,000 cases of rheumatoid arthritis develop over the years, along
with several thousand cases of lupus and the other connective tis-
sue diseases. Fibromyalgia, a symptom complex consisting pri-
marilv of diffuse aches and pains, could be expected to occur in
even higher numbers.
All of these would be expected in any population of a million
women, with or without silicone implants, and represent the back-
ground noise which can only be sorted out by good epidemiology.
In 1992, at the time of the implant hearings, there had been no
solid scientific studies done to look at this problem.
However, beginning that year and extending through last month,
there have been a number of large studies using a variety of epi-
demiologic techniques. Some of the medical centers which nave re-
ported studies on this issue include Johns Hopkins, the University
of Pittsburgh, M.D. Anderson, the Universitv of Michigan, the
Mayo Clinic and Foundation, the University of South Florida, and
Harvard.
All of these studies reached the same conclusion: There is no in-
crease in musculoskeletal symptoms or in any rheumatic disease in
women with breast implants. So, from a scientific standpoint, the
issue is resolved. I disagree with Congressman Ganske and with
Dr. Kessler. The negative has been proven. As Dr. Shaun Ruddy,
the current president of the American College of Rheumatology,
put it, the only thing keeping this issue alive is litigation, not sci-
entific inquiry.
But the litigation, fueled in part by the FDA moratorium, has
had effects that go far beyond the issue of silicone implants. Grood
scientists, from outstanding universities, have been narassed by
plaintiff lawyers, and they and their universities have been injured
in the process. A distinguished editor of the New England Journal
of Medicine has been similarly harassed for expressing her views.
This will surely make doctors reluctant to get involved in answer-
ing similar questions in the future.
The FDA moratorium and the explosion of litigation will also
have long-term repercussions in the whole field of implantable
medical devices, as has already been discussed today. The United
States has been the acknowledged leader of the world in this area.
I wonder how enthusiastic U.S. companies will be about new prod-
uct development in the years to come.
Finally, I would like to comment on the process the FDA used
to examine this issue. The panel on which I served was called pri-
marily to answer the question of whether FDA action was called
for in light of the reports of various rheumatic diseases occurring
in women with implants.
I maintained publicly at the time that the panel was almost
uniquely unqualified to answer such a question. It contained only
two rheumatologists. Dr. Nate Zvaifler and myself, neither of whom
is an epidemiologist. The only epidemiologist on the panel had no
apparent familiarity with the diagnostic difficulties involved in
complex rheumatic diseases, as was also true of the panel's only
immunologist.
110
Others on the panel were already on record as opposing implants
for a variety of reasons, most having little or nothing to do with
rheumatic diseases. For example, one panel member, in explaining
her vote to restrict implants, stated that she decided to change her
vote after a confrontation by the director of women's studies at her
university.
The question before the FDA in 1992 was this: Is there an in-
creased incidence of any rheumatic disease following silicone breast
implantation? That fundamental epidemiolo^c question can only be
answered one way, by good science. Good science is not decided by
voting in a media-charged atmosphere such as the FDA hearing; it
is decided by careful inquiry. In the case of breast implants and
rheumatic diseases, all of the solid science shows that there is no
relationship.
The primary responsibility of the FDA is to protect the public,
but that public protection should be carried out with respect for the
principles of good science and honest inquiry, not the junk science
of poorly designed and unconfirmed laboratory tests, and anecdotal
reports from doctors whose practice consists largely of women re-
ferred by plaintiff lawyers.
The FDA moratorium on silicone breast implants was an enor-
mous error. Unless the fundamental process of decisionmaking by
the FDA is changed, we can only expect more of the same in years
to come.
Thank you.
[The prepared statement of Dr. Sergent follows:]
Prepared Statement of John S. Sergent, M.D., Vanderbilt University
I am John Seraent, Chief of Medicine at St. Thomas Hospital and Professor of
Medicine at Vanoerbilt University School of Medicine, both in Nashville, TN. I am
a clinictd rheumatologist, and in 1992-93 I was President of the American College
of Rheumatology. After Dr. Kessler called for the voluntary moratorium on silicone
gel breast implants and reconvened the FDA panel, I was one of two
liieumatologists asked to be on that expanded panel.
Like mo^ clinical rheumatologists, 1 was familiar with the Japanese articles
which had appeared in the 60s and again in 1980s, and I was also familiar with
a few anecdotal reports by physicians reporting various symptoms in patients with
breast implants. At that particular time, scleroderma, a potentially fatal disease,
had been reported in women with implants, especially in the Japanese papers.
Again, like most rheumatologists, I thought there might be something to this as-
sociation. We already had evidence that drugs and environmental factors can cause
clinical features that resemble scleroderma.
When I read that Dr. Kessler had called the moratorium, and then was asked to
be on the panel, I assumed that we were going to hear new and convincing evidence
that there was truly some relationship between breast implants and rheumatic dis-
eases.
I was very disappointed by what occurred at the FDA panel. The only clinical ma-
terials presented were anecdotal series by physicians who had publicly stated that
there was a relationship between breast implants and rheumatic diseases. It was
clear that the pattern of referral of these physicians was based almost entirely on
the fact that their views were widely known, and much of it was from plaintiff law-
yers. I was disappointed that none of these physicians had made any attempt to
look objectively at their data in an epidemiolo^c way.
At this point, I think I need to explain to you a little bit about the rheumatic,
or connective tissue, diseases. The major rheumatic diseases bringing people to
rheumatologists' oflices, roughly in order of frequency, are as follows:
1. Fibromyalgia — this is a poorly defined symptom complex that consists primarily
of aches and pains, sometimes with poor sleep patterns and other symptoms. It is
extremely common, although no exact incidence ligures are available. It is estimated
by some rheumatologists uiat as many as 40% of their patients have this disease.
Ill
It is also said to be the most common cause of a rheumatology consultation in the
countiy. Virtually all of these patients are women, usually between ages 25 and 50.
2. Rheumatoid arthritis — this disease afFects between 1 and 2 percent of the popu-
lation, or about 10-20,000 cases per million people. Approximately 70% of the pa-
tients are women, and the peak age of onset is about 40, although it is seen at edl
ages.
3. Systemic lupus erythematosus — this disease occurs at a frequency of about 1
case per 1-2,000 women, and approximately 90% of the patients who have the dis-
ease are women. Most of the cases occur between age 15 and 45.
4. Scleroderma — this is much less frecpent, with about one new case per year per
100,000 people. It is also more frequent m women.
The other systemic inflammatory connective tissue diseases, including inflam-
matory muscle diseases, are also seen at a higher incidence in women than in men,
although they are much less frequent.
Therefore, the reason that good epidemiology is required to answer questions in
rheumatology is that out of the million or so women that the FDA estimates had
breast implants, one would expect to see 10-20,000 cases of rheumatoid arthritis de-
velop over the years, along with several thousand cases of lupus and the other dis-
eases. Fibromyalgia could be expected to occur in much higher numbers. All of these
would be expected in any population of a million women, with or without silicone
implants, and represent the "background noise," if you will, which can only be sort-
ed out by good epidemiology.
In 1992, at the time oithe implant hearings, there had been no solid epidemio-
logic studies done to look at this problem. The first, later that year, was a retrospec-
tive look at a large population oi patients with scleroderma at Johns Hopkins and
the University of Pittsburgh. Out of 741 women with scleroderma 7 had undergone
breast implantation, and tne overall incidence of implantation prior to scleroderma
was 0.6%, a figure not different from estimates of the incidence of breast implants
in the population at large.^
Since tnen a number of important epidemiologic studies have been performed, and
all have shown no increase in any rheumatic disease among implant recipients.
Briefly summarized, the following are among the most important:
1. A study comparing women with silicone breast reconstruction after cancer sur-
gery, compared to women who underwent breast reconstruction using their own tis-
sues.' This study showed no increase in any rheumatic disease due to silicone.
2. A large study from the Mayo Clinic^ which looked at 749 women with silicone
implants and compared them to controls without implants. Thev also found the
same incidence botn of rheumatic diseases and of various musculoskeletal symptoms
in the two groups.
3. A large study from Australia^ whidi found no relationship between silicone im-
plants and scleroderma.
4. Finally, a Harvard study'' looked at 121,000 women, and found 448 cases of
rheumatic diseases. There was no association between silicone implantation and any
liieumatic disease, nor were musculoskeletal symptoms reported with increased fre-
quency, which would make it extremely unlikely that silicone had caused a new pre-
viously undeflned, disease.
In addition, in a unique approach a group from the University of South Florida*
examined women who had had silicone breast implants and compared their symp-
tomatology to women who had undergone other forms of plastic surgery not involv-
ing silicone. There were no significant differences in their musculoskeletal symp-
toms, again refuting the emergence of any new disease due to silicone.
So, from a scientiflc standpoint I believe the issue is closed. As Dr. Shaun Ruddy
of Richmond, the current President of the American CoUege of Rheumatology, put
it, the only thing keeping this issue alive is litigation, not scientiflc inquiry.
^Wigley FM, Miller R, Hochberg MC et al: Augmentation mammoplasty in patients with ays-
temic sderoeis: data fix)m the Baltimore Scleroderma Research Center and Pittaburgh
Scleroderma Data Bank. Arthritis Rheum 35:S46, 1992 (abetr).
'Schusterman MA, Kroll SS, Reece GP et al: Incidence of autoimmune disease in patients
after breast reconstruction with silicone gel implants versus autogenous tissue: a preliminary
report. Annals Plast Surg 31:1-6, 1993.
^Gabriel SE, OTallon WM, Kurland LT, et al: Risk of connective tissue diseases and other
disorders after breast implantation. N Engl J Med 330:1697-702, 1994.
^Englert HJ, Brooks P: Scleroderma and augmentation nnammoplasty — a causal relationship?
Aust NZ J Med 24:74-79, 1994.
"Sanchez-Guerrero JS, Colditz GA, Karlson EW et al: Silicone breast implants and the risk
of connective- tissue diseases and symptoms. N Enal J Med 332:1666-70, 1995.
'Wells KE, Cruse CW, Baker JL, et al: The health status of women following cosmetic sur-
gery. Plast Reconstr Surg 93:907, 1994.
112
But the FDA moratorium has had effects that go far beyond the issue of silicone
implants. Good scientists from outstanding universities have been harassed by
Slaintiff lawyers, and they and their universities have been injured by the process.
, distinguished editor of the New England Journal of Medicine has been sunilarly
harassed for expressing her views. This will surely make doctors reluctant to get
involved in answering similar questions in the future, especially if there is a great
deal of pending litigation.
/Uad while I Know little of the process involved in making implantable medical de-
vices, I know something of the devices themselves. They are used for such things
as artificial joints, heart valves, pacemakers, eye lenses, and various shunts, just
to mention a few. The United States has been the acknowledged leader of the world
in this area. One can't help but wonder if the result of the FDA panel won't have
major repercussions in the area of new product development for many years to
come.
Finally, I would like to comment on the process the FDA used to examine this
issue. The panel on whidi I served was called primarily to answer the question of
whether FDA action was called for in light of tne reports of various rheumatic dis-
eases occurring in women with implants. I maintained publicly at the time, and be-
lieve even stronger today, that the panel was almost umquely unqualified to answer
such a (niestion. It contained only two rheumatologiats, Dr. Nate Zvaifler and my-
self, neither of whom is an epidemiologist. The only epidemiologist on the panel had
no apparent familiarity with the diagnostic difficulties involved in complex rheu-
matic diseases, as was also true of the panel's only inununologist.
TTien that group was mixed with additional people who were already on record
as opposing implants for a variety of reasons, most having little or nothing to do
with rheumatic diseases. For example, one panel member, in explaining her vote,
Eublicly stated that she had been confronted by the director of women's studies at
er university because the original FDA panel, on which she also sat, had favored
no restrictions.
The question before the FDA in 1992 was this: Is there an increased incidence
of any rheumatic disease following silicone breast implantation. That fundamental
epidemiologic ouestion can only be answer one way: by good science. Good science
is not decided by voting in a media-charged atmosphere such as the FDA hearing.
Indeed, the argument could be made that the FDA panel, and all the publicity, have
made it more diflicult to do good prospective epidemiologic research. The conclusion
the FDA reached was flawed, and it was flawed because the fundamental process
of decision-making was flawed.
Mr. Shays. Doctor, thank you very much.
Dr. Shanklin.
Dr. Shanklin. Thank you, Mr. Chairman.
I'm Radford ShankHn. I've been a physician for 40 years. And as
a physician and pathologist who used to be in chnical practice, I've
seen many unusual and marvelous things. Over this time, however,
I've not seen anything quite so distinctive as the tissue changes
which are found actually in the women who have problems arising
as a result of their implants.
I think there is another transportation vehicle that should be in
the metaphor of the morning's hearing. There is another vehicle —
whether it's a jet airplane or a truck on the parallel highway, we
will find out— but that is the impetus given by basic clinical prob-
lems these women have, which have been reflected in both clinical
and basic laboratory research. As a pathologist, I'm qualified to
speak to that.
One of the things that is very impressive to me about the tissue
diseases that they actually show is, in fact, the consistency that the
findings appear to be from woman to woman, and the duration and
consistency that they stay with that particular woman over many
years.
I view the hearings today as not only the inheritor of the 1990
hearings, but, as I have indicated in my printed remarks, of the
1936 hearings of the 74th Congress on the Gawley Bridge disaster
113
in West Virginia, which was an industrial disaster with an ac-
knowledged death toll of nearly 500 people, due to what we would
call today accelerated silicosis.
The reason for mentioning that is very clear. The chart has been
taken down, but it showed filler in the elastomer which is on the
outside of the shell of the implant. That filler is amorphous silica
and accounts for about 25 percent of the physical mass of that de-
vice, at that level.
There has been some talk about and some claims about amor-
f>hous silica being nontoxic. That is not true. There is an abundant
iterature, dating from the 1950's, showing that amorphous silica
has similar reactions in the body to so-called crystalline silica, and
we see tiiat, certainly, in the pathological material that I have been
privileged to examine over the last 10 years.
In addition to that, we recently made a presentation on the T-
memory cell response to the various forms of silica, which was pub-
lished m a FASEB journal in March of this year. It was a presen-
tation, in abstract form, at their national meeting in Atlanta in
April. All of these forms of silica are part of these products.
In addition to that, the basic chemistry indicates very clearly
that the silicone can redegrade back to silica through the medium
of silicate formation and tnen recondensation. The tnermodynamics
and the physics are very clear that this will happen, and we see
it.
I brought some photographs to show the committee, but we're not
able to do so. However, the staff does have my notebook, which I
sent through, which shows similar pictures illustrating many of
these lesions. We're talking about a real thing here, Mr. Chairman.
Not only that, in deference to my colleague to my right, he is es-
sentially correct. The classical diseases of autoimmune type are not
being seen with any increased frequency. This is a new disease, be-
cause this is a new substance that the human species has come
into contact with. We have referred to it, in some of our writing,
as an alien disease. It's actually sort of a wry joke, because its
man-made. Silicones do not occur in nature.
These things come together in my mind, as a basic scientist, be-
cause I see them in the tissues, and they cause a profound reaction
which has immunological consequences. Some of the studies have
indicated that there is not sufficient information about the atypical
forms of disease. We have done peptide tests on the serum of
women with so-called silicone disease, and their peptide profile is
different from that of classical autoimmune processes.
Accordingly, the study by my colleague on my left is correct in
that regard, but there is good evidence beginning to evolve in lab-
oratories all over the country. Witness was given to this by the
hearing, or rather, workshop, more correctly stated, at NIH in
March, at which a number of basic researchers came forward and
presented their material.
There was a consensus out of that that the products bleed gel
into the tissues and that gel causes an immunological reaction. We
have published work on that. The reaction or positivity rate is up-
wards of 90 percent of women with implants.
Another question which comes to my mind, as a physician and
basic scientist, is the magnitude of the problem. We heard numbers
114
today of a million women. There is no data validating that avail-
able. The best guess is probably about half of that. Tne reason is
because inflated figures were used early on in an attempt to gain
attention, but we do a disservice to everybody if we persist in using
false numbers.
On the other hand, if 80 percent or 90 percent of women become
sensitive, ultimately, to their product, to their device, that still
could constitute a very significant burden on public health facilities
in the United States, because we're talking about 400,000 or more
women.
The other question is, how long does it take for these things to
show? Gordon Robinson, a surgeon, plastic surgeon, in Bir-
mingham. AL, published a few months ago a study of 300 patients
who had been followed for 20 years. The rupture rate in his report
approximates 100 percent at the end of 20 years; that's 5 percent
per year.
And he came up with a recommendation which really startled
me, despite my familiarity with this field; namely, that these de-
vices be removed by 8 years, which would be at a 40 percent rup-
ture rate. That's a pretty high rupture rate, 40 percent. That is his
clear recommendation. This is a man who spent much of his profes-
sional career putting these things into patients, for various rea-
sons.
Now, the other question which comes to my mind is the
immunological response. We see that in about 90 percent of indi-
viduals who have these implants. We see it in other types of indi-
viduals with different kinds of implants, but at a lower level.
I have no problem with hydrocephalic devices; they need to be
done as a primary form of treatment. Breast reconstruction is a
secondary form of treatment, and perhaps there should be a dis-
tinction there. It's still valuable. You have to know what the risk
is. Time will tell. The length of time it takes to cause these dis-
eases may be measurable by 15 or 20 years.
Dr. Kessler was unwilling to give a figure as to how long it's
going to take. I would suggest that the real knowledge is now com-
ing in. And if you look at the publications that have already come
out in 1995, you see that there is a turnaround in these publica-
tions. It's now coming from basic centers, not from affiliates of any
particular point of view, but the basic research is beginning to
come forward from private sources, stimulated by clinical problems.
I realize the FDA is not a research organization, ana perhaps
they are not quite up-to-date on the literature either. But the data
is coming forward, and it will show that there is enough informa-
tion, in my personal opinion, to make a judgment on this. And the
judgment is that implants are not safe, and when they cause dis-
ease, they should be removed.
Thank you.
[The prepared statement of Dr. Shanklin follows:]
115
Prepared Statement of Douglas R. Shanklin, M.D., University of Tennessee,
Memphis*
During my 40 years as a physician and pathologist I have seen many unusual and
marvelous things but I have yet to see anything more impressive than the tissue
changes due to silicone and silica after use of manunary implant devices, findings
impressive for consistency of effect between different patients and for persistence
over many years in various individuals.
Mr. Chairman, I view these hearings as the direct inheritors of investigations by
Congress on two prior occasions. The more recent was on December 18, 1990 by this
8ub«>mmittee on closely similar topics. But equally to the point, in my opinion, were
the hearings of the 74th Congress, second session, on January 16, 17, 20, 21, 22,
27-29, and February 4, 1936 on the subject of the industrial disaster in the Hawks
Nest Tunnel, at Gauley Bridge, West Virginia. There were 476 acknowledged deaths
among tunnel workers from what modem medicine would now call accelerated sili-
cosis.
This tragic event is relevant to the issues surrounding siUcone breast implants
because (1) amorphous silica is part of the envelope or shell on the outside of the
device, and (2) because silicones degrade sjpontaneously and in the body to silicates
which recondense into silica. The pathological evidence is now compelling: gel bleed
from implants occurs into the surrounding human tissue (the periprosthetic capsule)
as a matter of course and silica is often found in both scars and in nearby
granulomas. The granulomas are a product of immunopathic responses mediated by
various cells of the immune system, macrophages and lymphocytes. The lymphocyte
response is through an interleukin-2 receptor process, one of the ways in which cells
of tne immune system signal to each other.
The body develops a memory through T-lymphocytes of the presence of both the
silicone and the sUica of these devices. The reaction is more severe to the silica,
making these lesions, in effect, a form of silicosis, one which can be designated as
capsular silicosis. It differs from the so-called traditional medical view of silicosis
in that the lung is bypassed by surgical implantation of these devices.
Several years ago the objection was raised that the devices make use of amor-
phous silica whereas it is crystalline silica which is most readily found in the tissues
of these women. This is a distinction without a difference. First, there is sunple evi-
dence in the scientific literature that amorphous siUca causes the same reaction as
crystalline silica. Extensive animal work was published in 1957 specifically on Dow
Coming Degussa amorphous silica and a number of papers have appeared since
demonstrating significant clinical disease in humtms under certain industrial condi-
tions. If anything, amorphous silica is somewhat more toxic. Second, direct compara-
tive T-ljnmphocyte tests show no effective difference in cellular memory in implant
patients to amorphous, fumed amorphous, or crystalline silica. The full range of
autoimmune diseases seen in implant patients, including atypical and mixed forms,
is seen in classical silicosis. Thus, the disaster at Gawley Bridge is directly relevant
to our problems today.
I have said the pathological findings are compelling. We recently published a de-
tailed survey of tissues on 100 patients which strongly supports this statement. The
March 1995 N.I.H. Workshop on Silicone Immunology had multiple presentations
confirming this work. But the immunological findings are also compelling. The reac-
tivity of T-lymphocytes to silicone and its byproducts have been shown now in three
independent laooratories and changes in immunoglobulins have been shown to tend
toward abnormal forms associated with malignant transformation of B-lymphocytes.
Abnormal antibodies are developed, in part due to chemical changes in surrounding
tissue proteins. Since silicone gel itself can migrate all over the body these con-
sequences are free to develop at sites far removed from the breast. The immune fac-
tors, of course, circulate freely in the lymphatic and blood circulations. I autopsied
a woman about 50 years old whose death was septic from silicone interference with
normal immune function; it was found in her brain and chest cavitv among other
extramammary sites. This case is just one of six autopsies I have been consulted
on.
Some of the tiseue and protein retictions are not those of traditional autoimmune
diseases. This is one of the reasons why various epidemiological studies, some re-
ceiving disproportionate publicity, have failed to fina a link. They have been looking
*Dr. Shanklin has served as an expert witness in the past, nnainly but not exclusively for
clainvants, and has one case in active mediation. Review of diagnostic materials has been vol-
untary and funding for all research published and in progress nas been internal. He was not
a witness in the Hopkins case. A leading recent paper from our laboratories and a disease flow
chart are attached to this statement. He represents no institution or group in these hearings.
116
for the wrong diseases in addition to certain failures of method including poor sam-
61e power. This set of circumstances has prompted the American College of
;heumatology to form a special study group to formulate appropriate diagnostic cri-
teria for a new autoimmune disorder, silicone disease, or whatever the lormal des-
ignation may come to be.
We are talking here about strongly empiric findings, ones that cannot be refuted
by insensitive field surveys or by promotional literature. Some of what is known
today has come from industry documents discovered during liti&^tion including
many studies on immune factors, which were never offered for medical publication.
Had these been generally available when done, beginning in the 19508, these hear-
ings would not have been necessary because the medical problems would have sur-
faced decades ago. The January 1992 moratorium on implants by Commissioner
Kessler was the right thing to do on medical and toxicological grounds. It must be
understood, however, that it was not the result of FDA staff work or a historical
time review of implant manufacture compared to the progress of inomunopathology,
but in large measure from litigation documents. The language of Doctor Kessler's
declaration in Hopkins v. Dow Corning, requesting release oi the protective order
for purposes of puoUc disclosure, some 24 days after his request for a voluntary mor-
atorium (which was heeded), and after the iury verdict for the claimant, does not
clearly indicate whether Dow Coming supplied certain documents (including some
in the case cited) requested by FDA before or after the FDA received other various
documents from outside sources [Kessler, 30 January 1992, C8&-4703 TEH]. The ul-
timate release of many such documents in 1992 has been followed by others as part
of the Multi-District Litigation. Correlation of industry research shows awareness
of the involvement of the immune system in silicone disease but, in general, these
studies were of limited scope and little follow up has been found in similar records.
One set of internal documents was especially revealing: memoranda by Woodbury
and Delongchamp showing that estimates of 1-2,000,000 women with implants sim-
ply could not be validated [Document DCCK MM 489617, December 10, 1990; docu-
ment DCC 080011571-2, December 12, 1990]. Their estimates settled down to
320,000 women by mid-1990. This fi^re seems valid in retrospect. There were just
over 400,000 registrants with the claims office of the MDL by June 1995 and almost
100.000 physician certifications have been filed for these women so far. The public
health is not well served by touting falsely high numbers of women at risk. (Jn the
other hand, 100-400,000 sick or potentially chronically ill women is a large burden
on the health care facilities of the nation. The trends are clear pathologically: more
and more women will need explantation and a cogent therapy will have to be de-
vised. The risk of malignancy remains to be determined and may not become obvi-
ous for a decade or more in the future, due to the long induction period of many
human cancers. In addition, there is now accumulating laboratory and clinical evi-
dence of second generation effects in children bom to women after implantation. The
good news is, when explanation is done along with careful removal of the capsular
scar tissue surrounding the implants, the health of most women does improve. The
extent of recovery is a subject for future study, as numbers are presently small. For
women satisfied with their implants and unaware of any illness brewing within
their bodies one can only say, may it ever be thus for you. The growing evidence
of a limited product life, especially for implants of the late 19708 and the 1980s,
is against them. Present data indicate a practical product life of twenty years within
theDody; Robinson now recommends removal at 8 years [Ann. Plast. Surg. 34:1-
6, 1995]; the FDA is wrong not to recommend removal. Not all ruptures are recog-
nized as such.
In sunmiary, my experience in studying human tissues for almost ten years tells
me that silicone devices are not inert in the human body, that gel filled ones leak
and rupture with profound pathological and immunological consequences, that
women can and do die from effects of their implants, ana devices of this type are
not the medical solution to post mastectomy reconstruction, or for mammary
aplasia.
117
CELLULAR INTERACTIONS AND FATE OF SILICONE IN CAPSULAR TISSUES
Sources: spall iation from surface of envelope
gel bleed >= —
rupture with bulk dumping
Interface capsule
P formation
R
O
G Cell responses:
R
E
S
S
I
o
N
O
F
C
A
P
S
U
L
E
F
O
R
M
A
T
I
O
N
bulk collections
macrophages
I
V
1
presentation
immune
processing
lymphocytes
Thickening
of capsule
Contracture
of capsule
droplets, globules
molding, partial containment
extracapsular
migration
granuloma
formation
silicone
micronization
self
reinforcing
granulomatosis |]
[si
liconoma]
* vasculitis
* extrathoracic migration
* plasmacytic reaction
* lymph node reaction
* implant rejection
* abscess formation
tumorigenesis
118
STRUCTURE OF
SILICONE POLYMERS
H
H-C-H
-Si-0-
H-C-H
H / n
Siloxane Monomer
OILS
Linear Polymers
GELS
Lightly
Cross-Linked Polymers
ELASTOMERS
Cross-Linked Polymers
Reinforced with Fillers
119
RESEARCH COMMUNICATION
Immunologic stimulation of T lymphocytes by silica after use
of silicone mammary implants
DAVID L. SMALLEY,* '•' DOUGLAS R. SHANKLIN,'' MARY F. HALL," MICHAEL V. STEVENS/ AND
ARAM HANISSIAN^
•Baptist Memorial Health Care System, Memphis, Tennessee 38105, USA; 'Departments of Pathology and 'Obstetrics
and Gynecology, University of Tennessee, Memphis, Tennessee 38163, USA; and ^Department of Medicine, Baptist
Memorial Hospital, Memphis, Tennessee 38120, USA
ABSTRACT Difficulties in showing the biologic ac-
tivity of silicones in vitro have contributed to the con-
troversy over eifects of silicone mammary implants in
vivo. We adapted a standard lymphocyte stimulation test
to detect evidence of cellular immunity in patients with
silicone gel implants. Initially, lymphocytes were har-
vested from 70 implant patients, 76 normal controls
without implants or symptoms, and 18 patients with clas-
sic rheumatic disorders and without a history of silicone
implants. The harvested lymphocytes were stimulated
with PWM, PHA, Con A, and pharmaceutical grade col-
loidal silicon dioxide (silica). Implant patients showed
increased SI compared to controls and those with rheu-
matic disorders. The mean SI of implant patients was
195.0 ± 19.3, 18-fold that of normal controls (< 0.0001).
Patients with rheumatic disease showed the same SI as
controls (P = 0.3577). A follow-up study included 220
normal controls without implants, 942 silicone gel im-
plant patients with demonstrable rheumatic symptoms,
and 34 implant patients without symptoms at the time of
the study. The average SI for the 220 normal controls was
10.0 ± 0.41. Among the symptomatic implant women,
860 (91.3%) had SI significantly above those of the nor-
mal controls. Of these, 171 (18.2%) had SI between 25
and 50, 316 (33.5%) had SI between 50 and 100, and 373
(39.6%i) had SI over 100. The data presented confirms
that silicone implant patients respond immimologically
to the silicon dioxide contained in mammary prostheses.
Smalley, D. L., Shanklin, D. R., Hall, M. F., Stevens,
M. v., Hanissian, A. Immunologic stimulation of T lym-
phocytes by silica after use of silicone mammary im-
plants. FASEBJ. 9. 424-427 (1995)
Key Words: lymphocyte stimulalion • silicon dioxide • silicone
breast implants • silicones
During the past several years, much debate has centered
over the effects of silicone breast implants on women. The
authors of one study claimed the "natural" incidence of au-
toimmune diseases was higher than that seen in implant pa-
tients (1). Yet reports of systemic sclerosis (2), scleroderma
(3), and connective tissue disease (4) in implant patients con-
tinue to be published. Studies have established the physical
presence of silicon (4, 5) and silicones (6, 7) in tissues at or
closely adjacent to the prostheses, including axillary lymph
nodes (8, 9). Antibodies to silicone elastomers have been
reported in patients with silicone ventriculoperitoneal shunts
(10) as well as after silicone mammary implants, especially
after leakage or frank rupture (11). Such evidence, although
confirming the presence of silicones and/or breakdown
products outside prostheses and the existence of silicone an-
tigenicity, has not resolved whether or how autoimmune dis-
ease inight result from implanted silicone mammary
prostheses. The results reported here demonstrate cell medi-
ated immune reactivity, specifically the response of T lym-
phocytes when stimulated with silicon dioxide (silica).
METHODS AND MATERIALS
The inilial study was done on 164 palienis. It included 70 implant patients
with two or more of the symptoms previously described (12), 76 normal
adull female controls without implants or symptoms, and 18 patients with
classic rheumatic disorders without history or use of silicone implants. Of
the rheumatic disorder group. 4 had lupus erythematosus, 10 had fibromyal-
gia, and I each had been diagnosed previously as mixed connective tissue
disease, rheumatoid arthritis, osieoarthritis. and scleroderma. None of ihc
18 had silicone mammars' implants and were otherwise typical of the clinical
disorders noted The average age of women with silicone implants was 43
with a range of 24-67 years; average implant time was 12.4 years wiih a
range of 3-25 years. The average age of the control group was 42 with a
range of 19-52 years.
.\n expanded study of 1,196 patients was done. It included 220 normal
adults, both male and female, with no history of silicone implants, silicone
injections, or other known exposure, none had any clinical symptoms of
rheumatic disorders. The normal controls had an age range from 18 to 52
years A total of 942 silicone gel breast implant recipients were tested, their
ages ranged from 24 to 69 years All demonstrated two or more of the sym-
ptoms previously reported as common in breast implant patients (12). These
included excess fatigue or flu-like symptoms, arthralgia, myalgia, skin
rashes, alopecia, night sweats, headaches, sicca syndromes, lymphadcnopa-
thy, and the Raynaud phenomenon There were also reports of poor
memory or cognitive dysfunction, shortness of breath, dyspnea on exertion,
photosensitivity, and esophageiJ dysfunction. Thirty-four silicone breast im-
plant patients without demonstrable symptoms were also tested. Their age
range was 36-56 years.
The methods used to test lymphocyte response make use of venous blood
lymphocytes (13). Briefly, 20 ml of blood drawn by standard venipuncture
was placed into tubes containing acid citrate dextrose as anticoagulant.
Blood was transported to the laboratory within 24 h for testing Lympho-
cytes were recovered by standard ficoll-paque (Pharmacia LXB Biotechnol-
ogy AB. Uppsala, Sweden) and washed three times in RPMI-1640 tissue cul-
ture medium (Grand Island Biological. Grand Island. NY). Purified
lymphocyte suspensions were used in microliter plates. Three thorough
washings were done to minimize nonspecific background reactivity. The ini-
tial stimulation studies used triplicate testing of unstimulated cells in
RPMI-1640. mitogen stimulated cells in pokeweed mitogen (PWM),^ phyto-
hemaggluiinin (PHA), and concanavalin A (Con A), and stimulation with
colloidal pharmaceutical grade silicon dioxide (Paddock Laboratories, Min-
neapolis, Minn). The larger, expanded study was simplified by using only
Con A as the comparison mitogen, with unstimulated cells in RPMI-1640
and test cells with colloid<U silica as before.
'To whom correspondence and reprint requests should be ad-
dressed, at: Baptist Regional Laboratories, 22 N. Paulino, Mem-
phis. TN 38105. USA.
^Abbreviations: Con A. concanavalin A; PHA, phytohemaggluti-
nin; PWM, pokeweed mitogen; SI, stimulation index or indexes.
0892-6638/95/0009-0424/$01.50. © FASEB
120
RESEARCH COMMUNICATION
TABLE I . Mean stimulation indexes Jot implant patients compared to
normal adult controls, initial stud/
Slitnulani
Conirols
Implant Patients
(n - 76)
(n = 70)
PWM
23.5 ± 1.85
23.7 ± 1.86
0.9380
PHA
290.8 ± 28.1
258.5 ± 26.1
0.4052
Con A
455.3 ± 29.3
452.4 ± 37.1
0.9148
Silicon dioxide
11.4 ± 0.73
195.0 ± 19.3
<0.0001
'Mean ± SEM.
The choice of soluble Con A as the sole comparison mitogen was based
in pan on T cell specificity of the agent (13) and in part on our accumulated
experience with this agent for 8 years before the start of this work. Over time
we have adjusted the strength of Con A when a new supply was put into use
to maintain a constant range of lymphocyte response to Con A. This has
made it possible to compare the results of current testing with previous sam-
ples, but has led to a different concentration in the methods reported by
Ceha and Mcrlcr (13). They reported maximal T cell responses at final Con
A concentrations of 5-10/ig/ml; SI for Con A in their Table 2 was 45.3 (over-
all reported range = 45-71) with an average raw count for unstimulated
cells of 684 (13). We found the most effective concentration for hand harvest-
ing was 83 n^/ml. This has maintained the expected range of raw counts for
unstimulated cells at 18-49 with only rare outliers in contrast to the value
of 684 reptoned by Geha and Merler (13) Our raw counts for Con A ranged
consistently between 7.000 and 14,000/min, less than half their mean of
3I.0I5/min (13). We use at least five washings per test, with visual control
of cell harvest- This has been our consistent practice for 8 years and keeps
background counts low Standard tritiated thymidine incorporation [0 5
/»Ci/ml) was the method of detection for lymphocyte proliferation (14). This
contrasts to the strength of tritiated thymidine used by Geha and Merler
(13), which was 1.0 /iCi/ml. Beta counts were recorded for 5 min and
reported as counts per minute. Triplicate values were averaged and results
for lymphocytes stimulated by mitogen or silicon dioxide were expressed as
a stimulation index found by dividing the average minute count for each
agent by the count for unstimulated lymphocytes The final result is also de-
pendent on totiil cell culture time and thymidine incubation time. Geha and
Merler (13) reported 72 h for cell culture and 16 h for tritiated thymidine
pulse labeling- We used 96 h and 18 h. respectively. Standard statistical
methods were used for determining the mean indexes, standard errors of the
mean, and values of P through the unpaired, two-tailed Student's / test In-
ternal analysis of relative strengths and times accounts for the differences in
raw counts; our system is more tightly controlled with consistently lower
background counts (16).
O-IO 10-20 20-25 25-50 SO 100
Figure 1. Stimulation indexes of 70 symptomatic breast implant
patients compared to 76 normal controls and 18 rheumatic disorder
patients after lymphocyte stimulation with silicon dioxide (silica,
initial phase).
0-10 10-20 20-25 25 50 SO 100 > 1 00
Figure 2. Stimulation indexes of 942 symptomatic breast implant
patients compared to 220 normal controls after lymphocyte stimu-
lation with silicon dioxide (silica, expanded phase).
RESULTS
In the initial study, all but three implant patients demon-
strated normal lymphocyte stimulation by PWM, Con A,
and PHA. These three individucds had low stimulation in-
dices after PWM but were well above the expected response
with the other mitogens. The implant group showed an in-
creased stimulation to silicon dioxide compared to normal
controls (Table 1). The mean index of this group was 195.0,
which is approximately 18-fold the index for the control group.
The correlation coefficient between duration of implant
and the index was r = -0.1556, representing no correlation.
There was no statistical difference between the silicone pa-
tients and controls for the three standard mitogens (Table I)
with /* values from 0.4 to >0.9. The results of mitogen and
silicon dioxide stimulation for women with rheumatic dis-
orders was indistinguishable from the normal controls
{P = 0.3577). The average stimulation index for silicon diox-
ide in the rheumatic disorder patients was 7.1 (Fig. 1).
Among the 220 normal adults tested in the expanded
study, the mean stimulation index (SI) was 10.0 (Fig. 2). To
assess the distribution of SI for the implant patients, we used
2.5 times the mean of normal controls, 5.0 times the mean.
TABLE 2 , Mean counts/min of implant groups separated by level of response
compared to normal controls (expanded study)
Unstimulated
Con A
Silicon dioxide
Group
CPM
CPM
CPM
Normal controls
31
8690
281
(n - 220)
SI, 0-25
33
7897
500
{n = 82)
SI, 25-50
34
8740
1308
(n - 171)
SI, 50-100
28
8357
2101
(n = 316)
SI, >100
24
9264
3912
(« - 373)
IMMUNE RESPONSE IN SILICONE DISEASE
425
121
RESEARCH COMMUNICATION'
f
■
H ASVMPTOMATIC
«
^ 4
^n
^3^—,
1 i
U— LJ
JU
lOJO 20-2S 25-50 50-100
Figure 3. Stimulation indexes of 34 asymptomatic silicone breast
implant patients after lymphocyte stimulation with silicon dioxide
(silica, expanded phase).
and 10.0 times the mean as points of significant levels. Nine
hundred forty-two implant patients were tested; 860 (91.3%)
had SI above 25 (2.5 times the control mean), which we es-
tablished as the threshold for positivity. One hundred
seventy-one (18.2%) of the symptomatic patients had SI be-
tween 25 and 50; 316 (33.5%) has SI from 50 to 100; and 373
(39.6%) had SI greater than 100, more than 10 times the
control mean (Fig. 2). As shown in Table 2, the mean un-
stimulated counts per minute for all groups had little vari-
ance as did the mean for Con A counts per minute. The raw
cr- f,*'.
"^^
Figure 5
giant cells m mammary prosthesis tapsular tissue 1 lie .suljstagc has
been set down slightly to enhance the optical quality of the silicone,
which does not stain (arrows). Hematoxylin and eosin. Original
magnification, 100 x.
^^
Figure 4. Intense lymphocytic infiUration about vaned globular
pockets of silicone, mammary prosthetic capsular tissue Hematox-
ylin and eosin. Original magnification. lOOX.
counts for implant patients after stimulation with silicon di-
oxide varied from 500 to 3912 as reflected in the range of SI.
The SI distribution for asymptomatic women is shown in
Fig. 3. Twenty-two (64.7%) of these women were above the
index of 25 and 19 of the 22 (86.4%) were below an index
of 100. As shown in Fig. 4, the lymphocyte reaction is occa-
sionally very severe in human implant capsules with globular
silicone throughout the tissue; sometimes the reaction is es-
sentially pure foreign body granuloma (Fig. 5). Both reac-
tions to silicon dioxide are commonplace in human and
animal material; studies with fumed amorphous silica have
shown it to cause a more severe lymphocyte reaction (15).
DISCUSSION
The data demonstrates clearly that women with silicone
mammary implants develop a cell-mediated immunopathic
response to silica. Previous observations confirmed the
specific cellular response was CD3* T lymphocytes (16). The
lack of correlation between the T cell SI and the length of
prosthesis exposure time is suggestive of variable reactivity
among recipients over time and supports the belief that sen-
sitization occurs early. In assessing patients with leakage or
ruptures confirmed by ultrasound, magnetic resonance im-
aging, or surgical observation, we found the amount of leak-
age did not correlate with the level of response. Among 64
patients in the 0-25 range of SI, 33 (51.6%) had confirmed
leaks. In the remaining groups with confirmed leaks, 60 of
148 (40.5%) patients had SI between 25 and 50; 126 of 280
(45.0%) patients were in the range 50-100; and 122 of 303
426 Vol. 9 March 1995
The FASEB lournal
SMALLEY ET AL.
122
TABLE 3. Principal ingrtdimts of representative envelope ("skeW) maUrial
in use. 1967-1992
Envelope maierial
bv siotk number'
MDF-077
Q7-2423
Dimethyl methylvinyl siloxane,
dimelhylvinyl-tcrminaled
Dimelhyl siloxane, dimelhylvinyl-
icrminatcd
■"Amorphous silica"
Mcthylhydrogcn siloxane
Dimcthylhydrolyaic
Hcxamethyldisiloxane
Hexamclhyldisilazane
Dimethyl methylvinyl siloxane
Dimethyl methylhydrogen siloxane
Chloruplatinic acid
Methylvinyl cyclosiloxane
63.29%
6.32
0.00
57.52
26.50
26.18
0.00
4.77
0.00
3.08
0.00
1.90
8.83
0.08
0.00
0.08
1.07
0.00
0.15
0.07
0.15
0.00
'Dow Corning Corporation.
(40.3%) patients had SI greater than 100. These findings
suggest exposure to low molecular weight gel bleed and the
outer silicone shell (Table 3). Mitogenic studies among the
implant patients confirm that normal stimulation occurs and
that it is not different from the normal controls. None of the
initial patients had SI below 25; however, in the expanded
study nearly 10% of symptomatic patients showed no in-
creased response to silicon dioxide This may represent a
group of women postexplant with immune quiescence or
they may be nonresponders to silicon dioxide with the possi-
bility their symptoms are due to some other cause or causes.
A large percentage (91.3%) of symptomatic implant pa-
tients did demonstrate T lymphocyte response to silicon di-
oxide. Silica accounts for a quarter of the envelope (Table 3)
(17), and in vivo degradation of silicone has now been estab-
lished by nuclear magnetic resonance (18). In addition, clear
evidence of spread of silicone and its metabolites to nearly
every major organ may facilitate the immune reaction and
account for many specific symptoms among implant patients (19).
The demonstration of specific T lymphocyte response to
silica is in agreement with the comparative studies recently
reported by Ojo-Amaize et al. (20). These authors studied
lymphocyte responses to elemental silicon, unspecified sili-
cone, silica, and various other metals, including beryllium,
chromium, and nickel. Silica caused a consistently more
vigorous result than either silicon or silicone as well as all
other substances that were compared (20).
Asymptomatic implant patients clearly show a different
distribution of SI. Of the 34 tested so far, 22 had SI below
100. This suggests some patients may be immunologically
reactive at low levels and have not begun to manifest sym-
ptoms. Another possibility is the data are showing a group
of nonresponders with the need for assessment for genetic
markers for tolerance.
The present study confirmed that lymphocytes from
women exposed to silicone gel mammary implants can be
antigenically stimulated by silicon dioxide. Accordingly, hu-
man tissue reactions to substances in or from the implants
follow the expected immunopathic sequence of processing by
RESEARCH COMMUNICATION
macrophages, .sometimes leading to granuloma formation,
and presentation to lymphoid centers for specific T cell
f*roduction. This study shows a T lymphocyte response to
silicon dioxide (silica), which likely contributes to tissues
changes seen pathologically and to the spectrum of clinical
silicone-associated disease. [fTl
REFERENCES
1. Shons. A, R.. and Schubert. \V (1992) Silicone- breast implants and im-
mune disea.ie. Ann. Blast. Surg 28, 491-499
2 Varga. J., Schumacher, R., and Jimenez, S. A- (1989) Systemic sclerosis
after augmeniaiion mammoplastv with silicone implants. Ann /nt Med
111, 377-383
3. Spiera, H.. and Kerr, L, D. (1993) Sclerodrrrr.d following silicone im-
plantation: a cumulative experience of 11 cases. y. Rheumatol 20, 938-961
4. Silver. R M., Sahn. E. E.. Allen. J A. Sahn. S.. Greene. W. Maize.
J, C, and Garen, P. D (1993) Demonstration of silicon in sites of con-
nective tissue disease in patients with silicone-gel breast implants. Arch
Derynatol 129. 63-68
5. Rudolph. R . Abraham. J-. Vecchione. T. Guber. S,. and Woodward.
M. (1978) Myofibroblasts and free silicon around breast implants. Plasl
ReconstTuct Surg. 62, 223-229
6. Baker. J L.. LeVier. R R., and Spielvogel. D. E. (1982) Pbsiiive
identification of silicone in human mammary capsular tissue, f^l.
Reconstruct Surg 69, 56-60
7 Thomsen. J L . Christensen. L.. Nielsen. M.. Brandt. B., Breitling.
V, B.. Felby. S,. and Nielsen, E. (1990) Histologic changes and silicone
concentrations in human breast tissue surrounding silicone breast
prostheses. PlasI Reconstruct Surg 85, 38-41
8, Shanklin. D. R (1991) l^te tissue reactions to silicone and silica. In 5t/i-
fon^m A/«/Ka/D«'ifa(Stratme\'er. M. E. ed) pp. 103-125. USHHS/FDA.
Conference Proceedings. Baltimore
9. Shanklin, D, R, (1993) Silicone-associated diseases: tissue findings. South
Med J 86. S104
10 Goldblum. R M . Pelley. R, P.. O'Donell. A A . Pyron. D. and Heg-
gers, J. P (1992) Antibodies to silicone elastomers and reactions to vcn-
triculoperitoneal shunts. Lancet 340, 510-513
11 Wolf. L E . Lappe. M , Peterson. R D. and Ezrailson. E G. (1993)
Human immune response to polydimethylsiloxane (silicone): screening
studies in a breast implant population. FASEB J 7, 1265-1268
12, Bridges, A. J.. Conley. C. Wang. G,. Burns, D. E.. and Vasey. F, B,
(1993) A clinical and immunologic evaluation of women with silicone
breast implants and symptoms of rheumatic disease. Ann. Int. Med 118,
929-936
13, Geha. R. S.. and Merler. E. (1974) Response of human ihymus-derived
(T) and non-thymus-derived (B) lymphocytes to mitogenic stimulation
in vitro. Eur J Immunol 4, 193-199
14 Chilson. O P. and Kelly-Chilson. A. E. (1989) Mitogenic lectins bind
to the antigen receptor on human lymphocytes. Eur / Immunol 19,
389-396
15 Picha. G. J., and Goldstein, J. A. (1991) Analysis of the soft-tissue
response to components used in the manufacture of breast implants: rat
animal model. Plast. Reconstruct Surg Z7, 490-500
16 Smalley. D, L,. Shanklin. D. R.. Hall. M F. and Stevens. M V. (199.^)
Detection of lymphocyte stimulation by silicon dioxide, ^ Occupat Med
Ibxicol In press
17. D()w Coming Corporation (1968. 1979) Mammary implant material
formulations, MDF-077 and Q7-2423. in Silicone Breast Implant Team
Leaders' Report. Surgery Device Panel, U.S. Food and Drug Adminis-
tration, released 1993. pp 42. 51
IB Garrido, L , Pfleiderer. B.. Papiso\. M . and Ackerman. J. I. (1993) In
vivo degradation of silicones. Magn Reson Med 29, 839-843
19 Schmiterlow, C G,. and Sjogren. C (1975) The distribution of '*C-
labelled KABI 1774, Ada Pharmacol lixicol 36, 131-138
20 Ojo-Amaize, E A., Come. V, Lin. H-C . Brucker. R F. Agopian.
M. S.. and Peter. J B, (1994) Silicone-specihr blo<xJ lymphocyte
response in women with silicone breast implants. Clin Diag Lab Im-
munol I, 689-695
Received for publttatton August 22. 1994
Accepted Jor publication Sotrmber 2H. 1994
IMMUNE RESPONSE IN SILICONE DISEASE
123
Mr. Shays. Thank you, sir.
This is an interesting panel.
Dr. Gabriel.
Dr. Gabriel. Thank vou.
Mr. Chairman, memoers of the committee, my name is Sherine
Emily Gabriel. I'm a rheumatologist and associate professor of
medicine smd epidemiology at Mayo Medical School and the prin-
cipal investigator of the study entitled "Risk of Connective Tissue
Diseases and Other Disorders After Breast Implantation," which
was published in the New England Journal of Medicine on June 16
of last year.
Connective tissue diseases are autoimmune disorders such as
rheumatoid arthritis and lupus, which are characterized by inflam-
mation of the joints, skin, and internal organs, as you have heard.
Since 1962, approximately 900,000 North American women have
received silicone breast implants. An increased risk of connective
tissue diseases related to implants has been postulated in the med-
ical literature. This is an important concern for many of these
women.
Mr. Chairman, strong scientific evidence now indicates that there
is no link between breast implants and an increased risk of these
conditions. My testimony will focus on that evidence.
In order to establish whether breast implants cause connective
tissue diseases, it is not enough to note that some women with im-
plants have developed these conditions. Instead, it is necessary to
determine whether women with implants are developing these con-
ditions at a higher rate than women of the same age and health
who do not have implants.
The only way to determine whether the rate of these diseases is
higher among women with implants compared to women without is
to perform vmat is known as a controlled study. In the absence of
a control gfroup, that is, a comparison group of women without im-
plants, the conclusion that medical conditions among women with
implants are, in fact, caused by these devices is not scientifically
valid.
Until recently, the published medical literature describing the re-
lationship between breast implants and connective tissue disorders
consisted virtually entirely of case reports and case series; that is,
descriptions of one or more women with implants who subsequently
developed a variety of medical problems. Such reports contribute
virtually no scientifically valid information bearing on the question
of whether implants cause connective tissue diseases.
As you have repeatedly heard today, numerous controlled, sci-
entifically valid studies have now been published which specifically
address this question. As an aside. Dr. Brown earlier testified to
the relative strengths and weaknesses of case control and cohort
studies, citing a single case control study.
There are, in fact, several others which are referenced in my tes-
timony, including a multicenter case control study among 869
women with systemic sclerosis, recruited from three university-af-
filiated rheumatology clinics and 2,061 matched community con-
trols. The relative risk of that study was also not statistically sig-
nificantly different from unity.
124
Our study included virtually all Olmsted County women who re-
ceived breast implants between January 1, 1964, and December 31,
1991, a total of 749 women with implants who were compared to
1,498 community women who did not have implants. We found no
connection between breast implants and connective tissue diseases.
These results have been confirmed in numerous additional con-
trolled studies, as I have mentioned.
Most recently, a controlled study from Harvard also found no as-
sociation between silicone breast implants and an increased risk of
either connective tissue diseases or a list of 42 related symptoms
amone 121,700 registered American nurses followed since 1976.
And Uiese results also, as you have heard, were published in this
year's New England Journal of Medicine, this June.
To summarize, not one of these controlled epidemiologic studies
identified a link between breast implants and connective tissue dis-
eases. These remarkably consistent results prompted the govern-
ments of some countries to review this topic. For example, in De-
cember 1994, the medical devices agency of the Department of
Health in the United Kingdom reported their evaluation of the evi-
dence for an association between breast implants and connective
tissue diseases.
The resulting 60-page document, which included critical apprais-
als performed by an independent scientific expert advisory group,
concluded that "There is no evidence of an increased risk of connec-
tive tissue diseases in patients who have had silicone gel breast im-
plants and therefore no scientific case for changing practice or pol-
icy in the United Kingdom with respect to breast implantation."
In light of this overwhelmingly consistent accumulation of sci-
entific research, I respectfully recommend that the Food and Drug
Administration assemble an independent panel of scientific experts
who have no ties with industry and have not been involved in
breast implant litigation. This panel would carefully review the
available evidence specifically regarding an excess risk of connec-
tive tissue diseases among women witn breast implants and pro-
vide a public policy statement. It is my hope that this statement
will reduce some of the anxiety that women with implants feel re-
garding the future.
Finally, Mr. Chairman, this was not part of my prepared com-
ments, but there have been some comments made this morning
about research funding, so I would just like to clear the air on this
issue with respect to my own study. For my study, there were three
sources of funding.
Mayo Foundation provided the initial funding. We then success-
fully competed in a peer-reviewed research grant competition from
the Educational Foundation of the American Society for Plastic and
Reconstructive Surgeons. And, finally, the National Institutes of
Health provided the funding for the Rochester epidemiology project,
which is the underlying data resource upon which this study was
based.
I wanted to emphasize that my interest in the breast implant
issue has always been strictly scientific. And while we did receive
the grant from the Plastic Surgery Educational Foundation, the
study was independently conceived, designed, and implemented by
the research team under my direction.
125
In fact, the design was complete and the study was already
under way, using Mayo funds, before the grant was awarded.
The Plastic Surgery Educational Foundation had no input into
the design, analysis, or interpretation of the results, and they
placed no limitations or restrictions on the publication of the re-
sults. The bottom line, Mr. Chairman, is that we would have done
exactly the same study, exactly the same way, regardless of who
^nded it.
Thank you.
[The prepared statement of Dr. Gabriel follows:]
Prepared Statement of Sherine E. Gabriel, M.D., Mayo Cunic
Mr. Chairman, members of the committee, my name is Sherine Emily Gabriel. I
am a rheumatologist, and an Associate Professor of Medicine and Epidemiology at
Mayo Medical School. I am also the principal investigator of the study entitled ^isk
of Connective Tissue Diseases ana Other Disorders After Breast Implantation"
which was published the New England Journal of Medicine on June 16, 1994.^ Con-
nective-tissue diseases are autoimmune disorders such as riieumatoid arthritis and
lupus, which are characterized by inflammation of the joints, skin, and internal or-
gans.
Since 1962, approximately 1 to 2.2 million North American women have received
silicone breast unplants.^*^ An increased risk of connective-tissue diseases, related
to implants, has been postulated in the medical literature.*"^'* This is an important
concern for many of these women. Mr. Chairman, strong scientific evidence now in-
dicates that there is no link between breast implants and an increased risk of these
conditions. My testimony will focus on this evidence.
In order to establish whether breast implants cause connective-tissue diseases, it
is not enough to note that some women with implants have developed these condi-
tions. Instead, it is necessary to determine whether women with implants are devel-
oping these conditions at a higher rate than women of the same age and health who
do not have implants. The only wav to determine whether the rate of these diseases
is higher among women with implants compared to women without implants is to
perform what is known as a controlled study. In the absence of a control group, i.e.,
iGabriel SE, CFallon WM, Kurland LT, Woods JE, Beard CM, Melton LJ, III: Risk of connec-
tive-issue diseases and other disordere afler breast implantation. N Engl J Med 330(24): 1697-
1702, 1994.
'Kesaler DA: The basis of the FDA's decision on breast implants. N Engl J Med 326:1713-
1715, 1992.
^Independent Advisory Committee on Silicon-Gel- Filled Breast Implants: Summary of the re-
port on silicon-gel-filled breast implants Can Med Assoc J 147:1141-1146, 1992.
*Hito8hi S, Ito Y, Takehara K, Fujiba T, Ogata E: A case of malignant hypertension and
scleroderma after cosmetic surgery. Jpn J Med 30(1):97-100, 1991.
'Gutierrez FJ, Espinoza LR: Progressive systemic sclerosis complicated by severe hyper-
tension; Reversal aOer silicone implant removal. Am J Med 89(3):390-392, 1990.
^Varga J, Schumacher HR, Jimenez SA: Systemic sclerosis afler ugmentation manunoplasty
with silicone implante. Ann Intern Med lll(5>.377-383, 1989.
''Sahn EE, Garen PD, Silver RM, Maize JC: Scleroderma following augmentation
mammoplasty. Report of a case and review of the literature. Arch Dermatol 126(9): 1198-1202,
1990.
*Spiera H: Scleroderma afler silicone augmentation mammoplasty. JAMA 260(2):236-238,
1988
"Brozene SJ, Penske NA, Cmse CW. Espinoza CG, Vasey FB, Germain BF, Fspinoza LR:
Human adjuvant disease following augmentation mammoplasty. Arch Dermatol 124(9):1383-
1386, 1988.
^"Okano Y, Nishikai M, Sato A: Scleroderma, primary biliary cirrhosis, and Sjogren's syn-
drome afler cosmetic breast augmentation with silicone injection: A case report of possiole
human adjuvant disease. Am Rheum Dis 43(3):520-522, 1984.
^^Kumagai Y, Shiokawa Y, Medsger TA, Jr, Rodnan GP: Clinical spectrum of connective tis-
sue disease after cosmetic surgery. Observations on eighteen patients and a review of the Japa-
nese literature. Arthritis Rheum 27(1): 1-12, 1984.
^Kumagai Y, Abe C, Sldokawa Y: Scleroderma afler cosmetic surgery. Four cases of human
a<«uvant disease. Arthritis Rheum 22(5):532-537, 1979.
"van Nunen SA, Gabenby PA, Basten A: Post- mammoplasty connective tissue disease. Ar-
thritis Rheum 25(6):694-697, 1982.
^* Baldwin CM Jr., Kaplan EN: Silicon induced human adjuvant disease? Ann Plast Surg
10(4):270-273, 1983.
"Byron MA, Venning VA, Mowat AG: Post-mammoplasty human adjuvant disease. Br J
Rheumatol 23(3):227-229, 1984.
126
a comparison group of women without implants, the conclusion that medical
condidons among women with implants are, in fact, caused by these devices is not
scientifically valid. ^® Until recently, the published medical literature describing the
relationship between breast implants and connective-tissue disorders consisted vir-
tually entirely of case reports and case series, i.e., descriptions of one or more
women with implants who subsequently developed a variety of medical problems.
Such reports contribute virtually no scientifically valid information bearing on the
question of whether implants cause connective-tissue diseases.
Over the past 18 months, 7 controlled, scientifically-valid studies have been pub-
lished whicn specifically address this question. Our study included virtually all
Olmsted County, Minnesota women who received breast implants between January
1, 1964 and December 31, 1991; a total of 749 women with implants and 1498
women who did not have implants.^ We found no connection between breast im-
plants and connective-tissue diseases. These results have been confirmed in 6 addi-
tional controlled studies. ^'"^ Most recently, a controlled study from Harvard found
no association between silicone breast implants and an increased risk of either con-
nective-tissue diseases or related symptoms among 121,700 registered American
nurses followed since 1976. ^'^ These results were published in the New England
Journal of Medicine in June of this year. To summarize, not one of these 7 con-
trolled epidemiological studies identified a link between breast implants and connec-
tive-tissue diseases.
These remarkably consistent results prompted the governments of several Euro-
pean countries to issue policy statements on this topic. For example, in December
1994, the Medical Devices Agency of the Department of Health in the United King-
dom reported their evaluation of the evidence for an association between breast im-
plants and connective-tissue diseases.^ The resulting 60-page document, which in-
cluded critical appraisals performed by an independent expert advisory group, con-
cluded that "there is no evidence of an increased risk of connective tissue diseases
in patients who have had silicone gel breast implants and therefore no scientific
case for changing practice or policy in the United Kingdom with respect to breast
implantation". Likewise the French Ministiy of Health stated in a press release on
January 24, 1995 that "an analysis of international scientific literature dem-
onstrates that the risk of a patient developing an autoimmune disease or cancer fol-
lowing the implantation of gel-filled breast prostheses is no greater than the risk
of such diseases in the general population . . . and that the moratorium of January
1992 ... has been liaed".^*
In light of this overwhelmingly consistent accumulation of scientific research, I re-
spectfiolly recommend that the Food and Drug Administration assemble an inde-
pendent panel of scientific experts who have no ties with industry, have not been
involved in breast implant litigation, and have not participated in the existing stud-
ies. This panel woulci carefully review the available evidence, specifically regarding
an excess risk of connective-tissue diseases among women with breast implants, and
provide a public policy statement. It is my hope that this statement will reduce
some of the anxiety women with implants feel regarding their future.
Thank you for your attention.
Mr. Shays. I thank you, Doctor.
^'Fletcher RH, Fletcher SW, Wagner EH: Cause, Clinical epidemiology the essentials. Edited
by N Collins, C Eckhart, GN Chalew. Baltimore, Williams & Wilkens, 1988 208.
^'Sanchez-Guerrero J, Colditz GA, Karlson BW, Hunter DJ, Speizer FE, Liang MH: Silicone
breast implants and the risk of connective-tissue diseases and symptoms. Arthritis Rheum
332(25): 1666-1670, 1995.
18 Dugowson CE, Daling J, Koepeell TD, Voigt L, Nelson JL: Silicone breast implants and risk
for rheumatoid-arthritis. Arthritis Rheum 35:866, 1992 (Abstract).
i»Hochberg MC, Perlmutter DL, White B, Steen V, Medsger TA, Weisman M, Wigley FM: The
association of augmentation mammoplasty with systemic sclerosis: Results from a multi-center
case-control study. Arthritis Rheum 37 (Supplement):S369, 1994 (Abstract).
** Strom BL, Reidenberg MM, Freundlich B, Schinnar R: Breast silicone implants and risk of
systemic lupus erythematosus. J Clin Epidermiol 47(10):121 1-1214, 1994.
'1 Englert HJ, Brooks P: Scleroderma and augmentation mammoplasty — a causal relationship?
Aust NZ J Med 24:74-80, 1994.
** Bums CG. The epidemiology of systemic sclerosis: A population-based case-control study.
(A dissertation submitted in partial fiijfillment of the requirements for the degree of Doctor of
Philosophy [Epidemiologic Science], University of Michigan, 1994) (unpublished).
"United Kingdom Department of Health Independent Expert Advisory Group, Medical De-
vices Agency: Evaluation of evidence for an association between the implantation of silicones
and connective tissue disease. Longon, Medical Devices Agency, 1994.
*• French Ministry of Health. Press release, Januaiy 24, 1995. Subject: Implantable Breast
Prostheses.
127
Dr. Connell, nice to have you here.
Dr. Connell. Good afternoon. I'm Dr. Elizabeth Connell.
Mr. Shays. You were probably expecting you were going to be
able to say "Grood morning."
Dr. Connell. You read my notes. I have crossed out "morning"
and substituted "afternoon." I realized this was inevitable.
Mr. Shays. We're new at this, and we have to learn to maybe
have some of the panels come later. But we're learning.
Dr. Connell. Oh, I wouldn't have missed this for the world.
Mr. Shays. Nice to have vou.
Dr. Connell. I am professor in the Department of Gynecology
and Obstetrics at Emory University in Atlanta. Mr. Chairman, I
want to thank you for inviting me today.
This is a meeting which I believe is critical in its importance,
particularly to American women. As I thought about what to talk
about that might be useful, I thought I would try to base my testi-
mony on three things: First, a doctor who has provided health care
to women for more than 40 years; second, as an advisor to the FDA
for 25 years; and then, also, as a teacher, researcher, author, and
program director.
First and foremost, I am a physician. I was a general practitioner
in rural Maine for 5 years. I got my training in OB/GYN, spent a
year doing cancer surgery. While I was in rural Maine, I took care
of men, women, and children, from all walks of life, with all types
of diseases.
I have delivered women of their babies under ideal cir-
cumstances, in aseptic, brightly lit hospital delivery rooms. One
cold, bitter night, I also delivered one woman of her baby by moon-
light on the front seat of an ancient pickup truck, surrounded by
her distraught husband and seven utterly fascinated children. I
might add, parenthetically, they never paid me.
I then went into practice and developed clinics in New York City.
I worked for the Rockefeller Foundation as a philanthropoid for
about 5 years. At the Federal level, I was on the research advisory
council to the State Department. And during these same years I
also managed to have six wonderful children, five sons and one
daughter.
I originally thought it might not be appropriate to approach my
testimony in this very highly personal fashion, but I thought it
might be useful to share with you my national and international
experience in these areas.
When I was first invited to chair the General Plastic Surgery De-
vices Panel, convened first in 1991, I was told the reasons for this
were two: first of all, my many years of working in women's health
care; and second, because of my extensive experience serving on
FDA advisory panels. I've now been on six, and I've chaired three
of them.
As you have heard, our mandates from Dr. Kessler were two in
number: First, we were to evaluate the PMA's of four companies
making breast implants; second, we were asked, was there a public
health need for these devices. After three rather arduous, stress-
filled days, we gave our recommendations.
First of all, we said that the data from the four companies were
not adequate for approval. However, I think it's absolutely critical
128
that two points be made. This in no way said that the panels felt
these devices were unsafe or that they posed a threat to women.
If this were the case, we would immediately have recommended
getting rid of the devices.
Second, I think it has been misconstrued, the fact that we did
not approve these PMA's. It's not the least bit unusual for PMA's
not to be approved, to be asked to come back with additional infor-
mation. I think it's critical that we make these distinctions.
As regards the second question, we said, yes, we have heard from
both augmentation and reconstruction patients that these were
critical to them. We felt, as a panel, they should continue to be
made available, but with informed consent.
You know about the moratorium, and we were reconvened in
February 1992 and, happily, were joined this time by Dr. John
Sergent. We were asked to look at three issues: documents from
Dow Corning, information on local issues — you've heard a lot about
that this morning — and then additional case reports — I emphasize
"case reports" — looking at a possible connection between silicone
gel breast implants and autoimmune disease.
We were asked two questions: Given these concerns about leak-
age, rupture, and so forth, what should we tell women who were
wearing devices? And, second, should they continue to be available;
and if so, under what circumstances?
We concluded that, again, we did need additional data and that
there was a public health need. We recognized that there were
local conditions. These had been known for many, many years.
They are in labeling. We felt women should be given the best pos-
sible scientific advice, and they should make tneir own informed
decisions, along with their physicians.
We again concluded there were no significant data linking breast
implants and connective tissue disease. This time we said, yes, we
should continue to make them available; we should develop proto-
cols, FDA, NIH, and others, that will allow us to answer the unan-
swered questions.
Now, the third area I would like to look at is what the current
climate is doing to many of us, particularly the health care of
women. I strongly believe that there are critical implications for a
number of important and, as you have heard, life-saving devices,
and I am particularly concerned, as a researcher, about what is
going to happen in the future, in terms of development of new, in-
novative, and creative technology.
I would hasten to point out that there has been a lot of discus-
sion about the data. The data we had at the hearings was strictly
anecdotal. It came from case reports, and you never can answer
questions of this type with that type of data. Very happily, as you
have heard, we then had a series of excellent studies published in
our leading scientific journals. You have heard the decision of the
British.
I think it is critical to point out that I believe we should put an
end to this. This has had a profound effect on women, the medical
profession, the research community, the pharmaceutical industry.
We have seen fear. We have seen panic. We have seen many
women who are asymptomatic undergoing surgery, with attendant
risks.
129
In addition, I would like to point out that many women have
been advised to have extensive and costly laboratory tests carried
out, and I would like to read you a position statement of the Col-
lege of American Pathologists. "Such tests provide no findings
uniquely indicative or supportive of purported silicone-induced
autoimmune disease in implant recipients. To date, the FDA has
not approved any such tests."
I think, even more unfortunate, women subjected to these tests
have submitted to untested, expensive, unapproved, and possibly
dangerous treatments. Many of these women do, in fact, have auto-
immune disease; they blame them on their implants. They do not
get a correct diagnosis, nor do they get effective therapy. As some-
body who spent 5 days last week worrying about what if the mass
in my breast was cancer or not, I can assure you the agony of this
wait is horrendous.
I would like to point out, as OB/GYNs, we have lost Bendectin,
a series of lUDs; we are about to lose Norplant. I firmly believe
that the time has now come to give visibility to this issue. I would
like to make two recommendations:
First of all, I think the new information should be made avail-
able. I think it's time that the FDA made a public statement about
the scientific consensus. There is no question there is a chilling ef-
fect on industry, what is going on now. And I would like, finally,
to recommend to you that you urge, in some fashion, the various
agencies, the FDA, NIH, and others, to convene a scientific — and
I would say urgently — scientific meeting in order to finally put to
rest the question of silicone autoimmune disease.
I really believe that only in this fashion will be begin to see the
end of this extremely destructive and tragic situation.
Thank you very much.
[The prepared statement of Dr. Connell follows:]
Prepared Statement of Elizabeth B. Connell, M.D., Emory University
Good morning. I am Dr. Elizabeth B. Connell, professor in the Department of
Gynecology and Obstetrics, Emory University School of Medicine in Atlanta, Geor-
gia.
Mr. Chairman, I would first like to thank you for inviting me to appear before
you today. I fully recognize the tremendous importance, particularly to American
women, of the course and the outcome of this hearing. When one first receives such
an invitation, one has a moment of introspection — what should I talk about that
would be of maximum value to you and your colleagues today and possibly in the
future? After much thought I decided that there were three key areas in which I
might possibly be able to make a contribution based on my own personal experience:
(1) As a doctor who has provided health care to women for over 40 vears; (2) as an
advisor to the Food & Drug Administration (FDA) for 25 years; and (3) as a teacher,
researcher, author and program director.
First and foremost I am a physician. I was a general practitioner in rural Maine
for five years. Following this, I received my training in obstetrics and gynecology
and spent an additional year doing cancer surgery, wnile in rural Maine 1 took care
of a wide variety of patients — men, women and children from all walks of life, suf-
fering from many dinerent diseases. I have delivered women of their babies under
ideal circumstances in aseptic, brightly lit hospital delivery rooms and one bitter
cold night I also delivered one woman of her baby by moonlight on the front seat
of an ancient pickup truck, surrounded by her distraught husband and seven utterly
fascinated children.
After completing my training I went into practice in New York City. I also began
to develop clinics in Spanish Harlem, offering health care to women, first at New
York Meoical College and subsequently at Columbia University's College of Physi-
cians and Surgeons. During these years I had the opportunity to conduct numerous
130
research projects and I began to publish scientific papers which now number close
to 200.
Following this, I had the privilege of working for five years at the Rockefeller
Foundation in New York City, as the Associate Director of Health Sciences. On the
federal level, I have been associated with the U.S. Department of State, Agency for
International Development, serving as a member of their Research Advisory Com-
mittee. During these years I also managed to have six wonderful children, five sons
and one daughter.
I originally shrank from approaching my testimony in such a highly personal
fashion. However, it seemed to me that my multiple areas of experience, both na-
tionally and intemationallv, might perhaps prove to be of some value to you today.
When I was first invited to chair the General and Plastic Surgery Devices Panel
to be convened in 1991 to evaluate silicone gel-filled breast implants, I was told the
reasons for this were two in number: first, because of my many years of experience
working in various aspects of women's health care and second, because of my exten-
sive experience serving on FDA advisory panels, now numbering six, three of which
I have chaired.
I would like to first describe for you the mandate given to the Panel and the con-
clusions it reached during the first hearings which took place from November 12-
14, 1991. When Dr. David Kessler, the FDA Commissioner, opened our meeting, he
gave us two major charges. First, we were to evaluate Premarket Approval Applica-
tions (PMAs) 01 four manufacturers who had submitted data on the safety ana effi-
cacy of their breast implants, and then advise the FDA whether or not the PMAs
were adequate for approval. Silicone breast implants had been on the market for
30 years. Secondly, we were asked to consider whether there was a public health
need for breast implants. In this context, we were asked additionally to decide
whether particular groups of patients, specifically those who had undergone major
breast surgery or had significant defornuties, should be viewed as distinct from the
laiver group of women wno had had their implants put in for augmentation.
After three arduous, stress-filled days of hearing from dozens of witnesses fol-
lowed by our Panel deliberations, we p;ave our recommendations to the FDA regard-
ing these two mandates. First, we dia not find the data from the four manufacturers
to be adequate for approval. However, it is absolutely critical to point out at this
juncture that this in no way was a statement by the Panel that these devices were
unsafe or that they posed a threat to the health of the women who were wearing
them. If we had felt that this was the case, we would have recommended that they
immediately be removed from the marketplace. As to our second mandate — whether
there was a public health need — we unanimously agreed that there was; we felt that
there was aimple evidence that silicone breast implants were of significant impor-
tance to both augmentation and reconstruction patients.
Following this meeting, on January 6, 1992, tne FDA requested a voluntary mora-
torium on the use of silicone breast implants pending the evaluation of new evi-
dence. It also promised that we would be reconvened as a panel within the next 45
days. This second meeting occurred from February 18-20, 1992. The panel member-
ship remained essentially the same; however, three additional consultants were
added, most importantly, two individuals expert in the field of rheumatology. Dr.
Nathan J. Zvaifler and Dr. John S. Sergent, one of your witnesses today.
As he had done in the previous November meeting. Dr. Kessler gave very specific
mandates to the Panel. He first advised us that we were not being asked to revisit
the decisions regarding the PMAs that we had made at our first meeting. He said
that we had been asked to reconvene because of new information that had become
available to him. He listed three sources: documents from one manufacturer, Dow
Coming; second, information from clinicians about issues such as breast implant
rupture, leakage and bleed; and third, additional case reports suggesting a possible
connection between silicone gel breast implants and inflammatory and autoimmune
disorders.
We were asked at this meeting to answer two basic questions:
First, given concerns about leakage and rupture, what recommendations should
be given to women who already had breast implants?
Second, in light of the new information, should these devices continue to be used
and, if so, under what conditions?
Following another three arduous days of testimony and deliberations, the Panel
continued to conclude that, although additional data on the implants themselves
and on their safety and efficacy should be required, there continued to be a public
health need for these devices. The Panel recognized that there were complications,
including rupture, bleed, and contracture, which resulted from the use of breast im-
plants; but these had been known and documented for many years. The panel there-
fore recommended that the best available scientific information be given to women;
131
those who were asymptomatic were advised to continue their use, if so desired, and
those with any symptoms should consult their physicians. However, on the key safe-
ty issues, the Panel again concluded that there were no scientific data that silicone
breast implants posed a significant health risk to women, most specifically in the
area of connective tissue or autoimmune disease.
Thus, the Panel this time again concluded that the devices met a public health
need and should continue to be available but should be studied in order to answer
the remaining safety questions. In this regard, the Panel recommended that breast
implants be made available 1x) all individuals who needed them for reconstruction,
most importantly, those women who had breast cancer. In addition, the Panel rec-
ommended that some women be allowed to have implants for augmentation. In both
cases, the Panel recommended that the implantations be done under clinical proto-
cols to be designed by appropriate agencies and organizations such as the FDA,
NIH. plastic surgeons ana other relevant groups, in order to gather new and statis-
tically valid scientific information.
The third area which I would now like to turn to is a more general consideration
of what has transpired in the three years since our second Panel meeting, including
an overview of the current climate with regard to the health care of women. I be-
lieve strongly that there are critical implications of the current situation for a num-
ber of important and sometimes life-saving devices we already have and for the fu-
ture development of new and innovative products needed in the field of medicine
in general and the field of women's health care in specific.
TTie material which came to the Panel suggesting a possible association between
silicone breast implants and autoimmune diseases was derived exclusively from an-
ecdotal information and case reports. These types of information can never provide
an adequate scientific basis on which to prove a causal relationship. Followmg our
deliberations, as we had urged, a number of controlled epidemiologic studies were
undertaken to look at the possible association. These studies have uniformly failed
to demonstrate a statistically significant association between silicone breast im-
plants and any autoimmune disease, connective tissue disease or symptom complex.
A list of some of the most important of these, along with their conclusions, is at-
tached to my testimony.
It is important to note that in contrast to the earlier anecdotal information avail-
able to the Panel, these studies originated from research done in some of our niost
highly qualified medical institutions such as the Mayo Clinic, Harvard Medical
Scnool, University of Michigan School of Public Health, Johns Hopkins Medical In-
stitutions, Emory University, and M.D. Anderson Cancer Center. These researchers
looked not only at the medically recognized connective tissue diseases such as svs-
temic lupus erythematosis, scleroderma, and rheumatoid arthritis, but also evalu-
ated a large number of symptoms — more than 40 — which have been alleged to have
an autoimmune origin. Also, it should be noted that the publications which I have
listed for you have not only originated in our best medical centers but have been
and continue to be published in our most outstanding scientific journals, including
the New England Journal of Medicine, the Journal of Clinical Epidemiology, and Ar-
thritis and Rheumatism.
It is, I believe, of great interest and importance that similar evaluations of sili-
cone breast implants have been carried out by regulatory agencies in other coun-
tries. Two of the most extensive and important of these were conducted in 1992 and
1994 for the Medical Devices Directorate of the U.K. Department of Health. It set
up an Independent Expert Advisory Group which reviewed all of the relevant lit-
erature ana studies available and concluaed "that there is no evidence of an in-
creased risk of connective tissue disease in patients who have had silicone gel breast
implants and therefore no scientific case for changing practice or policy in the U.K.
with respect to breast implantation." Similar evaluations reaching the same conclu-
sion, have been carried out in other countries.
Finally, I would like to conclude by examining the effect this series of events has
had on women, the medical profession, the research community and the pharma-
ceutical industry viewed from my perspective of many years as a practitioner, re-
searcher and advisor. My greatest concern is for the women who either are pres-
ently wearing silicone breast implants or are contemplating their use in the future.
Because of the intense and often misleading media coverage of this issue, particu-
larly after the moratorium, we have seen fear, panic, and incredible levels of dis-
tress all over the country among those women who have been led to believe that
they were wearing very dangerous devices and were at risk of serious health con-
sequences, particmarly in the area of autoimmune disease, ^yomen, including many
who were asymptomatic, have requested explantation of their prostheses, often not
an inconsiderable as well as expensive surgical procedure, usually requiring general
anesthesia with its own attendant risks.
132
In addition, many women have been advised to have extensive and costly labora-
toryr tests carried out on blood, urine, and tissue, looking for abnormalities alleged
to be caused bv their breast implants. In a recent position statement of the College
of American Pathologists it was pointed out that "such tests provide no findings
uniquely indicative or supportive of purported silicone induced autoimmune disease
in implant recipients." It further noted that, "To date, the FDA has not approved
any such tests.
Even more unfortunate, many women have been subjected to expensive, untested,
unapproved and possibly dangerous treatments based on the results of these tests.
Moreover, symptomatic women who actually are suffering from some form of auto-
immune disease, which they blame on their implants, fail to obtain a correct diag-
nosis and effective medical therapy.
Another major, very critical and potentially very damaging outcome of the current
scene is the rapidly escalating number of lawsuits filed against the manufacturers
of silicone gel-fiUed breast implants, many of them by women alleging autoimmune
sequelae resulting from the use of their devices. This is ironic and inappropriate in-
asmuch as there is now a general consensus in the medical community, particularly
amongst those involved in the field of riieumatology, that such an association does
not exist. The recent epidemiologic studies suggest that these are women who would
have developed their autoimmune problems m any event and who only coinciden-
tally also had silicone breast implants.
Finally, in the broadest possible sense, I believe that it is critical to evaluate the
impact of what is going on in the United States today as the direct result of this
type of litigation, particularly as it relates to the impact on the health care of
women. For example, Bendectin, the only drug we had available to treat severe nau-
sea and vomiting of early pregnancy, disappeared from the medical armamentarium
based solely on litigation, not on scientific evidence. We have also seen the with-
drawal from the marketplace of several intrauterine devices, for the same reason,
despite the fact that they are still FDA-approved. We are currently witnessing mas-
sive litigation being mounted against an excellent contraceptive product, the silastic
subdermal implant named Norplant. Plaintiffs' attorneys once again claim that it
causes autoimmune disease in the total absence of scientific evidence.
There is also growing concern about the possible fate of other critical medical de-
vices made of silicone such as testicular implants, hydrocephalic shunts, pace-
makers, heart valves, artificial joints, etc. There is even greater concern about the
potential loss of medical materials made out of silicone by manufacturers based on
the very real fear of litigation. Valuable time, money and effort are now being spent
looking for possible replacements for these materials. Even more ominous are the
incredible pressures currently being applied by claimants' lawyers to individual re-
searchers, their institutions and their publications.
It is even more frightening to look into the future. We are seeing companies who
previously spent major portions of their time and money developing new and inno-
vative medical drugs and devices, particularly those for women, disappearing from
the scene. The United States, very sadly, is rapidly losing its previous leadership
role in the development of medical technology. A significant number of American
companies are starting to develop and market their new products overseas; many
of these products may never become available to American consumers.
I believe that the time has come to give great visibility and credibility to the re-
cent epidemiologic studies which I have discussed. There are known complications
of the use of silicone breast implants such as rupture, bleed, and contracture that
do exist. These risks can and should be discussed with any woman using; or consid-
ering implants, allowing her then to make her own informed decisions in conjunc-
tion with her doctor. Even more important, however, women, their doctors and the
public need to be made aware of the new studies dealing with the alleged risk of
autoimmune disease.
The Panel members were often deeply impressed by the testimony of many
women as to the importance of these devices. This led to our conclusion, on both
occasions, that implants should remain available inasmuch as they served a public
health need. Repeatedly, we heard about what the availability of^implants metmt,
particularly to women who faced major surgery for breast cancer, a matter of grow-
ing concern for women, given the rising incidence of this disease. Again, on a very
personal — and I hope appropriate — note, I spent five agonizing days last week wait-
ing to find out whether the lesion just discovered in my right oreast was malignant
or not; happily it turned out to be benign. Thus I am painfully aware of the agony
women suiier while awaiting a final diagnosis. The importance of implants, particu-
larly to women faced with the ultimate adverse diagnosis of a malignancy, ought
not to be underestimated. We also were told by a number of women — somewhat to
133
our surprise — that they would forego mammography looking for early cancers, if im-
plants were not going to be available.
I would like to conclude by making two reconunendations to the Subcommittee.
First of all, I would urge that ways be found to make this growing body of scientific
information immediately and widely available to the scientific community, the pub-
lic and the media. It is the legal and moral obligation of the FDA and other federal
agencies to protect the public health. At the same time, there is an equal obligation
not to overreact to anecdotal evidence and to give full credence and visibility to new
and valid medical and research information. In this regard, I believe it is now time
for FDA to make a public statement about the consensus which has developed in
the medical community that there are no scientific data linking breast implants
with autoimmune disease.
It is also clearly the function of such groups to establish reasonable criteria for
evaluating the safety, efficacy and risk: benefit ratio of all medical drugs and de-
vices. Having done so, it is then incumbent on them to make firm, accurate and ap-
propriate decisions based on their findings.
It must also be pointed out that the continuing escalation of litigation, often un-
substantiated, has had a chilling effect on our ability to carry out research to de-
velop new and better drugs and devices. It is increasingly difiicult or impossible for
companies to obtain adequate protection against potential product liability claims
and enormous punitive damages, thereby encouraging many of them to abandon this
critical medical field. What has unfortunately transpired in recent years is that sci-
entific conclusions have often been drawn by the media, trial lawyers, and by juries,
rather than by the scientific community and relevant agencies.
My last recommendation would be that you urge that the various agencies and
groups involved with silicone breast implants — the Food & Drug Administration, the
National Institutes of Health, and other relevant agencies, organizations and indi-
viduals knowledgeable in this field — to rapidly convene a scientific meeting on all
of these issues in order to put the entire question of autoimmune disease and breast
implants into its proper scientific perspective. I believe that only then will we begin
to see the end of this extremely destructive and tragic situation.
Epidemiological Studies
Dugowson, CR, et al. Silicone Breast Implants and Risk for Rheumatoid Arthritis.
Arthntis Rheum. 35[9] (Supp.), Abstract 192:866, Sept. 1992.
"Theoe data do not support an increased risk for rheumatoid arthritis among
women with silicone breast implants."
Englert, HJ, et al. Scleroderma and Augmentation Mammoplasty — A Causal Rela-
tionship? Aust NZ J Med 24:74-79, 1994.
. . . this study failed to demonstrate an association between silicone breast
implantation and the subsequent development of scleroderma."
Gabriel. SE. et al. Risk of Connective-Tissue Diseases and Other Disorders After
Breast Implantation. ^fEJM 330[24]: 1697-702, 1748-^9, June 1994.
"We found no statistically significant elevation in the relative risk of any of
the specified connective-tissue diseases or other disorders among the women
with Dreast implants as compared with the control subjects."
Goldman, JA, et al. Breast Implants Are Not Associated with an Excess of Con-
nective Tissue Disease (CTD). American College of Rheumatology 35[9] (Supp.), Sep-
tember, 1992.
". . . those with a history of breast implants were no more likely to have di-
agnostic considerations of a connective tissue disease, whether the analysis was
matched or unmatched."
Sanchez-Guerrero, J., et al. Silicone Breast Implants and the Risk of Connective-
Tissue Diseases and Symptoms, The New England Journal of Medicine, Vol. 332,
No. 25, June 22, 1995.
"In a large cohort study, we did not find an association between silicone
breast implants and connective-tissue diseases, defined according to a variety
of standardized criteria, or signs and symptoms of these diseases."
Hochberg, et al. Association of Augmentation Mammoolasty with Systemic Sclero-
sis: Preliminary Results From a Case-Control Study. Arthritis Rhem. 36:871.
"These d!ata extend previously published preliminary results and fail to dem-
onstrate a significant causal association between augmentation mammoplasty
and the development of SSc [systemic sclerosis]."
Schottenfeld D. [U. Mich.], a doctoral dissertation reflecting an epidemiologic
study later described in Schottenfeld, et al.. The Design of a Population-Based Case-
134
Control Study of Systemic Sclerosis (Scleroderma), Journal of Clinical Epidemiology
48:583 (April 1995) [University of Michigan].
"In summary, this study found no statistically signiflcant association between
silicone breast implants and scleroderma."
Sanchez-Guerrero, J., et al. Silicone Breast Implants (SBI) and Connective Tissue
Disease (CTD). Arthritis Rheum. 1994; S232. Harvard Medical School, Abstract (Oc-
tober 1993).
". . . We found no association between silicone breast implants and connec-
tive tissue disease."
Schusterman, et al. Incidence of Autoimmune Disease in Patients After Breast
Reconstruction with Silicone Gel Implants Versus Autogenous Tissue: A Preliminary
Report. Ann Plast. Surg. 1993; 31(1): 1-6. [MD Anderson Cancer Center]
"The incidence of autoimmune disease in mastectomy patients receiving sili-
cone gel implants is not different than in patients who had reconstruction with
autogenous tissue."
Strom B.L. et al. Breast Silicone Implants and Risk of Systemic Lunus
Enrthematosus. J. Clin. Epidemiol. 1994; 47(10):1211-1214. [University of Penn-
sylvania]
"In conclusion, based on this very large case-control study of SLE [lupus], no
association was seen between silicone breast implants and the subsequent de-
velopment of SLE."
Weisman, et al. Connective Tissue Disease Following Breast Augmentation: A
Preliminary Test of the Human Adjuvant Disease Hypothesis. Plastic and Recon-
structive Surgery, 1988; 82[4]:626-630.
"Our survey did not reveal a single subject with an inflammatory rheumatic
disease or condition following breast augmentation."
Wells, et al. The Health Status of Women Following Cosmetic Surgery. Plast
Reconstr Surg. 1994; 93(5):907-912. [University of South Florida].
". . . Although anecdotal reports of human adjuvant disease or silicone-asso-
ciated connective tissue disease are present in the medical literature, the exist-
ence of a causal relationship is unproven."
See also: Medical Devices Agency of the United Kingdom, Silicone implants and
Connective Tissue Disease: Evaluation of Evidence for an Association Between the
Implantation of Silicones and Connective Tissue Disease, December 1994. This was
a systematic review of the literature which concluded:
". . . [T]here is no evidence of an increased risk of connective tissue disease
in patients who have had silicone gel breast implants and therefore no scientific
case for changing practice or policy in the United Kingdom with respect to
breast implantation."
Mr. Shays. Doctor, I thank you very much and appreciate your
suggestions.
Both Ms. Ransom and Tara, you are on. I don't know in which
order you would like to proceed.
Mrs. Ransom. I'll start first.
Mr. Shays. OK. And are we OK? We kept you waiting a long
time. Tara?
Mrs. Ransom. She will be fine. Thank you.
Mr. Shays. OK Tara, I'm in awe. I have a young daughter, and
I think she's a pretty sharp kid, but I think you have been a won-
derful participant today. And it's nice to have both of you here, as
well as the others.
Mrs. Ransom. We thank you for letting us use the conference
room. She enjoyed that.
Grood afternoon. I'm Linda Ransom, patient advocate. Translated,
that means mother, frightened and frustrated.
Tara was 9 weeks premature and experienced an
intraventricular bleed which created scar tissue and blocked the
flow of cerebrospinal fluid down the spinal column, much like a
clogged drain. She was shunted for hydrocephalus. The shunt is a
flexible, silicone plastic tube with a pressure-regulating pump
135
which drains off the fluid and which can only be corrected or ad-
justed with additional surgery.
She has scored in the 99th percentile on the Iowa Test of Basic
Skills for 2 consecutive years at the Magnet Traditional School
where she will be in third grade.
Before silicone plastic shunts were developed, there was no treat-
ment for hydrocephalus, and most infants died. Those who survived
were severely handicapped and had tremendously enlarged heads.
Unless the current trends in scientific research and implant avail-
ability are changed, Tara may not have a future.
Her neurosurgeon told us that shunts are so scarce in Russia
today, they are removed from bodies during autopsies and then
usea in new patients. Would you want a used device, such as a
pacemaker? Will there be waiting lists or buying devices on the
black market? Just like fan belts and batteries on cars, implants
sometimes need to be adjusted or replaced. Our expectations need
to be more realistic.
We know all too well that the shunt only controls the hydro-
cephalus. Tara's long-term future lies in the realm of medical re-
search. Not enough people are going into research today because of
the frustrations of getting raw materials needed to produce a de-
vice for experimentation.
If a device can be produced, years may pass before final approval
allows it to be marketed. How many people die waiting? If we lived
in Europe, Tara might have access to more technically advanced
shunts.
Which use of silicone might you or your family need someday, a
life-saving device like a pacemaker, an angioplasty stent, or just a
life-enhancing one like an artificial hip or cataract implant?
Tara needs a ventriculoperitoneal shunt. Surgery is scary for all
of us, but it is our only hope today. If we cannot replace her shunt
whenever she needs one, the increasing pressure on her brain will
cause progressive retardation, paralysis, blindness, and death. And,
yes, Tara has been told this. If things continue and silicone is re-
moved from the market, shunts could disappear and so would our
hope.
We can deal with possible complications tomorrow but only if we
have a tomorrow. Some perspective and reason needs to be put
back into the research and approval of medical products. What dif-
ference does it make to know if a device could potentially cause
cancer in 20 years if your life expectancy without it is days or
months?
Life-enhancing and life-saving devices should have different test-
ing criteria. No one wants unregulated devices flooding the market.
This goes into my daughter's brain. However, when regulations and
politics interfere with the availability of life-saving devices and peo-
ple die, something needs to be changed.
How many years and inventions preceded the first successful air-
plane flight? Medical strides have been just as tenuous. Progress
today in all fields of science is being made faster than any agency
can evaluate. Maybe what needs to be regulated is the research in-
stitutions, not the specific devices.
Certified peer review committees could evaluate the science and
testing procedures. There needs to be responsibility from the medi-
136
cal industry and scientific community, but there also needs to be
legislative and regulatory responsibility. Patients need to accept
that not every product will have the same outcome for everyone.
We do not ban penicillin and aspirin because patients experience
allergic reactions.
Don't allow the silicone shunt to be taken from Tara. Can you
look at Tara today and guarantee that a shunt will be available
when she needs one? The onlv thing I know for sure is that the
farther away we are from her last surgery, the closer we are to the
next. Can you even guarantee that the silicone from which the
shunt is made will be available for medical uses tomorrow?
This shouldn't be a legal business or a political issue; it is a med-
ical issue. Tara is not a Democrat or a Republican; she's an 8-year-
old child. We appeal to you to use common sense in evaluating the
legislation in this very critical area.
Congressman John Shadegg was quoted following a day of Waco
testimony as saying, "I think it's frustrating. We spent 80 percent
of the day on red herrings that have nothing to do with the purpose
of this hearing." Don't be sidetracked from the real issue, the avail-
ability of raw materials and implants necessary to preserve the
lives of very real people.
There are approximately 50,000 shunt-dependent hydrocephalics
in this country. You're talking numbers equivalent to the Vietnam
battle deaths, but there will be no wall with their names. We need
you to recognize what the impact of any new legislation or the fail-
ure to provide real reform will have on your life and that of your
family.
Don't take hope away. Tara sits before you today; put her before
you when you make your decisions.
Thank you. Now, Tara.
[The prepared statement of Mrs. Linda Ransom follows:]
Prepared Statement of Linda Ransom, Phoenix, AZ
I represent the Ransom family — particularly a 4-foot-tall, 50 pound, 8-year-old,
3rd grader named Tara Anne. I have found myself listed as a "Patient Advocate".
The correct title is "Mother."
In April, 1987, Tara was delivered 9 weeks prematurely because my liver and kid-
neys were failing. She weighed 3 pounds 9 ounces, and breathed on her own. Within
24 hours she was moved to the Annex of the NICU and listed as a feeder/grower.
Obviously, the story only starts there. Seventy-two hours later she began vomit-
ing. A spinal tap revealed blood in the spinal fluid. An ultrasound confirmed an
intraventricular bleed which I was later told was a Grade 3 with Grade 4 being the
most severe. Over the next month efforts were made to resolve the hydrocephalus —
including 3 different lumbar drain attempts — all to no avail. At the age of 1 month
she was shunted, and shortly thereafter discharged.
Cerebralspinal fluid is produced constantly within the brain to coat it and keep
it pliable. Tne excess fluia drains down the spinal column and is reabsorbed by the
body. In Tara's case, the bleeding created scar tissue which blocked the flow of fluid
much like a clogged drain. The shunt is a flexible silicone plastic tube with a pres-
sure regulating pump which drains off the fluid. One end is implanted in the ventri-
cles of her bram, the pump is just under her scalp, and the tube is threaded through
the tissue of her neck and chest wall into an incision in her abdomen and the peri-
toneal cavity. The surgery requires two incisions, and a surgical infection usually
causes meningitis, because the brain is involved. The shunt is totally contained
within the body. The only way to make any correction or adjustment is with sur-
gery. Shunts are outgrown, some have tissue invade the ends like tree roots grow
into sewer pipes, and some need to be replaced to change the pressure. It is just
as damaging to the brain to have too much fluid drain off as too little.
137
At 11 weeks old, she was rehospitalized with meningitis — a staph bacteria. The
swelling around her optic nerve blinded her. She had hypotonia and was a limp rag
doll. According to all I read — her prognosis was not very promising.
Today the hypotonia is barely noticeable and she has mastered skipping, lump
rope, roller skates and all the other skills with her peers. Her sight returned and
until this last year, she didn't even need glasses. She never read the "risk" statistics
because she has been too busy reading the original 14 books of the Wizard of Oz
series — not the edited-for-children versions.
Tara has always attended the Magnet Traditional School, a highly structured pro-
gram emphasizing academic performance, where she will be in 3rd grade in the fall.
She has been the top student in her class for 2 years. She has also scored the 99th
percentile on the lOwA Test of Basic Skills for two consecutive years. Her composite
grade equivalent score is 5th grade 6th month and her reading equivalent to 6th
grade 2nd month.
We know that she has achieved much more than should have been medically ex-
pected of her. She is the perfect example of hope, the surgeons' skills, advances in
medical technology, improvements in the shunt itself, and faith. Faith largely based
on the belief that God s miracles are the hands of the surgeons and the minds of
the scientists who make the discoveries and create the devices. Shunts were not suc-
cessful before improved flexible silicone plastics were developed. Before shunts there
was no treatment for hydrocephalus and most infants died within months. Those
who survived were severely handicapped and had tremendously enlarged heads.
Tara has had 5 shunt surgeries and will need more. There are no guarantees that
there won't be any complications from the surgeries or the materials in the shunt,
but there are also no guarantees in life. She could be killed by a drunk driver or
paralyzed in a random shooting leaving this building today.
Unless the current trends in scientific research and implant availability are
changed, Tara may not have a future. K the current course is followed, medical im-
plants may well disappear from use or become so scarce as to lead to the ethical
questions which are raised when someone famous like Mickey Mantle gets a liver
transplant. Will there be waiting lists or buying devices on the black market? Some-
one needing a shunt may have as little as 4 to 5 hours before the fluid starts to
crush brain cells and cause permanent brain damage. There would be no time for
any committee decisions. Tara's neurosurgeon told us of how shunts are so scarce
in Russia today that they are removed from bodies during autopsies and then used
in new patients. Would you want a used device like a pacemaker?
Common sense needs to return to the "practice" of medicine. Just like fan belts
and batteries on cars, implants sometimes need to be adjusted or replaced. Our ex-
pectations need to be more realistic. Implants are designed to help control a medical
Problem, but they are not a cure. We are just very grateful to have a shunt to keep
ara alive.
We know all too well that the shunt only controls the hydrocephalus. Tara's long-
term future lies in the realm of medical research. We have no idea if it will take
the form of a device which can be altered without surgery or only a minor proce-
dure, a drug to control the production of the fluid in the first place, or a procedure
which will be able to reduce the area of scarring and remove the obstuction. Like
cancer, which takes many forms and responds to diflerent interventions, hydro-
cephalus is caused by different traumas and some genetic causes. One solution will
not "cure" all of the victims.
Today, not enough people are going into research because of the frustrations of
getting devices off the drawing board to test. Often raw materials needed to produce
a device to experiment with are unavailable because of industry fears of liability.
No one thinks of suing the pulp mill because of words written on paper produced
from the wood pulp, but large companies and institutions are targeted under today's
law.
If a device can be produced, years and even decades may pass before final ap-
proval allows it to be marketed. How many people die waiting for a lifesaving drug
or device to become available? The irony is that if we lived in Europe, Tara might
very well be able to get more technically advanced shunts than living in Phoenix,
AZ, which is home to the Barrow Neurological Institute. Barrow's is a famous medi-
cal facility which offers the most skilled surgeons and techniques in the world, but
not necessarily the most advanced devices as their availability is controlled by agen-
cies and the proverbial red tape.
Tara may be the person to find the cure for AIDS or become the first woman
President. Maybe, she'll choose to become the mother of that person. Whatever
Tara's future — she has a future because of a little piece of silicone plastic which we
know will need surgical revisions and replacements in its current form.
138
Allan Bergman of the United Cerebral Palsy Associations is quoted as saying that
"Every person under 65 years of age will experience, directly or indirectly through
a family member, disability or chronic illness as a result of illness, disease, injury,
the aging process or the birth of their next child, grandchild, niece or nephew." Who
is that person in your family? Is it you? Your spouse? Your child? Which use of sili-
cone might be needed — a life-saving device like a pacemaker, an angioplasty stent,
or just a life-enhancing one like an artificial hip or cataract implant? Tara needs
a ventriculoperitoneal shunt! Maybe you have been lucky enougn to already have
a device before they disappear.
My husband Jerry and I wish we had never heard of hydrocephalus and a shunt,
but wishes aren't reality. We want both Lindsey, our 10-year-old daughter, and Tara
to have the same opportunities to grow up, get an education, and eventually have
their own families.
When I became aware of the current problem involving raw materials for medical
devices, I was frantic. I still am very frightened, though 1 have tried to educate my-
self to the issues and help find solutions. I immediately wrote to all 538 Senators
and Congressmen on the ust. I had 12 replies and my first lesson in political proto-
col. I have worked closely with Arizona Senators John McCain and Jon Kyi, as well
as Congressman Ed Pastor. Although they are not from my district, I am also re-
ceiving support and encouragement from Congressmen John Shadegg, J.D.
Hayworth, and Matt Salmon.
I had more success contacting the chemical companies, having received replies
from each letter that I wrote. In fact, Mr. Richard Hazelton of Dow Coming person-
ally called me to reassure me of their commitment to make life-saving raw materials
available. Unfortunately, the Chapter 11 filing may make that impossible.
I have also been invited to speak as a patient representative on a panel entitled
"Medical Science and Device Industry Put Tort Law on Trial" sponsored by the
American Institute for Medical and Biological Engineering and endorsed by the
American Association for the Advancement of Science Section on Engineering and
Society for Biomaterials in Atlanta, Georgia in February, 1995. Participating with
me were Mr. Bruce Burlington of the FDA, Mr. Richard Hoover of Dow Coming,
and Mr. James Benson of HIMA (Health Industry Manufacturers Association). In
May, 1995 I spoke at a conference entitled "Tough Decisions II: Risk-Free Medi-
cine?" sponsored by the Memorial Blood Centers of Minnesota in Minneapolis. Dr.
Susan Alpert of the FDA sat next to me on the same panel and I met Ms. Barie
Carmichael of Dow Coming who participated with a different group.
Only my actual expenses were reimbursed. I have never been paid for anything
related to my activities. I have spoken to many people and no one yet can guarantee
that a shunt will always be available when Tara needs one. I will not stop until
I have that assurance. Saving Tara's life is our only motivation.
Surgery is scary for all of^us, especially for Tara, but it is our only hope today.
We at least need that chance for ner. The risk of complications is not really an
issue. We've dealt with them before, and we'll deal with them if they occur again.
If we cannot replace her shunt as often as she needs one, we all lose our future.
The increasing pressure in her brain will cause progressive retardation, paralysis,
blindness, and aeath. If things continue and silicone is removed from the market,
shunts could disappear — and so would our hope.
We do not want to put some untested proauct into Tara's brain. A contaminated
shunt could kill her. But so can the lack of any shunt! We would risk an experi-
mental device if the alternative was death.
Some perspective and reason needs to be put back into the research and approval
of medical products. What dilTerence does it make to know if a device could poten-
tially cause cancer in 20 years if your life expectancy without it is days or months?
You can deal with the complications if you are still alive! I think it is reasonable
to put different testing requirements on different product usages. Life-enhancing
and life-saving devices should have different criteria. Decisions related to product
availability need to be based on scientific research.
No one wants unregulated devices flooding the market. In Tara's case, the shunt
is implanted directly into her brain. Of course, we want a sterile, safe device. How-
ever, when people start dying because regulations and politics interfere with the
availability of life-saving devices, something needs to be quickly and radically
changed.
Also, rather than punish companies and institutions for their attempts to advance
medicine, they should be encouraged to participate with products and talent.
History is full of failed attempts before success is finally achieved. How many
years and inventions preceded the first successful airplane flight? Medical strides
nave been just as tenuous — successes and failures. We don't want Tara to be part
of an experiment, but we are not willing to let "nature take its course" either.
139
Progress today in all fields of science is being made faster than any agency can
evaluate. Maybe what needs to be regulated is the research institute, not the spe-
cific device, and have certified peer review committees to evaluate the science and
testing procedures. Yes, there needs to be responsibility from the medical industry
and scientific community, but there also needs to be legislative and regulatory re-
sponsibility. Patients also need to accept that not every product will have the same
outcome for every patient. We do not ban penicillin and aspirin because patients ex-
perience allergic reactions. Don't aUow the silicone to be taken from Tara.
Can you look at Ttira today and guarantee that a shunt will be available when
she needs one? I can't tell you if shunt failure will occur in a few hours or a few
years. Medically, Tara is stable now. The only thing I know for sure is that the far-
ther away we are from her last surgery, the closer we are to the next.
Can you even guarantee that the silicone from which the shunt is made is ^oing
to be available for medical uses tomorrow? This shouldn't be a legal or busmess
issue. It shouldn't be a political issue. It should be a medical issue. Tara is not a
Democrat or a Republican. She is a child. She could be your child, grandchild, or
even yourself. Shunts are simply used to treat head injuries and tumors when some-
thing interrupts the normal flow of fluid from the brain.
We appeal to you to use common sense in evaluating the legislation in this very
critical area. Congressman John Shadegg was quoted in the Arizona Republic on
July 20, 1995 following a day of the Waco testimony as saying "I think it's frustrat-
ing. We've spent 80 percent of the day on red herrings that have nothing to do with
the purpose of this hearing." Don't be sidetracked from the real issue; the availabil-
ity of raw materials and implants necessary to preserve the lives of very real people.
Today's regulations will not insure implant availability for tomorrow.
There are approximately 50,000 shunt-dependent hydrocephalics is this country.
You are talking numbers equivalent to the Vietnam battle deaths. They would never
get a wall, but they would leave just as many devastated families.
We need you to recognize what the impact of any new legislation, or the failure
to provide real reform, will have in your life and that of your family. Don't take hope
away from either yourselves or Tara. She sits before you today. Put Tara before you
when you make decisions.
Miss Ransom. Hello. My name is Tara Ransom, I'm 8 years old.
My favorite book is the Wizard of Oz. I like to jump rope, bike ride,
and run. Fm going to be in third grade this year.
I have a shunt. It is this bump on my head. I have a shunt be-
cause I have hydrocephalus. The shunt goes into my brain. The
tube goes down my head and neck, down my chest, down into my
tummy. I got the hydrocephalus when I was a baby. I can't do gym-
nastics or stand on my head, but I can do lots of other things.
I need a shunt to live. The shunt is made of silicone plastic, I
need you to save the plastic shunts to save the people.
[The prepared statement of Miss Tara Ransom follows:]
Prepared Statement of Tara Ransom, Phoenix, AZ
Hello.
My neune is Tara Ransom,
I am 8 years old.
My favorite book is the Wizard of Oz. I like to jump rope, bike ride, and run. Fm
going to be in 3rd grade this year.
I have a shunt. It is this bump on my head. I have a shunt because I have hydro-
cephalus. The shunt ^oes in to my brain. The tube goes down my head and neck,
down my chest, down into my tummy.
I got the hydjx>cephalu3 when I was a baby.
I can't do gymnastics or stand on my head. But I can do lots of other things.
I need a shunt to live. The shunt is made of silicone plastic. I need you to save
the plastic shunts to save the people.
Mrs. Ransom. And Tara wrote that herself.
Thank you.
Mr, Shays, Thank you, Tara.
Mrs Groldrich, you're on.
Ms. GOLDRICH, Thank you for the opportunity to be here today.
140
I am a bilateral mastectomy patient. I was offered breast im-
plants. I accepted breast implants in 1983. Breast implants were
removed because they called me a breast implant failure. I don't
believe I failed; I think the product failed.
In 1988, I had a hysterectomy and bilateral salpingo-
oophorectomy. Silicone was found in my uterus, my ovaries, and
mv liver. I have been an activist in making sure that women get
adequate information to make an informed decision to get or not
get breast implants. I was reconstructed with a new technology
called a flap operation, which is formidable but doable, for cancer
patients. So there are alternatives for some cancer patients that
don't require the use of a medical device.
And I must tell you that I would defend the right of a child or
any human being to a life-saving device, just as I will defend my
daughter's right to have absolute truth about the product that they
may have to choose, whether they want to or not, because they are
at greater risk of developing breast cancer because I had breast
cancer.
So today I offer you five suggestions to how we might be able to
solve some of these problems. In 1976, Congress left a loophole in
the Food, Drug, and Cosmetic Act when it grandfathered this de-
vice into place. And it wasn't until many, many vears later, prob-
ably about 30 years later, that women became alarmed and came
forward with problems.
I can't understand why a manufacturer, who had 30 years or
even from 1976 to 1983 to come forth with adequate data to prove
this product safe, which they knew was the standard from day one,
and they haven't done it. Where are they? They should have had
the studies already. They have been given borrowed time.
When David Kessler came on the scene, he stopped a regulatory
stance that allowed women to be used as human guinea pigs. Be-
fore Dr. Kessler came, we had diethylstilbestrol and we had the
Dalkon Shield. I know you will agree that none of us want to see
that period in our history, our meoBcal history, repeated.
The current FDA and current scientific ethical and legal stand-
ard for medical devices is that they be proven safe and effective.
Proven not unsafe, and proven not ineffective is not the standard.
It never was the standard and should never be the standard. And
the manufacturers of these products knew that all along.
Products made of silicone — this is my second suggestion — should
be made available in life-and-death situations only when the recipi-
ents are fully informed of all risks and benefits. Tara has been in-
formed. I was not informed.
In the case of breast implants, full disclosure would require that
patients be advised that Dow Coming tampered with the early sili-
cone studies and was later found guilty twice of fraud. Those cases
are, for your reference, Stern v. Dow Corning and Hopkins v. Dow
Corning. The Hopkins v. Dow Corning fraud was upheld by the Su-
preme Court of the United States, and during those trials, causa-
tion was proven using the Daubert standards for scientific accu-
racy.
It seems to me that some of these companies — ^you asked Dr.
Kessler so many times why all these companies are not coming for-
ward with studies. They don't come forward because they don't
141
have them, and they knew they were required to have them. People
in foreign countries come here for redress for products that are
made by companies in the United States. That's unfortunate. We
don't get a great reputation out there. Nobody wins from that kind
of sale.
When silicone can make a difference between life and death for
a patient, a lack of long-term data may be irrelevant. But where
anything less than life is at stake, it's important that the long-term
effects of a product should be known, because otherwise the patient
is committed to life imprisonment without the possibility of parole.
My third suggestion is that you limit tort reform as it deals with
medical devices. At this point, it seems that Congress wants to pro-
vide further protection lor industry and to limit consumer protec-
tion. At the same time, it is attempting to guide the scope and re-
sponsibility of the FDA to move faster.
Last year, the U.S. Senate failed to pass the Sunshine In Litiga-
tion Act; it failed by one vote. That would have allowed people to
know when a court case had information in it that would affect
pubHc health, that that information would be made available to
people. Instead, they have sealed these documents with secrecy or-
ders.
So, in 1983, when Maria Stem won her case about causation of
silicone problems for her autoimmune disease, I was having my
first breast cancer surgeries, and I wasn't told that because the
court sealed it. So please pass that kind of legislation so that we
can be forthright with people who need to know.
It might be a good idea to reform the bankruptcy laws to make
it difficult and even impossible for manufacturers to hide in bank-
ruptcy only to leave the citizens and taxpayers to pick up the tab
for product liability and corporate wrongdoing. People who are in-
jured by these products, by breast implants, have been waiting a
long time for the resolution of the case and certainly the resolution
of the science, which is definitely not forthcoming.
The financial burden will fall on local governments and will fall
on medical programs sponsored by the States, and will also require
Social Security disability for those women who are severely dis-
abled. Once again, the taxpayers are going to pay the bill for a cor-
porate bailout, because they had the opportunity to come forward
with the science in the first place.
It was Dow Corning that wanted those records sealed in the
Stem case. It was Dow Coming that tampered with those studies,
for which they were found guilty of fraud. The best tort reform will
come when everybody serves on jury duty and we don't have all of
these massive jury verdicts to change the structure of who has and
who has not any money in this country.
When corporate executives are given — and doctors and lawyers —
are perhaps given a tax credit for serving on juries, we woula prob-
ably have a more meaningful effect than passing maior laws about
tort reform, because you would then hear exactly what the people
want.
Manufacturers whine about the costs of litigation and the legal
aspects of medical device production, but for every plaintiffs lawyer
they cite as making tons of money with contingency fees, there is
a defense firm racking up millions, on an hourly basis, paid up
142
front and regularly. The defense bar has a disincentive to find
quick resolution for product liability cases. By the way, Dow Cor-
ning has spent $200 million on their legal fees.
My last two I will do very quickly. Please don't release a product
before it's appropriately tested. We must remain mindful of the pri-
vacy needs of patients, but perhaps, when a medical device is is-
sued, the person should appear on a registry of sorts. And informa-
tion, information, information; it must be free-flowing and correct.
It must not be weighted and manipulated, and it must be readily
available in language that is understandable.
The Pope asked Michelangelo when he would be finished with
the Sistine Chapel. I can't recall the name of the movie at the time,
but it was Rex Harrison who asked whoever was playing Michelan-
gelo— ^the Agony and the Ecstasy. The Pope said, "When will it be
done?" And Michelangelo said, "When it is finished." So that's what
I would like to see done with the science, appropriately, this many
years after the product was released on the market.
Thank you.
[The prepared statement of Ms. Goldrich follows:]
Prepared Statement of Sybil Niden GSoldrich, Command Trust Network
Mr. Chairman and Members of the Committee: I speak to you this morning as
the co-founder of Command Trust Network, the largest information clearinghouse
and advocacy group for women with breast implants. And I speak to you, this morn-
ing, as a cancer patient who had bi-lateral mastectomies and who was reconstructed
in 1983 and 1984 using seven implants that failed and an innovative reconstructive
surgery that succeeded: the trans abdominal island flap. I have survived my cancer
for thirteen years but I have been plagued with problems arising from migrating
silicone and decomposed polyurethane foam since 1983.
My medical records describe me as "an implant failure". I do not accept that de-
scription because it was breast implants that failed me by leaking and spreading
silicone gel throughout my body. I have had a total abdominal hysterectomy, bi-lat-
eral salpingo oophorectomy and liver biopsy with silicone being detected in rep-
resentative slides of my uterus, ovaries and liver. I have had five tumors removed
from my ankle, thigh and wrist respectively. Tumors such as these are frequently
found to form around mass collections of silicone but, at this point I ask my sur-
geons only if the tumors are benign or malignant because there is no known way
of removing silicone from the body; there are ways to treat a person for cancer.
If it were not bad enough for people like me to have been sold a product that was
inadecruately proven and released for sale prematurely, now we are inundated with
after-tne fact, scientific studies claiming to prove that breast implants were safe all
along. Manufacturers of these unsafe devices are pouring money into research
projects designed, however poorly, to provide evidence for courtroom confrontations.
Alas, for already injured patients and patients who need silicone based products to
help manage matters of life and death, there is not now, nor will there ever be an
answer that can be trusted. Where the silicone is contained in a product that can
make the difference between life and death for a patient, the absence of long-term
answers may be irrelevant. But where anything less than life is at stake, the lack
of information is a term of life imprisonment with no possibility of parole.
Thirty years after the release of breast implants on the market there are no valid
scientific studies to prove the product safe. The scientists who developed breast im-
plants and other silicone based products committed fraud in their basic research.
This finding of fraud is cited in Stern v Dow Corning and in Hopkins v Dow Cor-
ning. Evidence admitted in Hopkins v Dow Corning withstood the rules cited in
Daubert (the case that defined the standards for scientific evidence). Further, the
Hopkins case was taken to the Court of Appeals in California and the Supreme
Court of California and the fraud count was upheld. The Supreme Court of the Unit-
ed States, by allowing the decision to stay, affirmed the fraud count against Dow
Coming.
Scientific findings emanating from fraudulent basic science can never be proven
and certainly can never be taken seriously. Once there is fraud, there is no con-
143
sress-person, physician, scientist, government regulator, or medical ethicist who can
dispute that.
Please accept the following five suggestions as a way to avoid another medical de-
vice debacle:
1. A STRONG FDA WITH STRONG AND CAREFULLY ESTABLISHED REGU-
LATIONS IS ESSENTL\L. Congress did a good thing by passing the 1976 Food,
Drug, and Cosmetic Act Amendment. However, they left a loophole that in many
instances denied Americans the chance to have implantable medical devices that
were proven to be safe and effective. It was Congress that allowed products to be
"ffrandfathered" into the marketplace. Few, if any, congress-people are scientists.
But, Congress is not exclusively to blame. It was a weakly run FDA, seduced by
medical device lobbyists and plastic surgeons, who made sure that breast implants
were not re-examined until women began to report iniuries en masse. It was not
until David Kessler came on the scene that anyone took seriously the fact that the
FDA's weedc regulatory stance had allowed more than a generation of women to be
used as human guinea pigs. Before Dr. Kessler, we had Diethylstilbestrol (DES) and
the Dalkon Shield. I would venture that nobody would ever want that period in
America's health history repeated. Dr. Kessler has made great strides toward main-
taining the scientific, ethical and legal standard that medical devices must meet the
safe and effective scientific threshold. Not proven unsafe and not proven ineffective
is not the standard, never was the standard and should never be the standard.
2. LIFE AND DEATH SITUATIONS ONLY WHEN THE RECIPIENTS ARE
FULLY INFORMED OF THE ALL RISKS AND BENEFITS. Patients and their
loved ones can then perform their own risk benefit analysis. Only after that infor-
mation is provided them can there be true informed consent which is a choice made
freely and aft«r consideration. Then manufacturers of such products could be pro-
vided immunity from suit. As an extension of this process, eiTorts to develop alter-
native and safe products to improve the risk/benefit ratio must be supported.
3. LIMIT TORT REFORM AS IT DEAI^ WITH MEDICAL DEVICES. The Con-
gress is attempting to provide further protection for industry and strip consumers
of protection at the same time as it is attempting to limit the scope and reach of
responsibility by the FDA. If there is to be reform, then reform the bankruptcy laws
to make it difficult, if not impossible, for manufacturers to run to hide in bank-
ruptcy only to leave the citizen/taxpayer to pick up the tab for corporate wrong-
doing.
If our system of compensation via the judiciary is further limited, people who are
irnured will not have enough money to care for their expanded medical needs. They
will increasingly turn to local government for medical assistance and to the Federal
Government lor Social Security disability. And once again, taxpayers will foot the
bill for a bailout of enormous proportions.
Lobbyist groups welcome former FDA employees into their midst with enthu-
siasm. There should be a waiting period for all former government employees to join
lobbying groups and trade associations. Even the most honorable FDA employee
who is planning to become a lobbyist has a mixed agenda. In this case, the appear-
ance of impropriety is impropriety itself because it impugns the integrity of the FDA
as an institution.
For every plaintifPs lawjyer that tort reformers cite as earning tons of money,
there is a defense firm making much more money on a regular basis and up front.
As a member of the Tort Claimants Committee for the Dow Coming Bankruptcy,
I can assure you that Defense law firms have billed Dow Coming for well over thir-
ty-six million dollars. Plaintifl's attorneys haven't collected a dime and may never
collect a dime. In the past two years, defense firms have billed $190 million in costs
to implant manufacturers. This fact was placed in record during the bankruptcy
hearings of Dow Coming before Judge Arthur Spector of Michigan.
4. NEVER RELEASE A PRODUCT BEFORE IT IS APPROPRIATELY TESTED.
The standards of the FDA are that a product must be proven safe. Not Proven Un-
safe is decidedly diiterent. It is important to the healtn and safety of every Amer-
ican that you and the lobbyists who approach you remain mindful of this basic
truth. That standard — to be proven safe — must never be altered. We are entitled to
that security. A product/recipient registry would make for easy recall of a faulty
product.
5. INFORMATION, INFORMATION, INFORMATION. It must be correct and free
flowing. It must not be weighted and manipulated. It must be readily available in
language that is understandable. Without it, consumers of medical devices are
doomed. Their doctors are doomed by the liability of failure to inform. Manufactur-
ers are doomed by failure to inform and breaches of responsibility. Dow Coming
stated the risks of auto-immune disease in their 1985 package insert — more than
twenty years after the development of their silicone product. They did so only after
144
losing Stem v Dow Coming, a case where a woman proved causation of autoimmune
response by silicone. Information, correct, clear and available is essential.
I implore you, as our representatives in Congress, to provide citizens with the
safeguards necessary to assure life, liberty and the pursuit of happiness. Science,
after the fact, regardless of what it shows, is too little too late. Decreasing regula-
tion and decreasmg opportunity of redress may keep some re-election coiiers full,
but it does not provide just service to the Americans you represent.
ADDITIONAL NOTES ON THE HARVARD NURSES STUDY
Scientific studies with enormous flaws are touted by the manufacturers and their
gublicity agents to be ^he truth". Let us look at the Harvard University Nurses
tudy, for an example. District Court Judge Sam C. Pointer, Jr., who heads MDL
926, Breast Implant litigation has ordered that the raw data of the Harvard Nurse's
Study be made available for review.
1. Some of the women had implants for only two months. Nobody thinks implants
can cause autoimmune disease that quickly. They should have compared three
groups: no implants, implants for less than 5 years, and implants for more than 5
years. This criticism also applies to other studies that purport to show that implants
are safe — they need to focus on women who have had implants for at least 5-7
years.
2. The article stated that some of the women had breast implants for forty years,
thirty-seven years, etc. This can't be. Breast implants had only been on the maricet
for thirty years when the study was conducted. Even if the very first breast implant
recipients were in the study (which seems very unlikely) they could not have had
implants for more than thirty years. This obvious error makes one wonder if the
authors knew anything about breast implants.
3. Most women with breast implant problems describe their symptoms as chronic
fatigue, etc. They do not fit in a perfect diagnostic category, such as scleroderma.
When researchers study scleroderma, that does not really answer questions about
whether implants cause immune problems or connective tissue diseases.
4. Researchers doing this study are also paid as expert witnesses by Dow Coming
Corporation and have nad to step down from the project.
Just because a study has the words "Harvard University" attached to it does not
mean that the study is without taint or flaws. Now, with regret for my appropriate
cynicism, consumers must investigate who writes the check for the research at the
same time as the research is evaluated.
Mr. Shays. Thank y€u very much. We appreciate your testimony,
as well.
Thank you, Sharon Green.
We're coming to conclusion, and we will take some questions
after Jama Russano.
Ms. Green. Thank you. I'm Sharon Green, the executive director
of the Y-ME National Breast Cancer Organization. Joining me
today is Rosemary Locke, a Y-ME volunteer and implant recipient.
I want to thank the committee for the opportunity to speak on
behalf of the thousands of individuals who contact our national hot-
line each year on all aspects of breast health. Everv day our na-
tional hotline counselors offer compassion and understanding to
women devastated by the loss of a breast due to breast cancer. We
also hear from hundreds of women living with implants who are
seeking reassurance or direction on decisions they made years ago.
Y-ME did not agree with the FDA's decision to restrict the avail-
ability of silicone gel implants, but we accepted it because there
was a strong mandate to do further research. Meanwhile, we have
worked tirelessly to calm the anxietv over breast implants and en-
sure that women have access to the latest information.
We have promoted participation in the clinical trials that were
created to answer remaining questions. We have worked with the
FDA, reviewing and distributing patient materials, even though we
have been frustrated by the lack of opportunity to review final doc-
uments before they are released.
145
Y-ME has a solid reputation for providing information based on
science and not hearsay. We recognize that no treatment or device
exists without risk. We beheve that women must be part of their
health care choices, and this includes accepting the risks associated
with those choices.
There are people who say that breast cancer survivors should be
happy to be alive and that a breast is not important. Tell that to
a breast cancer survivor who cannot nurse her baby, or wear her
favorite bathing suit, or feels that her sexuality has been com-
promised by the loss of her breast.
The implant debate is out of control, and, as a result, we all lose.
Women who want silicone gel implants have little or no access.
Women with perceived problems have been exploited bv unscrupu-
lous doctors and labs who offer bogus treatments tnat are far
riskier than implants and tests that tell us nothing. Women with
breast cancer fear that their insurance will be canceled, not be-
cause of cancer but because of their implants.
Lawsuits based on junk science are siphoning off much needed
dollars from health care delivery and research. The major concern
of the device panel that restricted gel implants was the relation-
ship to immunological diseases. Renowned researchers have pub-
lished studies that find no significant increase in these disorders.
The fact that some of these studies include women with ruptured
implants should be even more reassuring. We allow drugs and de-
vices with much higher risk profiles than silicone gel implants on
the market. Are we creating a new set of standards for breast im-
plants?
Now that the results of studies are being published and other
governments are accepting them, Y-ME looks forward to a timely
statement from the FDA, the very agency that requested them. On
May 31, 1995, Y-ME representatives met with members of the
FDA Center for Radiological Devices. We inquired if the FDA
would be making a statement regarding these new studies so
women living with gel implants could get on with their lives.
The FDA representatives said that some of the studies were too
small and that the meta analysis was flawed. Yet they have accept-
ed even smaller studies on other aspects of implants. When we
asked how they defined acceptable risk, they refused to answer.
They turned the discussion to their own concerns about rupture,
even though this was not a priority concern raised during the ear-
lier panels.
Y-ME knows that there is a possibility of rupture, and we sup-
port continued research to determine the actual rates so that re-
placement guidelines can be developed. In our view, that is an ac-
ceptable risk and not one that should prevent the availability of
implants as the studies continue.
We sent a letter requesting a public statement from the Commis-
sioner, on June 9, 1995. Every day without an official statement
encourages women to rely on information from tabloids, talk shows,
and courtrooms. A response was FedEx'd to my home last Satur-
day, and our major Questions remain unanswered.
Dr. Kessler voiced great concern for women living with gel im-
plants when he announced the moratorium, yet he is allowing this
media and legal frenzy to flourish by not defining acceptable end
146
points to the inquiry. We believe it is time to bring this issue back
to a sound scientific process. The FDA must establish measurable
and consistent guidelines for answering questions on risks and ben-
efits. If they cannot do it, maybe it is time to turn this over to
someone else.
Silicone gel implants provide the easiest, most inexpensive meth-
od of breast reconstruction, with some of the best cosmetic results,
yet they are an almost obsolete option for women with breast can-
cer. And contrary to what was said this morning, we have found
the current clinical trial system not adequate. Thank you.
[The prepared statement of Ms. Green follows:]
Prepared Statement of Sharon Green, Executive Director, Y-ME
I am Sharon Green, Executive Director of the Y-ME National Breast Cancer Or-
fanization. Joining me is Rosemary Locke, a Y-ME volunteer and implant recipient,
want to thank the committee for the opportunity to speak on behalf of the thou-
sands of individuals who contact our national hotline each year on all aspects of
breast health. Every day, our national hotline counselors offer compassion and un-
derstanding to women devastated by the loss of a breast due to breast cancer. We
also hear from hundreds of women living with implants who are seeking reassur-
ance or direction on decisions they made years ago.
Even though we did not agree with the FDA's decision to restrict the availability
of silicone gel implants, we accepted it because there was a strong mandate to do
further researdi. Meanwhile, we have worked tirelessly to calm the anxiety over
breast implants and insure that women have access to the latest information on
these devices. We have promoted participation in the clinical trials that the FDA
and the manufacturers agreed were needed to answer remaining questions. We have
worked with the FDA on reviewing and distributing patient materials even though
we have been frustrated by the lack of opportunity to review final documents before
they are released.
Y-ME has a solid reputation for providing information based on science and not
hearsay. We are realistic about risks and benefits and recognize that no treatment
or device exists without risk. We believe that women must be part of their health
care choices and this includes accepting the risks associated with those choices.
There are some in this room who will say that breast cancer survivors should be
happy to be alive and that a breast is not important. Tell that to a breast cancer
survivor who cannot nurse her baby or wear her favorite bathing suit, or feels that
her sexuality has been compromised by the loss of her breast.
The implant debate is out of control — and, as a result, we all lose. Women who
want silicone gel implants have little or no access. Women satisfied with implants
have to deal with increased anxiety. Women with perceived problems have been ex-
ploited by unscrupulous doctors and labs who ofler bogus treatments that are far
riskier than implants, and tests that tell us nothing. Women with breast cancer fear
that ^eir insurance will be canceled — not because of cancer — ^but because of their
implants. We anticipate increased insurance rates or decreased benefits because
lawsuits are siphoning off much-needed dollars for health care services and re-
search.
The major concern of the device panel that restricted silicone gel implants was
the relationship of immunological diseases to these devices. Renowned researchers
have begun puolishing studies that find no significant increase in these disorders
in women with silicone implants. The fact that some of these studies include women
with ruptured implants should be even more reassuring. The FDA says that manu-
facturers are responsible for getting these studies done, but when these studies are
criticized because they are funded by manufacturers, the FDA remains silent.
We allow drugs and devices with much higher risk profiles than silicone gel im-
plants on the market. Are we creating a new set of standards for breast implants?
Now that the results of studies are being published and other governments are
commenting on them, Y-ME looked forward to a timely statement from the FDA —
the very agency that requested them. On May 31, Y-ME representatives met with
members oT the FDA's Center of Radiological Devices. We inauired if the FDA would
be making a statement regarding the latest scientific studies on silicone gel im-
plants, so women living with these devices could bring some closure to their con-
cerns. The FDA representatives said that some of the studies were too small and
that the meta-analysis was flawed. When we asked how they determined acceptable
147
risk, they refused to answer. They turned the discussion to their concern about rup-
ture, even thou^ this originally was not the focus of the recent studies. Y-NIE
knows that there is a possibility of rupture and we support continued research to
determine the actual rate so that replacement guidelines can be made. Like other
implanted devices, one's silicone implants will probably need to be replaced during
their lifetime. In our view, that is an acceptable risk and not one that should pre-
vent their availability as studies continue.
We formally requested a public statement from the Conunissioner on June 9.
Every day without an official statement encourages women to rely on information
from tabloids, talk shows and courtrooms.
Dr. Kessler voiced great concern for women living with implants as he announced
the moratorium on silicone gel implants, yet he is allowing this media and legal
frenzy to flourish by not defining acceptable endpoints to the inquiry. We believe
it is time for the FDA to bring this issue back to a sound scientijfic process. They
must establish measurable and consistent guidelines for answering questions on
risk and benefits. If they cannot do it, maybe it is time to turn the issue over to
the Institute of Medicine or other body that puts science before politics.
Some say that this debate is good because it forces the industiy to create better
products, u you were a biotech company, would you go into the implant business?
The reality is that silicone gel implants provide the easiest, most inexpensive meth-
od of breast reconstruction with some oi the best cosmetic results, yet they are no
longer a viable option for women with breast cancer. What silicone product will be
the next to go?
Mr. Shays. Thank you very much, Ms. Green.
Ms. Russano.
Ms. Russano. Thank you for allowing me to address the commit-
tee. It seems appropriate for me to be the last speaker today, for
the children have been the last on the list when it comes to the
relationship of silicone. Joining me is Tom Talcott, biomaterial ex-
pert, an ex-Dow employee.
I asked for a few extra minutes because of the children's issue
and because this is new to you, as well as many. I speak before you
representing hundreds of thousands of children, from teenagers
who were implanted with breast implants to infants born to moth-
ers with silicone and saline breast implants. I would like to show
you the snowball effect of the manufacturers' negligence in totally
discounting proper research, falsification of laboratory animal tests,
lack of manufacturing quality control, suppression of information,
and flagrant irreverence to be forthcoming with Congress and the
FDA.
My question is: Has the FDA really had sufficient funds to look
into this issue properly?
I want to point out how the medical community never recognized,
or addressed, or stood up for the effects of silicone's compositions
and derivatives used in the breast implants. There were no human
studies relating to pregnancy, breast-feeding, or documentation
during the development of a young girl's body. Misinformed, the
FDA and consumers could not make a valid decision regarding the
safety and efficacy of a breast implant.
My name is Jama Russano. I live in Northport, NY, and I've
been married for 15 years. I had a breast implant at age 14 due
to a problem at birth. I have decided not to go into my health his-
tory because I felt it would take too long, but I would like to take
the opportunity, and I would also like to show you some pictures
of what no one has discussed here today, and that is the effects,
what after having a silicone breast implant looked like.
Nobody told me that trying to take this thing out would discard
[sic] my body and millions of other women's that have had im-
148
plants. Nobody told me of the incredible cost of medical bills that
it would take. Nobody told me that I would be lying on an operat-
ing table. So I would be happy, at any point in time, to discuss that
issue with you. These are just a few samples of the disfigurement
after having implants taken out.
During my 22 years — the first implant remained in for 19
years — during my 22 years of implantation of two Dow Coming
Silastic implants, Silastic I and Silastic II, I gave birth to two
beautiful boy^, now aged 9 and 12, and I wish I nad brought them
here today. They weren't invited.
I have had 20 years of experience in sales and marketing with
various consumer product companies. Additional personal informa-
tion, as well as my health history, will be provided in written testi-
mony. I have been on both sides, to live with a deformity, to have
a perfect body, and to live with the latter, the disease. And I would
take the decision of having a nonperfect body.
My children suffer the same symptoms as I, a particularly rare
disease, esophageal motility disorder. I am fighting for their lives
as well as mine. Questioning the relationship of causation to sili-
cone breast implants and my children's health problems, I realized
there was very little information as well as very few studies an-
swering my question. Is there a correlation between the mother's
experience with silicone breast implants and miscarriages, infertil-
ity, birth defects, and childhood illnesses?
We have been scared for years, not understanding the reaction
of our disease from silicone implants. That has pushed us to go
from doctor to doctor. That has sent the junk scientists out there.
I mean, we need answers. We could have had answers many years
ago. Shouldn't the manufacturer have known how to remove a
product before they put it in?
In 1992, I felt it was vital that these questions be answered, and
I formed a not-for-profit foundation, Children Afflicted by Toxic
Substances, C.A.T.S. for short. C.A.T.S. was designed the spear-
head the evaluation and research necessary to answer the compel-
ling questions. C.A.T.S. developed a questionnaire centralizing
medical information in a data base. In 3 short years, we have
heard from 5,000 families reporting the health status of their chil-
dren.
C.A.T.S. has worked closely with Dr. Jeremiah Levine and Dr.
Norman Illowite to author the January 1994 JAMA article,
"Sclerodermalike Esophageal Disease in Children Breast-Fed by
Mothers with Silicone Breast Implants." This small study com-
pared the health of 11 implant children, 8 breast-fed and 3 bottle
fed, to that of 17 whose mothers did not have implants but who
had similar gastrointestinal complaints.
Their findmgs: 6 of the 8 breast-fed children suffered esophageal
dismotility. The continuation of this study in larger numbers shows
a consistent pattern. This study was criticized by the implant man-
ufacturers, but the fact remains that it is the only study that has
been performed on children exposed to breast implants.
The hydrocephalic shunt study, reference Lancet Journal 1992,
Volume 340, pages 510-513, also produced an immune response,
and its safety is still an issue, but the material is solid and doesn't
seem to migrate through the lymph system to other organs as sili-
149
cone and secondary chemicals in the implants. In addition to the
difference in medical necessity between women receiving a silicone
breast implant and hydrocephalic children, the difference in mate-
rial between gel and solid materials used in silicone shunts makes
any comparison between the two extremely difficult.
My question is: What happens to children who are now silicone-
sensitive, born to the exposure of an implant, that may need a
product, a silicone product, but cannot because they may have an
allergic reaction to it?
The manufacturers of silicone breast implants have had 40 years
to conduct proper studies; however, only recently did Dow Coming,
Elastic surgeons, and other breast implant manufacturers help
ind the studies of the Mayo Clinic and the Harvard study. I have
before you, and I would like to present this for documentation, a
Harvard study that was done years ago.
I would like to read — note: This is a Harvard study of 212,500
nurses and includes 6,019 who reported breast implants and is
therefore far more powerful than the nurses' study which included
1,183 of the Mayo Clinic study, with 749 implant women. In fact,
it includes more implanted women than all cohort studies that
have been done on implanted women combined. It finds a statis-
tically significant 50 percent increased risk of rheumatoid arthritis
in women with implants by 1980, but only a smaller, nonsignificant
risk associated with implants in the latter.
These are the same authors of the latest Harvard study. Why
was this study never published? Why was this study never pub-
licized?
These studies did not ask the right questions. They did not look
at the children's issue of birth defects, childhood illnesses, mis-
carriages.
Mr. Shays. Ms. Russano, I just want to have a sense of how
much more your testimony is.
Ms. Russano. A couple minutes.
Mr. Shays. OK
Ms. Russano. They did not look at the children's issue of birth
defects, childhood illnesses, miscarriages, rupture, or infertility. Re-
searchers relied on industry for research funding. This makes one
concerned that there is an impact on the results, including the
tjrpes of questions one may ask in an epidemiological study.
Studies concerning the effects of reproductive performance of the
fetus were initiated by Dow Corning in the 1960's. I won't take the
time to reference the study. I will read quickly that in this study
in the 1960's, in the rabbit and three rats employing both dermal
and subcutaneous routes of exposure, "Regarding fetal abnormali-
ties, there was a significant increase in skeletal defects following
dermal treatment with PDMS," which is a silicone compound.
In the 1970's, a small study, D-4, using a similar chemical make-
up as was used in the Silicone Silastic Gel, showed the chemicals
transcend to the placental barrier, working their way to the pitui-
tary gland, and passing the liver, kidney, and spleen. It was also
found to atrophy the reproductive organs of test animals. The same
chemical application is used as an insecticide for roaches.
The question: Were these tests repeated on new, better Silastic
II Gel, or was it assumed that the response would be the same? If
150
the manufacturers were so confident bearing children and breast-
feeding with silicone implants did not cause a problem, why was
the subject not addressed in their literature? If the implants were
such a small and unprofitable part of their business, why did they
continue to conduct business without proper studies or research, or
the real question is, is Dow Corning and Dow Chemical protecting
the thousands of patents that they hold on other silicone products?
An executive of Dow Corning recently stated, "Dew's philosophy
was to ignore the problem and it will go away." I have news for
them, we are not going away.
C.A-T.S. recently published a preliminary report of 250 mothers.
I have the report here. I would be happy to discuss the report, but
I won't go into it because of length of time. There are strong sug-
gestions from old data and new data that children may be ad-
versely affected. Dr. Levine's work and C.A.T.S.' data comprise the
largest study to be done on children of implanted mothers.
^e we giving carte blanche to the manufacturers, or is this giv-
ing them a message that their studies need to be better, that they
need to look harder? Does the FDA have as much money as they
need for this issue? I would suggest that the committee arrange to
speak with women on both sides of the issue to fully understand
the effects. How can we ask individuals to pay the price of science
if there is no health reform in place?
Every day questions are being asked of the medical community,
mostly consisting of plastic surgeons, pediatricians, lactation spe-
cialists, and La Leche league. Is it safe to have a baby and breast-
feed? Today this "yes" is used freely, and there is still no docu-
mentation by the Pediatric Society or the manufacturers. They do
not acknowledge that there have not been proper tests on child-
bearing or breast-feeding.
The medical community based this information on pure hearsay,
fueled by an erroneous endorsement of the manufacturer's sales
representative who quoted a report which was admittedly fictitious.
The Human Milk Banking Association, a not-for-profit organization
that administers breast milk banks to U.S. hospitals, now screens
for women with implants. They have issued a directive, in March
1994, that stated, "Mothers with silicone breast implants will not
be accepted as donors." A Tylenol bottle has more information per-
taining to breast-feeding and pregnancy than the package insert of
a breast implant.
[The prepared statement of Ms. Russano follows:]
Prepared Statement of Jama Kim Russano, Children Afflicted by Toxic
Substances
Dear Subcommittee Members, Thank you for allowing me to address the commit-
tee. It seems appropriate for me to be the last speaker today, for the children have
been the last on the list when it comes to the relationship of silicone.
I speak before you; representing hundreds of thousands of children froin teenagers
who were implanted with breast implants to infants bom to mothers with silicone
and saline breast implants. I would like to show you the snowball effect of the man-
ufacture's negligence in totally discounting proper research; falsification of labora-
tory animal tests; lack of manufacturing quality control; suppression of information
and a flagrant irreverence to be forthcoming with Congress and the FDA. I want
to point out how the medical community never recognized or addressed the effects
of silicone's composition and derivatives used in breast implants. There were no
human studies relating to pregnancy, breast feeding or documentation during the
151
development of a young girls body. Misinformed, the FDA and consumers could not
make a valid decision regarding safety and efficiency of the breast implants.
My name is Jama Kim Russano. I live In Northport, NY, and have been married
for 15 years. I had a breast implant at age 14. During my 22 years of implantation
of 2 Dow Coming implants, Silastic I and Silastic II, I gave birth to 2 beautiful boys,
now ages 9 & 12. I have had 20 years of experience in sales and marketing with
various consumer product companies. Additional personal information as well as my
health history is provided in written testimony.
My children suffer some of the same symptoms as I, particularly a rare disease.
Esophageal Dismotility. Questioning the relationship of causation to my silicone
breast implant and my children's health problems, I realized there was very little
information as well as very few studies answering my question, "Is there a correla-
tion between the mother's experience with silicone breast implants, miscarriages, in-
fertility, birth defects and childhood illnesses?"
In 1992, I felt it was vital these questions be answered and I founded a not-for-
grofit foundation. Children Afflicted by Toxic Substances (CA.T.S. for short).
iA.T.S. was designed to spearhead the evaluation and research necessary to an-
swer these compelling questions. C.A.T.S. developed a questionnaire, centralizing
medical information in a database. In three short years we have heard from 5,000
families reporting the health status of their children.
Our research has assisted Dr. Jeramiah Levine and Dr. Norman Dlowite to author
the January 19, 1994. JAMA article, "Sclerodermalike Esophageal Disease in Chil-
dren Breast Fed by Mothers with Silicone Breast Implants . This small study com-
pared the health of 11 "implant" children (8 breast-fed, 3 bottle-fed) to that of 17
children whose mothers did not have implants, but who had similar gastrointestinal
complaints. Their findings?: 6 of the 8 breast-fed children sufTered esophageal
dysmotility. The continuation of this study in larger numbers shows a consistent
pattern.
This study was criticized by the implant manufacturers. But the fact remains that
it is the only study that has been performed on children exposed to breast implants.
The Hydrocephalic Shunt study, reference Lancet Journal — 1992, Volume 340, pes.
510-613, also produced an immune response and its safety is still an issue. But the
material is "Solid" and does not seem to migrate through the lymph system to other
organs as the silicone and secondary chemicals in breast implants. In addition to
the difference in medical necessity between women receiving a silicone breast im-
plant and children Hydrocephalic, the difference in material between gel and the
solid material used in silicone shunts makes any comparison between the two ex-
tremely difficult.
The manufacturers of silicone and breast implants have had 40 years to conduct
proper studies. However, only recently did Dow Coming, Plastic Surgeons, and
other Breast Implants manufactures helped fund studies from the Mayo Clinic and
Harvard. Those studies did not ask the right questions. They did not look at the
children's issue of birth defects, childhood illness, miscarriages, ruptures or infertil-
ity. Researcher's rely on industry for research funding. This makes one concerned
that there is an impact on the results, including the type, of questions' one may ask
in an epidemiological study.
Studies concerning effects on reproductive performance and the fetus were initi-
ated by Dow Coming in the 1960*8. I reference Dow Coming Wright Silastic Gel Sa-
line Mammary Implant H.P. and Silastic MSI Gel Saline Mammary Implant H.P.
PreMarket Approval Application for the record. Teratology tests of PDMS include
four studies in the rabbit and three in the rat employing do th dermal and subcuta-
neous routes of exposure. "Regarding fetal abnormalities, there was a significant in-
cretise in skeletal defects following dermal treatment with PDMS".
In the 70's, a study using a similar chemical make up as Silicone Silastic Gel
showed the chemicals transcended the placental barrier, working their way to the
pituitary gland and passing the liver, kidney and spleen. It has also been found to
atrophy the reproductive organs of test animals. The same chemical application is
used as an insecticide for roaches.
The question. Were these tests repeated on the "new, better Silastic II Gel, or was
it assumed that the response would be the same? If the manufactures were so con-
fident bearing children and breast feeding with silicone implants did not cause prob-
lems, why was the subject not addressed in their literature? If breast implants was
such a small and unprofitable part of their business, why did they continue to con-
duct business without proper studies or research? Are Dow Coming and Dow Chem-
ical protecting over 1,000 or more patents they hold on other silicone products? An
executive of Dow Coming recently stated "Dow's philosophy was to ignore the prob-
lem and it will go away". I have news for them; we are not going away!
152
CA.TS. recently published a preliminary report of 250 mothers with silicone im-
Elants and the health of 151 children bom before and the health of 362 children
om after implantation. There is a significant pattern of complaints with children
that are breast-fed over bottle-fed. Children that are bom to mothers with an im-
plant of 5-6 years or older (at the time of birth) are displaying more symptoms.
There are strong suggestions from the old data and new data that children may be
adversely affected. Dr. Levine's work and CA.T.S. data comprise the largest study
to be done on the children of implanted mothers.
Every day, questions are being asked of the Medical Community, mostly consist-
ing of Plastic Surgeons, Pediatricians, Lactation Specialist and Le Leche League, "Is
it safe to have a baby and to breast feed?" Today this "YES" is used freely, and still
there is no documentation by the Pediatric Society of the Manufactures. TTiey do not
acknowledge that there have not been proper tests on childbearing or breast feeding.
The medical conmiunity based this information on pure "hearsay", fueled by an erro-
neous endorsement of the manufactures sales representatives who quoted a report
which was admittedly fictitious. The Human Milk Banking Association, a nonprofit
organization that administers breast milk banks to US Hospitals, now screens for
women with implants. They issued a directive in March 1994 that stated, "Mothers
with silicone breast implants will not be accepted as donors." A Tylenol bottle has
more information pertaining to breast feeding and pregnancy than the package in-
sert of a breast implant.
Unfortunately, as a non-profit organization, we rely totally on donations. Since we
are contra to manufactures, there is no source of their funds. In addition, research
we attempt may be considered biased as we are a benefited party. However, WHO
is going to fund the research and collect the data to fully understand the effects if
these products to insure future generations be bom healthy and that Government
and Taxpayers are not burdened with their medical costs.
Women and children rely on the safety and fair treatment of elected officials. Our
laws serve as a bulwark protecting the weaker against the stronger and promoting
the common good (in this case the health and safety of all Americans) against those
who would sacrifice it to their quest for personal and corporate gain. We work hard
for a decent living and rely on our system of laws and justice to protect ourselves
and our children from unsafe products, corporate greed and dishonesty.
Due to the Bankruptcy of Dow Coming and the lengthy time it will take for
women and children to get needed medical care, we ask this subconmiittee to
strongly consider issuing immediate emergency funding for research programs relat-
ing to this issue as well as an explant fund that is so desperately needed.
I would be happy to expand on the numerous topics at hand today and I would
like to thank you for your valuable time expression of concerns for women and chil-
dren.
Children Afflicted by Toxic Substances Research Study Program
clinical history vl\ questionnaire
Methods
Randomly Selected (n=250)
Children bom to mothers before implants (n=151)
Children bom to mothers with breast implants (n=352)
Background
DOCUMENTED DISEASES IN WOMEN WITH SILICONE IMPLANTS
Possible second generation affects
• Incidence of associated diseases
• Disease patterns in affected children
• Specific type of implant
153
V
Results — Women: n=250 Average Age=37
Gel
Polyuretliaiie Ooubl* Lumen
Type of implant:
Health of women:
Fair
Poor
Miscarriages
64%
9%
27%
11.5 yrs
3 yrs
7 yrs
27%
16%
18%
23%
29%
32%
50%
55%
50%
28%
2%
2%
Results — Children Bom Before Implant (n=151)
Health
Sllicane Gel
Polyuretliane
Double Uirnen
Fair
84%
16
91%
9
0
76%
24
Poor
0
0
Most frequent diagnosis: ear infections, allerjies, asthma.
Results — Children Bom After Implants (n=352)
Age: &-10 Years
Age of Implant at Birth: 5-6 Years
Gel
Polyurelhane Double Lumen
Method of feeding:
Breast fed ...
Bottle fed ....
Health:
Fair
Poor
65%
64%
78%
35
36
22
23
39
52
33
18
30
44
43
18
Results — Specific Symptoms
Symptoms Gel Polyureltiane Double Lumen
Gastrointestinal:
Abdominal pain 81% 61% 51%
Esophageal 41 36 9
Rheumatologic 35 25 24
Siaa 49 28 7
Fatigue 6 Weakness 53 43 27
Renal 4 0 0
Lymphadenopathy 25 32 17
Rashes 34 21 17
Most common complaints: Allergies, Upper Respiratory Inlections, Abnormal bone growth, muscle weakness, Leukemia, Precocious puberty.
81% of chiUren bom to Silicone implants are reporting symptoms.
47% of chiWren bom to Double Luman are reporting symptoms.
50% of chiUren born to Polyurelhane are reporting symptoms.
CONCLUSIONS — MORE STUDIES ARE NEEDED
Motility Disorder:
Abdominal pain
Esophageal symptoms
Neurologic:
Are children's fatigue/weakness due to neuropathies? How does ADD fit in?
Rheumatologic:
Are children following the same pattern as the mothers?
(
154
Renal:
Stenosis of urethra & frequent bladder infections are common in boys.
Rasfies:
Rashes come and go. Are children displaying an allergic reaction?
Mr. Shays. Thank you very much.
I'm somewhat in a quandary on how to proceed, because not only
do we have pros and cons, but we have people who have very per-
sonal experiences, and we have experts who have spent their lives
studying these issues.
I guess I would like to start out — Dr. Sergent, you started in the
beginning. I would like you, if you wouldn't mind, to just comment
on some of the testimony you have heard that followed you and
your kind of reaction with the different testimony that you heard.
Dr. Sergent. With regard to the last comment, the Harvard
study that was referred to, that was a preliminary report, and it
was not 200,000 patients; it was 200,000 person-years. A person-
year is determined by taking the number of people in the study
and multipljdng it by the number of years that they have been fol-
lowed.
The final Harvard study had well over 1 million person-years,
and it clearly showed no — as a matter of fact, the patients with im-
plants had a slightly decreased incidence of rheumatoid arthritis,
although not statistically different, and nobody would make any-
thing of it. But that was a preliminary report, and it is certainly
not the complete data.
With regard to the doctor at my lefl, I would say that I'm very
disturbed by people who make no effort to try to look at the global
picture. There's no question that women are sick. There's no ques-
tion that women with implants have rheumatic diseases. The issue
is, are these diseases occurring at an increased frequency?
With regard to the so-called new disease that he spoke of, I
would say that both the Mayo Clinic study, the study from Har-
vard, £ina the very interesting study from the University of South
Florida all looked at a variety of musculoskeletal symptoms, and
they were looking at it specifically to see if some new disease that
was nondefined might be appearing in this population. And in all
of those studies the answer was, no, there is no new disease ap-
pearing in the breast implant population.
Mr. Shays. Dr. Shanklin, I feel like, in a way, it's a description
of the economists, the lefl and the right. I was hoping that all of
you would solve our problem here, but you obviously have much
disagreement. Bottom line: How did you get into this issue, and
what has given you such an impetus to proceed the way you are
proceeding? Because I get the sense that you are not in the main-
stream.
Dr. Shanklin. Well, I don't know. I may be the future.
Mr. Shays. Well, the mainstream isn't necessarily the future.
Dr. Shanklesi. Well, I don't know about that. I'm a pathologist.
I look at the tissues when they come out. I performed an autopsy
on a woman who died of direct complications of her implants. I
know of eight other similar deaths. The FDA has records of some
sort on 52 deaths. They have not even shared the details of these
with the medical profession in summary or specific form. I would
155
like very much to know what they have. I don't even know if they
have in their records the ones that I have.
There is a cellular toxicity and a tissue toxicity of silicone. That
has been shown clearly. There have been deaths which have fol-
lowed directly upon injection of silicone into the body. That's why
silicone injections were banned a long time ago, and they are
against the law in cer£ain States because of the inherent danger of
that.
There is very little difference, in terms of the toxic load in the
body, between something that is injected by a syringe and that
which comes there because a device ruptures. As a matter of fact,
you get a lot more of it in the body when a device ruptures. We're
talking about, oh, say, two average sized implants, if they both rup-
ture in a woman, we're talking about 1 pound of silicone gel that
is released into her body. And the body does respond to it. It re-
sponds to it when it bleeds out of the envelope.
Mr. Shays. Let me ask you, if this is a man-made device and
man-made material, how do you find out what will happen in the
fiiture. Obviously, in this case, this device was already in people's
bodies, and we can go backwards.
Dr. Shankun. Yes.
Mr. Shays. But, in general, any man-made device, my challenge
is, how would you know the effect 50 years from now or 40? I
mean, it seems to me then you would basically put an end to every
type of device development.
Dr. Shanklin. Well, the point is well-taken, Mr. Chairman.
There is an imponderability over that period of time. As a con-
sequence of that imponderability, a variety of animal research has
to be done, on a broad enough scale, over a long enough time to
give an indication relative to life span of given animals.
The amount of work that was done and published in the medical
literature up until, roughly, 1980 was rather minuscule. There was
a lot of work done by industry which they never brought to the
public light, which has come to our awareness only because of liti-
gation.
It's a long-term problem. The consequences over time are difficult
to estimate, I grant you.
Mr. Shays. Are you involved in any litigation yourself?
Dr. Shanklin. I have been in the past. I have nothing active at
the moment. I have one case in mediation; I don't really know
what's happening to it.
Mr. Shays. Dr. Gabriel, you speak with a tremendous sense of
confidence in your study and the results of it, and you're sharing
your study. How would you transfer your study into other areas?
Does this lead you to just have total confidence in silicone not
being a problem, or does it just lead you to believe that your study
shows in this instance?
Dr. Gabriel. I think my confidence stems from looking at all of
the data, not just my study. I have a lot of confidence in our meth-
ods and the way we did the study, and I stand behind that. But
the confidence that I expressed was due to the totality of the data
of the controlled studies, and I think that's reallv the most impres-
sive thing is that all of the well-done, controlled, epidemiologic
156
studies done tx) date are all negative. And that's what has im-
pressed me.
Mr. Shays. So it's not just your study, but when you continue to
look at other studies, you get reinforced with your position.
Dr. Gabriel. Right. Exactly. All the case control and cohort stud-
ies.
Mr. Shays. Dr. Connell, you have been involved in this process,
and I was intrigued by trjang to figure out your position until the
end. And your position is that it should be resolved. Do you have
the same confidence level that Dr. Gabriel has?
Dr. Connell. I do. I have thought so often, in recent years I
wish we had had her data when we were meeting in November
1991 and February 1992. As John Sergent pointed out, we antici-
pated, when I returned and he joined us in 1992, that we were
going to see a lot of very negative, very dangerous information
forthcoming. We were, I think, all of us, quite disappointed — actu-
ally, rather delighted that this was simply not the case.
I think it's critical to look at then and at now. At that point, we
made judgments based on anecdotal information and case reports.
Today would be very different.
Mr. Shays. If I could interrupt, the point is that you made a de-
cision earlier on, and it has been reinforced, as well, by the studies.
Dr. Connell. We've been absolutely delighted to see these stud-
ies come out because they answered many of the questions that we
had. And we felt very discomforted that we couldn't answer them
at that time. That's the reason we said there's a public health need,
that women get them with informed consent, and let's get some an-
swers.
Mr. Shays. My only regret in this hearing is that we've had no
votes, because, if we had, I would have loved to have taken Tara
on the floor of the House. I can do that if she's my daughter, and
I would have adopted her for a short period of time. But evidently
we won't have a vote before you all leave.
I'm just interested to know if you have any additional comment
based on other points that were made, or if Tara does, before you
all catch your plane, which you have rescheduled.
Mrs. Ransom. We had to, yes. Basically, I think that everyone
needs to remember that there are two types of implants. One type
goes into a nonhealthy body. It controls the problem, much like an
insulin, has its own problems, maybe, maybe not. But you are
weighing one direction against another. In Tara's case, it's very
simple: life or death.
The other thing is when you choose to put an implant into a
healthy body. What does an oyster do to a seed of sand? It makes
a pearl. Bodies are not designed — they are very hostile environ-
ments, basically — they are not designed to have implants. It's going
to fight against it. Somebody may have a problem. I'm not saying
that they do or they don't. I don't know. I'm not a scientist. But
what I ao know is that for some people it is the only alternative.
You can learn to deal with the problem if you get to tomorrow, but
that's what we need to do.
Mr. Shays. We're going to continue with other questioners. I'm
going to go to Mr. Barrett. I just need to say that if any witness
157
does need to leave, obviously, you are free to. I don't want you to
all get up and leave, but we will be going on a little bit more.
Mrs. Ransom. I think I will let Tara go back to the room.
Mr. Shays. I sure understand that.
Mrs. Ransom. Thank you. Did anyone have a question for her be-
fore she left?
Mr. Shays. Yes. Let me just say to any Member who would like
to ask Tara a question or her mother, let's do that, and then I will
come right back to you.
Mr. Barrett.
Mrs. Ransom. I can stay. It's just Tara.
Mr. McIntosh. Mr. Chairman, no question, but just a comment.
Thank you very much for coming today.
Mr. Barrett. I'd like to know from Tara who her favorite char-
acter is in Wizard of Oz?
Mr. Shays. That is a very good question.
Mrs. Ransom. Who's your favorite character? Tell him.
Mr. Shays. You have to answer a Member of Congress.
Mr. Barrett. Who's your favorite?
Mr. Shays. Maybe the question is, do you have a favorite?
Mrs. Ransom. She has to think. It's all the books.
Mr. Shays. You're just convincing me that you're a young lady
who's 8 years old.
Mrs. Ransom. Dorothy.
Mr. Barrett. Thank you very much.
Mrs. Ransom. She brought a rabbit with her that has a little
gingham dress. Tara doesn't want to write her story, but Dorothy
Rabbit is going to write her story about going to Congress.
Mr. Barrett. That sounds very good.
Mr. Shays. I would love to see that story if you would send it
to me. Thank you very much.
Mrs. Ransom. We'll try.
Mr. Shays. Thank you very much, Tara.
I'm going to ask Mr. Barrett, you have questions, and you can
ask any the other witnesses who their favorite ones are, too.
Mr. Barrett. Ms. Green, I was interested in a comment that you
made sort of at the tail of your testimony, when you talked about
what appeared to be your disagreement with the FDA in terms of
the effectiveness of the trial mechanism they have for women to re-
ceive implants. If you could comment on that further.
Ms. Green. Right. Well, the trials are restrictive in some regard.
First of all, a woman's doctor has to indicate that this would be the
very best implant for her, so she can't be a candidate for saline or
some of the other method, and that she would need the silicone to
get the best result. So there is a restriction there.
Second, you have to go to a doctor who is part of the trials. And
people who are part of HMO's and I believe some of the military
gproups do not have a plastic surgeon who is part of the trial. So,
therefore, a woman would not have access to them.
Our own medical advisors, several who are plastic surgeons, have
told me most of them, even though they prefer the silicone implant,
are using saline just because of the difficulty in guaranteeing
whether a woman can get a replacement down the road or that her
158
hospital is concerned on using silicone implants because of the cli-
mate in the legal system.
So they really aren't as available. And besides, just the overall
media frenzy, you know, adds that little bit of doubt.
Mr. Barrett. OK
Ms. Green. And also — one thing I forgot — ^that basically they are
not going to be available. I think there are enough to complete
some of the trials now, but if there are no manufacturers in the
business — they are not open-ended studies. As soon as the product
is gone, so are the studies.
Mr. Barrett. OK, Ms. Ransom, have you had difficulty in get-
ting the shunts for Tara? I understand, obviously, where your con-
cern lies,
Mrs. Ransom. Not yet. Tara's last surgeries were when she was
3V2. She's 8 now. Ajid extended life on a shunt is somewhere
around 8 years. They fail because of growth. They fail because the
brain tissue invades them. I've got one in my purse, if you'd like
to see it later, that literally the brain tissue invaded the end of it.
And they can fail because of illness. They have to be removed be-
cause they cannot guarantee that the illness will not travel up the
shunt right into the brain.
Mr. Barrett. What is your understanding now? If you had to
have the operation now, would it be available?
Mrs. Ransom. My understanding now comes from working with
trying to contact Congress and also going direct to the manufactur-
ers, and basically, as long as Dow Coming can sell the silicone,
then we're OK If that bankruptcy judge sitting there now with the
case says no, we could be in some real trouble.
Mr. Barrett. OK
Mrs. Ransom. I want the reassurance that whenever, whether 1
year, 5 years, or 25 years from now that Tara needs to go to the
Hospital, there will be an available medical technology that works
as well as the shunt. Now, maybe it will be something new. That's
our hope for her, because surgery itself has complications, anesthe-
sias, things like that.
We realize this is not — if I had my wish right now, it would be
never to have heard of hydrocephalus and the shunt. But barring
that, we have to deal with the fact that I need the knowledge, and
I don't have that comfort level yet.
Mr. Barrett. OK
Mrs. Ransom. A year ago I did. Now I do not.
Mr. Barrett. Dr. Shanklin, you obviously hold some strong opin-
ions on the safety issue here. How do you respond to Ms. Ransom?
How should we be dealing with that issue? Do you view that issue
differently from the silicone breast implant?
Dr. Shanklin. Well, first of all. Congressman, let me say that my
opinion has evolved over the 10 years I've been studying this prob-
lem as a physician. Initially, I saw some very interesting and chal-
lenging things in tissue and went to the literature to see what this
was all about. And I found, in 1986, there were already about 100
papers on the subject. There's now over 400.
I asked myself questions: Are we evolving a data base, published
data base, that correlates, that gives us an answer? In my judg-
ment, over this period of time, yes. There's been a lot of isolated
159
reports which are not correlated, but the basic thing coming up
from the basic science laboratories, particularly in immunology, is
now fairly clear.
There is a profound reaction which is self-perpetuating, which
produces granulomas, since the stuff migrates all over the body —
we know tnat for a fact, both in animals and humans. This is going
to happen anywhere. And then it becomes a matter not of whether
an adverse reaction occurs but in how many of the people who have
these implants?
Our current figures, in Memphis, 90 percent of the women with
silicone gel implants have positive T-cell memory tests. Not all of
them are equally symptomatic; that will happen in time. We also
have studied something about the way it changes over time as
things happen to the women.
Mr. Barrett. But do you have the same concerns about the
shunt?
Dr. Shanklin. No, I do not. I have no problem with the shunt;
I said that.
Mr. Barrett. OK. My question then is, how do we ensure that
products such as the shunt stay on the market when, at the same
time, whether it's the litigation pressure or it's pressure from the
FDA, or wherever it's coming from, is making the suppliers of it
less likely to want to keep that product on the market? What
should we be doing to make sure that the shunt stays in existence?
Dr. Shanklin. The figure was given of 50,000 hydrocephalics
with shunts in place. I don't know where that number comes from,
but let's take it for purposes of discussion.
Mr. Barrett. Fine.
Dr. Shanklin. That's a pretty good sized market. Maybe it comes
under the orphan drug concept that it should be encouraged. I
mean, we have to have a little common sense here. That's a pri-
marily therapeutic method for a very particular problem. Some of
the other uses of silicone devices may not be primarj^ therapeutic.
They may be secondary therapeutic or nontherapeutic but useful.
Mr. Barrett. So you would draw that distinction, then, between
primaiy therapeutic and secondarv?
Dr. Shanklin. Absolutely. Absolutely.
Mr. Barrett. All right. I think my time has expired.
Thank you, Mr. Chairman.
Mr. Shays. Gentlemen, the chairman is recognized.
Mr. MclNTOSH. Thank you, Mr. Chairman.
My first question is for Sharon Green, and I was wondering if
you could share with us what Y-ME's view of the fact that breast
implants are available for cancer survivors and reconstructive sur-
gery but not for cosmetic purposes, do you think that's an appro-
priate difference to be made?
Ms. Green. That was a question we struggled with quite a bit,
and actually we felt it was rather outlandish of us to have an opin-
ion for one group of people that we didn't hold with someone else.
So our opinion is that they should be available to anybody who
wants them and feels that they need them.
So we really don't distinguish between people with cancer and
those without, because some of the needs that the women who
don't have cancer have for these devices have been very compelling,
160
and I would be, I think, overstepping my line if I put my morals
and my opinion on those people.
And I would like to point a concern out about the clinical trials
and the studies. By eliminating women who don't have cancer, we
really are compromising the studies in some way. Here we are,
only looking at these diseases in people whose immunological sys-
tem has already been upset by cancer. So if we're getting relatively
good results from this group, I suppose we can say that it would
e even probably better for the augmentation patient. But it really
is an unfair study.
Mr. McIntosh. Thank you. I appreciate that.
Let me also ask Dr. Gabriel, is it common practice, when these
studies are being done, that financing for them comes from outside
sources, including sometimes companies that may end up manufac-
turing the product or components in it?
Dr. Gabriel. It's not unusual.
Mr. McIntosh. And does that, in your experience, compromise
the integrity of the science?
Dr. Gabriel. It depends on the institution, and it depends on the
funding agency. In this case, at least in my case, the funding agen-
cy had specific guidelines set out which tney followed, in terms of
how the proposals were evaluated and how tne studies were funded
and what kind of interaction there should be. Likewise, my institu-
tion has very similar restrictions put on those relationships.
Mr. McIntosh. So when there are safeguards like those present,
then we can be assured of the integrity of the study?
Dr. Gabriel. I believe so.
Mr. McIntosh. Do the other doctors share that perspective?
Dr. Shanklin. Yes. May I add also that the plastic surgeons,
many of whom I know by their first names, are actually desirous
of determining what's going on here, because it obviously has an
influence upon their future practice.
Dr. Connell. I think it's important to point out, as was said ear-
lier, most of the drugs and devices that we currently have available
came through this particular route. And I think we have all been
investigators looking at drugs and devices, and I think it is a mis-
understanding and actually a little insulting to investigators to im-
pugn their honesty simply because it's accepted practice to inves-
tigate drugs and devices not only within NIH money but with phar-
maceutical, foundation money, and others.
Mr. McIntosh. You have to pay for it somehow.
Dr. Connell. I don't believe anv decent investigator is ever in-
fluenced by the source of the funds. They are influenced by what
they find.
Ms. RUSSANO. I'd like to say something. I think that it's not the
fact that the companies are giving these institutions money, be-
cause we know that basically that is one way that the institutions
function. I would like to present to the committee tomorrow a stack
of all of the foundation money that was given to the institutions
across the country and show, basically, how long this was re-
searched and that fact that why is it, now that the implants are
in litigation, why is it now coming out?
Why hadn't this information come out far before? That's the real
question here. It's not that the — ^you know — and the problem is, do
161
the lawyers come up to the step of the manufacturers and also do
their studies? Is that ethical? Are we all on the same playing field
here?
We are in a disaster situation. You're going to end up with hun-
dreds of thousands of women with the problem and hundreds of
thousands of kids. How do we work this out?
Mr. McIntosh. Let me ask you a slightly different question, Ms.
Russano. If all of this information is made available to patients,
and they nonetheless decide they want to go forward, either be-
cause they are suffering from disease or for cosmetic reasons, to
have these types of implants, should we allow that, or should we
make a decision that perhaps, as the government, we know better
than they do and not allow them to make that choice?
Ms. Russano. Well, I think that, first of all, like formaldehyde
and other toxic products we have found over the years, silicone
may fall into that category, and that is yet to be aetermined. So
it's basically like I've spoken to many, many women who have said,
if only the doctor, when I asked him the question, told me that I
could have a problem with breast feeding, if only I had the facts
then, could I make an informed decision?
So I think that, as I said before, in yoimg bodies this wasn't doc-
umented, in children this wasn't documented, so, as Dr. Kessler
stated, there are so many questions that are left unanswered, it's
almost impossible. My quest is — ^you know, you want an answer,
well, let's get the funding to get an answer. Let's call it disaster
relief and get the funding.
Mr. McIntosh. Or let's give people the information that we have.
Mrs. Ransom. Mr. Mcintosh.
Mr. McIntosh. Thank you.
Ms. GoLDRlCH. I'd like to add to what Jama just said, in the
sense that whatever science is coming forward now replicates the
original fraud, what do we do about that?
Mr. McIntosh. I'm not sure I followed your statement.
Ms. GoLDRlCH. In my comments — I don't know whether you were
here — I presented the fact that Dow Coming was found guilty of
fraud in their basic science. One of the studies that they did was
a seven-dog study. When it wasn't coming out so great, they killed
off two of the dogs; it became the five-dog study.
Mr. McIntosh. Ms. Goldrich, my real question is, where do we
go forward for people who may want to make these choices for
themselves?
Ms. Goldrich. And I'm suggesting to you that, if we're going to
rely on the studies we even have now, how can we go forward? Be-
cause all of the scientific studies that are being done now replicate
the original fraud. We've lost this battle. There s no way to proceed.
Yes, a woman should have a choice. Everybody should have a
choice to have this product because it's been made available for far
too long. But with that choice comes a responsibility of partially
the government, certainly the manufacturers, to pay lor wnat they
have done.
Mr. McIntosh. Let me wrap up on this. Especially from the ear-
lier testimony with Dr. Kessler, I think we're seeing an instance of
what I refer to as the bureaucratic imperative, where mistakes, I
think, were made earlier, in the 1991 timeframe, and the agency
162
doesn't want to pull back from that and finds it difficult to be able
to be appearing to reverse themselves, even though, in fact, what
we have is a situation where new and more data is available. And
I particularly appreciated Dr. Connell's testimony urging that we
do that.
I think there are some important things that came out in this
hearing. We do know, based on what Dr. Kessler said, that there's
no increased risk of most autoimmune or connective tissue dis-
eases, that we can't rule out entirely a small increase of risk of
very rare diseases like scleroderma, diseases that, in fact, are very
rare and hard to even study.
And I think that's something that we need to make available to
the public at large, because most of us don't have access to these
studies. Most of us don't read the New England Journal of Medi-
cine. Most of us couldn't understand it if we did read it. And I
think it's important for the agency to move forward in clarifying
the state of knowledge.
So I think Dr. Connell's point is one well-taken. But we also need
to point out that there are continued risks to society by failing to
act, because will we have a danger that companies won't offer the
product for Tara and other children? Will women continue to avoid
treatment because they are not certain that they will be able to
have reconstructive surgery? I think those are important risks for
the agency and all of us to also talk about and put onto the public
record so that we can have a balanced discussion of this.
Mr. Chairman, I, unfortunately, have to leave to a leadership
meeting, but I will try to ^et back for the next panel. I want to
again commend you for havmg this hearing and putting forward all
of this information.
Mr. Shays. It will be probably the first of a few. I thank the gen-
tleman.
We're going to finish up with this panel with Mr. Gutknecht and
Mrs. Morella, and then we're going to get on with the other one.
We may have a vote at 4, and it might be nice if we can try to con-
clude everything. If not, the fourth panel has waited, and they will
have their day. So we'll see what happens.
Mr. Gutknecht. Thank you, Mr. Chairman. After that admon-
ishment I maybe shouldn't ask a question.
Mr. Shays. No, you ask your question. We have eight panelists
here who have waited a long time.
Mr. Gutknecht. And let me also say that we appreciate not only
the assembly and the patience of the people who are here.
Mr. Shays. Ask your questions.
Mr. Gutknecht. But I did want to ask, and maybe. Dr. Gabriel,
you're the correct person, maybe not, it has been said that a little
knowledge can be a dangerous thing, and maybe this is a little
knowledge. But could you talk a little bit about what I think is
called the herd factor; do you know what I'm talking about?
Dr. Gabriel. No, I do not.
Mr. Gutknecht. OK. It's my understanding that if a certain pop-
ulation of people — well. Dr. Shanklin, maybe you can respond to
that.
Dr. Shanklin. You said "hurt"?
Mr. Gutknecht. Herd.
163
Dr. Gabriel. Herd immunity; is that what you're referring to?
Dr. Shanklin. Oh, herd.
Mr. GuTKNECHT. Yes. H-e-r-d.
Dr. Shanklin. Yes. Well, there's an old saying that if you're
going to behave foolishly, go in a crowd.
Mr. GuTKNECHT. No, the question, though, that I'm asking is, if
a certain population of cattle are exposed to a certain disease, there
will be some that won't get it. OK I mean, for biological reasons.
Dr. Shanklin. That's correct.
Mr. GUTKNECHT. In this whole issue, it's one of the frustrating
things, because obviously some people may experience some nega-
tive reactions to certain things, but at what point do you say, gee,
you know, maybe that's just tne way it is.
Dr. Shanklin. Maybe just them. Maybe it runs in the family.
That's the kind of thing.
Mr. GUTKNECHT. Right.
Dr. Shanklin. There are people who are especially sensitive to
certain things which excite the formation of bronchial asthma. Sta-
tus asthmaticus can be a fatal disease. I know of one clear-cut case
of a women who developed fatal status asthmaticus relative to im-
plant use. I know of another where, after a quiescent period, im-
plants were put in because they thought "she had grown out of
childhood asthma." She developed immediate severe asthma, and to
the physicians' credit, they took the implants out within 2 weeks,
and she was back to normal.
That's an example of a special kind of situation. I suggested to
the FDA in 1989 that they consider allergic history as part of their
clinical indications for use. Nothing came of that suggestion.
But you're quite right, there are some things to which we all are
relatively resistant, for one reason or another, often not under-
stand. Triat's what herd immunity means or herd behavior, basi-
cally.
Mr. GUTKNECHT. Well, the reason I raise the point — and I said
that a little knowledge can be a dangerous thing — it's almost like,
with this issue, almost too much knowledge, too much information
can be dangerous, too. Because it seems like we've had study after
study and all this information piled onto more information and
more studies, and all it does is raise more questions. You know, at
some point, we do have to make decisions and move forward. And
that's the concern I have.
I do want to particularly thank the two ladies from Arizona for
coming out.
And that really does get to my basic principal concern, and that
is that the way we've constructed the FDA and the way it seems
to be working today is that we're going to see fewer and fewer new
technologies and new products and new cures and new answers
coming onto the market because we've literallv said that before you
can leave home, you have to make certain that all the lights are
green. And I'm not certain we can ever reach that point.
This whole hearing has raised an awful lot more questions, in my
own mind, as far as breast implants.
Dr. Connell, did you want to say something?
Dr. Connell. Yes, I'd like to address this issue as a long-time
researcher. There have been many, many studies, most recently
164
iust one reported by Tufls, you may be familiar with, commissioned
by one of the Federal agencies, pointing out — and I think we've all
seen this — ^how many American companies are moving out.
I see this particularly as an obstetrician/gynecologist in the
health care of women. We have lost the battle. We are a Third
World country in terms of medical product development. To me, it's
very distressmg after working in this for many, many years to find
that we are no longer the leaders. Our companies are going to Eu-
rope. They are developing products, and the likelihood of Ameri-
cans, particularly American women, having the advantage of these
products I think is increasingly remote.
This, to me, is a most distressing situation from many, many
points of view.
Mr. GUTKNECHT. That gets back to my concern. The founder of
one of the — the fellow who developed the first pacemaker, in the
State of Minnesota — I think it was the first one; I believe it was
the first one — he was quoted in the paper last year as saying that
if he had to start over again, he would not start the company in
the United States of America.
Dr. CoNNELL. I read that, and he's, I think, representative of
many, many conipanies and many, many scientists, sadly.
Dr. Sergent. Congressman, may I make a comment?
Mr. GuTKNECHT. Sure.
Dr. Sergent. I simply can't let this comment about asthma go
unchallenged. We've now heard another disease that is being
brought up exactly in the same anecdotal manner that all the oth-
ers have been. There's absolutely no scientific proof that silicone
breast implants cause asthma. Surgery itself can induce asthma.
And the fact that Dr. Shanklin knows a case of a patient who de-
veloped asthma after surgery is certainly no indication that asthma
was caused by that implant.
Dr. Shanklin, I didn't say it caused it. It may have aggravated
the condition.
Dr. Sergent. I think you did say it caused it.
Dr. Shanklin. We need to know about these things. Excuse the
exception.
One of the problems of the cacophony of reports, in my judgment
and professional experience, is that we're asking the wrong ques-
tions. Basic science is now demonstrating the mechanisms which
occur when the body responds to silicone and silica. We know, for
example, that it's an interleukin-2 receptor of a lymphocyte which
is stimulated. We know that for a fact. We have studied that in
many ways, and so have other people.
Once we have the basic information about the mechanism, how
the body responds to this stuff, then field surveys can be directed
at the proper questioning, in my opinion, to answer some of these
broader policy matters. What is the risk at large? I don't think we
have been looking at it yet from quite the right point of view.
Thank you.
Ms. GOLDRICH, I wanted to say something about what we're
going to do now that we're a Third World country as far as medical
devices are concerned. Perhaps we've behaved in a Third World
way, and that is not to have done the science up front. It seems
to me that when the U.S. Government has enough money to supply
165
people with the kind of health care that's required from a failed
medical device of any kind, then you can have any device you want
on the market, as long as you give information enough to have it.
Here we have a country where Dow Coming's own insurance
companies are refusing to pay for the mistakes that they made.
Now, where are we to turn for the money to take care of these peo-
ple. You can have any device you want. You just have to figure out
who's going to pay for it.
I'm a taxpayer. I would gladly pay my taxes for Tara to have a
shunt, but I'm not going to pay taxes for somebody who arrogantly
goes off and develops a product and then comes back to me and
says, "Well, you have to pay for all the people I injured."
Mr. GuTKNECHT. But the difficult question we have is, I mean,
there are I don't know how many hundred thousand women out
there who are not affected. I mean, so this is not
Ms. GOLDRICH. Wonderful. Then we don't have to pay for them,
but we do have to pay for those people who are, and there are a
substantial number of those people.
Mr. GuTKNECHT. My point, though, about the herd factor is that
people react differently. And many times — and, you know, I'm not
going to defend fraud or abuse of anybody, but, on the other hand,
we cannot predict what the reaction of some people may be. Some
people may take aspirin and have intestinal bleeding. Does that
mean we should keep aspirin off the market or sue all the compa-
nies that manufacture it? I don't know.
Ms. GOLDRICH. No, but there's another problem. My mother just
died of lung cancer in March. Did they let her have products that
were not safe for her? No. I believe that the FDA had provided the
kind of medication for my mother to have a peaceful end. I was
fratef\il for that. I didn't have to look to anybody to explain her
eath.
The point is that, when you have women or you have anybody
who is hurt and injured by an out-of-control manufacturer, there's
got to be somebody to pick up the tab for that. The insurance com-
panies aren't doing it. Certainly, they are denying the women who
are now in trouble any coverage for breast care. They don't even
get to have any form of cancer care should they develop it quite by
circumstance.
Mr. GUTKNECHT. Ms. Ransom, you had something you wanted to
say.
Mrs. Ransom. Yes. I keep thinking that we always talk about the
practice of medicine. Medicine is not a perfect science. It's an evolv-
ing science. We have to put reason in that. There is a great deal
of patient responsibility. If you step in front of train, you're prob-
ably going to be injured. At what point do you have a responsibility
for your part in it? Why should everybody else always have to pay
for it?
Also, not every form of cancer can be treated the same way. Why
does there have to be one answer for eveiything? It seems to me
that we need to just stop and ask some of those very basic ques-
tions. What do we want from medicine today, and then how do we
get it?
Ms. GrOLDRiCH, I would agree with what she says.
Mr. Shays. Excuse me. I need to interrupt.
166
Mr. GuTKNECHT. My red light is on, and I'll have to yield back
to the chairman.
Mr. Shays. Yes, if that's all right. I need to get on to Mrs.
Morella who has been extraordinarily patient.
Mrs. Morella. I'll try to just ask one question. You represent a
freat range, and I appreciate very much your not only being here
ut waiting also to be on this panel, and I value the testimony that
you've submitted and, of course, the statements that you made.
I'm trying to find like common ground. Where do we all come to-
gether? It appears to me that everybody thinks that we should con-
tinue to encourage research and technology; right?
Ms. RUSSANO. With the right questions answered. I'm sorry.
Mrs. Morella. Who wants — ^you said
Ms. RussANO. I said — I'm sorry — ^the research and technology
with the proper questions answered in the beginning, not at the
end.
Mrs. Morella. Right. I would agree with you in that regard. You
also feel that we do need more studies that should not be stul-
tified— ^that more studies would be very helpful. You also all believe
that there should be some legal reform, that we have a litigious so-
ciety, and that this also can hamper further research.
Ms. GrOLDRlCH. I can't agree with that totally. I think that the
problem with the litigious society is that there is no other way to
turn to have a person be able to confront a manufacturer if they
feel they have been harmed and denied informed consent. This en-
tire issue would never have come up if women had been told the
issues involved with breast implants. They were sold a product for
a lifetime. So I can't go into that tort reform with you.
Mrs. Morella. I can understand where you're coming fi-om and
what you're saying, and I would agree that you have the courts as
access for people. But that gets into the next point, you all believe
that everybody should be given the facts to be able to come up with
the right answers.
Ms. GoLDRiCH. Absolutely.
Mrs. Morella. So I think, you know, Mr. Chairman, there are
a number of areas where we feel that we can come to some kind
of agreement, in terms of where we go from here, the informed con-
sent being part of it, too.
I was also very interested in what — I think it was Ms. Green —
the statement that she made about the fact that all women should
be included in the clinical trials. I had not even thought about that
before. But whether it's reconstructive or cosmetic reasons, I think
that makes some sense.
So what I'm hoping is that, as a result, as we put together the
statements that have been made throughout this entire day, we
can reach some conclusions, with some variation in terms of where
we, as Members of Congress, go from here.
You wanted to make a comment?
Ms. RussANO. Yes. I'm concerned because no one seems to be ad-
dressing the children in these studies. Are we going to have before
us in the next 2 years hundreds of thousands of children who have
been exposed to this in the same situation that Tara is in today?
I mean, how do we protect those children? What are we going to
167
do to those children? Are we going to wait, Hke DES, 20 years and
say, gee, we should have thought of that?
We have an obligation. Elected officials have an obligation. Those
questions were never answered.
Ms. GoLDRiCH. But they were asked.
Mrs. MoRELLA. Yes, Doctor.
Dr. CoisnsfELL. I would like to go back to my final recommenda-
tion. I think we all recognize, it's very, very clear, many scientific
decisions now are being made not by scientists but by litigation, by
juries, and others. This is not the way to deal with issues of this
sort.
You want to find out a good way to go? I think we are now suf-
fering from the impact of nonscience. Women are terrified. Compa-
nies are leaving. My final suggestion to you is to urge that we put
this thing to rest, the FDA make a statement based on Dr. Gabri-
el's and others' research.
But, ultimately, I think, to convince the scientific community to
reflect what we have learned ever since our panel self-destructed
in 1992, I think it's critical that we put a mass of scientists to-
gether, let them evaluate the current situation, and then come to
some value judgment, hopefully with your help.
I don't think you're going to get a scientific outcome unless we
have your help to have a good scientific evaluation of the situation,
reaching a conclusion, and putting an end to this deplorable situa-
tion that we're currently in. And we need your help to do it.
Mrs. MoRELLA. I think that's the reason that this whole hearing
was put together. And I certainly think that we should remember
the cnildren and that we should make sure that we ask the right
questions, too. Thank you.
Thank you, Mr. Chairman.
Mr. Shays. I thank the gentlewoman.
I think we have concluded, except I would like to say for the
record, the point you made about children and how they are af-
fected is something that this committee will have to address in
greater detail. All of you have contributed, I think, a great deal to
our committee, and I appreciate each and every one of you being
here. Thank you very much.
Our next panel is Richard Hazleton, James Benson, and Jerome
Schultz.
While those witnesses are coming to the table, I would like to
recognize Mr. Fox for an introduction of someone who is visiting
with us right now.
Mr. Fox.
Mr. Fox. Thank you, Mr. Chairman.
It gives me great pleasure to introduce someone who is no
stranger to anyone who is in the United States. We have with us
today, and I would ask him to please stand
Mr. Shays. Well, why don't you have him stand when everybody
is sitting. Why don't you first tell us who he is.
Mr. Fox. We have with us today, Mr. Chairman, Dr. Henry
Heimlich, best known for the Heimlich maneuver that has saved
many lives from choking. I did want to say that with him today is
Dr. Jack Scianci from the Montgomery County Health Department
and AIDS Task Force.
168
Mr. Shays. Dr. Heimlich, please stand up. I'm assuming that it's
you. It's a privilege to have you here, and thank you for all your
good work. Your name is well-known and deservedly so. Nice to
have you here, Dr. Heimlich.
[Applause.]
Mr. Fox. May I just finish, Mr. Chairman?
Mr. Shays. Yes, you may.
Mr. Fox. Dr. Heimlich, while best known for his work dealing
with victims of choking, is now working with many groups across
the country to also have his methods used to prevent drowning, as
well as working on therapy for AIDS. And the Heimlich valve was
used during time of war to save many of our veterans on the field
of battle.
Dr. Chen is with him and Dr. Scianci. We appreciate your visita-
tion today and look forward to your attendance at future hearings
of the subcommittee.
Thank you.
Mr. Shays. I thank you, Mr. Fox.
Gentlemen, you're sitting down; I'm going to ask you to stand up.
As is customary, we swear in all our witnesses. If you would raise
your right arm.
[Witnesses sworn.]
Mr. Shays. For the record, all three witnesses have responded in
the affirmative.
This has been a very long day. For me, it has been a very stimu-
lating day. It's been a very interesting day. I thank you for your
patience in waiting to be the fourth panel.
I might say to you, Mr. Hazleton, you should feel free to correct
the record where you think the record needs to be corrected. You
sat in, I think, on most of the hearings today; is that correct?
Mr. Hazleton. Yes, sir.
Mr. Shays. So there have been mentions of various companies
and motives, and everything, and you should feel free to just state
the record as you see it.
We will go in this order: Mr. Hazleton, Mr. Benson, and then Dr.
Schultz.
STATEMENT OF RICHARD A. HAZLETON, CHAIRMAN AND
CHIEF EXECUTIVE OFFICER, DOW CORNING CORP.; JAMES
E. BENSON, SENIOR VICE PRESIDENT, TECHNOLOGY AND
REGULATORY AFFAIRS, HEALTH INDUSTRY MANUFACTUR-
ERS ASSOCIATION; AND JEROME S. SCHULTZ, PHJJ., PRESI-
DENT, AMERICAN INSTITUTE FOR MEDICAL AND BIOLOGI-
CAL ENGINEERING, AND DIRECTOR, CENTER FOR BIO-
TECHNOLOGY AND BIOENGINEERING, UNIVERSITY OF
PITTSBURGH
Mr. Hazleton. Thank you, Mr. Chairman, and good afternoon.
I am Dick Hazleton, chairman and chief executive office of Dow
Corning. I want to thank you first for your patience and then for
this opportunity to share my views about risk assessment, espe-
cially as it pertains to silicone breast implants and silicone mate-
rials used in other medical devices.
169
And I would like an opportunity to comment on some of the is-
sues. I'd like to complete my prepared testimony, I think, and then
I'm sure these things will come up in questions.
The story of breast implants clearly shows the consequences
when the powerful influence of billion-dollar litigation trumps risk
evaluation based on science. The testimony from many at this hear-
ing speaks more poignantly to those consequences than I could ever
hope to.
Clearly, there are many victims. I understand very well that
women represented by Ms. Goldrich and Ms. Russano are sincerely
convinced that they have been harmed by silicone breast implants,
and it's no mystery that they are angry at my company. While I
cannot agree that they are victims of Dow Coming or our products,
I don't question that they are victims. They are certainly victims
of their illnesses. I would argue that they are also victims of a legal
environment that has done more to exploit their problems than to
resolve them. Unquestionably, they deserve concern from all of us.
But there are also thousands of women with implants who are
not ill but have been victimized by the fear generated by this con-
troversy. Breast cancer survivors, represented today by Congress-
woman Lloyd, Ms. Green, and Ms. Locke, feel victimized because
they no longer have meaningful access to a product they believe to
be very beneficial. These women deserve our concern, as well.
Another group of victims are women who have these same cruel
diseases but are not breast implant recipients. Their question is
what does cause their illness, since they know for sure it isn't sili-
cone. I only wish that some of the money that we've all paid to law-
yers could have gone instead into research to provide answers to
these women.
Finally, there are victims such as Tara Ransom and her mother.
In addition to Tara's hydrocephalus shunts, Dow Corning provides
silicone materials that are vital for products like pacemakers and
defibrillators, that literally keep people alive every second of the
day. Our people have also developed silicones for devices that re-
store hearing to the deaf, mobility to arthritis sufferers, and wound
healing to burn victims.
In all of these applications we've taken the business risk to inno-
vate new medical materials that make a difference in people's lives,
and we've backed that research with sound science. In fact, these
silicones are among the most researched medical materials avail-
able today, yet they might follow the course of other materials and
be withdrawn from the marketplace as they become litigation tar-
gets. The question is not whether Dow Coming will continue to
manufacture these materials, it's whether silicone, as a class of ma-
terials, will become tainted and unavailable.
Our good-faith participation in a $4.25-billion global settlement
to try to resolve the implant controversy is often characterized as
an admission that our products were unsafe. Or, alternatively, in
the words of Forbes Magazine, as a "splendid act of corporate cow-
ardice." And now some view our decision to utilize the Chapter 11
to achieve resolution as an attempt to avoid responsibility. None of
that is true.
It's not really very complicated. Believe me, our every instinct
was to stand and fight for our principles, and we've had consider-
170
able success doing that in individual cases. But when our legal sys-
tem has been distorted from one which seeks justice based on
soimd scientific evidence to a business driven by billion-dollar eco-
nomic incentives, in our case resulting in nearly 20,000 lawsuits,
then CEOs like me have no choice. We must make business judg-
ments for the survival of our companies, regardless of our instincts.
As to Chapter 11, it's now the only way that we can equitably
address all claims, not just those of plaintiffs whose lawyers have
succeeded in getting them to the front of the line on the courthouse
steps.
On the science itself, I won't dwell on the studies of autoimmune
disease. The well-qualified scientists on the panel ahead of me
should do that and did that well. But to me, as a layman, the most
compelling summary of the evidence is the review recently con-
cluded by the British health authorities. They examined over 250
studies and references, not only those which show no link between
implants and disease, but also those that claimed to find a link.
And their firm conclusion is that there is no evidence of an in-
creased risk of these diseases among women with implants.
Let me turn briefly to another aspect of the breast implant issue,
that of local complications, such as hardening of the surrounding
tissues and implant rupture. We agree these deserve further atten-
tion, but they have been well-known and well-documented for many
years, and the absence of a link between silicone and disease
means they are not life-threatening. They can be dealt with by a
patient and her physician who are in the best position to balance
the benefits of breast implants with these possible complications.
I've made all this sound pretty bleak, but I hope and believe
there can be a solution to this madness. It starts by ensuring that
science, not scare tactics, is our standard for risk assessment. Our
public health institutions must serve as a fire wall that can with-
stand the sometimes enormous power of those who specialize in a
calculated appeal to fear over fact. And I've suggested some specific
possible improvements in my written testimony.
I want to conclude with a comment to those who are convinced
that they have been harmed by my company. It's very discouraging
to me and to every one of my 8,300 fellow employees that all the
anger and mistrust generated between some women and ourselves
has made it so difficult for us to listen to each other and have
much of a constructive dialog.
But despite the anger and mistrust, I hope that at least they will
accept the sincerity of our intention to fairly address the claims
with a resolution that does recognize what the scientific evidence
says, but is also viewed by most women with implants, and by the
world at large, as responsible and honorable.
Thank you for your attention, and I do look forward to your ques-
tions.
[The prepared statement of Mr. Hazleton follows:]
Prepared Statement of Richard A. Hazleton, Chairman and Chief Executive
Officer, Dow Corning Corp.
Good morning. I'm Dick Hazleton, chairman and chief executive officer of Dow
Coming Corporation. I want to thank Chairmen Shays and Mcintosh, as well as the
other members of the subcommittees, for this opportunity to talk about the issue
171
of risk assessment of medical devices, particularly as it pertains to silicone breast
implants and silicone materials used in medical devices.
The story of breast implants clearly shows the consequences when the powerful
influence of billion dollar litigation trumps risk evaluation based on science. I'd like
to talk about those consequences, their causes, and potential solutions. Then I would
be happy to answer any questions.
Clearly there is a broad spectrum of opinion among the participants in this hear-
ing on tne consequences of this highly-charged, divisive issue. Many women with
implants disagree with the scientific evidence that shows no link between implants
and disease. They remain convinced that their implants have caused a wide range
of immune system symptoms and illnesses. While I disagree with that opinion, I re-
spect the depth of their conviction. I also know that immune system diseases have
afflicted some women with implants, since these diseases, by their very nature occur
for more frequently in women than they do in men. But we disagree that their im-
plants cause these diseases, and we have an equally deep conviction that respon-
sible and rigorously conducted science must be the sole basis for determining the
issue of causation
There is also a very large number of women with implants who are not convinced
that implants are dangerous. But they are uncertain and scared. This widespread
fear tmd uncertainty nave significant public health consequences. For example,
many women have been scared into undergoing expensive, unproven, and sometimes
risky treatments like chemotherapy and steroid cocktails. In fact, the merchandising
of breast implant fear has created a cottage industry of blood tests sold to women
for $600 or more to diagnose diseases that are not even recognized by any medical
association. Some are even questioning if women with implants should bear chil-
dren. In one recent media report, the interviewer wondered on camera if an abortion
should be considered for pregnant women with implants. As a recent Washington
Times editorial put it, this is madness.
Breast cancer survivors can also speak to the public health consequences of the
breast implant issue. Those who have elected a mastectomy have far fewer choices
for reconstructive surgery. Many who would like to have silicone gel implants can
no longer obtain them even in clinical trials because the fear of lawsuits has driven
many physicians and hospitals away from using the device. They also fear the loss
of saline implants as hospitals avoid clinical tests because of the risks of lawsuits.
Their only remaining choices are to go overseas where silicone gel and saline im-
plants remain available or to undergo maior surgery involving the transfer of their
own tissue. For the minority of women who can afiord it, going overseas is an in-
creasingly used option. The other option of breast reconstruction through tissue re-
placement is not available to many women. Women who are too slim do not have
enou^ fat tissue for the procedure, and other women who have disqualifying medi-
cal conditions or insufficient financial means are not eligible.
The public health consequences of the breast implant issue have also affected
women who do not have breast implants but who do nave immune system diseases.
They are seeing billions of dollars going to lawyers fees and the legal system that
could be better spent researching wnat causes these diseases. These illnesses affect
women far more frequently than men and unfortunately the cause for them is un-
known. As lawsuits continue to thrive involving these diseases, manufacturers move
their new product development to less litigious applications, and with that redirec-
tion go their research dollars.
The final consequence of the breast implant issue threatens the health of people
like you and me and our families. We risk losing lifesaving medical devices as medi-
cal materials that are targeted for billion-dollar litigation are withdrawn from the
marketplace. For example, right now the FDA-approved Norplant contraceptive de-
vice is already in the cross hairs of the plaintifl's' bar. The same lawyers who have
mass marketed the fear of breast implants are now holding seminars on how to sue
manufacturers, and advertisements soliciting lawsuits are being published. What's
next? SUicone medical materials are critically important for cardiac pacemakers, hy-
drocephalus shunts, heart valves, kidney dialysis, insulin production, and many
other critical health care applications. I fear that hydrocephalus shunt patients, like
Tara Ransom, may not be able to access these devices if companies like Dow Cor-
ning must withdraw medical materials from the marketplace. But at the same time,
as the Chairman and Chief Executive Officer, I cannot put our organization, our
people, their families, and the communities in which we operate at risk by produc-
ing medical materials that are targeted for lawsuits, despite the scientific evidence.
Let me explain who Dow Coming is and what materials we make. As a person
who has worked for Dow Coming for 30 years, it's frustrating to me that most peo-
ple only know us from news reports that routinely lead off with, "Dow Coming, once
the leading manufacturer of silicone breast implants. . . ." Certainly we no longer
172
make breast implants, and we will never do so in the future. But Dow Coming is
more than that.
The Dow Coming that I know is 8,300 men and women from around the world
whom I am proud to call my colleagues and friends. For the past 53 years, the peo-
ple of Dow (Joming have had the vision to innovate new products and materials that
sometimes make the difference between life and death for hundreds of thousands
of people. We developed the silicone material for the hydrocephalus shunts that
keep children like Tara Ransom alive. Our silicone materials are vital for products
like pacemakers and defibrillators that literally keep people alive every second of
the oay. Our people have also developed silicone materials for devices that restore
hearing to the deaf, mobility to arthritis sufferers and wound healing to bum vic-
tims. In all of these applications, we have taken the business risk to innovate new
medical materials, and we have backed that risk with research based on sound
science. In fact, the silicone used in the devices is one of the most researched medi-
cal materials available today.
But those products are only 3% of the over 8,700 different products and materials
that have allowed Dow Coming to grow to the $2.2 billion company it is now. Our
people also develop and produce materials that make possible airplane travel as we
Know it today; materials that make automobiles safer to drive; and materials that
form the basis for the enormous power of computer chips that are revolutionizing
the way we communicate.
In short, the Dow Coming I know is not a breast implant company. Instead, we
are a company founded on science and technolo^. Working with thousands of cus-
tomers, we invent new applications for our materials that make a positive difference
in people's lives. In fact, we are the world leader in silicone technology. And I be-
lieve we have only scratehed the surface of the innovative potential of our people
and the materials they develop.
Ironically, as I stand before you todav, however, the Dow Coming I have just de-
scribed is also a company who has filed under Chapter 11 of the United States
Bankruptcv Code. We made this decision reluctantly and as a last resort, after ex-
hausting alternative wavs to resolve the breast implant issue.
If we nad not taken this action, we risked compromising our ability to participate
in a global settlement that would end this controversy. Let me explain. At the time
we tmk this action, we had agreed to participate in a $4.25 billion breast implant
settlement because it provided a manageable wa^r to end this legal controversy.
But that proposed settlement — the largest of its kind in this country's history —
was not enough money for some. These plaintiffs lawyers encouraged a number of
their clients try to get more money through individual trials. Ultimately, we were
lefl with 7,000 lawsuits in addition to the global settlement. By mid-1995, we faced
75 trials involving 200 plaintiffs over the next 6 months alone. Even if we had gone
to trial and won the majority of those cases, the enormous resource drain rep-
resented by this number of trials risked permanently damaging our business. With-
out an ongoing, financially stable business, Dow Coming would not have the ^nds
to participate in a global settlement. Therefore, Chapter 11 became our only reason-
able alternative to preserve our business and, therefore, our ability to fairly resolve
the claims of women with breast implants.
But these disputes are, in fact, legal disputes. The central question before this
committee is scientific evidence and risk assessment. So let me turn to what the
science says about the risks of breast implants. Many other far more qualified par-
ticipants in this hearing have and will address that question, so I will only offer
some summary comments.
The most pressing public health question concerning breast implants has been
whether the devices cause immune system diseases. This concern became a national
event in early 1992 with 5,000 news articles filed per month, conjuring up images
of women terrified by these diseases. The stories driving this concern were anecdotal
case reports. At that time, not a single peer-reviewed epidemiology studv showed
a link between implants and these mseases, but there were also no epidemiology
studies that disproved that link. As a result, the mere possibility — not the prob-
ability— that implants might cause immune disease drove the product off the mar-
ket.
Today, the British government has just finished a review of silicone breast im-
Slant research — reviewing studies that show no link between breast implants and
isease and studies that claim to find one. They concluded that there is no evidence
of an increased risk of disease in women with implants. In June of this vear, the
New England Journal of Medicine published a Harvard Medical School study funded
by the National Institutes of Health that showed no link between implants and im-
mune diseases or even the symptoms of immune disease. This study is not unique.
Today there are 18 epidemiology studies conducted at prestigious medical and re-
173
search institutions that also show no link between the implants and immune dis-
ease. The consistency of these results has led some researchers to declare that if
it weren't for the hype on this issue, this case would be closed from a scientific per-
spective.
Breast implants do carry some well documented risks of local complications. Many
women with invpltrnts, for example, may develop a fibrous capsule around the de-
vice. In some ofthe cases, the capsule may become hard and painful requiring fur-
ther treatment to break the capsule. In the last state-of-the-art implant that Dow
Coming had developed before we permanentlv withdrew from the implant business,
our people had nearly eliminatea this problem. Rupture is another complication,
whicn has been reported to us in less tnan 3% of the implants we manufactured.
Both of these complications — rupture and fibrous capsules-— deserve attention.
But the absence of a link between imj^ants ana disease means that neither of
these complications are life-threatening. They can be dealt with by an implant pa-
tient and her physician who are in the test position to balance the benefits of breast
implants with the complications.
That is the science and the data regarding breast implants risks as we know it
today. But even research from institutions like Harvard Medical School, The Mayo
Clime, Johns Hopkins and others cannot compete with the public health scare that
was burned into the national consciousness in early 1992. Instead, those highly re-
spected institutions have found their very ethics attacked by those who actually
claim that any funding from manufacturers — no matter how remotely connected to
the actual research — inevitably compromises their work. Does anyone seriously be-
lieve that a prestigious medical institution would risk its reputation, act unethically,
or commit fraud tor the funding of studies? Ironically, these same critics also vilify
companies like Dow Coming for allegedly not funding enough research. Frankly, I
find these allegations cynical and preposterous. In truth, they are nothing more
than a poorly disguised tactic to focus on anything but what the science says.
So far I've described a pretty bleak picture. But I hope and believe there can be
a solution to this madness.
It starts by ensuring that public policy is driven by scientifically based risk as-
sessment and that our public nealth institutions serve as a firewall that withstands
the sometimes enormous power of those who specialize in made-for-the-media scare
mongering. Put another way, should plaintifls' attorneys — who stand to gain lit-
erally bUlions of dollars by the mass marketing of fear — determine whether a prod-
uct is safe or should regulatory and research institutions like the FDA, NIH, Har-
vard, Mayo and Johns Hopkins? The answer should be obvious, but our experience
would suggest otherwise.
More specifically, let me close by suggesting the following three recommendations
for improving the process for evaluating risk in medical devices:
1. Guidelines must clearly establish what degree of risk is acceptable before a de-
vice can become available. If all devices must be totally risk-free, then informed con-
sumers will no longer have any role in deciding for themselves what risks they are
willing to assume. The government will make that decision for them and the num-
ber 01 devices available to consumers will be severely reduced. If devices can have
a reasonable level of risk, what is the standard of evidence that must be met that
both protects the consumer and maintains their right to decide for themselves what
risks they are willing to take? What are the standards that determine when enough
scientific evidence is enough?
2. When the guidelines and standards change for evaluating the risk of a device,
the manufacturers should be aware of those changes before they are implemented.
By definition, science and standards evolve. What is state-of-the-art today will not
be state-of-the-art tomorrow. Manufacturers not only understand this, they most
often drive these advances. But if you are competing in the high jump and the bar
is raised after you started your jump, then the incentive to even enter the contest
auickly goes away. This is especially true when the consequences of falling short of
lie rising bar can literally put well meaning companies out of business cased on
unproven allegations alone.
3. There is an ureent need for tort reform, particularly in the area of medical ma-
terials used in medical devices. The end device manufacturer or supplier must con-
tinue to be responsible for assuming the safety and performance oi their products.
However, continuing to allow medical materiel suppliers to be lawsuit targets sim-
ply because they have deep pockets will only have one result . . . the continued
withdrawal of those materials from the marketplace.
I want to conclude with a few comments to those who are convinced that they
have been harmed by our company. It is very discouraging to me, and to every one
of my fellow employees at Dow Coming, that this issue has generated so much
anger and mistrust between some women and ourselves that it is very difficult for
174
UB to listen to each other and have much of a constructive dialogue. But despite the
anger and mistrust, I hope that they will accept the sincerity of our intention to
fairly and equitably address their claims. My deflnition of a fair and equitable reso-
lution is one that does recognize what the scientiflc evidence says, but one that is
also viewed by at least most women with implants and the world at large as respon-
sible and honorable.
Thank you for inviting Dow Coming to share its thoughts on this most important
subject.
Response to Written Questions Submitted by Hon. Ed Towns to Richard A.
Hazleton
Question 1. During the Congressional hearings in 1990, the Committee Chairman
at that time, the late Congressman Ted Weiss, asked Dow (Coming) to produce cer-
tain documents that contained trade secrets. Were these documents given to the
Committee and if not, can you share with us the problem in not making them avail-
able?
Answer. Dow Coming believes that all documents requested by the Committee
have been produced through requests from the FDA, the Justice Department and
through the MDL (multi-mstrict litigation) data base. If there are specific docu-
ments in which you have a particular interest or which you believe were not dis-
closed, I would be happy to identify where they have been provided or expedite pro-
cedures to make them available to you.
Question 2. Early studies show that Dow Chemical conducted animal research on
silicone and its effects. Why then is Dow Chemical not being held accountable along
vdth Dow Coming?
Answer. Dow Coming was founded in 1943 at the request of the U.S. Government
to supply silicone materials, not available anjrwhere else in the world, for the war
effort. Both Dow Chemical and the then Corriing Glass Works, provided technology
needed to start the company. Since its founding, Dow Coming has operated as a
separate independent entity from its two shareholders. During the early years of the
company, Dow Coming was too small to have either the facilities or the trained per-
sonnel to conduct sophisticated toxicological studies. We, therefore, as is common
gractice in industry and government, contracted work with outside laboratories who
ad the capabilities. Dow Chemical was one of several outside laboratories utilized.
Dow Chemical did not design, test, or manufacture breast implants. Those activi-
ties are solely the responsibility of the Dow Coming Corporation. I believe deep
pockets, not facts, are the basis of attempts by plaintiffs attorneys to bring Dow
Chemical into breast implant litigation.
Question 3. The medical difficulties of children bom to women with breast im-
plants has not been well publicized. First, does Dow (Coming) acknowledge that
there have been health problems for these children? And, second, how can funds be
found for the needed research and treatment of children affected by these implants?
Answer. There is no credible scientific evidence to suggest increased medical dif-
ficulties in children of mothers with breast implants. The single published study by
Levine and Ilowite, claiming "Esophageal Disease," has been largely discredited due
to gross selection bias leading to skewed results. The British Department of Health's
evaluation of this work follows:
There are, in fact, a number of significant deficiencies in the study which pre-
vent any vaJid conclusions being drawn. These include the use of a highly se-
lected group of patients with bias evident at each stage of selection, inadequate
controls in terms of numbers and matching, inadequate numbers investigated,
inaccuracies in clinical correlations, lack of evidence that abnormalities were
clinically significant, lack of corroborative evidence, the effect of any anesthetic
agents used on esopha^al motility, inappropriate statistical methods and lack
of any evidence that silicone was present in milk or ingested. In spite of the
widespread publicity generated by this paper, it is of no value in assessing the
healtn effects of silicones.
Nonetheless, because of the fear such studies generate, Dow Coming is sponsoring
third party epidemiology work to address the claims being hypothesized. However,
I feel it is unconscionable that children are now being used by some as a pawns
in the breast implant litigation debate. Before we once again scare women and the
families of women with breast implants, as we allowed to happen with unfounded
claims of cancer, scleroderma and lupus, I hope we will require more than hearsay
and anecdotes before raising an unfounded health scare for children.
Mr. Shays. Thank you, Mr. Hazleton.
175
Mr. Benson,
Mr. Benson. Thank you, Mr. Chairman.
I also want to thank you for inviting me to be here today. Like
you said, it's been a long day, but I tnink much information has
come out, and I think even more is yet to come. As requested, I
have submitted my written testimony, and I would like here to
summarize that testimony.
My name is Jim Benson. I'm senior vice president for technology
and regulatory affairs at the Health Industry Manufacturers Asso-
ciation. In my comments today I want to stress three points:
First, one of the most essential materials in medical implants,
silicone, has been widely accused of being unsafe, though a growing
volume of evidence suggests otherwise. Second, the vilification of
silicone is one of the primary causes of current shortages of many
raw materials used in medical products. And third, these shortages
present a threat to patients because technology manufacturers may
not be able to develop countless new technologies.
Though much of this hearing has addressed the issue of breast
implants, my remarks today will not. As former Acting Commis-
sioner of FDA and former director of the Center for Devices and
Radiological Health, I am precluded by law from discussing propri-
etary information. I want to use my brief time today to address
questions of FDA risk assessment and science that hold even
broader implications for patient care.
Let me begin by focusing on risk assessment at FDA. The FD&C
Act requires FDA to find a reasonable assurance of safety and ef-
fectiveness before approving a new product. To meet that standard,
medical technology companies perform a variety of tests on their
devices. These include clinical trials in humans; animal studies;
mechanical, structural and chemical tests; and mathematic or com-
puter modeling.
Yet, even the most rigorous testing does not and cannot yield as-
surance of absolute safety. That's because science itself rarely, if
ever, yields absolute answers. By its very nature, science is open-
ended; it's ongoing; it's never complete. No matter how thorough
the testing, one can always ask one more question, study one more
patient, seek one more statistic.
Congress clearly recognized the nature of science when it con-
cluded, in the 1976 medical device law, that the agency should not
seek absolute assurance of safety and effectiveness of*^ medical de-
vices but a reasonable assurance. That means FDA must examine
the risks and the benefits of devices, then make its judgment on
the balance between the two.
The job of FDA is not to hold up a product indefinitely while de-
manding evidence that exceeds the standard of reasonable assur-
ance. If that happens, product approvals at FDA will stop com-
pletely, and patients will be harmed. At that point, the quest of ab-
solutes in protecting public health will, in itself, have become a
threat to public health.
Ultimately, the agency has ignored the dictates of Congress, pre-
ferring instead this "absolutist' mentality, this insistence that data
prove, with total certainty, that a product will or will not have a
specific effect. Let me give you an example. In recent months, some
17 or 18 epidemiological studies have all reached the same conclu-
176
sion: They do not find a link between breast implants with silicone
fel and connective tissue diseases. These are studies that have
een done by some of the world's leading institutions, such as Har-
vard University and Mayo Clinic.
In addition, FDA's counterpart agencies in such countries as the
United Kingdom, Australia, and New Zealand, have conducted
their own analyses and literature reviews. None of these countries
is finding a link between silicone and connective tissue diseases.
Yet, despite this growing body of evidence, FDA continues to argue
with these findings.
I would like to digress here just a moment and acknowledge that
Dr. Kessler said this morning, if I heard him correctly, that this
body of evidence does point toward no link between silicone and
tvpical connective tissue disease. We need to hear what he said
there very carefully, and I look forward to examining the record
more closely.
This is especially surprising since silicone is one of the most
ubiquitous substances in our society. Each of us uses and ingests
it every day. We use it in deodorants, suntan lotions, pain reliev-
ers, toothpaste, lip balm, shaving cream, soft drinks, and even
french fries, to name just a few.
The everyday, routine uses of silicone combined with its long suc-
cessful history in medical use, especially implants, represents an
enormous body of empirical data. If any significant danger existed
from silicone, it would have become obvious a long time ago.
Yet, this perception of silicone as being unsafe, together with
FDA's unwillingness to acknowledge studies of the highest caliber,
is having an increasing harmful impact on patient care. Unsub-
stantiated allegations about the safety of silicone have become the
centerpiece of widespread product liability litigation and publicity
in this country. This type of litigation has led many suppliers of
vital raw materials for medical devices to simply leave the device
market, thus creating growing shortages.
With due respect to the CDRH staff who were here this morning,
and they have been working with us toward finding substitutes for
some of these raw materials that have been withdrawn, we remain
deeply concerned that new raw material suppliers will not enter
the market. These are shortages that directly threaten patient
health. Again, I'm hopeful that Dr. Kessler's comments about the
relative safety of silicone this morning will positively affect these
shortages.
Countless medical technologies depend upon such raw materials,
including, to name only a few: heart valves used by 35,000 patients
annually; vascular grafts, 300 patients annually; and certain types
of surgical tools which are used to treat millions of patients every
year.
Though these products I've mentioned are comprised of a variety
of biomaterials, many devices depend upon silicone, in particular,
and they include hydrocephalus shunts, which we've heard a lot
about today; arthroplasty devices, such as artificial knees and hips,
600,000 patients a year; and catheters which are used in about a
million patients a year. Some of these products are displayed here;
others are demonstrated on Mr, Towns' chart.
177
Let me stress, Mr. Chairman, that the shortages our industry
faces today in raw materials can be traced directly back to the ab-
solutism of FDA. The roots of the problem lie in the obvious con-
tradiction that, on the one hand, convicts silicone before all the
facts are in, but on the other, refuses to exonerate silicone in the
face of growing proof of its innocence. It is this attitude which
unleashes a chain reaction that ultimately restricts the raw mate-
rials our industry that we need to improve lives.
We believe that four steps are necessary to alleviate this crisis:
First, we urge Congress to pass biomaterials legislation now con-
tained in House and Senate-passed product liability bills. This leg-
islation would limit the liability of raw material suppliers.
Mr. Shays. Mr. Benson, let me just ask you, just so you don't
lose me here. How much longer is your testimony?
Mr. Benson. I have two more pages.
Mr. Shays. OK That's fine.
Mr. Benson. Thank you.
The biomaterials legislation would limit the liability of raw mate-
rial suppliers to instances of genuine fault, thus reducing the likeli-
hood of unwarranted lawsuits. In effect, this bill would encourage
biomaterial suppliers to remain in medical device markets, but it
would not, in any way, diminish the existing and future liability of
device manufacturers which use these materials in their products.
Second, we believe FDA must reverse its course on silicone. It
must accept the growing volume of respected evidence that is show-
ing the unsubstantiated allegations about silicone to be wrong.
FDA must, once and for all, stand up and reassure the public of
the safety of silicone and the use of silicone in all of its forms.
Again, Dr. Kessler took a step in that direction this morning. I
hope we hear more.
Third, we recommend that FDA abandon absolutism in risk as-
sessment. Absolutes are not achievable, and the quest for absolutes
holds the potential to harm patients.
Finally, we believe FDA must view product approvals as a key
element in consumer protection. Getting new, safe, and better
treatments to the bedsides of patients can be just as critical in pro-
moting better health as keeping unsafe products off the market.
The fact is, we need both.
There's no question, Mr. Chairman, that FDA has a clear obliga-
tion to assess potential risks when evaluating products. Patients
have a right to know. But if the agency is to truly protect public
health, it must use an even-handed, objective, and rational ap-
proval process that ultimately rests upon sound science, reasonable
assurance, and common sense.
Thank you.
[The prepared statement of Mr. Benson follows:]
Prepared Statement of James E. Benson, Senior Vice President, Technology
AND Regulatory Affairs, Health Industry Manufacturers Association
introduction
Mr. Chairman, my name is James S. Benson. I am senior vice president for tech-
nology and regulatory affairs of the Health Industry Manufacturers Association
(HJMA).
178
I appreciate this opportunity to testify on the risk assessment standards used by
FDA in evaluating medical devices. In my testimony today, Mr. Chairman, I want
to leave this Subcommittee with three points:
• First, one of the most essential materials in medical implants, silicone, has been
unfairly accused of being unsafe, though decades of successful use and a growing
volume of research substantiates the appropriateness of its use in the body.
• Second, the vilification of silicone is one of the primary causes of the current
shortages of many raw materials which are essential to the development of new
medical products;
• Third, these shortages present a threat to the health of hundreds of thousands,
perhaps millions, of patients because technology manufacturers may not have the
materials they need to develop countless life-saving technologies.
I recognize, Mr. Chairman, that the focus of much of tnis hearing will be on
breast implants. But, for two reasons, my remarks today will not focus on these
products — nor on the companies that produce them: First, as former Acting Commis-
sioner of the FDA and former Director of the Center for Devices and Radiological
Health, I am precluded by law and by ethical considerations from discussing propri-
etary information. But in addition, I want to use my brief time today to address
some of the deeper guestions of risk assessment and science at the agency that I
believe hold implications for patient care and health that go well beyond the breast
implant controversy.
fflMA REPRESENTS MEDICAL DEVICES, DIAGNOSTICS, mS
For those members of the Subcommittee who may be unfamiliar with HIMA, let
me explain who we are and who we represent.
HIMA is the national trade association of the medical technology industry. It rep-
resents more than 700 manufacturers of medical devices, diagnostic products, and
health information technologies.
During the past 20 years, these medical technologies have revolutionized medi-
cine. Thanks to achievements in such iields as flberoptics, imaging, electronics, and
biotechnology, today's medical technologies are faster, more efficient, and more pro-
ductive than ever. But most important, such products — be they lasers, scalpels,
MRIs, home diagnostic tests, pacemakers, or a myriad of other products — have sub-
stantially improved health care for patients.
As I noted, many of these medical devices depend upon a variety of biomaterials,
including silicone — which is one of the most pervasive of all synthetic materials ana
is used widely in various forms (solids, liquids, gels) in countless medical and non-
medical products. It is used, for example, in such products as toothpaste, soft
drinks, deodorants, and pain relievers, as well as in a range of medical products,
including catheters, artificial joints, and shunts. Were it not for substances like sili-
cone and other biomaterials, much of the progress in medicine that each of us takes
for granted would not have occurred.
RISK ASSESSMENT AT FDA
Your chosen topic of risk assessment at FDA, Mr. Chairman, is of significant in-
terest to virtually every manufacturer of medical products.
All of the technologies developed by our industry must be reviewed by the Food
and Drug Administration or must otherwise adhere to the rules and pohcies estab-
lished by FDA. As such, our members are fully familiar with FDA procedures and
requirements regarding risk assessment. As former Acting Commissioner of FDA
and Director of the Center for Devices and Radiological Health — the office respon-
sible for device review at the agency — I, too, am familiar with FDA procedures on
risk assessment.
I commend your Subcommittee for examining this issue because I believe FDA's
risk assessment policies — in many important ways — lie at the heart of the problems
I noted a moment ago.
Let me begin by providing a baseline for understanding just what risk assessment
at FDA is and what it means. As members of the Subcommittee may be aware, the
Federal Food, Drug, and Cosmetics Act (FFDCA, Section 513(aXlXC) and Section
515(dX2)) requires that FDA must find a reasonable eissurance of safety and effec-
tiveness before approving a new product. Note that the term Congress chose was
reasonable, not absolute, not perfect, but reasonable.
To meet that standard, medical technology companies perform a variety of tests
and studies on their products. Depending on the type or nature of the product; how
it is intended to interact with the body; the disease or condition it is intended to
diagnose or treat; or how it will be used, where, and by whom; those tests might
include:
179
• Bench tests, in which the products are put through a range of mechanical, struc-
tural, and chemical examinations.
• Mathematical or computer modeling, in which the product is simulated to under-
go a variety of conditions which mimic virtually any human environment.
• Animal studies, in which the product or component material is tested in animals
in which certain biological responses are physiologically similar to those of humans.
• Long-term or short-term clinical trials, in which the product is studied over a
period of time in human subjects.
• And tests to determine now devices directly affect the tissues they contact and,
conversely, how the tissues and body fluids affect the device.
The testing process often takes many years. It involves many physicians, sci-
entists, engineers, and biomedical specialists. It involves the collection and analysis
of laboratory data and clinical results. And it may require millions of dollars to com-
plete.
Yet even the most rigorous testing, Mr. ChairmEm, does not, and cannot, yield as-
surance of absolute safety. Despite years of vigorous, aggressive, and persistent sci-
entific inquiry, testing of any device cannot yield absolute assurances about risks
because science itself^rarely, if ever, yields absolute answers. By its very nature,
science is open-ended. It is on-going. It is never complete. No matter how thorough
the testing, one can always ask one more question, study one more patient, seek
one more statistic. And when that is done, you can do it again.
That is especially true when someone is trying to prove a negative absolute — in
other words, that absolutely no risk exists. The universe of evidence required for
such proof is virtually limitless. So scientific inquiry must be content with finding
a reasonable indication of the probability of something good or something bad hap-
pening as the result of a medical intervention.
Therefore, the standard I cited a minute ago that Congress gave to the agency
and to the industry for deciding what is clinically safe and effective is especially im-
portant. Congress clearly recognized the nature of science — and at the same time,
the need for new products to reach patients within a finite period of time — and con-
cluded in 1976 that the agency should not seek absolute assurance of safety and ef-
fectiveness of medical devices, but should seek a reasonable assurance of safety and
effectiveness.
Congress said, in effect: We know science can never reach absolute determina-
tions. So let us be reasonably certain. By using this standard of reasonable assur-
ance, patients will ultimately be better served.
Translated into everyday terms and into the context of today's hearing, this guid-
ance means that FDA must make a judgment as it examines the kinds of studies
I noted earlier. It must examine the risks and the benefits reasonably and objec-
tively and then make its judgment on the balance between risk and benefit.
That is: The agency must ultimately ask, "Does the potential positive impact of
the device on health outweigh its potential hazards?" Stated somewhat differently:
"Are the predicted risks judged to be low enough in light of the predicted benefits?"
The job of FDA is not to hold up a product indefinitely while demanding evidence
that exceeds the standard of reasonable assurance.
I want to be clear, Mr. Chairman, that my goal today is not to blast the agency.
Our industry believes the agency has an important role to play in regulating me(U-
cal devices. At the same time, it is also accurate to say that the agency has suffered
from a kind of "absolutist" mentality in the recent past — characterized by an insist-
ence that data demonstrate the precise or absolute determination of risk of a prod-
uct or prove with total certainty that a product will or will not have a specific effect.
If that certainty is not there, tne agency too frequently concludes that the data are
inadequate and, therefore, patient access must be delayed or denied.
Yet this approach is fraught with danger. Carried to its extreme, it would stop
virtually all products because, as I have said, absolutes in science generally cannot
be achieved.
That means patients would be harmed because they would be denied access to the
latest life-saving and life-improving devices. And if that happens, Mr. Chairman, the
quest for absolutes in protecting public health will, in itself, have become a threat
to public health. That is exactly what Congress was trying to avoid when it crafted
so carefully the wording of the statute in 1976
Now let me turn from past to present. We have today what I believe to be an
almost perfect example of this demand for "absolutes." I want to draw it to the Sub-
committee's attention because I believe it is central to FDA's approach toward risk-
assessment and the long-term implications of that approach.
As members of the Subcommittee are well aware, the breast implant controversy
of recent years raised alarms about the safety of silicone. As you may know, Mr.
Chairman, silicone is one of the basic raw materials used in medical implants and
180
in a variety of everyday commodities. Because it is often used in devices that aug-
ment or replace body organs or functions and that come into prolonged contact with
body tissues, we must have reasonable assuremce of its safety.
As you also recall, the breast implant controversy has prompted some to foster
a perception that silicone is unsafe, dangerous, and harmful, though the greater
weight of scientific and epidemiological evidence is clearly on the side of safety. Re-
grettably, silicone has been vilified with no basis in sound science.
As a result of this controversy, many scientific and clinical studies were developed
to explore the safety of silicone. Specifically, their goal was to examine whether a
link existed between silicone and the development of connective-tissue diseases in
breast implant patients. In recent months, many of those epidemiological studies
have reported results.
So far, some 17 of these studies have reached the same conclusion: They do not
find a link between silicone and connective-tissue diseases. These are studies that
have been done by some of the world's leading institutions, such as Harvard Univer-
sity, the Mayo CUnic, Johns Hopkins University, and Emory University. And they
have been published by some of tne most prestigious, peer-reviewed medical and sci-
entific journals, such as the New England Journal oi Medicine, Journal of Clinical
Epidemiology, Annals of Rheumatic Disease, Journal of the National Cancer Insti-
tute, and others.
In the June 22, 1995 issue of the New England Journal of Medicine, for example,
the authors of the Harvard study said this: "Un a large cohort study, we did not find
an association between silicone breast implants and connective-tissue dis-
eases. . . ." ^ That is essentially what the other studies are finding as well.
In addition to these studies, FDA's counterpart agencies in other countries have
conducted their own analyses and literature reviews. These include agencies in the
United Kingdom, Austraha, and New Zealand. None of these institutions— I repeat,
none of these institutions — is finding a link between silicone and connective-tissue
disease.
I quote Dr. Kenneth C. Caiman, Chief Medical Officer of the UK Medical Devices
Agency, as he summarized his agency's findings: "The conclusion . . . was that
there was no evidence of any association between breast implants and connective-
tissue disease. . . ."^
Now, do these numerous studies mean that we are absolutely certain that there
is no link between silicone and such diseases? No. As I said, even here, one could
always insist on more. If the study had 1,000 participants, why not 2,000? Why not
10,000? If it was a year long, why not two years? Why not 10 years? And so on.
But do we have reasonable assurance that there is no link on the basis of these
studies? The answer is yes. The evidence to support that point is more than suffi-
cient if your standard is a reasonable assurance of safety and effectiveness. And I
believe that is the standard we must use because it is the standard which reflects
truly appropriate reliance on science. It is that standard which is consistent with
the expectations that Congress wrote into the law. And it is that standard, finally,
which reflects simple, common sense.
Despite this growing body of evidence from all of these prestigious institutions
and from all of these FDA counterparts in other countries, we find that the FDA,
as well as some observers, continue to try to refute these findings. They point to
statistical and other alleged scientific limitations.
Yet many of these observers were more than willing to suggest in the past that
silicone might harm patients. They arrived at that conclusion without pointing to
any data or any proof to support it. My question is this: How many studies, done
by how many institutions, and reinforced by how many government health agencies
will it take to convince FDA? In effect, FDA absolutism in risk assessment is alive
and well — at least when it comes to silicone.
Let me add an additional, somewhat ironic, counterpoint to this absolutism.
Despite the anguish and passion prompted by the use of silicone in some medical
technologies, silicone is one of the most uoiquitous, pervasive substances in our soci-
ety. It has been thoroughly tested in laboratory animals for ingestion and implanta-
tion.
In addition, each of us uses and ingests silicone in one form or another every
day — perhaps every minute of every day. We use it in deodorants, sun tan lotions,
1 "Silicone Breast Implants and the Risk of Connective-Tissue Diseases and Symptoms," New
England Journal of Medicine, Sanchez-Guerrero J, Colditz G, Karlson E, et al. June 22, 1995,
p. 1666.
'"Evaluation of Evidence for an Association Between the Implantation of Silicones and Con-
nective Tissue Disease, DaU Published from the End of 1991 to July 1994," Medical Devices
Agency, December 1994, Foreword.
181
and pain relievers. We use it in toothpaste, lip balm, and shaving creams. We use
it in soft drinks, hamburgers, and french fries. We use it to treat colds, bums, and
allei^gies. And, of course, we use it in and on a variety of medical treatments. It is
the lubricant on every catheter and hypodermic needle — substantially reducing the
discomfort of such injections as a result — and it is the substance of many medical
implants.
Let me present this point another way: Go to the grocery store and you'll find
shelves of products that use silicone, from condoms to antacids. Go to the drug store
and the fast food restauremt, and you'll find silicone. In effect, silicone has been used
in virtually every aspect of human behavior for decades.
As a result, there is an enormous body of empirical evidence from years and years
of continuous use that one must recognize and that one cannot discount. In light
of this, silicone — perhaps like few other products or substances — really can be
dubbed 'i.ried and true. If any significant danger existed from this substance, it
would have become extremely obvious a lone, long time ago.
But the fact is, what the Harvard and Hopkins and New Zealand studies are
showing is correct: The allegations about silicone in breast implants are untrue and
lack foundation.
As a matter of fact, what all of these data are beginning to show is that silicone —
at least as far as medical technology is concerned — has been wrongly accused. Yet
now that the juries from Harvard and Mayo and the UK are providing more than
adequate assurances, the FDA refuses to act on the results.
IMPACT OF UNSUBSTANTIATED ACCUSATIONS REGARDING SIUCONE
My purpose in providing this background, Mr. Chairman, is not to present an edu-
cational treatise on the arcane elements of scientific reasoning or on the potential
applications of a particular polymer. My purpose is to point out that this perception
of silicone as being unsafe, together with FDA's unwillingness to acknowledge stud-
ies of the highest caliber, is having an increasingly negative and harmful impact on
patient care.
Let me underscore a critical point: I am not referring here to breast implants. In
fact, this goes well beyond breast implants. I am referring to the fact that availabil-
ity of one of the most critical raw materials, silicone — which is essential to countless
medical devices and everyday applications, from soft drinks to toothpaste — is seri-
ously threatened.
More broadly, what I am also talking about is the fact that allegations about the
safety of silicone — unsubstantiated allegations — ^have become the centerpiece of
widespread product liability litigation and publicity in this country. Medical device
companies and suppliers of raw materials for medical devices have become the sub-
jects of growing litigation. At the heart of the litigation, of course, lie the unfounded
charges about the health risk associated with silicone
This type of litigation has led many suppliers of such materials to simply leave
the medical device market. And it's not surprising as to why. Under current U.S.
product liability law, the supplier of any commodity material that is used in a medi-
cal device — no matter how unrelated the supplier is to the design, sale, or manufac-
ture of the device — can be brought into a lawsuit involving a device that has alleg-
edly failed. Yet despite this enormous liability exposure, tne sale of such materials
represents a minuscule fraction of the business of^ these suppliers. The annual sales
of polyester yam to the medical market, for example, is estimated at less than
$200,000, while sales to other industries are estimated at $9 billion.
Consequently, the obvious recourse has been to withdraw many of these
biomaterials from the device market. During the past three years, suppliers such
as Dow Coming, Dow Chemical, and DuPont have all done so. This is clearly a ra-
tional business decision by raw material suppliers who must balance the revenues
they receive from the device market against the liability exposure they incur.
As many of these raw material suppliers leave our industry, medical device mak-
ers are facing growing shortages of vital raw materials. A recent study of the device
industry by the Wilkerson Group found that 41 percent of companies interviewed
said they were having difUculty obtaining raw materials as a result of supplier con-
cerns over product liability. Among companies producing implantable products, 73
percent said they had difficulty obtaining raw materials.
Device companies are responding to these shortages in a variety of ways. Some
are stockpiling resources that are still available. Some are seeking alternative sup-
pliers or trying to redesign products, thereby expending resources that could be used
to develop new products. And some are simply oropping projects altogether.
In some cases, alternate suppliers that have been identified for certain materials
have also expressed liability fears. And in many cases, no other suppliers may exist.
182
The effect of this shortage on patient care could be devastating. The range of ma-
terials being restricted is vast and will affect the entire spectrum of medical special-
ties, from cardiology and neurology to urology and ophthalmology. To give you some
sense of the magnitude, consider the types of life-saving and quaUty-enhancing
products that depend upon biomaterials. These products are either oeing affected by
these shortages already or could be aiTected by them in the neeir future:
• Heart valves, which are used to control tne flow of blood to and from the heart
and between chambers of the heart. Some 35,000 patients receive heart valves an-
nually.
• Vascular prafl,s, which repair or replace arteries in people whose own arteries
have been iryured or are in danger of catastrophic failure. Approximately 300,000
patients beneiit from vascular graft,s annually.
• Pledgets, which are surgical tools that buttress fragile tissue for suturing. It is
safe to estimate that millions of patients benefit from their use every year.
• Intraocular lenses and related technologies used in cataract surgery. Some 1.5
million patients annually are affected by these products.
Let me stress that the products I've just listed are comprised of a variety of
biomaterials. But let me also point out a number of the critical medical devices that
depend upon silicone in particular.
• Hydrocephalus shunts, which drain the build-up of cerebrospinal fluid from the
brains of affected infants. About 75,000 shunts are implanted annually.
• Arthroplasty devices — such as artificial toe joints and finger joints and artificial
knees — which help 600,000 patients per year.
• Catheters, which are used in about a million patients annually.
And this is just a start. Other products that would be significantly affected if sili-
cone is totally withdrawn from the market include IV drip systems, pacemaker
leads, implantable infusion pumps, wound drainage sets, wrist joint replacements,
ostomy systems, and any number of grafts. In fact, for some medical products — such
as cardiac pacemaker leads and hydrocephalic shunts — silicone is the only approved
material available for production.
Given the potential impact of restricted access to such materials, Mr. Chairman,
HIMA commissioned a study ^ that forecast how certain shortages might affect pa-
tients, innovation, and product development. In the short term — that is, within ap-
proximately 1-3 years — the forecast found that:
• Many small companies, which are the prime innovators in our industry, will be
forced out of business because of the costs of managing such shortages.
• U.S. manufacturers will have to direct resources away from R&D on new types
of products to search for replacement materials.
• Foreign competitors will be able to focus on production of entirely new kinds of
medical products, thereby seizing this country's competitive edge in many critical
technologies.
But in the longer term — that is, within 3-10 years — the study projected that:
• Inventories will have diminished and a full-force biomaterials embargo — touch-
ing the very products I mentioned a moment ago and many more — could nit the de-
vice industry.
• Patients will face shortages of vital medical implants.
• Materials that have enjoyed some 40 years of oeneficial use will completely dis-
appear.
• Major segments of the medical implant industry will move overseas.
• The U.S. will lose its leadership in medical implants.
These are sobering conclusions Mr. Chairman. They hold implications for jobs, for
trade, for economic growth, for competitive leadership, and — most importantly — for
the continued patient health of this country. And these very issues — the fear over
litigation, the shortages that result, the threats to innovation — begin, ultimately, in
the kind of absolutist thinking that today pervades our product liability law and
FDA's regulatory risk assessment.
The roots of this issue run deeply into the obvious contradiction by FDA and oth-
ers that, on the one hand, convicts silicone before all the facts are in but, on the
other, refuses to exonerate silicone in the face of growing proof of its innocence. And
it is this absolutist attitude that unleashes a powerful and continuing chain reac-
tion— a chain reaction that begins with unsubstantiated allegations, which them-
selves lead to widespread lawsuits, which then lead to wide-spread publicity and
public belief in the allegations, which then lead to growing shortages. And it is these
shortages which ultimately threaten this industry's ability to provide the medical
treatments necessary to protect the public health.
^Market Study: Biomaterials Supply for Permanent Medical Implants, New York, AronofT As-
sociates, March 1994.
183
RECOMMENDATIONS
Let me turn for a moment from problem to solution, Mr. Chairman. I recognize
that I have touched on many disparate themes in describing a most complex prob-
lem. But let me outline a series of steps that we believe can begin to address these
challenges. These are not sweeping, quick-fix answers. Instead, tney address various
pieces of this complex issue and, together, form the basis of a long-term solution.
Congress must pass biomaterials legislation.
First, we urge Congress to pass legislation now contained in House and Senate-
passed product liability bills that would prevent a public health crisis by encourag-
ingbiomaterial suppliers to remain in the medical device market.
The specific legislation incorporated in the product liability bills is the
Biomaterials Access Assurance Act. This legislation was introduced by Sen. Joseph
Lieberman (D-CT) and Sen. John McCain (R-AZ), as well as by Rep. George W.
Gekas (R-PA), and was ultimately incorporated into product liability legislation
Eassed by both chambers. It has attracted strong bipartisan support. Rep. Dennis
[astert (R-IL) led an impressive array of Commerce Committ^ members in em-
bracing these protections for raw material suppliers in the product liability meas-
ure.
The bill would be an important element in addressing the biomaterials crisis be-
cause it would limit the liability of raw material suppliers to instances of genuine
fault. In effect, this change would reduce the likelihood that these companies would
be burdened with unwarranted or catastrophic lawsuits where they have met their
contractual agreements and strictly adhered to contract specifications.
But the bill would not in any way diminish the existing liability of medical device
manufacturers — that is, of the members of our industir who use these materials in
their products. As a result, the bill would not diminish the ability of consumers to
seek redress against appropriate parties for harm alleged to be caused by an im-
plant.
But we believe it would keep the biomaterials suppliers in the medical implant
market and would encourage others to enter it. As such, this legislation would play
a key role in addressing an acute health care crisis by ensuring that a continuing
supply of vital raw materials is available.
We urge the House and Senate leadership to act quickly to pass product liability
legislation this year to avert this crisis.
FDA must reverse its course on silicone.
In addition to encouraging Congress to adopt biomaterials legislation, Mr. Chair-
man, we also believe it is time for FDA to reverse its historical course on silicone.
As I have shown, reliable, respected, and thorough scientific research is making
clear that unsubstantiated allegations about silicone are not accurate.
It is time to accept these findings and to defuse the passion that has, too often,
surrounded this substance and has snowballed into the longer-term problem I've de-
scribed. Reversing the silicone conviction, as it were, is another vital component in
reducing the pressure on raw material suppliers to flee the medical implant market.
I might add that we hope FDA will begin to show the same kind of openness in
this area that it has shown in another critical aspect of this issue — that is, in help-
ing smooth the regulatoiy hurdles for manufacturers' use of silicone from alter-
native sources. The FDA Center for Devices and Radiological Health worked closely
with HIMA to develop clear parameters for establishing the equivalence of silicones
from alternate sources.
Following that work, HIMA submitted to the Center a materials analysis para-
digm that it had developed with the intent of making the materials acceptance proc-
ess more systematic. FDA has agreed to woric with us to develop this concept fur-
ther. Contmuing in this cooperative mode, I recently received a letter from Dr.
Bruce Burlington, director of the Center, offering to work with and assist HIMA in
addressing the potentially increasing numbers oT materials shortages that could be
generated by concerns over current market withdrawals and the Dow Coming bank-
ruptcy filing.
FDA must abandon absolutism in risk-assessment.
I would also like to add another suggestion in this mosaic of solutions to the
biomaterials crisis and risk assessment issue. That is, we urge the FDA to abandon
its absolutist attitude on risk assessment generally and return to the standard of
"reasonable" assurance of safety and effectiveness that the Congress wrote into the
original medical device law and that remains a sound base for policy and regulation
to(&y.
184
FDA must recognize that absolutes are not achievable, and that the auest for ab-
solutes holds the potential for harming patients. Only bv adhering to tne standard
of reasonableness can we expect to encourage continued innovation and continued
investment in innovation. And only by adhering to this standard can patients expect
to receive timely access to new medical advances.
With respect to silicone in particular, a reasonable analysis must take into ac-
count the long-term, wide-spread empirical data from millions of uses in all aspects
of everyday me — from toothpaste to french fries. These aren't narrow studies. This
is real-life — and it must be taken into account.
FDA must view product approvals as a key element of consumer protection.
More broadly speaking, Mr. Chairman, our industry would also like to encourage
a fiindamental change m FDA's — and society's — view of consumer protection and
public health.
There are those who believe that consumer protection only means protecting con-
sumers from unsafe products — and that is certainly an important aspect oT this
issue. It is also one tnat we strongly support. But too often, we overlook another
important aspect of consumer protection. That is, consumers are protected when
companies bring forward new products that attack diseases that make people
healthier and that often save lives.
We believe FDA must realize that getting new, safe, and better treatments to the
bedsides of patients can be iust as critical in promoting better health, as keeping
unsaife products off the market. The fact is, we need both. This new focus should
become a central tenet of FDA's entire risk assessment philosophy and day-to-day
operations.
CONCLUSION
In conclusion, Mr. Chairman, such relatively arcane subjects as risk assessment,
absolute vs. reasonable assurance, and the details of legislative intent are some-
times overlooked in the heat and passion of the debate over breast implants. While
not dismissing in any way the importance of the breast implant debate, we believe
that these deeper issues nold enormous meaning for how and if new products are
developed, for whether innovation can continue to progress, and for whether pa-
tients— and future generations of patients — can continue to receive the implants and
other medical technologies they need.
Without a doubt, FDA has a clear obligation to calculate risks, or potential risks,
with regard to the safety of products. But as part of that, FDA should do everything
within its power to debunk junk science. If we are truly to protect public health,
we need an even-handed, objective, and rational FDA approval process that ulti-
mately rests upon sound science and common sense.
TTiere is no question that such an approach, with regard to the issues surrounding
silicone, requires the agency to stand up and reassure the public of the safety oT
silicone and use of silicone in all of its lorms. It is time for FDA to bring common
sense into its views on silicone and to accept the convincing, respected, and com-
prehensive evidence that is now available.
Attention to this and all the related issues we have raised today is not a luxury,
it is an absolute necessity. Nothing less than the future of patient health hangs in
the balance.
Mr. Shays. I thank you, Mr. Benson, as well as Mr. Hazleton.
Dr. Schultz, we would love to hear from you.
All three of your testimony — all two of your testimony has been
very interesting and generate a number of questions.
Dr. Schultz.
Dr. Schultz. Thank you. Mr. Chairman, distinguished members
of the subcommittee, my name is Jerome Schultz.
I'm president of the American Institute for Medical and Biologi-
cal Engineering, or AIMBE, for short. We are an independent pro-
fessional organization which is financially supported by member
dues and foundation contributions. The core of our group is com-
prised of 400 distinguished physicians, scientists, and bioengineers,
many of whom are responsible for the innovations that have made
the United States a world leader in medical device technology. In
addition, our institute can draw upon the talents of over 20,000 af-
filiated scientists/engineers.
185
Earlier Mr. Shays mentioned new and future biomedical prod-
ucts. Our members represent that future, and we are convinced
that we must participate in public policy if this future is ever to
be realized. There are technologies called gene therapv and tissue
engineering which will revolutionize the whole area of medical de-
vices, and we would like to get to that stage.
This morning I will briefly address two areas.
Mr. Shays. Did you say "this morning"?
Dr. SCHULTZ. That's right.
Mr. Shays. Is that what you actually said? Boy, we really misled
you. [Laughter.]
Dr. ScHULTZ. I was going to say, as a college professor, I'm pro-
grammed to speak for an hour, so I'll try to keep it to 5 minutes.
How can we, AIMBE, help in their evaluation and use?
Mr. Shays. Excuse me. Doctor. As one of your students, I'm pro-
grammed to listen only 5 minutes. [Laughter.]
Dr. Schultz. OK. First, I'd like to touch on the larger issue of
FDA regulation of medical devices. In our written testimony, we
offer specific suggestions for short-term and long-term legislative
improvements, and I won't go into those here, but we think that
you should consider those seriously.
Some brief comments on biomaterials. Over here on the table we
see many example of medical devices and biomaterials. Actually,
the modern area of biomaterials started with the development of
the artificial kidney after World War II, when it was shown that
blood could be detoxified by circulating it through dialysis tubing.
Over the last half century, while many improvements have been
made in dialyzers, still the fundamental problem with the
biomaterial still exists: It causes blood clots.
So, even after 50 years, we haven't had a material that works
perfectly. But most importantly, this major biomaterial deficiency
has been managed by the combination of physicians and engineers
developing anticoagulant therapy.
In general, biomaterials fall into two classes, so-called hydro-
philic and hydrophobic. What you have to realize is the human
body is like a sea of salt water, a very corrosive environment. And
the silicone material falls into the category of hydrophobic; that is,
it is sort of invisible to water or not water-wetting.
As a polymer of an inorganic material-sand-silicone polymers are
rather resistant to attack by enzymes. Silicone-based polymers
have been primarily used as a barrier or as a volume filler. An ex-
traordinary amount of research effort and practical experience has
been accumulated for the biomedical use of silicone polymers, and
I believe silicones could be modified to meet new needs or modified
to manage newly identified side effects.
Now, some brief comments on how we can help. Two major issues
loom: First, how do we balance our desire to deliver state-of-the-
art, safe medical devices when, in reality, the use of nonnatural
materials in the human body carries some degree of risk? The liti-
gious environment surrounding this issue hinders our scientific and
biomedical engineers from becoming involved. The proposed legisla-
tion in the House and Senate, as mentioned earlier, may reverse
this trend, and we support that legislation.
186
Second, how do we best use our bioengineering talent to provide
meaningful guidance to the manufacturers of devices and also to
the FDA in their evaluation of these devices for safety? Today
we've heard concerns about the strength of gel prostheses. This is
an engineering problem, and we are the group of engineers and
bioengineers who can help find that answer. But there's a gap be-
tween the FDA and the manufacturers on how to get this informa-
tion, and we can fill that gap.
So I make two proposals: First, we propose that a standing advi-
sory committee be established by Congress for the development and
continuous updating of our knowledge base for material implants.
This panel would be authorized to develop an equivalent to a phar-
macopoeia, but for biomaterials. The biomaterials pharmacopoeia
should have official status; that is, its procedures must be accepted
by the FDA as methods for testing and evaluation of implants.
Second, AIMBE also suggests that Congress mandate the use of
outside expertise groups from the FDA. These other expertise
groups, like those of our membership, can provide the technical re-
view of new medical devices. They would function like the peer re-
view groups of physicians that provide guidance for the treatment
of specific diseases or indications.
To operate effectively, however, our proposed biomaterial and
medical device advisory groups must be protected from legal entan-
glements. We would be pleased to provide you with some example
legislation that has been enacted at the State level for this pur-
pose.
Thank you for the opportunity to testify.
[The prepared statement of Dr. Schultz follows:]
Prepared Statement of Jerome S. Schultz, Ph.D., President, American Insti-
tute FOR Medical and Biological Engineering, and Director, Center for
Biotechnology and Bioengineering, University of Pittsburgh
Mr. Chairmen, distinguished members of the subcommittees, my name is Jerome
Schultz. I appear before you today in my capacity as President of the American In-
stitute for Medical and Biological Engineering (AIMBE). I am also Director of the
Center for Biotechnology and Bioengineering at the University of Pittsburgh.
A^BE is a national scientific and educational society representing approximately
400 members of our College of Fellows who are selected for their accomplishments
in bioengineering by an intensive peer review process. These physicians, scientists,
and engmeers have been responsible for many of the innovations that have led to
medical devices in this country. AIMBE also includes 12 biomedical engineering so-
cieties comprising over 20,000 engineers/scientists, and over 50 academic
bioengineering departments at universities around the United States. AIMBE is
supported primarily by member dues and contributions from foundations.
1 am delighted to have been invited to testify before you this morning, and will
address two areas. One, some information on materials designed for use in the body,
and how to improve the scientific flow of information and commercial possibilities
for these materials. And two, the larger issue of improving FDA regulation of medi-
cal devices.
In an effort to provide our technical and scientific assistance to the issues that
have surfaced on materials for implants and the regulation of medical devices, we
have been active on a number of fronts. We have chaired several meetings to review
the science related to implants and devices, we have assisted the Biomaterials
Availability Coalition in preparing position statements and we have supported the
National Institutes of Health in dr. Claude Lenfant's convening of a workshop on
biomaterials (to be held October 25-96 in Bethesda).
This written testimony includes AIMBE's suggestions for short and long term leg-
islative improvements of medical device regulation, which was developed over the
past year. I wish particularly to thank you, Representative Mcintosh, for your ad-
187
dress at our Annual Event this past March at the National Academy of Sciences,
which was most helpful to us in developing our position statement.
I. MATERIALS DESIGNED FOR USE WITH THE BODY
Although the average person may not be very aware of materials that are inserted
in the human body for medical purposes, the vast majority of American either make
use of sudh materials, or know somebodjr who has benefited from such materials.
Dental fillings, cardiac pacemakers, artificial ioints, vascular grafts, hydrocephalus
shunts, and hearing aids are just a few examples of an array ofcommercial products
that have b^n developed by engineers and scientists to improve the quality medical
care. The raw materials that make up these finished commercial applications in-
clude silicone, polyurethane, polyester, and other polymers. These raw materials
have come to be known as biomaterials, although in fact they are largely synthetic
products developed for numerous purposes, only a few of which are in the medical
and health care field.
The modem era of materials designed for use with the body started with the de-
velopment of the artificial kidney after World War II. Wilhelm Kolff, then a young
Dutch physician, showed the therapeutic effectiveness of circulating blood througn
dialysis tubing for the removal of toxic materials from the blood. Over the last half
century, many improvements have been made in dialyzers, still the biomaterial
problems have not been solved. Namely, the formation of blood clots on the mem-
Drane surface. This deficiency has been managed by physicians by temporarily ad-
ministering an anticoagulant during the dialysis treatment.
This example is given to make two points: 1) Even with 50 years of research we
cannot be assured that we can develop a perfect biomaterial that carries out the de-
sired fiinctions without some untoward biological response. 2) In spite of these defi-
ciencies, satisfactory solutions can be achieved by combining the talents of physi-
cians and bioengineers to make an eminently successful therapy.
In the last 25-30 years a strategy has evolved for the development of materials
for use in the human body. Simply stated, the strategy has been to deceive the nor-
mal defenses of the body to foreign materials by either: 1) engineering materials
that are seen by the bodys defense mechanism as similar to itself, or 2) engineering
a material that cannot be seen by the body.
Tlie tissues of the body can be thought of as operating in a sea of salt water, and
the recognition systems of the body operate in this milieu. Thus, the class of mate-
rials that are stable in water (hydrophilic = water liking) are a starting point for
developing materials that may be compatible with the body's biochemical environ-
ment. On the other hand, materials that do not mix with water (hydrophobic =
water fleeing) may be "invisible" to the body's defenses.
In the last decade, a new paradigm has been developing. This concept is to select
a material that serves as a nome lor a specific cell type, so that the body does not
see the material, but sees its own cells. This approach is one of the products of a
new field called tissue engineering.
Silicone-based polymers fall in the category of hydrophobic materials. In addition,
silicones have another advantage as implants, as a polymer of an inorganic material
(sand) they are rather resistant to attack by enzymes. One major disadvantage of
silicone polymers is that they generally have very poor tear resistance, and thus
fillers must be used to give strength. Thus silicone-oased polymers have been pri-
maiy candidates for biomedical applications where one was looking for a barrier or
a conduit. An extraordinary amount of research effort and practical experience has
been accumulated for biomedical use of silicone polymers and I believe they could
be modified to meet new needs and/or modified to manage newly identified side ef-
fects.
Two major issues loom:
First, how do we balance the need to deliver to the American public state-of-the-
art, sate medical devices when in reality the use of non-natural materials in the
human body carries a degree of risk? Current U.S. product liability law allows sup-
pliers to be held liable for truce damage awards even though suppliers have no di-
rect role in the raw material's ultimate use as a biomaterial. The liti^ous environ-
ment in ^e U.S. has led three major suppliers — DuPont, Dow Chemical, and Dow
Coming — to announce that they would limit, or cease altogether, their shipments
to medical implant manufacturers. Both the House and Senate have passed legisla-
tion (H Jl. 956, S. 565) that incorporates provisions to allow the suppliers of raw ma-
terials used to make medical implants to obtain dismissal, without extensive discov-
ery or legal costs, in certain tort suits in which plaintiffs allege harm from a fin-
ished medical implant. AIMBE supports these efforts to ensure patient access to
materials needed in the creation of life-saving, life-enhancing medical devices.
188
AIMBE encourages the appointment of House and Senate conferees to work out dif-
ferences in the two bills.
Second, how do we best use our bioengineering talent to provide guidance to the
manufacturers of devices and to the FDA in their evaluation of these devices for
safety?
Most of the leading scholars and practitioners in the field of medical device im-
Slants are members of AIMBE and/or our sister societies, including the Society for
iomaterials and the American Society of Artificial Internal Organs. Thus we, and
other scientific and medical societies, nave the capability to provide state-of-the-art
guidance to evaluation of research materials for implantation and their use in medi-
cal devices. We propose two specific actions to effectively use this resource base:
1) We propose that a standing advisoiy panel be established by Congress for the
development and continuous updating of our knowledge base for materials for im-
plants. This panel would develop a "pnarmacopia of materials" that would have offi-
cial status, that is, its procedures would be accepted by the FDA as methods for the
testing and evaluation of materials for implants. The operation of the Biomaterials
Steering Committee of the Health Industries Manufacturing Association for the de-
termination of equivalent materials for silicone rubber is an example of this type
of cooperative panel (see "Biomaterials Availability: Development of a Characteriza-
tion ^rategy for Interchanging Silicone Polymers in Implantable Medical Devices,"
Gould et al, Journal of Biomaterials, vol. 4, 355-358, 1993).
2) AIMBE suggests that Congress mandate the use of other groups, outside the
FDA, to provide technical review of new medical devices. This action would make
use of existing expertise in the medical and scientific community to brin^ their expe-
rience to bear on the complex issues associated with implanted medical devices.
These peer groups would be composed of physicians, scientists, engineers and
knowledgeable patient, industry, and government representatives. They would func-
tion in a fashion similar to the peer review groups of physicians that provide guid-
ance for the treatment of specific diseases or indications. A statute mandating such
activity could be modeled on current state laws providing for the medical peer re-
view activities (see, e.g., Rhode Island Code 23-17-25).
II. LEGISLATIVE IMPROVEMENTS OF MEDICAL DEVICE REGULATION
AIMBE has concluded that legislative reform of the regulatory process for medical
devices is in the national interest. Such reform is necessary in order to maintain
the innovation and competitiveness of the U.S. medical industry and the biomedical
research infrastructure. AIMBE has further concluded that reform can most effec-
tively proceed in two phases: a first set of legislative remedies which must be ap-
plied without delay to address the most urgent issues in the medical device approval
process; and a second set of legislative reforms incorporating a new paradigm for
device regulation. This approach must be developed jointly by the academic and
clinical communities, patients groups, the medical device industry, and government
agencies, and must acknowledge the iterative nature of device development, and in-
corporate the concepts of clinical accessibility, cost effectiveness, and system wide
longitudinal evaluation and surveillance. AIMBE, as a representative of the aca-
demic and clinical communities, urges congressional action to streamline FDA proce-
dures, foster constructive oversight, and harmonize the regulatory process with U.S.
trading partners around the world. AIMBE stands ready to oner its expertise to
lawmakers and regulators in improving upon the current regulatory framework.
Statement of the Problem
As noted by the White House Office of Science and Technology Policy in its 1995:
National Critical Technologies Report, "[m]edical devices ana equipment make a
major contribution to the health of the U.S. population and to the improvement of
quality of life for individuals. These technologies provide greater independence and
functionality for the elderly and the injured, allowing them to remain productive
men:^ers oi society longer, and contribute to the effectiveness of the U.S. health care
system. They also reduce the human costs of U.S. military actions by providing in-
jured soldiers with care on and off the battlefield and with more normal lives follow-
ing battle injuries."
The Administration has also recognized the need to streamline the FDA's regu-
latory requirements, in its April 1995 report. Reinventing Drug and Medical Device
Regulations, the White House has provided a review of current FDA procedures arid
suggestions for improvement. Many of the recommendations offered by AIMBE in
this position paper are consonant with the above document. However, there is a dif-
ference in the mechanism of implementation of changes. While the Administration
suggests addressing the issues by operational modifications within the FDA, AIMBE
prefers legislative action so as to prevent drifting of guidelines over time.
189
Technological innovation in the medical device fleld during the past 20 years has
been dramatic, touching the lives of virtually every American. The U.S. medical de-
vice industry that has served as the underpinning for this innovation has annual
sales of $40 billion, employs 270,000 workers, and accounts for a $5 billion trade
surplus. Its annual research and development investment is high at 7% of sales. It's
an industry that thrives on small, creative manufacturers — 90% of these firms em-
ploy fewer than 100 people. This is a business of new ideas: 80% of all the world
s devices developed in the past 40 years came from the U.S.
Until 1992, the medical device industry was the second fastest growing American
industry at 8.5% per year. Lately, however, the U.S. leadership position has begun
to erode. In 1980, the U.S. accounted for 64% of the global sales of medical devices;
by 1995, the U.S. share of global sales had dropped to 49%.
A number of factors threaten U.S. leadership in the medical device technology in-
dustry. Some of these — e.g., inadequate funding of biomedical research, the unavail-
ability of raw materials for the development ofproducts, the current product liabil-
ity system, reimbursement of costs associatea with investigational devices — are
vital, but lay beyond the realm of regulatory law, the focus of this position paper.
Several trends in the U.S. regulatory framework have impeded the ability of the
U.S. medical device industry to deliver new technology and products to patients.
These include: 1) significant FDA delays in reviewing and approving products,
which has decreased the competitiveness of the innovation-driven companies that
are the core of the medical device industry; 2) FDA focus on enforcement rather
than on constructive oversight, which has fostered a culture of hostility and obstruc-
tionism in FDA's dealings with industry; 3) export controls that bar U.S.-based com-
panies from exporting non-FDA approved devices to other industrialized nations
where their introduction is legal, thus providing companies an incentive to shift re-
search, clinical evaluation, development and production off-shore at the expense of
U.S. jobs and overall competitiveness; 4) the presence of a regulatory framework
that is based on outdated law that fails to compete with standards enacted in Eu-
rope and other industrialized nations; 5) delays in regulatory approval of safe tech-
nologies until efiicacy can be proven, which often results in reduced safety, lack of
{>atient benefits, and added health care costs; and, 6) scientific advances that have
ed to the development of new products of cell based, and tissue engineered prod-
ucts, that need a review and approval process of their own.
Implantable devices differ from drugs in several aspects, which make the current
FDA model of drug regulation ill-adapted to devices. This difference is particularly
significant in the context of implants, life-saving or life-supporting devices, which
have little in common with simpler, short-term medical products. It is therefore un-
realistic to apply the same regulatory framework to class I, II, and III devices.
Industry is not the only victim of current regulatory practice. There is a decided
ripple eriect. Bioengineers, material scientists, contract laboratories, university
grantees' engineering students and ultimately, health care delivery are affected as
well.
Manufacturers now faced with an unduly protracted and burdensome regulatory
system are committing their dollars for new technology and product development
outside the United States, This is resulting in the loss of incentives and support for
American academic researchers by our own industry. Current public oolicy thus
harms science and undermines the renowned technical infrastructure oi this coun-
try.
AIMBE recognizes that revision of FDA regulatory practices is controversial and
complicated. A well-functioning FDA provides assurance to both the public and to
industry. The public benefits by knowing that life-enhancing and life-saving prod-
ucts arriving at the marketplace are safe for their intended use. Industry benefits
from oversi^t by meeting world-class standards in product development. It is im-
portant that any reorganization of federal authority result in a process that has the
confidence of both the public and industry, and embodies the following philosophical
principles:
• product accessibility must be promoted by prompt regulatory action.
• technologies must be safe in the context of the disease process being treated.
• medical devices must fulfill their intended performance as described by labeling.
A. SHORT TERM LEGISLATIVE REFORM
1. Place oversight responsibility and authority for limited preliminary or inves-
tigative trials with duly-constituted institutional review boards (IRBs), not in the
FDA. This action would increase the level of peer review in the scientific aspects
of device development, and free up FDA resources for other oversight responsibil-
ities.
190
2. Drop barriers (i.e., no FDA preapproval) to the exportation of U.S.-made medi-
cal devices (except for banned devices) to industrialized nations, providing that their
import is not in conflict with the laws and practices of the receiving country. This
action would serve as a stimulus for compames to keep manufacturing jobs and cap-
ital within U.S. borders, as well as increase the trade surplus of the medical device
industry by making U.S. products available in those nations which have a market
demand for them.
3. The newly evolving tissue engineering products cannot be regulated either as
standard devices, as traditional biologies, or as conventional drugs. To allow timely
introduction of these new technologies into medical practice requires that the FDA
promptly implement a new approval pathway for this class of products.
4. Establish a third-party certification system by which medical device manufac-
turing facilities are inspected and product conformance is confirmed according to
processes controlled by international standards. These third-party experts would be
subject to FDA registration approval. This action would free up FDA resources while
promoting international harmonization of good manufacturing standards.
5. Make public and transparent all FDA guidance documents used in the review
of 51(Xk)8. This will provide manufacturers with the essential information that will
promote better and mster compliance with federal standards. FDA guidance docu-
ments should be developed jointly with input from industry and the clinical commu-
nity.
6. For setting testing and material requirements the FDA should utilize standard-
setting organizations such as the American Association for Medical Instrumentation,
the American Society for Testing Materials, and the International Standards Orga-
nization. These groups have assembled the appropriate standards for device and
material testing with appropriate input from the clinical, manufacturing, and regu-
latory communities.
7. Allow FDA to use third-party review of 510(k) submissions so they can meet
the mandated 90 day time period, and establish a system for all third-party review
of 510(k) submissions not acted on within the mandated 90 day time period. Such
actions will increase FDA flexibility to use peer review mechanisms, as well as pro-
vide immediate attention to those applications that are not reviewed in a timely
fashion.
8. Facilitate reclassification procedures for preamendment class III devices, espe-
cially mature products with demonstrated satisfactory performance in human use.
Decades of successful clinical use, even for high risk devices, can provide sufficient
proof for reclassification to a lower risk category.
9. Allow products under premarket approval to be commercially marketed as soon
as the PMA and a postmarket surveillance plan are approved. Currently many
months, if not years, pass after FDA approval of a PMA and the ultimate conamer-
cialization of the product. This would allow for controlled marketing of such devices
and the early generation of post-market surveillance data.
10. All FDA records with respect to a company should be made available to the
company on request. Companies should be informed if they are put in an excra sur-
veillance status.
11. Withdraw the previous FDA draft policy statement on industry supported sci-
entific and educational activities that will prohibit American industry support of
clinical conferences where off label uses of products are discussed.
12. In addition to these recommendations for implants and life-sustaining or life-
supporting devices, AIMBE supports certain changes for all class I and class II de-
vices, as follows:
a) exempt all class I devices from the premarket notification process (510K)
b) re-review all class II devices in terms of risk assessment and the
postmarket surveillance requirements of the Safe Medical Devices Act to reclas-
sify those devices with an established record of safe performance.
c) provide guidelines which allows manufactures increased options with re-
spect to the need to file 510(K) submissions for product modifications.
B. LONG-TERM LEGISLATIVE REFORM
Fundamental long-term regulatory reform is also required in order to maintain
U.S. competitiveness in the medical device technology industry. In the long term,
this must be accomplished by developing a regulatory process that is responsive to
changes in science and in the increasingly competitive global economy. Recent
changes in European law serve as a model for new regulatory approaches in the
United States. AIMBE believes that several hallmarks of European device regula-
tion warrant further study and incorporation, as appropriate, in U.S. law. Hall-
marics of the European approach include:
191
• Efficacy is a medical not a regulatory determination.
• Technical definition of "essential recruirements" for all devices as also detailed
in ISOA'R 14283, which was approved and published March, 1995. The Inter-
national Standards Organization has defined essential requirements" as the nec-
essary minimum requirements for labeling, preclinical and clinical testing, and the
safe manufacturing of devices to allow conunercialization. Legislatively mandated
classiflcation of products by risk. A regulatory process based on international stand-
ards.
• Independence of institutional review boards.
• Regulatory process implementation by independent third party accessors accord-
ing to mtemational standards.
• Unified electronic patient data collection systems. Postmarket surveillance by
authority (not by mandate). Mutual transnational recognition of approved products
which conform to global harmonized regulatory process.
AIMBE advocates a new approach to todays regulatory and liability conundrum
focusing UDon accessibility of technolo^ as well as relative safety and mtended per-
formance. New medical device legislation must be written to sanction true and com-
plete harmonization with the European medical device system. Without legislative
reform, large device companies with international capabilities will continue to move
their dinical trials, research, development, and manufacturing outside the United
States. Smaller companies will continue to perish. Harmonization and mutual
transnational recognition is the optimum solution — one that benefits American pa-
tients, researchers, physicians, manufactures, and ultimately our nation. Each of
these groups deserve, contribute to, trust in, and expect new technology.
Thank you for providing me the opportunity to testify. I would be happy to answer
any questions you may have.
Mr. Shays. Thank you, Dr. Schultz.
We have kind of hodgepodge here Mr. Benson, you represent a
lot of different companies that are in the same field that Dow Cor-
ning is in, but you represent other companies.
We obviously have a specific instance with your company, Mr.
Hazleton, of actually settling a case and getting out of the business.
I have to tell you, I wasn't surprised that you settled, but I was
concerned that you might have settled before it was really deter-
mined whether you were truly responsible.
And this may be a side question, but was the judgment of Dow
Coming that it was, in fact, responsible, or did they just decide,
based on the legal process, that ultimately it would have to settle?
If you would just refresh my memory, very briefly.
Mr. Hazleton. It was clearly a judgment that had a lot of busi-
ness content to it. And I would agree with you that we settled —
participated in the settlement — before there was any clear resolu-
tion of the legal responsibility and what the science was saying
about that, and how the science that has come through is being
played out in the legal process.
We felt we had no choice in that respect, because, in the space
of 3 years time, from the end of 1991 to the end of 1994, we got
to the point where we faced 20,000 lawsuits. And the financial li-
ability, much less the physical ability to manage that kind of a liti-
gation load, became such that it was just not possible to continue.
We have participated in trials. We've won as many cases as
we've lost. When the evidence is all presented, juries do a reason-
ably good job, I think, of trying to sort out very complex scientific
issues. But 20,000 is a lot of lawsuits to try to work your way
through,
Mr. Shays. How many cases actually were heard before you
made a settlement?
Mr. Hazleton. Before we made the settlement, there had been,
I think, about half a dozen that came to trial.
192
Mr, Shays. And the same basic evidence was presented in each
trial but with different conclusions?
Mr. Hazleton. Well, it varies from case to case as to the specific
circumstances, Mr. Chairman, but the basic issue of causation was
very oflen common, yes.
Mr. Shays. Now, you got out of the business. I mean, mavbe it's
an obvious question, but why did you get out of the business/
Mr. Hazleton. Well, we got out of the business because, again,
the litigation situation, even with the settlement — and as we've
seen, the global settlement which we're talking about has not
proved to be successful in resolving the issue — so, from a business
judgment and viability point of view for my company, it was our
conclusion that we could no longer participate in that business.
But it was also our judgment, based on the way things developed
after the FDA moratorium, that there was not going to be a viable
business for silicone breast implants, at least for the foreseeable fu-
ture.
Mr. Shays. How much did breast implants contribute to your
total revenue?
Mr. Hazleton. About 1 percent.
Mr. Shays. About 1 percent.
Mr. Hazleton. That s right.
Mr. Shays. Ninety-nine percent of your revenue came from other
sources.
Mr. Hazleton. That's right. About 3 percent of our revenue, in
total, comes from our participation in the medical field, the kinds
of devices that we've talked about today, and materials for uses in
those devices. And breast implants, as a subset of that, when we
were in the business, was never more than 1 percent.
Mr. Shays. Would a larger company, then, make a logical deci-
sion simply not to get in this area? I think of you having a factory
that operates, and 3 days out of a year the plant operates only to
make breast implants.
How much of your total operation was involved in breast im-
plants?
Mr. Hazleton. It would depend on how you measure, but it
would be roughly — it's a very minuscule part; your point is cer-
tainly valid.
Mr. Shays. OK So the bottom line is, there is no economic incen-
tive for you to stay in that business or for future manufacturers to
get into certain kinds of businesses like this, if it represents such
a tiny part of their total revenue.
Mr. ELazleton. I think that's certainly correct. If we had known
30 years ago, when we first got into the business, to the breast im-
plant business, what would develop out of this, no economic judg-
ment would have made sense to participate in that business.
Mr. Shays. Does a business that chooses to get into this area
have to separate from another business and start out as a small,
independent organization that would have what I'd call limited re-
sources?
Mr. Hazleton. Perhaps either Mr. Benson or Mr. Schultz is bet-
ter qualified to answer that. What I would say is that, from my
knowledge of the situation, I think it is an ironic fact that, at the
time when many consumer activists are saying we need to be sure
193
that there's a lot of high-quality research on these things, the only
companies that are able to go into these kinds of businesses and
see the risks are those that are small, thinly capitalized, startup
kinds of companies.
Mr. Shays. Doesn't the possibility that you had a settlement give
validity to those who think that silicone is, in fact, a dangerous
substance?
Mr. Hazleton. Certainly that has added to that perception.
That's one of the reasons that it made it a very difficult decision
for us. If I could just add a point to that, and it goes to the question
of what research did we do and what didn't we.
I was interested in Ms. Goldrich's point in response to the ques-
tion of future research. And if I paraphrase her wrongly, I apolo-
gize, but I think I caught what she said, "What do we do if the cur-
rent research, or the new research, replicates the previous fraudu-
lent research?" by her characterization.
Now, if, in fact, the current studies and the current science con-
cludes the same things that we have been saying about these prod-
ucts for 30 years, then if you believe that what we've been saying
about them for 30 years is fraudulent, you reach her conclusion
that there must be something fraudulent, I guess, with the current
research.
There is an alternative suggestion, or possibility, and that is that
if the current information is valid, it challenges the question as to
whether the previous research was fraudulent or not. And I'm very
willing to have the safety of my company's products and our rep-
utation stand on what the science says today and what inferences
people may draw about what our behavior and science, the quality
of that, was in the past.
Mr. Shays. We had three basic reasons — or four questions that
we, as a committee, wanted answered, and the last one is, finally,
what standards should guide the FDA in the quantification and
evaluation of the benefits and risks of new medical devices and
biomate rials?
You were here for most of the day, and are you of the same opin-
ion that a number of us are, that we're never going to come to a
conclusion if we continue the way we are, as it relates simply to
breast implants?
Mr. Hazleton. Well, I think the question that has been asked
many times with breast implants — and you could apply it to other
things — is, when is enough enough, and will we ever get to enough,
given the way the process works?
Mr. Shays. Well, I'm asking something more than that.
Mr. Hazleton. I'm sorry.
Mr. Shays. I'm asking really a question of— does the FDA have
an incentive to try to find a conclusion and resolve this issue, or
is allowing the system to just continue, ad infinitum, almost the
mind-set of an agency like the FDA?
Obviously, you have to interact with them in other ways, and I'm
not looking to have you criticize the FDA. I mean, they have
enough critics. I'm just trying to understand how we could change
the statutes or change the agency's attitude to bring resolution to
certain issues.
194
Mr. Hazleton. Well, I think you spoke to it well in the com-
ments you made in your interaction with Commissioner Kessler
this morning, Mr. Chairman. And I would agree, there is a mind-
set issue. And I'm not trying to just score points with the FDA, but
I would honestly say that it's not just with the FDA. I think there's
something in our whole — I don't know — the gestalt of how we're
dealing with this whole situation.
I was interested in a couple of things that Dr. Kessler said, and
I tJiink some of this testimony has referred to it, as well, when he
said that he felt it was important that the FDA stay out of the liti-
gation situation. Well, first of all, I can certainly understand why
ne would want to do that. Second, it is not, in my view, the FDA's
responsibility to resolve litigation situations.
But he gave a couple of examples. He gave, as Mr. Benson has
indicated, a pretty strong endorsement to the safety of the
Norplant product. And Dr. Burlington gave us a good chemistry
lesson, which I'm glad I didn't have to, on the difference in dif-
ferent kinds of silicones.
Mr. Shays. Let me say I'm going to have to interrupt you.
Mr. Hazleton. I'm sorry.
Mr. Shays. Just because I do feel that I'm going over my time,
and Mr. Barrett and others — I think we're going to have a vote
soon, and I'd just like you to conclude your point.
Mr. Hazleton. OK. He made a strong endorsement of Norplant,
and it's a different kind of silicone. As we meet today, the same
plaintiffs' lawyers who destroyed the breast implant situation are
now marketing the same kind of fear with respect to Norplant. And
they are not making the distinction that the Commissioner made
about different kinds of silicones.
Mr. Shays. Point well taken.
Mr. Barrett.
Mr. Barrett. Thank you, Mr. Chairman.
Mr. Benson, in your testimony you cite a number of products in
which silicone is used: deodorant, sun tan lotion, toothpaste, and go
on to state that the safety of silicone is tried and true. But isn't
the form of silicone used in those products different from the gel
that we're talking about here today?
Mr. Benson. Well, there are a variety of different types of sili-
cone. Again, I think the chart summarizes it very nicely. Basically,
three types: oil, which loses its fluid; gel, which is, just as the name
implies, a gel; and then the strongly cross-linked product known as
a solid. And a variety of those, also combined with other ingredi-
ents, go into making various products.
The point I wanted to make is that the very same basic material
that we are so concerned about on the one hand, you know, is like
the air we breathe and the water we drink on the other.
Mr. Barrett. But they are different products?
Mr. Benson. Well, they are different forms of the same product.
Mr. Barrett. So are you implying that the dangers that we were
seeing in the marketplace because of silicone gel are dangers we
can expect to see with respect to toothpaste or deodorants?
Mr. Benson. No, I would turn it and say just the opposite. I
think the dangers — I don't think we're seeing dangers with silicone
gel. I don't think we're seeing risks
195
Mr. Barrett. I'm talking about the marketplace reaction, your
reaction, the reaction of Dow.
Mr. Benson. Unfortunately, I think that may well be a function
of the fear that gets markets, that Mr. Hazleton referenced a
minute ago.
Mr. Barrett. Do you honestly think that Dow Chemical or other
companies that make products with silicone in them are going to
take them off the market?
Mr. Benson. I'm sorry?
Mr. Barrett. Are they going to take them off the market?
Mr. Benson. They are — other materials that go into medical de-
vices have been taken off the market.
Mr. Barrett. But I'm not referring to medical devices; I'm refer-
ring to toothpaste, deodorants, the things that you mentioned in
your testimony.
Mr. Benson. I don't know. I don't know. My point was not to stir
that fear but rather to point out that silicone is ubiquitous.
Mr. Hazleton. If I can just add to that, I would say that I cer-
tainly would hope that common sense would kick in somewhere
along the line on this. But, frankly, that's something we've been
concerned about, because 3 percent of our business is in the medi-
cal business, but if the whole thing is tainted, that's a concern for
all of us.
And if I may also just correct you on one point, which I suspect
was inadvertent, we're Dow Coming; we're the people that make
silicones. Dow Chemical is one of our shareholders, and they are
not in the silicone business.
Mr. Barrett. I understand. I apologize for making the mistake.
Mr. Hazleton, if we could turn to the settlement. So I have a bet-
ter understanding, there was a $4.25-billion settlement. Your con-
cern, as you stated it, was that — and you had plaintiffs outside the
class who continued to file lawsuits — ^you entered bankruptcy pro-
ceedings at that time. For those who are members of the class, are
they protected now that you're in bankruptcy?
Mr. Hazleton. Well, Congressman Barrett, I'm learning a lot
about the bankruptcy laws as we go.
Mr. Shays. Could we, for the record, just state, your liability is
$2 billion of this?
Mr. Hazleton. Our commitment to the original global settlement
agreement was to pay $2 billion into the total $4.25 billion.
Thank you, Mr. Chairman.
Mr. Shays. OK.
Mr. Hazleton. There are a lot of complex possibilities as to how
this will work out. There are now difficulties, as you may be aware,
with the global settlement itself that are independent of the fact
that we're in the Chapter 11 process. So how all of that is going
to play out together, and how all of that situation is going to be
resolved, has a lot of uncertainties to it at this point.
Mr. Barrett. OK But from your testimony, I inferred that the
reason that you did was because of — we can call them the inde-
pendent plaintiffs.
Mr. Hazleton. Yes.
196
Mr. Barrett. But it sounds to me now you're saying that there
are no assurances that the women who were part of that original
settlement are ever going to get their money; is that correct?
Mr. Hazleton. Excuse me. I was not trying to imply that.
Mr. Barrett. I inferred that. I'm not saying
Mr. Hazleton. What I'm saying is that there are a lot of uncer-
tainties about what will happen. Our intention, in our bankruptcy
process now, is to still try to find some resolution, including some
kind of a global settlement, a modification of the original one, per-
haps something different, but something which fairly and equitably
deals with all of the claims that are valid, of all women, those that
were members of the settlement class and those who are outside
of it.
Mr. Barrett. OK You talked about other products that Dow
Corning has sold, the shunt patients, heart valves, kidney dialysis,
insulin production. One that you didn't mention was the TMJ de-
vices. If you could just bring me up to date on the marketing life
of that device and what happened with that one.
Mr. Hazleton. Yes, let me try to, very briefly, both for reasons
of time and because I'll get way over my head on the biomechanics,
if I don't.
TMJ stands for temporomandibular joints. They are a medical
device that's used to correct deformities or other problems with the
jaw, and they are involved in load-bearing physics between the var-
ious parts of the jaw. And a number of materials have been used
for that.
Silicones have had some part in that, historically. We have never
recommended them for any device where they would be part of a
load-bearing with a lot of stress on it, because that is not one of
the properties of silicone that it can stand up to loads, and there's
danger of it bearing down.
There have been some few instances where doctors were using
those kinds of materials, along with others, that have resulted in
some product claims and lawsuits. It's a relatively small number
that silicone is involved in, and there are some controversies over
some of the other materials that have been involved in that.
Mr. Barrett: Mr. Hazleton, you seemed to indicate that, from
your standpoint at least, your frustration seems to be more with
the plaintiffs' bar than FDA; is that correct?
Mr. Hazleton. Yes, I think that's a fair characterization.
Mr. Barrett. And yours seems to be more with the FDA, your
frustration; is that correct?
Mr. Benson. I wouldn't say the frustration is with FDA; I would
say the frustration is with the whole system that we're facing in
the raw materials area. This thing you just brought up on TMJ
was responsible, in no small way, for causing DuPont to withdraw
from the raw materials market.
And I wanted to mention that, when Mr. Hazleton was talking
about getting out of the business, there are really two businesses
that I think Dow Corning is considering getting out of. One they
are clearly out of, and that's the manufacture of breast implants.
The one that principally concerns me is the raw materials that go
into making other people's medical devices, the shunts, and so on,
and that's the business that DuPont also has withdrawn from.
197
That's the scary part of this whole thing. When you put that to-
gether, it's a combination of, I think, FDA needing to make a
stronger pronouncement about the safety of these raw materials,
the relative safety of the raw materials, so that we can balance
risks and benefits. So it's a combination. Litigation, I think, genu-
inely drives FDA's concern.
Mr. Barrett. Mr. Chairman, if I could indulge for another 30
seconds or so, I would appreciate it.
Mr. Hazleton, I can certainly understand your frustration with
the plaintiffs' bar. If I had been in litigation of that size, I would
be frustrated, too.
At the same time, I guess I'm a little troubled by some of your
comments, because I, frankly, had not had much exposure to this
issue prior to today and heard Mr. Traficant this morning, who I
assume you heard go on and on about the need for full disclosure,
and then this afternoon read for the first time the document from
your company — I think it's from your company — where the cor-
porate medical director was concerned because one of his employees
was asked to destroy documents.
I certainly can't put those guys in the black hats if documents
are being destroyed in your company.
Mr. Hazleton. If I can respond to that, I'd be happy to. There
were no documents destroyed. We had an ethics process that, in
fact, worked in that situation. And I, coincidentally, was the chair-
man of our corporate ethics committee at the time of that incident,
so I was personally involved and knowledgeable about that.
We did look into it. Ms. Woodbury, at least initially, believed that
she had been asked to destroy documents. Mr. Rylee's contention
was that was not what he had requested and that this was a com-
munication that was going on through intermediaries across a dis-
tance. He was in Tennessee, and she was Michigan.
The conclusion of the committee was that it was a misunder-
standing, and, at the end of the day, no documents were destroyed.
She knew exactly how to bring forward her concern when she nad
it, how to deal with that through our ethics process. From my view,
it's a process that worked.
Mr. Barrett. OK Thank you very much.
Mr. Shays. Before I recognize Mrs. Morella, are all Dow Corning
documents regarding silicone safety now in the public domain?
Mr. Hazleton. As far as I know, certainly, Mr. Chairman, all
relevant documents that relate to the safety of our products, the
studies we've done, what those show, what they didn't show, are
now in the public domain, through some combination of the civil
litigation, the Justice Department investigation which went on for
2V2 years and concluded with no findings of bringing any charges
or indictments, the FDA PMA process, and various others. I believe
everything relevant is in the public domain at this point.
Mr. Shays. We specifically haven't made the request of asking
whatever Mr. Weiss asked you to ensure that all of that is before
this committee, because, knowing Mr. Weiss, it was probably a
great deal of information. We would only want it if we needed to
use it, but just so you know, we will just follow up on that one
point.
Mr. Hazleton. Certainly.
198
Mr. Shays, And if there is something that we think is pertinent,
we will ask you for it.
Mr. Hazleton. And we would be very happy to provide any of
that to you.
Mr. Shays. I thank you.
Mrs. Morella.
Mrs. Morella. We miss Mr. Weiss, too.
Thank you, gentlemen. I appreciated hearing about the criteria
and a reasonable assurance and the problem of the possibility — or,
you think, a reality — of the shortage of silicone. I guess I just have
a few questions I'd like to direct really to Mr. Hazleton.
Are your implants safe for long-term use in a female body?
Mr. Hazleton. I believe — if I can preface that answer with per-
haps referring back to another question that Congressman Trafi-
cant raised this morning regarding Mr. Rylee's testimony — as I un-
derstand it, and I have reviewed and I'm familiar with that testi-
mony, what he said in 1990 was that he believed, based on the sci-
entific evidence available at that time, that breast implants were
safe and effective for their intended use. I believe he also said that
certainly more studies and more could be learned as time went on.
I believe the same thing today and will state the same thing
today. And I think that, as we've heard today, there has been con-
siderable science that has developed since Mr. Rylee testified that
confirms that belief.
Mrs. Morella. Are you aware that silicone has a more severe re-
action in the body of a female rather than a male?
Mr. Hazleton. No, I am not aware of that.
Mrs. Morella. There are no studies that you've found that?
Mr. Hazleton. There are no studies that I'm aware of that show
any gender-specific reaction of silicone.
Mrs. Morella. And you have checked with the — women and men
have been tested so that you feel reasonably certain that that's the
case? I've heard to the contrary, obviously, and I'm very interested
in the fact that women have been kept out of so many of the clini-
cal trials and protocols, and, again, we've not tested some things
with men.
Well, knowing also that silicone gel migrates if there's a rupture
or a leakage of an implant, what testing has been done to deter-
mine what the effects would be of this migration?
Mr. Hazleton. Well, fundamental testing has been on the safety
of the materials that are comprised in silicone gel implants them-
selves. And it is known that certain low molecular weight — again,
it goes back to the chemistry lesson; a lot of different kinds of sili-
cones— low molecular weight materials, as with other things than
silicones, do migrate through the body.
But the fundamental conclusion is that there is no connection
that's been shown between silicones, certainly not the materials
that are in breast implants, and systemic disease. And I think
that's important, because the question of rupture that Dr. Kessler
raises is one that, as I said in my testimony, certainly deserves
more attention.
But that attention can be given in a considerably more rational
environment if we accept the assumption that silicone does not
cause serious systemic disease. If the assumption that has been
199
created by the litigation is that, whenever an implant ruptures or
the slightest amount of silicone moves from one part of the body
to another, that immediately sets up a terribly toxic, poisonous sit-
uation, then it's very difficult to address that issue rationally.
Mrs. MoRELLA. But have there been studies that have been con-
ducted that demonstrate this?
Mr. Hazleton. There have been studies of silicone, various com-
ponents, various types of silicone, various chemical constituents
and what rate of migration — what degree of migration occurs. And
that phenomenon has been studied, has been documented, and has
been available to the FDA throughout the history of the products.
Mrs. MoRELLA. I thank you, gentlemen.
In the interest of time, I yield back so that Mr. Fox can ask any
question. Thank you, Mr. Chairman.
Thank you. We look forward to your comments about how we can
resolve this whole situation, too, at the end of this hearing.
Mr. Shays. I thank the gentlewoman and call up Mr. Fox to end
up this hearing.
Mr. Fox. I just have a couple of questions, Mr. Chairman. I ap-
preciate the committee's indulgence and the panel.
We heard some allegations earlier about problems in children of
women who have implants. Would you respond to those allega-
tions?
Mr. Hazleton. Yes, I'm really glad that question came up. In
fact, I was trying to figure out a way to play on your invitation to
correct the record, if it didn't get asked specifically. I think Ms.
Russano raised a very important question, and certainly it is our
responsibility to answer that question.
I will confess I'm a little nervous about doing it, honestly, be-
cause, when I do so, I will perhaps make myself vulnerable to a
perception that I'm not sensitive to children s illnesses or, worse
yet, maybe that I'm not as sensitive to the illnesses of Ms.
Russano s children as I am about Tara Ransom. That's not true. I
am very concerned about illnesses with those children, and that's
why I'm willing to take that risk and be a bit direct in my re-
sponse.
To me — and it comes back to the fundamental issue of the hear-
ing— to me, the great tragedy of the breast implant situation is the
amount of fear that has been caused by what I believe is unsound
science related to the litigation situation, or however it came about,
but the fear that's been created in women about illnesses caused
by their breast implants.
If we let the same thing happen with the children of women with
breast implants, we all ought to be ashamed of ourselves. If you
will indulge me for a second, I'd like to read to you a few sentences
from what the British health authorities have said — this is not
what Dick Hazleton thinks, not what Dow Coming thinks; this is
the British equivalent of the FDA — and their commentary on the
studies that Ms. Russano referred to, by Levine and Illowite.
Quoting now, "There are, in fact, a number of significant defi-
ciencies in the study which prevent any valid conclusions being
drawn. These include use of a highly selected group of patients
with bias evidenced at each stage of selection, inadequate controls
in terms of numbers and matching, inadequate numbers inves-
200
tigated, inaccuracies in clinical correlations, lack of evidence that
abnormalities were clearly significant, lack of corroborative evi-
dence, the affect of any anesthesia agents used on esophageal mo-
tility, inappropriate statistical methods, and lack of any evidence
that silicone was present in milk or ingested.
"In spite of the widespread publicity generated by this paper, it
is of no value in assessing the health effects of silicones."
Mr. Chairman, Mr. Fox, if there are legitimate questions to be
raised about the health of children and silicones, by all means we
should investigate them. But if we let that kind of science create
an environment — and I'm not making this up — where a television
reporter can seriously suggest that pregnant women should con-
sider an abortion because they have breast implants, then I don't
know how to cope with that as a businessman or a father or a citi-
zen of this country.
Mr. Fox. If I could just follow up with one last question. I appre-
ciate your indulgence.
We found in the testimony today — and I think it was a frustra-
tion to the chairman as wen as the rest of panel on both sides of
the aisle — there was no causal connection, as far as I could tell, be-
tween silicone breast implants and connective tissue disease. And
the FDA wants yet to continue studying this topic for some time.
My trouble, and I think that with the committee is, whether its
silicone breast implants or drug approval or disapproval, the public
needs more prompt resolution of tnese issues. In my view, if the
FDA were in charge of the Apollo 13 instead of NASA, then they
would still be circling the moon.
My concern, not only for the breast implant but, frankly, with
other devices that we have, medically, before FDA, how many will
fro overseas, with loss of the medical benefit to our patients and
oss of the jobs that go with it, to the United States, if we don't
have a speeded-up process and resolution of issues by FDA.
Do you have a response to that?
Mr. Hazleton. I think you raise very good, very valid questions
that we all need to be asking ourselves. The question is fundamen-
tally, as it's been said several times today, when is enough? I be-
lieve, in the situation of silicones and silicone breast implants, we
have enough information. And, like Mr. Benson, I was encouraged
by many things Commissioner Kessler said this morning.
Mr. Fox. Thank you very much.
Mr. Shays. I would like to thank our three panelists. But, Dr.
Schultz, I want to explain whv you weren't asked questions. I think
your basic message is quite clear to us, that you're saying that any
substance introduced to the body is going to have a reaction. And
I guess my only question to you would be, is there a better material
otner than silicone that you icnow of for breast implants?
Dr. Schultz. I couldn't really respond. I'm not that expert in the
area. Let me just make, if I could, a comment.
Mr. Shays. You may. You stayed awake during the whole time
we asked the other gentlemen questions. So that's all right.
Dr. Schultz. It seems to me that there is a disconnect between
the need for information and the generation of information. The
FDA appears to rely on industry to provide information through
their applications. Yet, now in tnis litigious society, you may not
201
have companies coming forward with products. If you don't have a
company coming forward with products, they never get the infor-
mation.
So it appears, in this environment, that there has to be another
g^oup which can generate the information and can assess the infor-
mation.
Mr. Shays. There is a gigantic disconnect, and I came with cer-
tain preconceptions. The one that I had the most difficulty accept-
ing is why we wouldn't see materials for other uses, medical uses,
why they wouldn't still be forthcoming. And I think this hearing
has satisfied that question.
I mean, I think it's a given that if we don't resolve this, not only
are we going to have a continued problem with silicone breast im-
plants and this never-never land of resolution, but I'm absolutely
convinced that other very necessary medical devices will slowly dis-
appear from the market. And I'm absolutely convinced that you're
not going to see new manufacturers get into this field in the way
that we need to unless we resolve this.
This is why the FDA needs to be more proactive in helping us
understand how we can help the industry provide benefits to the
public.
So this has been a very interesting hearing for me. It wasn't like
church where sometimes my mind may disappear slightly over cer-
tain times. I was connected the whole time. I thank you.
This hearing is adjourned. I thank all the Members.
[Whereupon, at 4:35 p.m., the subcommittee was adjourned, sub-
ject to the call of the Chair.]
[Additional material submitted for the record follows:]
Prepared Statement of Hon. Ed Pastor, a Representative in Congress From
THE State of Arizona
This morning, the Subcommittees are turning their attention to an issue which
is of great concern to me, the continued availability of raw materials, or
biomaterials as they are called, for life-saving devices.
Due to a limited market, low profitability and the real potential of very high legal
costs in defending against lawsuits, the manufacturers of these biomaterials, which
go into medical devices such as heart valves and heart pacemakers, are no longer
able to produce them or are considering removing them from the market. As such,
these devices will no longer be available to those that need them to survive.
Today, you will hear from a constituent who brought the issue home to me. Eight
year old Tara Ransom of Phoenix, Arizona, suffers from hydrocephalus. She is kept
alive by a medical device called a hydrocephalus shunt, which allows excess brain
fluids to be drained into the abdomen. As she grows, this shunt will need to be re-
placed periodically, and without it, Tara will die. I hope, for Tara's sake, any deci-
sion on the safety of silicone is based on sound science.
Today you are discussing silicone and the question of their continued availability.
Silicone is one of the most basic raw materials and is contained in over 2,000 medi-
cal devices — devices which enable many people worldwide to enjoy healthy and pro-
ductive lives. Making silicone unavailable for medical devices would be devastating
as there is no known substitute. A wide range of medical devices are made with sili-
cones and are used in the medical profession by a multitude of specialties including
ophthalmology, neurology, and cardiology.
Last year, I asked my colleagues to support me on this issue by requesting that
they co-sponsor the "Biomaterials Access Assurance Act" and I am pleased to report
its provisions were supported by the House earlier this year. This issue remains on
the agenda of many Members of Congress, and I only hope that continued availabil-
ity of biomaterials will enable Tara and others like her to live long and fulfilling
lives.
202
Prepared Statement of Thomas D. Talcott, Former Employee, Dow Corning
The speakers list for subject Congressional Hearing (as of 5 PM July 27, 1995)
indicates that there is a serious iinbalance between supporters and critics of sili-
cones as safe biomaterials. The critics of silicone are continuing to make very signifi-
cant strides in understanding the biochemical pathways of silicone related disorders
and how it ailects human health. Those familiar with the activities of the speakers
and the issues will recognize this imbalance with supporters in the majority.
It will be very interesting to hear from Congress as to their concept of the nature
of the real issues currently confronting the severely ill men, women and children
of the world. Many children, yet unborn, are victims at birth due to the lack of
warnings that silicones can aiTect children by crossing the placential barrier and/
or also contaminating the mothers' milk. Based on my 43 years of experience with
silicone and related medical devices, I see the following issues:
Physicians and surgeons involved with silicone gel-filled breast implants have
been confronted for years by patients with a wide variety of symptoms which did
not fall nicely into known disease categories. The medical community was unable
to understand how silicone could cause such a wide variety of symptoms. They sug-
gested that these troublesome patients seek psychiatric help. Ine patients bounced
From physician to physician without fmding helpful response.
In 1990, Congressional hearings by Ted Weiss helped expose that silicone gel-
filled implants caused disease. Prior to that time, Dr. Vasey had also convinced him-
self and other colleagues by clinical experience that silicones were causing disease.
At one hearing, I personally demonstrated the mechanism of device rupture where-
by fluid gel is exposed to tissue and also how silicone fluid bleeds from the device.
Drs. Anderson, Kossovsky and Blais have also testifled concerning the risks of gel-
niled breast implants. In reality, the lawsuits came later, initiated by women when
they realized the cause of their disease.
THE HEALTH EFFECTS OF SILICONES ON HUMANS
The health of affected men, women and children is becoming better understood
by many clinicians in the specialities of Rheumatology, Neurology, Immunology, Pe-
diatrics and Toxicology. Tests concerning the understanding of the biochemical path-
ways, including the effects of silica from the metabolization of silicone (Dr. Garrido)
and new immunological tests using patients' lymphocytes (Dr. Smalley) indicate
that silicone related disorders in symptomatic humans and children are very real.
Very significant health concerns were expressed at the National Cancer Institute/
NIH, Immunology of Silicones Workshop, March 13-14,1995. Two days were allo-
cated to discussing the safety and causation of silicone diseases. Two concerns in-
cluded plasmacytomas caused by silicone gel but not by simple silicone fluids and
precursor conditions leading to multiple myloma. Many of the speakers and authors
at the NCI workshop should be included in these hearings before they are oflicially
concluded. Other professionals that should be heard include those who wrote letters
to the editor of the New England Journal of Medicine regarding the Gabriel/Mayo
epidemiological study.
Thousands of destitute women are unable to pay to have their breast implants
explanted to help in the resolution of their diseases. Should not some Federal Agen-
cy come to their assistance, or, how else can they be helped? There are case reports
of suicides by distraught women.
The continual denial by manufacturers, medical professionals and FDA as to the
migratable small silicone molecules causing chronic inflammation leading to silicone
disorders, allows additional human exposure to toxic silicone poisoning to continue
world wide. The start of immunological response and problems is the ingestion of
the small migratable silicones by phagocytic cells.
It seems that a report is due on the FDA's critical need program. Such a report
now, however, would be untimely because low bleed implants are time bombs with
a much longer fuse than those which have caused current illnesses. Individuals in-
terested and concerned about the technology should study Volume 4, Number 1 of
the International Journal of Occupational Medicine and Toxicology. The authors of
the articles in this special issue on silicones and disease should also be included in
these hearings before the hearings are oflicially concluded.
The risk of individual silicone devices causing disease is difficult to assess because
of the extended incubation time for silicone related disease to occur. The use of a
wide variety of silicones with many and different small migratable chemicals con-
tributes to the difficulty and uncertainty of assigning risk of disease. Breast im-
plants are likely just the tip of the total iceberg of silicone poisoning.
203
A Table of Silicone Migratables in Typical Devices
Device Migratables Commeiit
Gel Breast Implants 1.5 to 28% of gel weight More data should be collected. The
amount of vinyl containing small
molecules is needed.
Saline infiatables To 20% of device weight 1.2% is macrocyclics & linears.
Most solid devices 4 to 6% of device weight Need more data on specific devices
and tubing.
It would seem to be conunon sense that devices used at early ages in devices such
as breast implants and Norplant should have warnings as to the development of sili-
cone related diseases. At age 50 to 75 the use of siUcone containing implants may
be justified since the patient is likely to die of causes other than silicone related
diseases.
Many medical professionals and Congressmen are concerned about the availability
of silicone for life saving and other critically needed medical devices. Legislation is
under consideration to exempt materials manufacturers from final device liability.
Since studies are indicating that extractables are one of the main explanations of
silicone related disorders, it seems that the technology of non-equilibration polym-
erization (used commercially for fluorosilicone products in 1958) should be used for
true medical grade silicones. The new immunological tests, where lymphocytes rec-
ognize extractables and metabolites, should also Be used as a method of sorting out
those materials which are the least toxic for use in medical devices.
Warnings about the amount of migratables and their chemistry should be re-
quired on the labels of all materials used in medical devices. Toxicological testing
of the extractables from medical devices and material components should also be re-
quired by FDA. Research will respond to such requirements by producing more suit-
able materials once the need is recognized by a ni^ percentage of surgeons, regu-
lators, end users and manufacturers. Additional research is also needed to prove
filler treatment chemicals are permanently in place and not leachable from the ma-
terials when implanted in tissue.
Joint Prepared Statement of the American Society of Plastic and Recon-
structive Surgeons, the Plastic Surgery Educational Foundation, and the
American Society for Aesthetic Plastic Surgery
The American Society of Plastic and Reconstructive Surgeons (ASPRS), the Plastic
Surgery Educational Foundation (PSEF), and the American Society for Aesthetic
Plastic Surgery (ASAPS) are pleaised to have this opportunity to provide comments
on the Food and Drug Administration's approval and enforcement standards for
medical devices, including silicone gel breast implants.
The ASPRS is the national medical specialty society for plastic surgeons and rep-
resents 97% of the approximately 5,000 board-certified plastic surgeons in the Unit-
ed States and Canada. Most American women who seek either cosmetic or recon-
structive breast surgery are treated by our member plastic surgeons.
The Society's research and clinical member-education activities are managed by
the PSEF, which also monitors ongoing breast implant research and provides re-
search funding for a variety of subjects, including over $2 million dollars for breast
implant research. PSEF research grant awards are the result of an open and com-
petitivejprogram patterned after the NIH grant review process.
ASAF*S was founded in 1967 to provide Doard-certified plastic surgeons with addi-
tional opportunities for continuing education and research in aesthetic (cosmetic)
Elastic surgery. ASAPS has approximately 1,100 members who are elected to mem-
ership basea on a demonstration of their special interest and wide experience in
performing aesthetic procedures.
Since the FDA's active review of silicone gel-filled breast implants began, our or-
ganizations' relationship with the agency has evolved from an adversarial one to a
more collaborative working relationship, which we value.
Much of the tension in those earlier days stemmed from the fact that the FDA
had no established process for allowing input from the medical community. Rec-
ognizing that the Agency's defined process for review of medical devices excluded
parties other than the FDA, the manufacturers, and the FDA's expert advisory
panel, the ASPRS sou^t and obtained permission to present testimony at the FDA
General and Plastic Surgeiy Device Panel hearings that took place in November,
1991 and February, 1992. We believed that the Panel needed to hear about plastic
204
surgeons' thirty plus years of clinical experience with silicone breast implants and
to hear from experts in the fields of oncology, radiology, immunology, teratology,
psychology and psychiatry.
After the November panel hearing, the Society filed a Citizen Petition ^ requesting
that the FDA continue to make the silicone gel implant available because the device
was necessary for the public health. In its petition, the Society analyzed the sci-
entific literature, the benefits and the known and speculative risks of silicone breast
implants. The Petition supported the conclusion of the FDA's Advisory Panel, which
on November 14, 1991, unanimously voted to keep silicone breast implants available
for general use. The Panel concluded that the continued availability of the device
was necessary for the public health.
Despite the Panel's unanimous recommendation that silicone gel implants remain
widely available, Conunissioner Kessler on January 6, 1992 declared a moratorium
on the sale and distribution of the implants. He called for another meeting of the
General and Plastic Surgery Device Panel to review "new information" on the safety
of the device.
Plastic surgeons were particularly troubled that the FDA's action seemed to be
unduly influenced by documents from the well-publicized case of Hopkins v. Dow ^
decided in December, 1991, and by anecdotal reports from physicians based more
on conjecture than science. In the Hopkins case, the jury came to a number of
alarming conclusions that were not scientifically validated. It was disturbing that
a lay jury's verdict seemed to carry more weight than the original FDA Advisory
Panel's considered scientific opinion.
"Junk science" is occasionally used by plaintiffs' attorneys to help sway jurors in
medical malpractice cases. However, we do not believe it should have any influence
on the FDA's actions and decisions — rulings that may affect the lives and health of
millions of Americans. A jury may be influenced by factors other than scientific in-
formation in reaching a verdict. The FDA should insulate itself from decisions
played out in the legal arena, particularly those based on evidence of questionable
reliability, because of the significantly different criteria in meeting scientific versus
fecal standards of proof.
Cases like Hopkins v. Dow underscore the pressing need for product liability re-
form, as the publicity surrounding the multimillion dollar punitive award helped
spur an onslaught of breast implant litigation and a $4.75 billion global settlement.
The majority of the lawsuits alleged that the implants caused connective-tissue dis-
ease, a claim that has not been substantiated by recent research findings.
Nevertheless, the breast implant litigation frenzy has now given rise to a new
wave of liability concerns and lawsuits against suppliers and manufacturers of med-
ical implants of all types — artificial joints, heart valves, shunts, etc. The litigation's
draining effect on manufacturers and suppliers may soon cause severe shortages in
some frequently used biomaterials, and might force smaller and more innovative
companies to abandon the market. Our organizations support the product liability
measures recently passed by the House of Representatives to help protect these
often life-saving devices.
Much of the case against silicone-gel implants revolved around "unanswered ques-
tions"; a demand for hard data proving substantial benefits to patients; a suggestion
by some that, particularly in the case of cosmetic patients, any risk would be unac-
ceptable; and a lack of scientific evidence establishing the safety of implants beyond
a doubt. Although plastic surgeons argued that the vast majority of implant patients
were happy with the device, the implant had a clinical safety record spanning more
than 30 years, and had received concurring reviews from distinguished
rheumatologists and immunologists, the FDA requested more information.
Now that some of the FDA's "unanswered questions" are being answered with
hard science, we are pleased to see that medicine's views about the device's safety
are being validated. A number of significant studies have been completed since the
Agency's review, bringing reassurance to breast implant patients and to the medical
community.
This past June, the results of a large cohort study published in the prestigious
New England Journal of Medicine found no association between silicone breast im-
plants and connective-tissue disease. The study, which searched for signs and symp-
toms for 41 types of connective-tissue disease among 87,501 nurses, determined that
^Citizen Petition to the FDA by the American Society of Plastic and Reconstructive Surgeons,
requesting that silicone gel-filled breast implants remain available as the device is necessary
for the public health, Nov. 20, 1991.
^Hopkins V. Dow. NDCA. Civ. No. C 88-^703.
205
on the whole, women with implants were actually less likely to have signs or symp-
toms of these types of diseases.^
Later that same month, the FDA announced the results of a study that tested the
potential cancer risk of polyurethane-coated breast implants, which were manufac-
tured until April of 1991. There was some fear ana speculation that the poly-
urethane coating on the implants could break down and cause cancer by releasing
a chemical known as "TDA". The FDA's report on the research states, "It is unlikely
that even one of the estimated 110,000 women with polyurethane foam-covered im-
plants will get cancer as a result of exposure to the TDA."'*
A numjber of European governments are also standing behind the safety of silicone
gel breast implants. These devices are currently available in all European countries.
After reviewing all available breast implant data published between the end of 1991
and the middle of 1994, the United Kingdom's Department of Health and Medical
Devices issued a report stating, ". . . there is no evidence of an increeised risk of
connective-tissue disease in patients who have had silicone gel breast implants."®
France and Italy both lifted their moratoriums on the use of the devices in Janu-
ary of this year, m Germany, Belgium and the Netherlands, no ban or moratorium
was ever introduced.
We recognize that the FDA's evaluation of silicone implants was a diflicult one.
It was difficult for everyone — patients, plastic surgeons, the medical community, the
Agency and the manufacturers of the device. WhUe it is regrettable that more sci-
entific data were not available at the time of the FDA's review in 1991 and 1992,
the studies now are confirming the positive experience of the plastic surgery com-
munity and the vast majority of implant patients.
Today, the ASPRS, PSEF and ASAPS are working with the FDA and the manu-
facturers of the saline-filled breast implant, also a Class III device, in preparation
for the agency's review of that device. Communication with the plastic surgery com-
munity has been established, and we are heartened that the FDA is taking steps
to include the medical community in this more "physician-friendl/' process. We hope
that any reforms of the FDA will strongly support and encourage input hom the
medical community in the agency's evaluation of medical devices.
Prepared Statement of Leslie Lilienfeld DeHoust, Co-Founder, Eastt Coast
Connection
"A baby nursing at its mother's breast. It is an image of tenderness, love, security.
But for many mothers — those who've had their breasts enlarged with silicone im-
plants— it may become an image of fear." Those of you who saw the July 1995 issue
of Redbook will recognize that statement. It was the opening of Amanda Spake's ar-
ticle which featured the work of C.A.T.S. and profiled two mothers, James Russano
of New York and P.J. Brent of Atlanta. It is the parallel saga of two women who
believe that they unknowingly transmitted their silicone induced autoimmune prob-
lems onto their children, in uterom and again by breast feeding. It is the story of
a medical profession at a loss for explanation and treatment. It is the prognosis for
a new generation of young women and their future offspring if what we propose
here today goes unheeded.
I am co-lounder of East Coast Connection, a local silicone survivors support net-
work (New York and New Jersey) and I am here today in support of all of our
500,000 afllicted women and their children. We beseech you to heed the testimony
of Jama Russano, founder of C.A.T.S. and of Sybil Goldrich, co-founder of Command
Trust Network. To date, C A.T.S., alone, has gathered information from over 4000
women and children exposed to silicone. CA.'T.S.' research has assisted Drs. Jere-
miah Levine and Norman Illowite to author the January 19, 1994 JAMA article,
"Sclerodermalike Esophageal Disease in Children Breast-Fed by Mothers with Sili-
cone Breast Implants." 'Hie answers to our fears are slowly becoming manifest. We
now realize that historically everything we were advised about this substance has
been proven false:
A. It is not biologically inert. It is, in fact, a strong adjuvant, provoking immune
response.
3 Sanchez-Guerrero, J. et al. Silicone Breast Implants and the Risk of Connective-Tissue Dis-
eases and Symptoms. NEW ENGLAND JOURNAL OF MEDICINE. 332:1666-1670, 1995.
* Update: Study of TDA Released from Polyurethane Foam-Covered Breast Implants. Food and
Drug Administration, June 27, 1995.
•Gott, D. et al. Evaluation of Evidence for an Association between the Implantation of Sili-
cones and Connective Tissue Disease. United Kingdom, Department of Health, Medical Devices
Agency, Dec. 1994. ISBN 1 85839 347 7.
206
B. It does transcend the placental barrier and has been found to atrophy the re-
productive organs of test animals.
C. Birth defects in tests animals have been recorded.
D. It has been used as, and in fact seems to be, a potent synthetic estrogen.
E. Silicone implants do not last a lifetime. Rupture rate is closer to 100% than
to the proported 5%, after a decade of use. Once lose from its silicone elastomer
shell, the gel is no different from liquid iryectable silicone, banned by FDA.
F. It's best application seems to be as an insecticide to annihilate the roach popu-
lation.
As we stand here before you, in mid 1995, more than 30 years after the introduc-
tion of these unregulated devices, we beseech Congress to support FDA in continu-
ing the ban of these same devices. We applaud Dr. Kessler in his steadfast position
on FDA's denial of approval to a device which has not demonstrated adequate safety
data. We cannot assure any more unsuspecting women of the ASPRS' (American So-
ciety of Plastic and Reconstructive Surgeons) claim that these devices are "perfectly
safe and will last a lifetime." We cannot assure expectant mothers that their chil-
dren wUl be bom safe. We cannot lead a new generation of young; women down the
garden path to illness and disability.
There is a considerable difference in placing an experimental and possibly dan-
gerous device into the body of an older woman who understands the risks and offers
informed consent because she has been revaged by a cancer which may kill her in
time. But, why should we allow teenagers and young women, only in their twenties,
to be compromised by the time it takes to wear an implant to rupture? Why should
we allow another generation of American children exposure to a chemical hazard be-
fore they are even bom?
If you chose to believe the testimony you hear today by the advocates of the uses
of silicone breast implants, you need to explain to us why thousands of documents
which incriminate the manufacturers of these devices have been shredded or hid-
den. In late 1990, shortly after the much publicized Connie Chung expose, a Dow
Coming internal memo (introduced to this hearing by Congressman James Trafi-
cant) dleged that two company executives ordered the destruction of internal re-
ports documenting a far higher complication rate for silicone breast implants than
the company publicly acknowledged. The incident went right to the top of the cor-
Ssration, involving both senior litigation attorney and Robert Rylee himself. A Dow
oming research scientist was asked to destroy all copies of a memo containing a
data analysis of a National Center for Health Statistics Survey of Surgical Device
complication rates, and the implant issues that sununarized the overall scope and
current status of epidemiology projects for the Health Care Business's Mammary
implant products. It was Robert Rylee who made this request.
Congressmen and women, Dr. Kessler, ladies and gentlemen, I submit to you that
as Mr. Traficant alleges, there has been egregious wrongdoing and immense harm
done to American women and children by allowing the use of these unapproved de-
vices. I allege that these same companies who have profited from our misfortune
are now manipulating the legal system to deny us our in court and to deny their
own responsibility for reckless disregard of human welfare. We must punish these
wrongdoers. We must have medical research dedicated to helping us and our chil-
dren to heal. We must be compensated and made whole economically or the burden
of our maintenance will fall on the American social security and welfare systems.
We must participate in the democratic process. We must make our country safe for
future generations to be bom healthy. We must be given "equal justice under the
law."
If you discount our message here today, ladies and gentlemen, you will be partici-
pating in the perpetration of an historic sham like the Watergate scandal which
Drought down a presidency and like the facist propaganda campaign which tried to
tell uie world that there was no holocaust. These lessons of history teach us that
the truth wins out and that we must honor those who survive least we allow our
darkest deeds to be repeated.
o
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