Table Of ContentFDA REGIMTION OF MEDICAL DEVICES,
INCLUDING THE STATUS OF BREAST IMPLANTS
Y4.G 74/7: M 46/13
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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
1995
1,
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Printed for the use of the Committee on Government Reform and Oversight
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U.S. GOVERNMENT PRINTING OFFICE
ForsalebytheU.S.GovernmentPrintingOffice
SuperintendentofDocuments,CongressionalSalesOffice,Washington,DC 20402
ISBN 0-16-052222-6
REGUUnON
IDA OF MEDICAL DEVICES,
INCLUDING THE STATUS OF BREAST IMPLANTS
4.G 74/7: M 46/13
"'""'"" HEARING
'' ""'"irr;:
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 1995
1,
^'^U^K-
Printed for the use of the Committee on Government Reform and Oversi^t
'^^,
U.S. GOVERNMENT PRINTING OFFICE
ForsalebytheU.S.GovernmentIMntingOffice
SuperintendentofDocuments,Congressional SalesOffice,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 CARDISS COLLINS, IlHnois
DAN BURTON, Indiana HENRY A. WAXMAN, California
J. DENNIS HASTERT, lUinoiB TOM LANTOS, California
CONSTANCE A. MORELLA, Maryland ROBERT E. WISE, JR., West Virginia
CHRISTOPHER SHAYS, Connecticut MAJOR R OWENS, New York
STEVEN SCHIFF, New Mexico EDOLPHUS TOWNS, New York
ILEANA ROS-LEHTINEN, Florida JOHN M. SPRATT, JR., South Carolina
WILLIAM H. ZELIFF, JR., New Hampshire LOUISE MCINTOSH SLAUGHTER, New
JOHN M. MCHUGH, New York York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida GARY A. CONDIT, California
PETER BLUTE, Massachusetts COLLIN C. PETERSON, Minnesota
THOMAS M. DAVIS, Virginia KAREN L. THURMAN, Florida
DAVID M. MCINTOSH, Indiana CAROLYN B. MALONEY, New York
JON D. FOX, Pennsylvania THOMAS M. BARRETT, Wisconsin
RANDY TATE, Washington GENE TAYLOR, Mississippi
DICK CHRYSLER, Michigan BARBARA-ROSE COLLINS, Michigan
GIL GUTKNECHT, Minnesota ELEANOR HOLMES NORTON, EMstrict of
MARK E. SOUDER, Indiana Columbia
WILLIAM J. MARTINI, New Jersey JAMES P. MORAN, Virginia
JOE SCARBOROUGH, Florida GENE GREEN, Texas
JOHN B. SHADEGG, Arizona CARRIE P. MEEK, Florida
MICHAEL PATRICK FLANAGAN, Illinois CHAKA FATTAH, Pennsylvania
CHARLES F. BASS, New Hampshire BILL BREWSTER, Oklahoma
STEVEN C. LaTOURETTE, Ohio TIM HOLDEN, Pennsylvania
MARSHALL 'TVIARK" SANFORD, South
Carolina BERNARD SANDERS, Vermont
ROBERT L. EHRLICH, Jr., Maryland (Independent)
James L. Clarke, StaffDirector
Kevin Sabo, General Counsel
Judith McCoy, ChiefClerk
Biro Myers, Minority StaffDirector
Subcommittee on Human Resources and Intergovernmental Relations
CHRISTOPHER SHAYS, Connecticut, Chairman
MARK E. SHOUDER, Indiana EDOLPHUS TOWNS, New York
STEVEN SCHIFF, New Mexico TOM LANTOS. California
CONSTANCE A. MORELLA, Maryland BERNARD SANDERS, Vermont Gnd.)
THOMAS M. DAVIS, Virginia THOMAS M. BARRETT, Wisconsin
DICK CHRYSLER, Michigan GENE GREEN, Texas
WILLIAM J. MARTINI, New Jersey CHAKA FATTAH, Pennsylvania
JOE SCARBOROUGH, Florida HENRY A. WAXMAN, California
MARSHALL "MARK" SANFORD, South
Carolina
Ex Officio
WILLIAM F. CLINGER, JR., Pennsylvania CARDISS COLLINS, Illinois
Lawrence J. Halloran, StaffDirector
Anne Marie FINLEY, Professional StaffMember
Robert Newman, Professional StaffMember
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, StaffDirector
Jon Praed, Professional StaffMember
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 ofPittsburg 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 ofIowa 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 ofPennsylvania, 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
ofTennessee, prepared statement of 20
Mcintosh, Hon. David M., a Representative in Congfress from the State
ofIndiana, prepared statement of 8
Morella, Hon. Constance A., a Representative in Congress from the State
ofMaryland, prepared statement of 11
Pastor, Hon. E<C a Representative in Congress From the State ofArizona,
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 ofPittsburg, 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
ofConnecticut, prepared statement of 3
Talcott, Thomas D., prepared statement of 202
Towns, Hon. Edolphus, a Representative in Congress from the State
ofNew York, prepared statement of 5
Traficant, Hon, James A., a Representative in Congress from the State
ofOhio, prepared statement oi 24
FDA REGULATION OF MEDICAL DEVICES, IN-
CLUDING THE STATUS OF BREAST
IM-
PLANTS
TUESDAY, AUGUST 1996
1,
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 offoods, 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
