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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 1995 1, "''^mi:^ Printed for the use of the Committee on Government Reform and Oversight "if . '^f?fl 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, ^'Û^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 regulatory 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 Congiêss from the âte 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 regulatory 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 Ganê, 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, professional 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 witnesses have a chance to tell their story. We want to give an opportunity to Members to question our witnesses. This is also a joint hearing held with Mr. Mcintosh's Sub- committee on Regulatory Affairs. So we have really two subcommittees that are participating in this hearing. And I'm going to invite all Members who want to, to have opening 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 subcommittee 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 permitted 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 medical 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 regulation in general. First, what is the agency's current view of the safety 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 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 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 implants. 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