CARDISS COLLINS, Illinois FRANK HORTON, New York

GLENN ENGLISH, Oklahoma WILLIAM F. CLINGER, Jr., Pennsylvania

HENRY A. WAXMAN, California AL McCANDLESS, California

MIKE SYNAR, Oklahoma J. DENNIS HASTERT, Illinois

STEPHEN L. NEAL, North Carolina JON L. KYL, Arizona

DOUG BARNARD, Jr., Georgia CHRISTOPHER SHAYS, Connecticut

TOM LANTOS, California STEVEN SCHIFF, New Mexico

ROBERT E. WISE, Jr West Virginia C. CHRISTOPHER COX, California

BARBARA BOXER, California CRAIG THOMAS, Wyoming

MAJOR R. OWENS, New York ILENA ROS-LEHTINEN, Florida

EDOLPHUS TOWNS, New York RONALD K. MACHTLEY, Rhode Island

BEN ERDREICH, Alabama DICK ZIMMER, New Jersey

GERALD D. KLECZKA, Wisconsin WILLIAM H. ZELIFF, Jr., New Hampshire

ALBERT G. BUSTAMANTE, Texas DAVID L. HOBSON, Ohio

MATTHEW G. MARTINEZ, California SCOTT L. KLUG, Wisconsin

DONALD M. PAYNE, New Jersey ____

GARY A. CONDIT, California BERNARD SANDERS, Vermont

PATSY T. MINK, Hawaii (Independent)

RAY THORNTON, Arkansas COLLIN C. PETERSON, Minnesota

ROSA L. DeLAURO, Connecticut CHARLES J. LUKEN, Ohio

JOHM W. COX, Jr., Illinois

HENRY A. WAXMAN, California CRAIG THOMAS, Wyoming

PATSY T. MINK, Hawaii WILLIAM H. ZELIFF, Jr., New Hampshire

ROSA L. DeLAURO, Connecticut DAVID L. HOBSON, Ohio

BERNARD SANDERS, Vermont (Ind.)

JOHN CONYERS, Jr., Michigan FRANK HORTON, New York

There has been increasing public concern about the safety of silicone breast implants since the Subcommittee on Human Resources and Intergovernmental Relations held a hearing on this topic in December 1990. During the past 2 years, there has also been new research and medical evidence of the potential risks of breast implants, as well as disclosures of evidence dating back to the 1970’s. This report, which has been prepared for use by the Committee on Government Operations by members of a staff research team, provides a summary of FDA’s role in the regulation of silicone breast implants.

The findings and conclusions contained in this report are those of the staff, and do not necessarily reflect the views of the members of the Committee on Government Operations.

John Conyers, Jr., Chairman

House of Representatives,

Hon. John Conyers Jr.

Dear Mr. Chairman: I have enclosed a copy of the staff report entitled "The FDA’s Regulation of Silicone Breast Implants."

The report is based on the subcommittee’s 3-year investigation of the FDA’s regulation of silicone breast implants, which was initiated by Chairman Ted Weiss. Because of his tragic death in September of this year, it was not possible to complete the report in time to release it as a committee report. Unfortunately, our investigation indicates that FDA continues to fail to safeguard implant patients, making it very important that this report be released in a timely manner. For that reason, it is being released as a staff report of the 102d Congress.

Thank you for your assistance.

Sincerely

______

I. Introduction 7

II. Background 7

A. Breast injections, breast implants, and the FDA 8

B. FDA oncerns: 1978-1990 9

Risks of surgery 10

Capsular contracture 11

Silicone leakage and migration, and autoimmune disease 12

Interference with mammography 13

Cancer 13

Polyurethane, TDA, and cancer 15

C. FDA delays and inaction 16

D. Implant patients as guinea pigs 16

III. Findings-and Conclusions 17

A. FDA ignored warnings about the need to regulate breast implantsfor more than 12 years 17

B. Scientists have been concerned about the risks of connective

tissue/autoimmune disorders since 1975 19

C. Physicians, engineers, and employees of implant manufacturers

have been concerned about breakage and leakage of silicone gel

implants since the 1970’s 22

D. FDA ignored their own scientists’ advise to reject manufacturers’

PMA applicatiobs in 1991 26

Dow Corning 27

McGhan 27

Bioplasty 28

Mentor 28

E. Professional pro-implant lobbyists included former FDA officials

and provided patient lobbyists with misleading information 29

F. Manufacturers have never provided proof of safety to the FDA 31

G. FDA officials and manufacturers prevented the 1991 FDA breast

implant advisory committee from considering crucial safety

information 33

H. FDA concerns about cancer led to the removal of breast implants

covered with polyurethane from the market in 1991 36

I. The 1992 FDA advisory panel lacked crucial information about

interference with mammography and other problems 37

J. In 1992, Dow Corning disclosed that the company sold implants to

doctors before they were shown to be safe in animals, failed to

disclose problems with the implants, and submitted fabricated

information about quality control 38

K. Patients have been misled about the safety of breast implants for

at least the last 15 years 39

L. Patients continue to be misled by the FDA-approved informed

consent form 42

Plastic surgeon’s attempts to change informed consent forms 42

AMA’s attempts to change informed consent forms 43

FDA’s capitulation to criticisms of informed consent forms 44

M. FDA’s public statements about breast implants minimized the risks 46

N. FDA inspections in 1992 indicated that McGhan had violated good

manufacturing practices, but FDA allowed McGhan sales to

resume before problems were corrected 47

O. From April 1992 to the present, FDA has failed to monitor the

use of silicone breast implants, despite the promises of the FDA

Commissioner 48

P. FDA has failed to evaluate available safety information that

lawyers have obtained from manufacturers 50

Q. NIH as failed to support research on the safety of breast implants

for cancer patients 51

R. Medicare and Medicaid are required to pay for removal of breast implants for medical reasons 52

IV. Recommendations 53

1. The committee should urge FDA’s Center for Devices and

Radiological Health to improve their regulation of medical devices 53

2. The committee should consider legislation to close the revolving

door between FDA and industry 54

3. The committee should assure that FDA request and examine all

relevant documents that are not under court protective orders 54

4. The committee should recommend that the President, by executive

order, clarify FDA’s authority to review protected court documents

related to products that it regulates 55

5. FDA Aadvisory committee should review all relevant safety and

efficacy information 55

6. The committee should ensure that FDA require implant manufacturers

to provide information about safety and effectiveness to patients

as well as physicians 55