The FDA’s Regulation of Silicone Breast Implants

U.S. Congress, Report of the Subcommittee of Human Resources and Intergovernmental Relations of the House Committee on Government Operations, 1993

The FDA’S Regulation of Silicone Breast Implants

I. Introduction

Under the Rules of the House of Representatives, Rule X, 2(b)(2), the Committee on Government Operations is authorized to “review and study, on a continuing basis, the operation of Government activities at all levels with a view to determining their economy and efficiency.” The committee has assigned this responsibility, as it pertains to the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), to the Human Resources and Intergovernmental Relations Subcommittee.

Pursuant to its authority, the subcommittee conducted an investigation of the safety and effectiveness of silicone breast implants, the regulation of those devices by the FDA, and research support by the NIH.

On December 18, 1990, the subcommittee conducted a hearing on the FDA’s regulation of silicone breast implants. The hearing included testimony from the following FDA witnesses: Walter Gundaker, Acting Director, Center for Devices and Radiological Health; Mr. Robert Sheridan, Director, Office of Device Evaluation; and Dr. Joseph Arcarese, Director, Office of Training and Assistance. Other witnesses included Dr. Nir Kossovsky, assistant professor of pathology and laboratory medicine at the University of California at Los Angeles; Dr. Frank Vasey, professor of medicine at the University of South Florida; Dr. Pierre Blais former senior scientific advisor for the Department of National Health and Welfare of Canada; Dr. Norman Anderson, former Chair of the FDA panel that reviewed the breast implant issue in 1988-90; Mr. Thomas D. Talcott, an engineer specializing in silicone implants for 20 years at Dow Corning; and Mr. Robert Rylee, vice president of Dow Corning Wright. Implant patients Sybil Goldrich, co-founder of Command Trust Network; Rosemary Locke of My Image After Breast Cancer; and Janet Van Winkle, founder of the American Silicone Implant Survivors (AS IS), also testified. Officials of three other manufacturers, Mentor, McGhan, and Surgitek, declined the subcommittee’s invitation to testify.

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