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May 20, 1992

Penile, Testicular, Other Silicone Implants Soon Will Undergo FDA Review

JAMA. 1992;267(19):2578-2579. doi:10.1001/jama.1992.03480190020004

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THE SILICONE breast implant soon will share the spotlight with several other silicone devices to be investigated by the Food and Drug Administration (FDA) (JAMA. 1992;267:2439-2442). By year's end, manufacturers of the solid silicone penile and testicular implants and saline-filled breast implants (with a silicone shell) will be asked to provide the agency with data from rigorously conducted safety testing.

Cerebral electrotherapy stimulators, used to treat severe depression, and cardiovascular bypass devices also will receive a call for data, says James Benson, director of the FDA's Center for Devices and Radiological Health.

These five products, plus silicone gelfilled breast implants, are among 130 medical devices marketed before 1976. That was when Congress passed an amendment providing the FDA with the authority to regulate medical devices.

Until recently, these "preamendment" devices and new devices based on them, even those with dramatic changes in design and materials, have escaped regulatory scrutiny.