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David A. Kessler, MD; Ruth B. Merkatz, RN, PhD; Renie Schapiro, MPH
Food and Drug Administration Rockville, Md

JAMA. 1994;272(4):273-274.

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In Reply.

—We agree with Dr Agnew that uncertainties about the safety of silicone gel breast implants make it impossible to provide women with adequate information about their risks. However, some risks have been established (eg, capsular contracture and ruptures do occur). This incidence of ruptures and their relationship to serious problems, such as autoimmune disease, are under intense investigation. Dr Kent and Dr Brody cite studies that they say show no relationship between silicone gel leaks and autoimmune disorders. At least some of those studies have been criticized for lacking sufficient power to definitively determine whether there is an increased incidence of autoimmune disease among women with implants. But rather than debate the merits of particular studies here, the critical point is that significant questions remain about risks associated with these devices. Under these circumstances, the FDA is not prepared to authorize their widespread use.

We agree with Dr . . . [Full Text PDF of this Article]

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