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July 27, 1994

Silicone Gel Breast Implants

Author Affiliations

Seattle, Wash

JAMA. 1994;272(4):272-273. doi:10.1001/jama.1994.03520040031026

To the Editor.  —The FDA accuses the CSA, and by extension the AMA House of Delegates, of "a missed opportunity" to ask "hard questions and insist on the answers."1 Hogwash! The FDA refuses to admit it missed its opportunity in 1976 to require scientific data be presented about the safety of silicone gel implants. This is an obvious attempt to exonerate the FDA by shifting blame to physicians.Statistically significant, prospective scientific studies concerning silicone gel implants in humans will not be completed for several years. The data were not known to surgeons or the FDA in 1976. Dr Kessler and colleagues use faulty logic to create a transparent double standard: they apologize for FDA inactivity years ago when data were lacking, then hold physicians responsible now for not acting on the same data that are still not available. What the FDA didn't know in 1976, we should have

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