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MISPLACED MANDATE: AN EXAMINATION OF FDA'S SILICONE BREAST IMPLANT POLICY

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1995

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MISPLACED MANDATE: AN EXAMINATION OF FDA'S SILICONE BREAST IMPLANT POLICY (1995 Third Year Paper)

Abstract

Why did the Food and Drug Administration (FDA) suddenly call for a forty-five day moratorium on silicone gel breast implants in 1 992 and then ban virtually all cosmetic breast implants' only months after an FDA advisory panel had recommended that silicone breast implants remain on the market for both reconstructive and cosmetic uses?2 Is FDA's policy, which remains in force today, justified? What is FDA's mandate, and has FDA overstepped it in banning cosmetic breast implants?

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Food and Drug Law, silicone breast implants, breast augmentation, cosmetic surgery

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