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July 27, 1994

Silicone Gel Breast Implants-Reply

Author Affiliations

Council on Scientific Affairs American Medical Association Chicago, Ill

JAMA. 1994;272(4):273. doi:10.1001/jama.1994.03520040031027

In Reply.  —Response to the comments of Dr Brody, Dr Kent, and Dr Wise is more appropriate for the FDA; therefore, the CSA response is limited to the comments of Dr Agnew, Dr Baines, and Dr Finegold.In response to Dr Agnew's question of what are the risks, the CSA report highlighted six major areas of concern about the potential for adverse reactions to silicone gel breast implants. The CSA recommends that he obtain directly from the manufacturer or a local institutional review board the Adjunct Clinical Protocol Study agreed on by the FDA and Mentor H/S-Corp; it must be provided by the surgeon to every patient who is considering this procedure. The document contains extensive background information and references as well as a mandated informed consent that the surgeon can use as a basis for discussions with the patient.Dr Baines is correct in concluding that the barrier function

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