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Article
July 27, 1994

Silicone Gel Breast Implants

Author Affiliations

University of Toronto Toronto, Ontario

JAMA. 1994;272(4):272. doi:10.1001/jama.1994.03520040031024
Abstract

To the Editor.  —The recent CSA report on the silicone gel— filled breast implant saga provided much useful information.1 It rightly pointed out that the FDA hearings in 1992 were characterized by an excess of anecdotal reports. The descriptive case series that were presented demonstrated an association of implants with disease, but certainly did not establish a causal relationship. It seemed to be forgotten that women without implants also get sick.What was troubling about the CSA report was a hint of selection bias. Yes, there has been a "barrier function" introduced to diminish diffusion through the elastomer envelope. What is not mentioned is that this barrier function was introduced relatively recently in the history of implant manufacturing. Thus, many women are wearing implants lacking this barrier function. Second, no mention was made of the potential problems that may be specific to foam-covered implants. The report states that there

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