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Correspondence
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Volume 328:732-735 March 11, 1993 Number 10
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The Breast-Implant Controversy

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To the Editor: Dr. Angell's editorial (June 18 issue)1 on the breast-implant controversy refreshingly highlights the forgotten half of the risk-benefit ratio: efficacy. As Dr. Kessler points out in the same issue,2 the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act require evidence of both safety and efficacy on the basis of which the Food and Drug Administration is to make a risk-benefit assessment. So much attention has been given to the risks, known and unknown (no matter how unlikely), that the benefits have been minimized. In the past year and a half, the media and consumer . . . [Full Text of this Article]

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