The Breast-Implant Controversy

Garry S. Brody; Frank B. Vasey; Mitchel J. Seleznick; Bernard F. Germain; Barry Meisenberg; William D. Dupont; Jan J. Van Wingerden; Ruth B. Merkatz; Jack C. Fisher; David A. Kessler; Marcia Angell

doi:10.1056/NEJM199303113281013

The Breast-Implant Controversy

Garry S. Brody, Frank B. Vasey, Mitchel J. Seleznick, Bernard F. Germain, Barry Meisenberg, William D. Dupont, Jan J. Van Wingerden, Ruth B. Merkatz, Jack C. Fisher, David A. Kessler, Marcia Angell

Research output: Contribution to journal › Letter › peer-review

5 Scopus citations

Abstract

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…

Original language	English (US)
Pages (from-to)	732-735
Number of pages	4
Journal	New England Journal of Medicine
Volume	328
Issue number	10
DOIs	https://doi.org/10.1056/NEJM199303113281013
State	Published - Mar 11 1993
Externally published	Yes

ASJC Scopus subject areas

General Medicine

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10.1056/NEJM199303113281013

Cite this

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abstract = "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…",

author = "Brody, {Garry S.} and Vasey, {Frank B.} and Seleznick, {Mitchel J.} and Germain, {Bernard F.} and Barry Meisenberg and Dupont, {William D.} and {Van Wingerden}, {Jan J.} and Merkatz, {Ruth B.} and Fisher, {Jack C.} and Kessler, {David A.} and Marcia Angell",

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AU - Brody, Garry S.

AU - Vasey, Frank B.

AU - Seleznick, Mitchel J.

AU - Germain, Bernard F.

AU - Meisenberg, Barry

AU - Dupont, William D.

AU - Van Wingerden, Jan J.

AU - Merkatz, Ruth B.

AU - Fisher, Jack C.

AU - Kessler, David A.

AU - Angell, Marcia

PY - 1993/3/11

Y1 - 1993/3/11

N2 - 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…

AB - 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…

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The Breast-Implant Controversy

Abstract

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