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December 1, 1993

A Call for Higher Standards for Breast Implants

Author Affiliations

From the Office of the Commissioner, Food and Drug Administration, Rockville, Md.

JAMA. 1993;270(21):2607-2608. doi:10.1001/jama.1993.03510210093034

THE COUNCIL on Scientific Affairs report on silicone gel breast implants, adopted by the AMA House of Delegates and published in this issue of The Journal,1 represents a missed opportunity. The Council encourages physicians to become fully informed about the current scientific data on these implants, but this report fails to provide a comprehensive safety review or a balanced discussion of the issues. The Council faults others for the controversies associated with these devices today, but it overlooks the serious failings of physicians and never articulates their responsibility with regard to the safety of medical devices. The Council makes policy recommendations that ignore the FDA's statutory authority and public health responsibilities and minimize the uncertainties and concerns that continue to surround these devices.

The Council report states that it reflects the scientific literature as of December 1992. However, since then, other important studies have been published. Recent animal studies