
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: WEDNESDAY, December 1, 1993                   TAG: 9312010119
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-1   EDITION: METRO 
SOURCE: The Washington Post
DATELINE: WASHINGTON                                LENGTH: Medium

FDA REBUKES DOCTORS FOR STANCE ON IMPLANTS

The head of the Food and Drug Administration criticized the American Medical Association on Tuesday for advocating the continued availability of silicone breast implants for cosmetic purposes.

The unusual head-to-head confrontation between the regulatory agency and the medical establishment takes place in the current issue of the Journal of the American Medical Association.

The AMA's Council of Scientific Affairs published a report in the journal that opposes the FDA's moratorium on implant use. The commission's findings, which were adopted by the AMA last year, called for more study of implant safety and for the creation of a registry to follow the health of women with implants.

The report, however, said there is no convincing evidence that implants cause health problems, and concluded that women should be allowed to make their own choices regarding breast surgery after being informed of the risks associated with implants.

The medical panel recommended in its report that "the AMA supports the position that women have the right to choose silicone gel-filled or saline-filled breast implants for both augmentation and reconstruction."

"That position is insupportable," FDA chief David A. Kessler said in a sharp response that follows the AMA article. Kessler's essay, written with two other FDA officials, accused the doctors' group of "abrogation of responsibility" to patients and of disregarding the FDA's statutory obligation to require that drugs and devices be shown to be safe and effective.

The FDA's policy, announced in April 1992, makes implants available only through controlled clinical trials. Such clinical trials for reconstructive surgery are ongoing, but no such trials for augmentation surgery have begun. Implants filled with saline solution still are available.

The Kessler response also noted that, since the AMA adopted the council's findings last year, new studies have shown that silicone gel is a potent stimulant to the immune system and could generate antibodies that attack collagen, a component of connective tissue.

James Allen, vice president for science and technology of the AMA, said the organization "is certainly aware" of the additional studies, but the "AMA does not believe this materially changes the recommendations."

The FDA received more than 23,000 reports of problems with implants in 1992.

by CNB