Breast implant safety unproved, panel votes Maker fails to win approval by FDA experts.

November 14, 1991|By Knight-Ridder

GAITHERSBURG RHC B — GAITHERSBURG -- A panel of experts has found that Dow Corning, one of the nation's leading makers of breast implants, failed to provide reasonable proof of the safety of its silicone-filled products.

Yesterday's finding, in a 9 to 1 recommendation to the Food and Drug Administration, could lead to the removal of the controversial implants from the market.

However, the panel of medical professionals was to resume meeting today to decide whether overriding public health benefits should allow the device to be sold on a limited basis, such as to women undergoing breast reconstruction after cancer surgery.

The General and Plastic Surgery Devices panel is examining whether the implants, widely used in reconstructive and cosmetic surgery, are safe. The panel concludes its three-day public hearing today.

A high ranking FDA official described the vote as "an unexpectedly strong blow to the industry leader." Separately, Susan Cruzan, a spokeswoman for the agency, said the action by the panel would not necessarily result in immediate removal of the devices.

"We think these products are safe and effective," said Robert R. LeVier, technical director of Dow Corning's Health Care Businesses. "There is some unfairness as to the standard the product is being held."

Dow Corning and three other manufacturers also being reviewed by the panel submitted hundreds of studies which they said proved conclusively that the implants, estimated to be in about 2 million American women, are safe.

In addition to Dow Corning, the other companies being reviewed are Mentor Corp., of Goleta, Calif., McGhan Medical Corp., of Santa Barbara, Calif., and Bioplasty Inc., of Minneapolis, Minn.

After its vote yesterday, several members of the advisory panel said Dow Corning had failed to provide women with a reasonable assessment of the long-term risks of the implants.

"I have a great fear that we may be creating an epidemic similar to asbestos, which we can't get rid of," said Dr. Genevieve M. Matanoski, professor of epidemiology at Johns Hopkins University School of Public Health.

Before the vote, FDA officials had voiced concern about breast implant devices, but sounded a less alarmist note for women.

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