FDA Panel Rejects Inamed's Silicone Breast Implants
Tue Apr 12, 2005 06:02 PM ET

GAITHERSBURG, Md. (Reuters) - A U.S. advisory panel on Tuesday narrowly rejected U.S. sales of Inamed Corp.'s_ silicone gel-filled breast implants by a 5-4 vote.

The U.S. Food and Drug Administration will consider the panel's advice as it decides whether to allow Inamed to widely market silicone breast implants. The FDA banned the devices for most women in 1992 because of concerns leaking silicone could be harmful.

http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=8161213

Inamed's Breast Implants Lose in U.S. FDA Panel Vote (Update1)
April 12 (Bloomberg) -- Inamed Corp.'s silicone breast implants failed to win the backing of a U.S. government advisory committee because of questions about their safety.

The panel of scientists and doctors voted 5-4 to recommend that the Food and Drug Administration find the company's application ``nonapprovable.'' Committee members said the company hadn't shown that ``there is reasonable assurance that this device is safe,'' the wording in the FDA's question to the panel. The agency usually follows such recommendations.

Silicone breast implants have been banned for general cosmetic use in the U.S. since 1992 because leakage of silicone gel was linked to connective-tissue disorders. The FDA, which is under pressure from Congress over its monitoring of medical safety, last year rejected another panel's backing of a previous Inamed request.

``We look at the data available and we have to judge if it's adequate to justify the benefit,'' said panelist Michael Miller, deputy chairman of the department of plastic surgery at M.D. Anderson Cancer Center at the University of Texas in Houston, after the vote. ``I would love to know everything about the device, an impossible standard.''

U.S. regulators last week asked Pfizer Inc. to withdraw its Bextra painkiller because of heart and skin risks, six months after Merck & Co. withdrew its similar Vioxx medication because of links to heart attacks and strokes.

The final vote contradicted the results an hour earlier of an informal sounding of the panel, in which most members ``expressed a reasonable assurance'' that Inamed's devices appear safe, panel chairman Michael Choti, a cancer surgeon from Johns Hopkins University in Baltimore, said. The vote came after two days of hearings in Gaithersburg, Maryland.

Shares of Santa Barbara, California-based Inamed plunged as much as $7.41, or 11 percent, in late trading after the vote. Earlier, the stock had jumped 76 cents to $66.41 as of 4:30 p.m. New York time in Nasdaq Stock Market composite trading. Medicis Pharmaceutical Corp., based in Scottsdale, Arizona, said March 21 that it intends to buy Inamed for about $2.8 billion in cash and stock.

Last Updated: April 12, 2005 18:17 EDT

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