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 group. The agency usually follows panel recommendations.

``There were strong signals sent out last week that this would be a very difficult application,'' Juan Noble, an Oppenheimer & Co. analyst in New York, said in a telephone interview after the vote. ``There was a predisposition at the FDA that this application in its present form wasn't very impressive. The panel vote reflects the same sentiment.''

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.

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.

Stephen Li, a specialist in the study of medical device failure who is president of Medical Device Testing Innovations LLC in Sarasota, Florida, expressed the mixed feelings about Inamed's device that some other members of the panel said they shared. He characterized his vote against approval as ``weak.''

``We don't know why this device fails,'' Li said after the vote. The company had presented research based on the experiences of women for three years after they received silicone implants. ``You could come back with five-year data, and it if looks as good as this, it could be a yes'' vote.

``I would like to see this device available,'' Li said.

Surgeon Marilyn Leitch of the University of Texas Southwestern Medical Center in Dallas said she voted for recommending approval because patients deserve the option of silicone implants.

``We want the life they have to live be as high a quality as it can be,'' Leitch said.

The decision contradicted the results an hour earlier of an informal sounding in which most panel members ``expressed a reasonable assurance'' that Inamed's devices appeared safe, according to panel chairman Michael Choti, a cancer surgeon from Johns Hopkins University in Baltimore. 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. Medicis shares lost as much as $2.58, or 9 percent, in late trading after the vote, after closing at $28.55 in New York Stock Exchange composite trading.

Tomorrow, the committee will consider a separate application for silicone breast implants made by Mentor Corp., also based in Santa Barbara, California. Shares of Mentor were unchanged today at $34.56 and fell as much as 76 cents in late trading after the panels' vote on the Inamed application.

Amit Hazan, director of equity research at SunTrust Robinson Humphrey, raised his rating of Mentor stock to a ``buy'' from ``neutral'' today before the Inamed vote, citing the potential that Mentor's implants will be favored by consumers because of studies showing lower rupture rates than Inamed's. He said he would rate Inamed a ``buy'' regardless of the panel's decision.

``We are not upgrading the stock on expectations of either a positive breast implant panel or an eventual FDA approval of silicone,'' Hazan wrote in a note to clients. ``Inamed and Mentor will most likely either sink or swim together'' in terms of an FDA ruling, he said.

Inamed sells silicone breast implants in Europe, the Middle East, Latin America, Asia and Australia, the company said in a March 16 regulatory filing. Revenue from breast implant sales rose 21 percent last year to $215.8 million, from $177.8 million in 2003, according to the filing, which didn't specify figures for each kind of device.

U.S. regulators banned the use of silicone implants in 1992 except for women in clinical studies, such as for reconstructive surgery or after mastectomies for breast cancer. The agency's decision was based on concern that the devices might cause connective-tissue diseases such as rheumatoid arthritis when they rupture or leak.

Damaged implants can allow silicone gel to leak into tissue around the breast, and the substance has been found in lymph nodes. The FDA staff last week projected that broadened sales of the devices might lead to as many as 22,500 cases a year of ruptured implants, based on a review of company and other studies.

In 1998, Dow Corning Corp. agreed to pay as much as $3.2 billion over 16 years to settle claims of more than 300,000 women who said they were harmed by the company's silicone implants.

Kerry Dooley Young in Gaithersburg, Maryland, at

1120 or kdooley@bloomberg.net

Geraldine Ryerson-Cruz in Washington at gryerson@bloomberg.net

To contact the editor responsible for this story:

Robert Simison at rsimison@bloomberg.net

Last Updated: April 12, 2005 18:51 EDT