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Return of Silicone Breast Implants Nixed
Thu January 8, 2004 03:34 PM ET

By Lisa Richwine
WASHINGTON (Reuters) - U.S. regulators on Thursday said they rejected Inamed Corp.'s (IMDC.O: Quote, Profile, Research) bid to return silicone-gel breast implants to the market and urged makers to provide more data on potential complications of the devices breaking open.

Inamed shares dropped as much as about 16 percent on Nasdaq, where it was one of the top percentage losers.

Food and Drug Administration officials confirmed they had turned down Inamed's application but declined to discuss what additional information the company needed to collect.

However, in new guidelines for manufacturers, the agency said it wanted to learn more about how often implants rupture and leak silicone, and what the consequences are.

"Patients need to have that information when they make the decision whether to use one of these products," Dr. David Feigal, director of the FDA's Center for Devices and Radiological Health, told reporters.

Inamed, in a statement issued late Wednesday, said it was "disappointed" with the FDA ruling but would cooperate with the agency to try to win approval in the future.

Silicone breast implants were banned for most women in 1992 amid controversy over their safety. An FDA advisory panel in October voted 9-6 in support of allowing Inamed to reintroduce them to the market.

The two-day panel meeting featured emotional testimony from dozens of silicone implant advocates and opponents. Major studies have found no evidence that the implants caused chronic diseases, but many women are convinced that leaking silicone from the devices caused disabling illnesses.

Others argued that women should be able to choose silicone implants either to rebuild breasts after cancer surgery or to make their breasts bigger. Many said silicone implants offered a more natural look and feel than the saline-filled implants that are widely available.

At the October panel review, Inamed acknowledged its implants carried the risk of rupturing but said most women in clinical trials were happy with them. The company promised long-term monitoring for potential complications.

In its guidelines, FDA officials said they wanted companies to develop new methods to better predict how often implants break open, and to look closely at whether some manufacturing processes and surgical techniques might contribute to ruptures
Consumer groups that had lobbied for more testing of the implants hailed the FDA's ruling.
"Their decision sends a crystal-clear message to women that silicone gel breast implants are not proven safe," said Diana Zuckerman, president of the National Center for Policy Research for Women and Families.

The FDA rejection was a setback for Inamed, which sells saline implants and other devices.

"Investors are likely to find plenty of reason to be skeptical for a near-term resolution of this situation," J.P. Morgan said in a research report.

Oppenheimer lowered its 2004 earnings-per-share estimate for Inamed to $1.95 from $2.25.

Rival Mentor Corp. (MNT.N: Quote, Profile, Research) in December submitted an application to the FDA for approval of its own silicone breast implants.

Inamed shares were down $7.40, or 14.86 percent, at $42.40 in afternoon trading on Nasdaq, after trading as low as $41.70 earlier. Mentor shares were up 14 cents, or 0.57 percent, to $24.70 on the New York Stock Exchange. (Additional reporting by Jed Seltzer and Jackie Sindrich in New York)

http://www.reuters.com/newsArticle.jhtml?type=businessNews&storyID=4096704