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Reuters
FDA Panel Rejects Silicone Breast Implants
Tuesday April 12, 6:22 pm ET
By Susan Heavey and Lisa Richwine


GAITHERSBURG, Md. (Reuters) - Inamed Corp. failed to provide convincing evidence that its silicone breast implants are safe enough to win U.S. approval and end a 13-year ban on the devices, an advisory panel narrowly ruled on Tuesday.
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Inamed shares plummeted in after-hours trading, falling 9.4 percent to $60.16 on the Inet electronic brokerage.

The advisory committee voted 5-4 against recommending approval of Inamed's implants. The Food and Drug Administration will consider the advice as it decides whether to lift sales restrictions imposed in 1992 amid concerns that leaking implants could cause long-term, disabling illness.

"I feel that (approval) is premature. I don't feel secure about the safety," said Dr. Amy Newburger, a panel member from Dermatology Consultants of Westchester in Scarsdale, New York.

Studies have failed to find a connection between silicone implants and chronic diseases such as lupus and rheumatoid arthritis. The implants can cause pain around the breast and other complications, and they can break and require repeat operations to replace them.

Fifteen months ago, the FDA rejected an application from Inamed to sell silicone breast implants and told manufacturers to collect more information about how often the devices break apart and what the consequences are. Now Inamed and rival Mentor Corp. are seeking approval to sell the silicone devices.

Inamed officials told the panel the silicone implants, widely available in other countries, were reasonably safe. In the United States, only breast cancer survivors and others needing reconstruction or implant replacements can now receive silicone implants, through clinical trials.

"We believe the risks are acceptably low," said Dan Cohen, Inamed's vice president of global government and corporate affairs. "The risks are largely related to the surgical procedure...rather than the nature of the device."

The panel's ruling followed nearly 12 hours of emotional testimony on Monday both from women who linked the implants to chronic illnesses and from others who touted them as safe and more natural-looking than saline-filled implants.

Both Inamed, which is being bought by Medicis Pharmaceutical Corp., and Mentor have said new silicone implants are more durable, and the gel is stickier and less likely to migrate.

On Wednesday, the panel will review Mentor's studies.