FDA Panel Backs Breast Implants From One Maker

Gardiner Harris, The New York Times: April 14, 2005

Silicone breast implants made by a California company should be available to women who undergo cosmetic breast surgery, a federal advisory panel voted on Wednesday, rejecting arguments about serious health problems.

The panel chairman called the 7-to-2 vote to approve an application by the company, the Mentor Corporation, unexpected.

On Tuesday, the panel voted, 5 to 4, to reject a similar application from the Inamed Corporation.

Before the vote on Wednesday, Mentor was widely seen as having the weaker of the two applications because it had followed patients in its principal breast-implant study for a year less than Inamed.

Most panel members said they were comfortable with the long-term safety of Mentor devices, and most dismissed concerns that ruptured implants caused the kind of serious diseases that some women’s groups have listed.

The diverging votes sent a mixed message to the drug agency, making predictions about what it would decide all but impossible. In 2003, the panel, with some different members, voted, 6 to 3, to approve an Inamed application. The drug agency rejected it in January 2004, saying more information was needed.

Many experts say they believed that the agency had toughened oversight of device and drug manufacturers in recent months. Yet, the agency generally follows the advice of its advisory panels.

The three-day hearing on implants began on Monday and included more than 160 witnesses who gave impassioned pleas to approve or reject silicone implants.

Dozens of women said implants had sickened them severely, and some gave gruesome testimony about silicone from ruptured implants squeezing out of their eyes and ears.

Dozens of other women pronounced silicone implants a safe boost to their self-esteem. Nearly all studies have found no link between silicone implants and serious disease.

The potential market for silicone implants could approach several hundred million dollars a year in the United States. About 250,000 breast augmentation operations are performed annually, and if the stigma and uncertainty attacked to silicone implants are removed, more women may choose the procedure.

At the moment, just saline implants are allowed for purely cosmetic operations, even though many patients and doctors say silicone implants feel more natural and look better. Several panel members said they had voted to approved the implants because Mentor made a more convincing presentation than Inamed.

“I want to explain to myself and everyone else why I could vote yes on one application and no on another,” Dr. Stephen Li, a panel member who is president of Medical Device Testing and Innovations in Sarasota, Fla., said after the vote.

Mentor silicone implants “had an extremely low rupture rate,” Dr. Li said.

“And we didn’t have nearly the questions on this application that we did on the last application,” he added.

The president of Mentor, Joshua H. Levine, said it was “very grateful that the panel looked at the science” and decided that “these products are not all created equal.” Mr. Levine said he hoped that the F.D.A. would follow the guidance from the panel.

Inamed and women’s groups complained about the votes.

“I’m stunned and amazed by a bizarre and strange decision by a few panel members who yesterday demanded longer-term safety data and today accepted shorter-term data,” a vice president of Inamed, Dan Cohen, said.

Dr. Diana Zuckerman, president of the National Research Center for Health Research, called the conflicting votes illogical and predicted that the drug agency would reject both applications.


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