Kevin Wolf  /  AP
Michael Choti, Chairman of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee, holds an uncoated Inamed silicone-gel breast implant as panel member Leigh Callanan reaches for a coated version.
updated 4/13/2005 12:43:09 PM ET 2005-04-13T16:43:09

A second manufacturer attempted Wednesday to persuade skeptical federal health advisers that it’s time to lift a 13-year near-ban on silicone-gel breast implants.

Newer versions of the implants only rarely break in the first few years after they’re put into place, and provide enough benefit to the women who seek them to outweigh that risk, Mentor Corp. told advisers to the Food and Drug Administration.

“Self-esteem ... is as integral to health and well-being as any medical issue,” said Mentor chief executive Josh Levine.

Mentor’s pitch came a day after the FDA’s advisers narrowly rejected rival Inamed Corp.’s bid to bring back to the U.S. market one of the nation’s most controversial medical devices.

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Rejected by 5-4 vote
Inamed didn’t study patients long enough to predict how likely implants are to break apart, requiring additional surgery to remove or replace — or to settle lingering questions of the consequences when silicone leaks into the breast or beyond, FDA’s advisers decided by a 5-4 vote. Inamed so far has tracked implant recipients for three or four years.

On Wednesday, the same panel began judging Mentor’s request to allow its own silicone implants onto the market. Just 1.4 percent of patients in its main study had their implants break within three years, although Mentor officials acknowledged that, like a car, implants will fail more often as they age. They cited a British doctor who tracked 100 of his own patients with Mentor implants, and found 5.4 percent had broken by around nine years.

But FDA scientists called Mentor’s data too limited to be of value in settling the key durability issue.

Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. In 1992, complaints that the implants broke and caused illnesses prompted the FDA to ban gel implants except for patients with breast cancer or a few other conditions who enrolled in strict research studies.

Thirteen years later, silicone implants largely have been exonerated of causing serious or chronic illnesses such as cancer or lupus. Aside from the risk of breakage, they also can cause infection and painful, rocklike scar tissue.

Last year, some 264,000 breast augmentations and 63,000 breast reconstructions were performed in the United States, most with salt water-filled implants that are sold without restriction.

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