FDA backs lifting silicone breast implant ban

'They're two different devices'
The advisers wrestled with the decision and acknowledged it was a surprise given their harsh criticism of competitor Inamed’s bid to sell its own silicone implants.

“They’re two different devices. ... We didn’t have nearly the questions on this that we had on the prior application,” Li said. “Those are the reasons that will let me sleep at night.”

The FDA isn’t bound by its advisers’ recommendations. Just 15 months ago the FDA overruled a recommendation by the panel to bring back gel implants, telling manufacturers it needed better data on durability and silicone leakage.

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.

Some 264,000 breast enlargements were performed in the United States last year, and 63,000 breast reconstructions, the vast majority with salt water-filled implants that today are sold without restriction.

Consequently, Newburger estimated that if silicone-gel implants return to the market, 200,000 women might seek them in the first year — meaning side effects that occur in only one in 10,000 people will become an issue.

Like Inamed, Mentor has tracked breakage rates for only three years in a study of about 400 people.

More reassuring to the panelists was research from a British doctor who tracked 100 of his own patients and found 5 percent of Mentor implants had broken by around nine years.

FDA scientists said the British research was skewed because it included only volunteers and excluded women at high risk of implant rupture because of rocklike scar tissue.

More troubling, when women in Mentor’s study chose to have their implants removed and not replaced, they were dropped from the study, Newburger said. That means no one knows if those women continued to suffer side effects.

Mentor pledged to continue study to answer outstanding questions, and it argued that silicone implants provide enough benefit that it’s unfair to withhold them from women in the meantime. Silicone-gel implants look and feel more natural than saline versions — and in Europe, where both types are sold, silicone implants are by far the most popular, the company said.

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

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