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FDA Flip Flops On Silicone

In a surprising turnaround, federal health advisers Wednesday recommended allowing silicone-gel breast implants to return to the U.S. market after a 13-year near-ban — but only under strict conditions that will limit how easily women can get them.

Mentor Corp. persuaded advisers to the Food and Drug Administration that its newer silicone implants are reasonably safe and more durable than older versions. The 7-2 vote came just one day after a rival manufacturer failed to satisfy lingering concerns about how often the implants break apart and leak inside women's bodies.

On Wednesday, FDA's advisers said Mentor had performed more convincing research that the implants only rarely break in the first few years after they're inserted, and some data that they may last as long as 10 years.

But they stressed that sales should resume only if Mentor meets some strict conditions:

  • Prospective patients must sign consent forms acknowledging that the implants ultimately may break and require removal or replacement.
  • Mentor may sell silicone implants only to board-certified plastic surgeons who complete special hands-on training to insert implants in a way that minimizes odds of breakage.
  • Mentor must open a registry to track how patients fare long-term, and it must continue more formal studies to nail down how often implants rupture within 10 years, something no one yet knows.

    Because implant breaks don't cause immediate symptoms, patients should get an MRI scan five years after their implant is inserted and every year or two thereafter — and have broken implants removed to minimize risk of silicone oozing into the breast, or beyond.

    "Patients can determine whether or not for them it is worth it to have a device that might need to be replaced within a 10-year period of time," said FDA adviser Dr. Marilyn Leitch, a cancer surgeon at the University of Texas Southwestern Medical Center who supported Mentor sales.

    Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. The implants were banned back in 1992, after thousands of women complained they ruptured and caused immune system diseases, joint problems and even suicides. But medical studies have never been able to prove the link, and now only women who have had breast cancer can opt for silicone, reports CBS News Correspondent Elizabeth Kaledin.

    Thirteen years later, silicone implants largely have been exonerated of causing serious or chronic illnesses such as cancer or lupus. But they can cause side effects, including infection and painful, rocklike scar tissue. Also, they can break, requiring additional surgery to remove or replace them — and those ruptures can result in silicone oozing into the breast and, sometimes, farther into the body.