FDA Panel Flip-Flops On Silicone

Breast Implants
An FDA advisory panel turned down a manufacturer's request to lift the long-standing ban on silicone breast implants Tuesday. But when a different company made the same request Wednesday, the panel said OK.

It's a surprising turnaround for federal health advisors, who voted overwhelmingly to recommend the FDA allow silicone-gel breast implants to return to the U.S. market after a 13-year near-ban. However, the panel also advises designing 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, Inamed, failed to satisfy lingering concerns about how often the implants break apart and leak inside women's bodies.

Mentor Corp. presented the FDA panel with studies showing that leakage rates have improved to just 2 or 3 percent of patients. But CBS News Correspondent Sharyl Attkisson met one woman who claims a direct connection between leaking silicone implants and health problems.

Kim Hoffman told Attkisson that she got sick after her first implants from Dow leaked. When she got them replaced with a set made by Mentor, another leak made her sick again, she said.

Hoffman says the silicone implants nearly killed her, so she's been taking on the FDA and the implant manufacturer for a decade. Hoffman said she became an amateur detective of sorts, collecting damaging information on Mentor, including testimony from former company employees.

What did she find?

"Incident after incident of quality control problems, contamination issues, documents being destroyed," Hoffman said.

FDA's advisers said Wednesday that Mentor had performed more convincing research that the implants only rarely break in the first few years after they're inserted, and showed some evidence 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 implant risks, including that they 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 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 two years. They should consider having broken implants removed to minimize risk of silicone oozing into the breast, or beyond.

    "We are holding it to higher standards than other implants," said FDA adviser Stephen Li, a Florida medical device-testing expert. "This device has a 30-year history that, at best, is checkered. Given that history, it behooves us to have a higher standard."

    But looking back into Hoffman's case, Attkisson reports that Mentor's relationship to the FDA raised flags to the patient. The most startling document related to Hoffman is her personal record, which Mentor is required to submit to the FDA. She was listed as having "no complaint."

    So Hoffman went to the FDA and connected with an investigator who gathered reports of Mentor hiding one safety problem after another.

    But according to the investigator, FDA managers seemed more interested in helping Mentor cover its tracks. He finally quit his job in disgust telling his bosses and even Congress he couldn't work for "an increasingly corrupt FDA".

    The FDA closed the criminal investigation into Mentor, and Hoffman's lawsuit has been dropped, since she couldn't prove a direct link between her illness and the implant leak.