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FDA Panel Flip-Flops On Silicone

Silicone-gel breast implants, virtually banned for 13 years, would return to the market if the government heeds a surprising recommendation from its scientific advisers.

After three days of emotional debate, advisers to the Food and Drug Administration said Mentor Corp. should be able to sell its gel implants but only if it meets strict conditions.

Mentor Corp. persuaded advisers to the FDA 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.

"[Durability] is the major concern. Whether or not these things rupture or women develop side effects such as this hardening or contractor and need surgery later on has been the main debate here," said CBS News Health Correspondent Dr. Emily Senay.

"Unfortunately, there is not a lot of good data to answer the specific question, how often does this happen?" Senay told Early Show co-anchor Hannah Storm.

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 regular, and expensive, MRI exams. 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.

    At Wednesday's hearing, doctors seemed willing to place the burden on the patient.

    "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," added Dr. Marilyn Leitch, a cancer surgeon at the University of Texas Southwestern Medical Center who also supported Mentor sales.

    Mentor hasn't proved they'll last even 10 years, argued New York dermatologist Dr. Amy Newburger, who opposed lifting restrictions. Instead, it closely studied patients for just three years and didn't settle concern about the consequences of silicone leaks.


    "I don't have the assurance that it's safe," Newburger said. "My concern was, since hundreds of thousands of patients will be exposed to this, I felt that the urgency (to sell) was not warranted at this time."

    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.

    "The way things are going lately, I think all bets are off on all the FDA will ultimately rule on this decision," said Senay.

    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.

    Despite Mentor's efforts to prove its new products are more durable with a lower rupture rate, Hoffman advises implant-seekers to be wary.

    "When you get on the implant merry-go-round, you're not just having one operation," she said. "This is a repeat operation."

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