FDA Panel Flip-Flops On Silicone

Breast Implants
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.