Breast implants: FDA clears new silicon implant despite consumer protests | Regulatory Roundup

March 12, 2012 By MassDevice staff Leave a Comment

FDA clears another silicon-gel breast implant
Despite continued protests at home and abroad, the FDA cleared silicon breast implants made by Sientra, making it the 3rd company with regulatory clearance to sell the controversial products in the U.S.

The Santa Barbara, Calif.-based cosmetic device maker joins Johnson & Johnson (NYSE:JNJ) and Allergan (NYSE:AGN) in offering silicon-based breast implants to U.S. patients.

"For the first time in 20 years, Sientra has successfully broken the existing duopoly in the U.S. by offering surgeons and patients a new choice," founder & CEO Hani Zeini said in prepared remarks. "And today, Sientra becomes the 1st and only company in the U.S. to provide a full portfolio of commercially-available breast implants, including shaped implants in addition to standard round implants."

Breast implants have been at the center of growing public outcry since last summer, when the FDA warned that, although the products are still considered safe and effective, women may be under-informed about their risks, including hardened skin around the implant, wrinkled or ruptured implants, scarring, pain and infection that may lead to reconstruction or removal.

Consumer groups, such as the National Organization for Women Foundation, petitioned the FDA to recall the devices on the grounds that implant makers hadn’t kept up with promises to collect post-market data.

JNJ’s Mentor division and Allergan won FDA clearance for silicone breast implants in 2006 on the condition that they would collect safety data on 40,000 patients over 10 years. At last glance, by the summer of 2011 Allergan had collected data for 60% of patients for 2 years, while J&J had data on 21% over 3 years.

The FDA determined that a lack of long-term data was not reason enough to issue a recall, but called on the manufacturers to ramp up their post-market tracking efforts.

As soon as the clamor seemed to have settled in the U.S., news broke that France was considering a recall of 30,000 sets of breast implants supplied by Poly Implant Prothèse over concerns that they might contain a non-authorized silicone gel known for high rupture rates.

By then, 523 women had already had the implants removed and 2,000 had filed complaints, spurring French authorities to launch a criminal investigation into PIP. British officials launched their own investigation a few weeks later.

PIP founder and former head Jean-Claude Mas was arrested in January as part of an investigation into manslaughter and involuntary injury associated with the implants.

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