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FDA Backs Silicone Breast Implants, Despite Safety Concerns and Lack of Data from Safety Studies

Sep 1, 2011 | Parker Waichman LLP

It looks like silicone breast implants aren't going anywhere anytime soon.   Yesterday, the U.S. Food & Drug Administration (FDA) announced the controversial devices would stay on the market, while their makers continue safety studies meant to assess their risks.

Silicone breast implants have long been suspected of causing serious complications, including capsular contracture, implant rupture, wrinkling, uneven appearance (asymmetry), scarring, pain, and infection.  The devices were actually restricted buy the FDA for about a decade until 2006.  When those restrictions were lifted, the FDA stipulated that manufactures of silicone breast implants - Allergan and Mentor - conduct safety studies to monitor for any increased risks.

Most recently, silicone and saline implants were connected to a rare form of lymphoma called anaplastic large cell lymphoma (ALCL).   In January, the FDA warned that silicone breast implants, as well as saline implants, might increase a woman's risk o developing ALCL.  At the time, the FDA said that 60 cases of ALCL had been reported among the 5 to 10 million patients with both silicone and saline breast implant.  In contrast, the cancer normally occurs in the breast in only 3 in 100 million women in the general population.

In June the FDA issued another safety communication stating that silicone breast implants should not be considered lifetime devices, and that complications often result in additional surgeries to fix or replace them.
This week, the FDA convened the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to take a look at the safety studies manufacturers have been conducting for silicone breast implants.  According to a report from MSNBC, during the two-day meeting, advisors heard “compelling” testimony from women who said they suffered numerous complications from their implants.

At the meeting's conclusion yesterday, William Maisel, the FDA's chief scientist and deputy director in the agency's device division, announced that despite their "significant complication rate," the agency "continues to believe currently approved devices are safe and effective."  The devices will remain on the market, he said.

One of the problems with tracking implant safety is that many participants in the studies being conducted by implant makers haven’t been followed. According to MSNBC, Mentor has three-year data for only one out of every five women in its study, while Allergan has two-year data for three out of every five, according to the FDA.

A report from Dow Jones News Service pointed out that the FDA has the authority to revoke approval of the devices if the required follow-up studies are not done or conducted properly.  But Maisel said yesterday that rather than exercising that authority, the FDA wants to work with the companies and groups representing patients and doctors to find ways to boost study participation.

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