United States

FDA Takes Action On Breast Implant Safety Concerns

Almost one month after an emotional hearing on breast implant safety, the Food and Drug Administration announced it would not ban textured breast implants, which have been linked to a type of lymphoma.

Allergan's textured implants have already been pulled off the market over safety concerns in 38 countries, including France and most recently Canada. But the FDA said Thursday there isn't enough evidence to warrant a ban in the United States.

The implants, which have a rough, sandpaper-like surface, are linked to breast implant associated-anaplastic large cell lymphoma or BIA-ALCL, a cancer of the immune system that can be deadly if it's not treated early enough. In the United States, 457 women have been diagnosed with the disease. Worldwide, 17 have died.

The agency says it plans to work with patient groups and manufacturers to make changes to the labels of textured implants that could include a black box warning - the FDA's strictest caution.

Manufacturers will also be required to submit adverse event reports instead of the current practice of quarterly summary reports, and details of these will now be made available to the public.

The FDA first identified a possible link between breast implants and ALCL in 2011. It's unclear how common the disease is. The agency cites incidence rates between 1 in 3,000 and 1 in 30,000.

You can read the full FDA statement here. 

The American Board of Costmetic Surgery recently posted this blog in an effort to clarify myth from fact in light of the recent media attention on BIA-ALCL and BII.

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