The implants have been associated with anaplastic large-cell lymphoma, a rare cancer of the immune system. A majority of the cases occurred in women with textured implants manufactured by Allergan. Many other countries have banned the use of textured implants.
However, the FDA said May 2 that there was not enough evidence to justify banning the implants.
“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the federal Food, Drug and Cosmetic Act,” the FDA said.
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