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FDA: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants

Posted Date: January 26, 2011

The FDA is issuing this communication to inform health care providers and the public about a possible association between breast implants and a type of anaplastic large cell lymphoma (ALCL). The number of identified cases is small compared to the estimated 5 to 10 million women who have received breast implants worldwide. But based on these data, the FDA believes that women with breast implants may have a very small but increased risk of ALCL.

The FDA is issuing this communication to inform health care providers and the public about a possible association between breast implants and a type of anaplastic large cell lymphoma (ALCL). Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. The FDA is also asking health care providers to report confirmed cases of ALCL in women with breast implants to the FDA.

Read the medical device safety alert - FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants - on the FDA website