STORY FROM: Drugs & Medical Devices

Allergan Initiates Worldwide Recall of Textured Breast Implants Amid Reports of Cancer Risk

WASHINGTON, D.C. — Allergan, in response to a request by the Food and Drug Administration, has initiated a worldwide recall of its textured breast implants and tissue expanders due to reports of cancer and cancer-related deaths associated with the devices.

According to a July 24 MedWatch Safety Alert, the recall was based upon newly submitted Medical Device Reports concerning worldwide cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and BIA-ALCL-related deaths.

After analyzing currently available information, including newly submitted data, the FDA found that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk ...



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