The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients and health care providers of the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with Allergan BIOCELL textured breast implants. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

This safety communication provides recommendations for patients who have Allergan BIOCELL Breast Implants and health care providers. The FDA is not recommending removal of these or other types of breast implants in patients who have no symptoms due to the low risk of developing BIA-ALCL. The FDA will continue to evaluate any new information and may, as a result, take action regarding other breast implants, if warranted. The FDA will also continue to update the public about developments in this area.

Read the Safety Communication