FDA Requests Recall of Certain Textured Breast Implants

To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the U.S. Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders.

The company agreed and is removing these products from the global market.

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.

These products have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan. 
A list of Allergan’s BIOCELL textured devices marketed in the U.S. that will be voluntarily recalled can be found here. 

The FDA notes that the macro-textured implants, like the BIOCELL textured implants manufactured by Allergan, represent less than 5% of breast implants sold in the U.S. 

Read the full FDA announcement, which includes recommendations for patients and providers.

Posted 7/24/2019