Allergan has voluntarily initiated a global recall of its Biocell textured breast implants and tissue expanders following a request from the FDA.
The agency recently identified an uncommon link between Allergan’s breast implants and anaplastic large cell lymphoma and asked the company to initiate the recall.
So far, the agency has reported 33 deaths from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Of these, 12 of the 13 patients for which the manufacturer is known were confirmed to have an Allergan breast implant when they were diagnosed.
The company said its Biocell saline- and silicone-filled breast implants and tissue expanders will no longer be available in any market they’re currently cleared for, and healthcare providers should no longer use them.