Allergan issued a voluntary recall of its BIOCELL textured breast implants and tissue expanders on June 24, 2019, pursuant to a request from the U.S. Food and Drug Administration. The product(s) in question, textured breast implants made by Allergan, are being recalled from the U.S. market due to higher incidences of cancer and death associated with the devises. The FDA issued the request in an effort to protect women after receiving new Medical Device Reports showing an increase in breast implant-associated anaplastic large cell lymphoma (known as BIA-ALCL).
The general risk of developing BIA-ALCL as a result of breast implants is estimated to be 1 case per 3,817 to 30,000 patients. However, the FDA has found the risk with the Allergan Natrelle BIOCELL textured implants to be approximately 6 times higher than the risk from other manufacturer’s, meaning a range of 1 in every 636 to 5000 patients could suffer from the rare immune system cancer.
Furthermore, Allergan … is now moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: