What does research say about Allergan breast implants and BIA-ALCL?
FDA says it “has identified an association” between breast implants and BIA-ALCL. It says the risk is higher for textured implants than for smooth ones. A link like this does not prove what caused one person’s cancer.
In July 2019, FDA asked Allergan to recall its BIOCELL textured implants and tissue expanders because of the risk of BIA-ALCL.
FDA said its analysis showed the risk with BIOCELL implants was about six times the risk with textured implants from other makers sold in the U.S.
FDA also counts reports it gets from device makers, hospitals and others. As of June 30, 2024, FDA had reports of 1,380 BIA-ALCL cases from the U.S. and other countries since 2011, and 86% named Allergan. FDA warns that these reports alone cannot show how often the cancer happens or what caused it.
The lawsuits claim BIOCELL implants caused BIA-ALCL or greatly raised its risk. In the federal court records we read, we found no ruling that the implants cause it. The court rulings we found were about which claims may go ahead and how to plan the first trials.