Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA),” they said. A total of 573 cases globally of anaplastic large cell lymphoma related to breast implants have been reported to the FDA until now. There have also been 33 patient deaths.
The specific textured breast implant products that have been recalled include Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recalled tissue expanders include the Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. “We will continually evaluate any new information and may, as a result, take action regarding other breast implants, if warranted,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said in Wednesday’s news release.