Special Report: Allergan Announces Worldwide Recall of Biocell Textured Implants
ANNOUNCEMENT FROM THE AMERICAN SOCIETY OF PLASTIC SURGEONS, PLASTIC SURGERY NEWS:
Allergan announced this morning that it is recalling its Biocell textured breast implants and tissue expanders.The move follows increased scrutiny on textured breast implants and their connection to BIA-ALCL, an uncommon lymphoma that can develop around breast implants. The U.S. Food and Drug Administration (FDA) requested that Allergan recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL, and Allergan agreed to voluntarily issue the recall as a precautionary measure.
Biocell saline-filled and silicone-filled textured implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. The company urged healthcare providers to cease implanting its Biocell products and return any unused devices to Allergan.
The recall does not affect the company’s Natrelle smooth or Microcell breast implants or expanders.
The FDA notes that women who have these implants but no symptoms, do not need to have them removed.