FDA Asks Allergan to Recall Textured Breast Implants

FDA has finally drawn a line in the sand on an issue that has plagued the breast implant industry for years. On Wednesday the U.S. regulatory agency called on Allergan to take specific models of its textured breast implants off the market due to the risk of a rare type of cancer. "To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with Allergan Biocell textured breast implants, [FDA] requested that Allergan recall its Biocell textured breast implants and tissue expanders," the agency said in a safety communication. "Allergan agreed and is removing these products from the global market." Allergan said it is recalling the devices as a precaution following notification of recently updated global safety information concerning the "uncommon incidence" of BIA-ALCL. Neither FDA nor Allergan recommended removal or replacement of these implants in patients who have not shown any adverse symptoms. "Patient safety is a priority for Allergan," the Dublin, Ireland-based company said. "Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns." In March the agency said it was taking a harder look at materials used in medical devices and potential adverse biological response resulting from contact of certain materials with the body over extended periods of time. Silicone breas...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news