FDA Requests Allergan™ to Voluntarily Recall Certain Breast Implants
Although the overall incidence of BIA-ALCL appears to be relatively low, the U.S. Food and Drug Administration on July 24th, 2019 took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan™, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL.
Following the FDA request, Allergan™ has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: 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.
As a patient if you have no symptoms (swelling or pain near the breast implant), the FDA is not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCA. However , if you have any questions, talk to your health care provider.
Below is a video from KTLA 5 News where Dr. Linder is asked about the recent recall.