The FDA Requests Allergan Voluntarily Recall BIOCELL Textured Breast Implants and Tissue Expanders

June 2, 2020 Tags: , , , , ,

"Biocell Product Safety Alert" in white capitalized text with a light blue background

The Food and Drug Administration (FDA) has requested that Allergan recall its BIOCELL textured breast implants and tissue expanders to protect individuals from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and BIA-ALCL-related complications and deaths. Based on current information and new data, the FDA analysis states that the risk of BIA-ALCL is six times higher for patients with Allergan’s BIOCELL textured breast implants than other textured implants marketed in the United States. Allergan has agreed to remove these products from the market. The FDA is not recommending that individuals who currently have BIOCELL textured implants remove them if no symptoms are present due to the low risk of developing BIA-ALCL. However, if one has Allergan BIOCELL textured implants and is experiencing swelling or pain near the implant, they should contact their health care provider to discuss further evaluation. If you have questions or received a breast augmentation from Dr. J. J. Wendel Plastic surgery and need to know if you have this type of implant, do not hesitate to contact our office.

Learn more: https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue?utm_campaign=2020-06-01%20FDA%20Updates%20Information%20on%20Allergan%E2%80%99s%20Actions%20to%20Reach%20Patients&utm_medium=email&utm_source=Eloqua