Allergan Recalls its Natrelle BIOCELL Textured Breast Implants and Tissue Expanders due to risk of BIA-ALCL
On July 24th, Allergan announced it was recalling its BIOCELL textured expanders and implants from the global market in response to a request from the FDA. The FDA made the request that Allergan recall all its BIOCELL textured breast implants and tissue expanders based on newly submitted Medical Device Reports reporting worldwide cases of Breast Implant Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL), and related deaths associated with these devices.
BIA-ALCL is a rare cancer of the immune system that develops in the scar tissue surrounding breast implants. Common symptoms include swelling, significant fluid accumulation around the implant, pain and/or lumps in the breast. When caught early, the cancer is curable by removing the breast implant and the surrounding scar tissue (known as a capsulectomy). Patients with advanced disease need more treatment in the form of chemotherapy and radiation.
To date, 573 cases of BIA-ALCL and 33 deaths have been confirmed worldwide. Additional cases have been reported but have not been confirmed. Of the 573 confirmed cases, 481 have been attributed directly to Allergan’s Biocell textured implants leading to a global recall of the devices.
The US recall comes after an official FDA hearing was held in March to evaluate textured breast implant safety. The FDA first reported the possible link between breast implants and anaplastic large cell lymphoma in 2011. All confirmed cases have been attributed to textured implants. While there have also been cases in women who had smooth implants, due to the lack of a comprehensive medical history and incomplete implant information in these patients, there have been no confirmed cases attributed solely to smooth implants.
Although the Allergan textured implants have been recalled, the FDA is not recommending preventative removal of these textured implants in women who don’t have any symptoms due to the very low risk of developing BIA-ALCL. The FDA does recommend patients be educated on the potential risks associated with textured implants as well as the signs and symptoms of any complications. Patients are encouraged to contact their plastic surgeons with any questions or concerns whatsoever about their implants.
Read the full FDA patient safety communication here.
