Allergan Textured Breast Implants: Recall

August 19, 2019

Last month, the pharmaceutical company Allergan announced a recall of their Biocell textured breast implants and tissue expanders in response to a request for a recall from the U.S. Food and Drug Administration (FDA). This recall comes after the release of a study linking textured breast implants with a rare kind of cancer called breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). Globally, there have been 573 cases of BIA-ALCL and 481 are attributed to Allergan BIOCELL textured breast implants. With the removal of these products from the global market, the FDA and Allergan hope to protect consumers from the potential increased risks associated with these textured implants.

BIA-ALCL is not breast cancer. It is a type of non-Hodgkin’s lymphoma, a cancer of the immune system. Most of the time, BIA-ALCL can be found in the scar tissue surrounding the implantation site, but in some cases it has been found to spread throughout the body. The earlier BIA-ALCL is diagnosed and treated, the better outcome patients can expect. While most cases of BIA-ALCL have been associated with Allergan’s BIOCELL textured breast implants, the FDA is recommending all patients considering breast implants of any type to be informed of the risk of developing BIA-ALCL.

It is important to note that the overall incidence of BIA-ALCL is relatively low, occurring in less than 1% of all breast implant patients. Every year in the US, nearly 400,000 people undergo a breast implant procedure, the vast majority of which do not result in an occurrence of BIA-ALCL. The reason for this recall is based on the evidence that Allergan’s textured implants are specifically linked to BIA-ALCL. At this time the FDA is not recommending the removal or replacement of textured implants or tissue expanders in women who are not experiencing any symptoms. In fact, the FDA believes the unnecessary removal of implants that are causing no problems is associated with more potential risks than leaving these implants in place.

If you have textured breast implants, the FDA recommends regular monitoring for symptoms of BIA-ALCL. Most of the people who have been diagnosed with BIA-ALCL went to their doctor after noticing fluid had collected around the implant years after placement. Doctors were able to test this fluid, called a seroma, which led to the diagnosis. In other cases, the diagnosis occurred after a mass was found or because the tissue around the implant tightened, causing discomfort and cosmetic issues. Those diagnosed with BIA-ALCL were treated by removing the implant and the scar tissue surrounding the implant. Radiation therapy and chemotherapy are rarely needed, but may be suggested in specific cases. If you are not experiencing any symptoms of BIA-ALCL, there is no need to remove the implants or make any changes to your regular medical care.

If you have an implant and are concerned, contact your doctor with any questions. They will be able to provide the best advice for your specific circumstances. Contact your doctor immediately if you are experiencing pain, lumps, swelling, or asymmetry, especially if these symptoms are surfacing years after your procedure. If you are considering breast implants, talk to your doctor about the risks and benefits of both textured and smooth implants. Your doctor will be able to give you all the information on your implant options and provide expert medical advice on what implant is best for you.

Dr. Teotia runs a practice centered on client health and satisfaction. Empowering clients with the knowledge to make the best decisions for their plastic surgery goals is an essential aspect of the process. Dr. Teotia and her experienced team will continue to provide informed medical advice based on the latest data and information released by the FDA.