Breast Implant ALCL Info Letter

You may have heard recent media reports regarding the FDA request for recall of Allergan textured BIOCELL breast implants and tissue expanders due to a rare form of cancer associated with these implants. The FDA requested this recall to protect patients because there are new reports that additional patients have been diagnosed with Breast Implant Associated-Anaplastic Large Cell Lyphoma (BIA-ALCL), including deaths related to BIA-ALCL. There are other companies that make textured implants and tissue expanders, but currently (as of July 25, 2019) only Allergan’s BIOCELL textured implants and tissue expanders have been recalled. About 550,000 breast implants are placed every year in the United States, and about 12% of those implants are textured.

Dr. Sasmor does not use Allergan textured BIOCELL implants or tissue expanders. She only uses round, smooth saline and silicone filled implants, and Mentor tissue expanders which are minimally textured and are not BIOCELL.

The FDA has decided that as long as patients do not have symptoms, they are not recommending removal of the recalled implants or expanders. This is because the risk of developing BIA-ALCL overall is extremely low. The lifetime risk for this disease is estimated to be 1 case for every 3,800 – 30,000 textured implants. This equates to a 0.03 – 0.003 percent risk. The recall is to prevent any future use of these implants and expanders.

The American Society of Plastic Surgeons is working closely with the FDA in monitoring and studying the disease. This disease has been found in women with textured silicone or textured saline implants, and women who had implants placed for reconstructive or cosmetic reasons. Thus far, there have been no confirmed cases of BIA-ALCL in women who have had only “smooth surface” breast implants. The symptoms of BIA-ALCL are most commonly persistent swelling and fluid buildup around the implant, but also can include breast lump (mass), skin rash, fever/night sweats, and enlarged lymph nodes. These symptoms develop on average about 9 years after surgery. BIA-ALCL is not a breast cancer, but a rare and treatable lymphoma (immune cell cancer).

If you develop any of the symptoms listed above, please contact Dr. Sasmor’s office right away. You will received comprehensive evaluation and testing to determine if treatment is indicated. Women who develop BIA-ALCL can often be cured by removing the implant and the scar tissue surrounding it. Some patients may require additional treatment (such as radiation or chemotherapy). For additional information about BIA-ALCL, consult the American Society of Plastic Surgeons website Here. For information about the FDA recall, Click Here.

If you have questions or concerns, please contact Dr. Sasmor’s office to schedule a follow up appointment.