In September 2019, the U.S. Food & Drug Administration reported that at least 12 women had died from breast implant associated anaplastic large cell lymphoma (BIA-ALCL)—a rare cancer of the immune system—caused by textured breast implants and tissue expanders made by Allergan.
Today, the American Society of Plastic Surgeons recognizes a total of 953 suspected and confirmed cases of BIA-ALCL.
Class 1 Recall
Knowledge of the increased risk of BIA-ALCL that accompanies certain Allergan textured implants and tissue expanders prompted the FDA to issue a recall of such devices last year. The recall was classified as a Class 1, the most serious type of recall the agency issues.
Allergan stopped manufacturing and marketing its textured implants and tissue expanders after the FDA reported grim numbers from its analysis of the devices. At the time of the agency’s report, there were 573 cases of BIA-ALCL worldwide. Of these cases, 481 of the diagnosed patients had Allergan breast implants.
The FDA discovered that the risk of BIA-ALCL with Allergan BIOCELL textured implants is around six times greater than the risk with other manufacturers’ textured implants.
Even more alarming, a total of 33 patients have died from BIA-ALCL, 12 of whom had Allergan implants. Manufacturers of the devices that prompted the remaining 21 deaths have not been determined.
BIOCELL textured breast implants feature a distinctive surface that only Allergan uses. The FDA says it is continuing to explore whether the BIA-ALCL risk is restricted to only certain models of textured implants or if the risk exists with all textured breast implants.
More on BIA-ALCL
BIA-ALCL is a form of non-Hodgkin’s lymphoma, a cancer of the immune system. The disease appears in the scar tissue and fluid around the breast implant. Although BIA-ALCL is treatable by surgical removal of the implant and surrounding scar tissue, a diagnosis of the disease can lead to death if not treated early and properly. In some cases, treatment includes required chemotherapy and/or radiation therapy.
What to Do if You Have Textured Breast ImplantsThe FDA does not recommend removal of your implants, unless you are experiencing symptoms of BIA-ALCL, which include pain or persistent swelling around the implant. If these symptoms do appear, talk to your physician, and inquire about an evaluation to diagnose BIA-ALCL. If you are diagnosed with the disease, the FDA recommends that you have the implants removed.
Strongly consider reporting your experience to the FDA using the agency’s MedWatch Voluntary Reporting Form.
If you are uncertain if you have BIOCELL implants, you can go to BIOCELLinformaiton.com to see if Allergan has information regarding your medical devices. You can also inquire with the hospital or surgeon where you received your implants to check if they have the information you need.