Yesterday, the U.S. Food and Drug Administration announced the recall of textured breast implants linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). According to the New York Times, BIA-ALCL is a rare cancer of the immune system. It impacts the tissue surrounding the implant but is not considered breast cancer. The manufacturer, Allergan, voluntarily recalled textured BIOCELL breast implants and tissue expanders worldwide.
According to the press release from the FDA, a new global analysis reported 573 cases of BIA-ALCL with 33 patient deaths. Of these cases, 481 have Allergan breast implants. Thirty-six percent of the patient deaths occurred in those known to have Allergan breast implants. The FDA reports that textured breast implants are less common in the U.S. than other countries, representing less than 5% of all breast implants sold in the United States. For comparison, textured implants have made up as much as 80% of the implant market share in France, Canada, and Australia.
FDA Principal Deputy Commissioner Amy Abernathy stated, “Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.” The FDA has been monitoring breast implant safety and associations with BIA-ALCL since the issue first came to light in 2011.
The FDA also released recommendations for those with Allergan BIOCELL breast implants. Because the risk of developing BIA-ALCL is considered low, they do not recommend removal if a patient is not showing symptoms. The FDA recommends monitoring the implant area for pain, swelling, and any other changes. Health care providers are to immediately halt the use of Allergan BIOCELL products and inform their patients about the risks of BIA-ALCL.
The video below is from earlier this month and is a summary of an advisory panel meeting on breast implant safety. The panel discussed BIA-ALCL as well as Breast Implant Illness (BII). Although currently there is no definitive evidence of BII, the FDA is working to gather information from patients and health care providers to monitor patient symptoms.