In 2019, Allergan recalled its Biocell textured breast implants after the FDA linked them to a rare cancer called breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL).
What is BIA-ALCL?
BIA-ALCL is a type of T-cell lymphoma that can develop in the scar-tissue capsule and fluid surrounding a breast implant. In some cases, it can spread throughout the body. BIA-ALCL is curable in most patients if it is diagnosed early and treated appropriately, but a small number of patients have died from the illness.
BIA-ALCL is not breast cancer. It can occur around implants filled with saline or with silicone gel that have been placed for breast reconstruction after mastectomy or cosmetic breast enlargement. It seems to develop only in women who have implants with a textured surface (shell) or have had them in the past.1
Allergan aesthetics is a pharmaceutical company in the medical-aesthetics industry. The company’s portfolio includes facial injectables, body contouring, plastics, skin care, and more.2 The products involved in this problem are Allergan’s Biocell Natrelle textured implants. Check the FDA website to see the complete list of recalled products.
Of the 573 BIA-ALCL cases, 481 were attributed to Allergan implants, according to the FDA. Twelve of the 33 patients who died were confirmed to have had breast implants from the company during their cancer diagnoses.3
Allergan has been accused of manufacturing a device which possesses a risk of cancer and for failing to warn consumers about the dangers of developing BIA-ALCL. Hundreds of Allergan breast-implant cases have been consolidated into a multidistrict litigation in the U.S. District court for the District of New Jersey.4
2. Allergan Aesthetics
3. U.S. Food and Drug Administration
4.United States Judicial Panel on Multidistrict Litigation. MDL No. 2921