In July 2019, the Food and Drug Administration (FDA) asked Allergan to voluntarily recall certain textured breast implant and tissue expanders due to an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Allergan complied by conducting a world-wide recall of its BIOCELL textured breast implants and tissue expanders.
What are textured implants?
Textured implants are able to stick to the inside of the breast, which helps the implant to stay in position over time. Only about 10% of the U.S. breast implant market share includes textured implants, but they are fairly common in the rest of the world. Some healthcare providers choose textured implants for patients who have very minimal tissue support, such as patients undergoing reconstructive surgery after breast cancer.
Although several manufacturers produce textured breast implants, Allergan has the most aggressive texture (called BIOCELL), according to Salvatore Pacella, M.D., MBA, FACS, Division Head of Plastic and Reconstructive Surgery at Scripps Health, Scripps MD Anderson Cancer Center, and a HealthTrust Physician Advisor. This texture is what is referred to as “macrotexture,” which creates a tighter adherence of the implant to the inside of the breast. This is different than other “micro-textured” implants, created by other companies, which have a less aggressive texture. The more aggressive texture may contribute to chronic inflammation, which is thought to pre-dispose patients to develop BIA-ALCL.
The scope of the risk
While these Allergan devices have been associated with a greater risk of BIA-ALCL, Dr. Pacella notes that this type of lymphoma, and its associated morbidity rate, is very rare. Only around 800 to 1,000 cases have ever been discovered.
“Typically, the act of removing the scar tissue, the capsule and the implant is curative for this,” Dr. Pacella says. “So even though women may have developed this problem, it is very curable.” Several months ago, Dr. Pacella himself had a patient with BIA-ALCL. He performed a surgery to remove the scar tissue and implant in one piece, and he says the patient is now doing well.
The impact of the recall
This voluntary recall has had a large impact not only on Allergan, but on other textured breast implant producers, Dr. Pacella says. “What you’re seeing in the community is that most plastic surgeons are moving away from using any textured devices, regardless of the company, because of this FDA concern,” he says.
Jennifer Westendorf, MSN, RN, CNOR, Director of Surgical Services at HealthTrust, says facilities that have Allergan’s recalled products on consignment should make physicians aware of this recall. They should also review the customer letter sent out by Allergan and collaborate with their local Allergan representative regarding their existing inventory of BIOCELL textured breast implants and tissue expanders.Share Email