The FDA says the textured surface, unique to Allergan's implants, are tied to 481 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma. There have been 573 cases of BIA-ALCL worldwide, including 33 deaths. In 13 cases where a patient died and the manufacturer of the breast implant was known, 12 of them involved an Allergan breast implant.
Most cases of this particular cancer, which attacks the immune system, are not diagnosed for years after the original implantation.
Daniel Maman, MD, a board-certified plastic surgeon with 740 Park Plastic Surgery in New York City, says it remains unclear why these types of implants could cause cancer.
"But these rare cases are showing that the texture of the shell surrounding the implant can cause this lymphoma response in capsule tissue that surrounds the breast implant," he says.
The FDA says anyone with an Allergan BIOCELL implant should not have it removed, unless symptoms are present. Those symptoms include persistent swelling or pain near the implant. Patients found to have BIA-ALCL would have the implants removed, along with surrounding scar tissue.
The FDA says in most cases, the cancer is limited to the scar tissue and fluid near the implant, but it can spread through the body. While the diagnosis is serious and can lead to death, the risk is considered to be low, the agency says. Some patients may need chemotherapy and/or radiation therapy.
The FDA says the risk of getting BIA-ALCL from an Allergan textured implant is roughly 6 times the risk compared to similar products from other manufacturers. Textured implants represent 10% of all breast implants sold in the United States.
"The popularity of the different types of implants is heavily dependent on the surgeon and what they prefer using, but there are pros and cons of each type of implant," Maman says. "I personally have not put in a textured implant in over 5 years."