Breast implant manufacturer Allergan, Inc. issued a worldwide recall Wednesday of certain textured breast implant models—a move that was sparked by the FDA's request that the manufacturer voluntarily recall the breast implants and remove them from doctors' offices and supplier outlets, since they've been linked to a certain type of cancer.
In the FDA news release, also dated Wednesday, the organization revealed that the textured breast implants in question—specifically four of Allergen's BIOCELL textured breast implant products—have been linked to 573 known cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and 33 patient deaths linked to BIA-ALCL since 2010.
“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,” Amy Abernethy, MD, PhD, Principal Deputy Commissioner for the FDA said in the statement.
Dr. Abernathy went on to say that anaplastic large-cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma or blood cancer, per the Genetic and Rare Diseases Information Center, was first associated with textured breast implants in 2011. Textured breast implants are designed to stay in place in women's breasts by developing scar tissue that will stick to the implants, according to the American Society of Plastic Surgeons.
The decision to recall the Allergan products Wednesday was “based on new data,” Dr. Abernethy said in the statement—specifically that there has been a significant increase of 116 new cases of and 24 deaths caused by BIA-ALCL since the FDA's last update on BIA-ALCL in February 2019.
It's important to keep in mind that this recall only affects textured breast implants—and more specifically, those made by Allergan. (The FDA found that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S., per the news release.) Textured breast implants in general are also less common than other implant types in the US, with macro-textured implants, like those made by Allergan, representing "less than 5% of all implants sold in the U.S.,” per the FDA.
Also important: The FDA isn’t recommending that patients who have breast implants who have not experienced ALCL symptoms get their implants removed. The FDA did, however, issue a safety communications to those with Allergan BIOCELL breast implants, urging them to know the symptoms of BIA-ALCL, which primarily includes persistent swelling or pain near the breast implant, and to monitor the area around their breast implants for any changes.
Fortunately, BIA-ALCL is considered highly treatable. "When caught early, BIA-ALCL is usually curable," the American Society of Plastic Surgeons says. That said, the FDA's decision to take harmful Allergan products off the market will do much to protect women from the potentially-fatal disease, Joshua Brody, MD, director of the Lymphoma Immunotherapy Program at The Tisch Cancer Institute at Mount Sinai in New York City, tells Health in a statement.
“The recall of these textured implants is a big deal in protecting women from the potential risks of developing, and dying from, this rare type of aggressive lymphoma,” Dr. Brody says. "By preventing further use of these implants, the FDA is helping women to protect themselves from the medically serious and emotionally exhausting effects of these risks.”