The FDA Announced a Breast Implant Recall

January 9, 2021

Breast implant maker Allergan issued a worldwide recall of certain textured breast implant models on Wednesday – a move prompted by the FDA’s request that manufacturers voluntarily recall the breast implants and remove them from doctors’ offices and vendor outlets because they have been linked to certain cancers.

In an FDA press release, also dated Wednesday, the organization revealed that since 2010, the textured breast implants in question – specifically Allergen’s four BIOCELL textured breast implant products – have been linked to 573 known cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and 33 cases of BIA-alternative lymphoma (BIA-ALCL). ALCL-related patient deaths.

“While the overall incidence of BIA-ALCL appears to be relatively low, once evidence becomes available that a particular manufacturer’s product appears to be directly linked to significant patient harm, including death, the FDA takes action to alert the company to new evidence indicating that a recall is necessary to protect women’s health,” said Dr. Amy Abernethy, FDA’s chief deputy commissioner at the The statement said.

Dr. Abernathy went on to say that regenerative large cell lymphoma (ALCL), a rare form of non-Hodgkin’s lymphoma or blood cancer, was first linked to textured breast implants in 2011, according to the Genetic and Rare Disease Information Center. According to the American Society of Plastic Surgeons, textured breast implants are designed to keep a woman’s breasts in place by developing scar tissue that will adhere to the implant.

Wednesday’s decision to recall Allergan products was “based on new data,” Dr. Abernethy said in a statement – specifically, a significant increase of 116 new cases and 24 deaths caused by BIA-ALCL since the FDA’s last update on BIA-ALCL in February 2019.

It’s important to remember that this recall only affects breast implants of good quality – more specifically, those made by Allergan. (According to the press release, the FDA found that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times greater than the risk of BIA-ALCL with textured implants marketed in the U.S. by other manufacturers.) In general, textured breast implants are also less common than other implant types in the U.S., like the macro-textured implants made by Allergan, which account for “less than 5 percent” of all implants sold in the U.S., according to the FDA.

Also important: The FDA does not recommend that breast implant patients who are not experiencing symptoms of ALCL have their implants removed. However, the FDA does send out a safety communication to those patients with Allergan BIOCELL breast implants, urging them to be aware of the symptoms of BIA-ALCL, which primarily include persistent swelling or pain near their breast implants, and to monitor the area around their breast implants for any changes.

Fortunately, BIA-ALCL is considered to be highly treatable.” When detected early, BIA-ALCL is usually curable,” says the American Society of Plastic Surgeons. Nonetheless, the FDA’s decision to take harmful Allergan products off the market will go a long way toward protecting women from the potentially deadly disease, Dr. Joshua Brody, director of the Lymphoma Immunotherapy Program at the Tisch Cancer Institute at Mount Sinai in New York City, told Health in a statement.

“The recall of these textured implants is a big deal to protect women from the potential risk of development and death from this rare and aggressive lymphoma,” Dr. Brody said.” By preventing further use of these implants, the FDA is helping women protect themselves from the medically serious and emotionally exhausting effects of these risks.”