FDA Orders Recall Of Breast Implants After Links To Roughly 500 Cancer Cases, A Dozen Deaths

The Food and Drug Administration requested that pharmaceutical company Allergan recall specific breast implant models that may cause cancer, the FDA announced Wednesday.

Allergan’s textured breast implants have been linked to a rare cancer called anaplastic large cell lymphoma (ALCL). The FDA warned of the implants, citing 33 patient deaths from breast implant-associated ALCL. Of the 13 deaths where the breast implant manufacturer is known, 12 involved implants made by Allergan, according to the FDA.

Textured implants like the ones being recalled make up roughly 5 % of the implants used in the U.S., according to The New York Times. The FDA recommends that women with the implants refrain from removing them unless they start to experience symptoms, and Allergan is taking the specific models off the market.

“Patient safety is a priority for Allergan and patients are advised to speak with their plastic surgeon about the risk and benefits of their implant type should they have any concerns,” Allergan said in a statement Wednesday.

Overall, the FDA has tracked 573 cases (481 of which were linked to Allergan models) of the cancer worldwide.

“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,” FDA Principal Deputy Commissioner Amy Abernethy said in a statement Wednesday.

The FDA “first identified the possible association between breast implants and ALCL in 2011,” Abernethy added.

Many European countries have already recalled models of textured breast implants, according to The NYT. It’s unclear how many implants are included in the FDA’s recall. Textured implants are designed to create scar tissue around the implants to better hold them in place.