FDA Now Wants Textured Breast Implants to Be Recalled

Almost three months after the Food and Drug Administration chose not to enact a wholesale ban of textured breast implants—a type of implant linked to a rare cancer—the agency has asked the breast implant maker Allergan to recall its textured implants currently available in the United States. According to the FDA, Allergan is “moving forward with a worldwide recall.”

Worldwide, textured breast implants have been linked to 573 cases of anaplastic large-cell lymphoma, and 33 people have died, according to updated numbers from the FDA. An overwhelming majority of both the cancer diagnoses—481—as well as the deaths in which the maker of the implant is known—12 out of 13—resulted from Allergan implants. “Based on the currently available information, including the newly submitted data, our analysis demonstrates 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,” the FDA wrote in its statement.

More specific details on what products are being recalled, per the New York Times:

The recalled devices are Biocell products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients before breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.

For those who currently have the implants but no symptoms, the FDA is not recommending they be removed. But as the New York Times wrote, “the recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergan.”

In May, after holding a two-day hearing during which numerous people with the implants testified they had been diagnosed with anaplastic large-cell lymphoma or autoimmune diseases, the FDA decided to not ban textured breast implants, writing that the agency “does not believe that the product—a kind of textured implant—meets the legal standard for being banned at this time, based on available data and information.”

The FDA is assessing “whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants,” said Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health. He added, “We continue to advise women and health care professionals that the use of breast implants is associated with a risk of developing BIA-ALCL and that the risk is greater with textured implants.”