FDA Rejects Textured Breast Implant Ban, Despite Cancer Link

Published on May 3, 2019 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) has decided against banning textured breast implants, despite hundreds of reports linking the devices to a rare form of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The agency apparently doesn’t believe that the available data on BIA-ALCL meets the standard for imposing a textured breast implant ban. In a statement issued on Thursday, the FDA indicated that it would instead ramp up its efforts to disseminate information about the risks associated with textured devices and other types of breast implants.

Textured Breast Implant Bans in Europe, Canada

BIA-ALCL is slow-growing form of non-Hodgkin’s lymphoma that develops in the scar capsule that eventually develops around breast implants. Signs and symptoms of the disease include:

• Lumps
• Swelling in the breast
• Asymmetry around the breast implant after the surgical site fully heals
• Pain around the breast implant

The FDA had received more than 450 reports of BIA-ALCL as of last September, and at 16 women died of the disease as of January 1, 2019. The vast majority of cases occurred in women with textured devices, which account for fewer than 10% of breast implant sales in the United States, but roughly 80% of sales worldwide.

Health Canada suspended Allergan’s license to market Biocell breast implants on April 4th, after a review found that 24 of 28 Canadian women with BIA-ALCL had received those textured devices. Similar cancer concerns prompted France’s National Agency for Safety of Medicines and Health Products announce a textured breast implant ban involving several devices, including the Biocell implants, just a day later.

Both textured breast implant bans followed Allergan’s decision to remove products from the European market after their certification expired last December.

FDA Mulls Breast Implant Black Box Warning

The FDA has so far been unable to establish a causal connection between breast implants and so-called “breast implant illness,” but agreed that evidence suggests some women experience systemic symptoms, including chronic fatigue, cognitive issues, join and muscle pain, that may resolve once the devices are removed.

According to yesterday’s statement, the agency is considering several actions to ensure women and doctors are aware of the risks linked to breast implants, including a black box warning and requiring that doctors go over a checklist with their patients prior to surgery.

The FDA also said it would require breast implant manufacturers to file individual reports on adverse events that will be made publicly available in the coming weeks. Previously, the manufacturers were only required to provide the agency with a summary of patient problems or concerns, but that method apparently allowed the FDA to miss “unusual, unique or uncommon adverse events, which, in the case of breast implants, included BIA-ALCL.”

Jamee Cook, co-founder of Breast Implant Victim Advocacy, told CNN she was hopeful the FDA would implement the black box warning and checklist requirements, but expressed disappointment over the decision to nix a textured breast implant ban.

“Not banning the textured implants is very discouraging to us and to the patients who have lymphoma,” she said. “We’re going to continue to push for that ban, even though that’s not a move they are willing to make yet.”