FDA adds boxed warning to breast implants

By Jen Christensen, CNN

The US Food and Drug Administration announced Wednesday that it made several changes to breast implant regulations, including new labeling that includes a boxed warning and a patient checklist that will inform people that implants are not a medical device that will last a lifetime.

After hearing testimony in 2019 from women who said their doctors did not adequately warn them about the potential health complications of breast implants, the FDA said it decided to restrict the sale of breast implants to only health care providers who offer patients a standardized checklist that explains the risks. The changes require doctors to walk patients through these potential problems and to give the patient an opportunity to sign off on the checklist to show they were properly informed about the risks to their health.

The older the implants are, the more health risks they pose, and those risks could require additional surgery.

The warning and the checklist will explain symptoms that some patients with implants have experienced, including fatigue, joint pain, tiredness, brain fog, and memory loss. It will also explain the possible link between implants and a rare type of cancer of the immune system known as anaplastic large cell lymphoma (BIA-ALCL). The cancer occurs more commonly in patients with textured breast implants than those who have the smooth implants. Many of the documented cases were tied to textured implants produced by Allergan that the company voluntarily recalled in 2019.

Scientists have known that breast implants can cause health problems since the 1960s, according to the Journal of the American Society of Plastic Surgeons.

The FDA maintains a registry to which doctors are supposed to report cases of anaplastic large cell lymphoma in individuals with breast implants.

Breast augmentation is among the top five most performed cosmetic surgical procedures, but the number of people who have had it done fell by 33% in 2020 from the year before. Nearly 200,000 people got breast implants in 2020, according to the 2020 plastic surgery statistics report from the American Society of Plastic Surgeons. Plastic surgery procedures were down across the board, but breast augmentations declined the most.

About 75% of those who get implants do so for cosmetic reasons. The rest get them following breast cancer surgery.

The FDA has also updated implant rupture screening recommendations for silicone gel-filled breast implants and updated its guidelines on what manufacturers will need to do with post-approval studies.

“In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants,” Dr. Binita Ashar, the director of the FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in a statement.

“By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”

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