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FDA tightens rules for breast implants, after deaths and years of scrutiny over health risks

October 28, 2021, 9:21 PM UTC

The U.S. Food and Drug Administration is making it harder for pharmaceutical companies and plastic surgeons to hide the risks of breast implants from patients.

The federal agency this week announced new rules for breast implant manufacturers, including Johnson & Johnson and AbbVie’s Allergan, who will have to add a “black box” or boxed warning label to their products. These companies will also have to disclose the specific materials used in their implants, and they will be allowed to sell them only to health care providers who review the potential risks with patients before surgery, using a new FDA-mandated checklist.

At least 36 women have died from a cancer linked to certain types of breast implants, and the products in general have also been tied to many other types of health problems, as Fortune reported in an 2020 investigation. But breast implants have remained on the market despite decades of inadequate testing and study, recurrent safety concerns, and poor regulatory oversight. These problems have increased the health risks to millions of women, including breast cancer patients who have gotten implants after undergoing mastectomies.

Patients, advocates, and some surgeons have been asking the FDA to increase its oversight of breast implants for years. In early 2019, the agency held hearings on the products’ safety. That summer, the FDA asked Allergan to recall a type of implant that has been linked to deaths from a cancer of the immune system known as ­BIA-ALCL, for “breast implant­–associated anaplastic large cell lymphoma.”

In the wake of Fortune’s reporting, the FDA last year asked Allergan to make more of an effort to contact tens of thousands of women affected by its recalled implants. Then, last September, the agency unveiled finalized guidance recommending that manufacturers add boxed warnings and patient checklists to their products. But the agency’s actions this week went a step further, by mandating that companies comply with these new requirements.

“By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery,” Binita Ashar, director of the FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in a press release. “As the FDA continues to evaluate the overall effects of breast implants in patients, today’s actions help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.”

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