FDA adds new restrictions, warning labels for breast implants following reports of cancer

The FDA added new restrictions to all breast implants on the market after years of chasing cases of rare cancers and reports of a constellation of symptoms that can include fatigue, memory loss, confusion, rashes and joint pain.

The agency curbed the sale and distribution of both saline- and silicone gel-filled breast implants—including products from Allergan, Johnson & Johnson’s Mentor division, Sientra and Ideal Implant—by restricting them only to providers who walk prospective patients through a decision checklist outlining the long-term risks and obtain their signature before the operation.

Last year, the FDA updated its count of recipients who developed breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, a cancer of the immune system typically found in the scar tissue and fluid surrounding an implant. While overall incidence is low, the disease can be fatal if not diagnosed and treated early.

This week the agency also handed down a boxed warning to be carried on the product’s labeling, required that descriptions list the specific materials used in the implant and updated MRI screening recommendations for catching so-called “silent ruptures” of silicone gel-filled implants.

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The boxed warning aims to make it clear that breast implants are not considered “lifetime devices,” according to an agency guidance document, and that the chance of developing complications including cancer increases over time, and will potentially require additional surgeries as treatment.

“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,” Binita Ashar, director of the FDA’s Office of Surgical and Infection Control Devices, 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.”

The FDA previously sent warning letters to manufacturers—including Allergan, Sientra and Mentor—for failing to complete postmarket evaluations of their products. These clinical studies were mandated to enroll thousands of women for annual follow-ups over at least a decade to collect data on implant complications and signs of cancer as well as rheumatologic or neurologic conditions.

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In mid-2019, Allergan launched a worldwide recall of its textured Biocell and Natrelle breast implants following a request from the FDA after reports of cases and deaths linked to BIA-ALCL. Textured implants have been less common in the U.S., according to the FDA, and the recall did not cover the company’s smooth breast implants or its other tissue expanders.