FDA strengthens safety requirements for breast implants

The Food and Drug Administration (FDA) announced Wednesday it will take several steps to strengthen safety requirements for breast implants, including requiring manufacturers and plastic surgeons to warn patients of the risks before they undergo surgery.

The new agency order also places new restrictions on how breast implants can be sold and distributed in an effort to ensure that patients considering breast implants can make informed decisions about devices.

The FDA is also approving new labeling for all legally marketed breast implants. It includes a boxed warning, a patient decision checklist and screening recommendations for women who receive silicone gel-filled breast implants. 

Additionally, the agency is updating information on the status of breast implant manufacturer post-approval studies, according to its statement on Wednesday.

“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, the director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in the statement. 

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

“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,” she added.

The new requirements come after tens of thousands of women have spent years complaining of experiencing symptoms following their breast implant surgeries, including brain fog, fatigue and other health issues often known as “breast implant illness,” The Washington Post reported. 

Some patients have even been linked to a rare and potentially fatal form of cancer. The FDA has documented that 573 cases of that cancer worldwide and 33 resulting deaths. 

Amid those ongoing complaints, advocates have long fought for a more consistent process so that patients considering breast implants can be better informed, according to the Post.

Regulators recommended in 2020 that manufacturers put an enclosed warning in a black box on the label to list possible complications associated with breast implants. 

The guidance also recommended medical officials use a patient checklist to guide customers through potential hazards.