FDA Sets Restriction, Updates Label Requirements For Breast Implants

The U.S. Food and Drug Administration (FDA) has taken action to strengthen the safety requirements for breast implants. This way, patients can make "fully informed decisions."

The FDA announced the stronger safety requirements for breast implants in a news release Wednesday. Under these new actions, the FDA ordered the restriction of the sale and distribution of breast implants only to facilities and healthcare professionals that would provide patients with vital information using the "Patient Decision Checklist."

"The checklist must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device," the FDFA noted. "The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device."

The new regulations also approved new labeling for all legally marketed breast implants. Now, product labels should have details, including a boxed warning of the "significant risks," a patient decision checklist and updated breast implant rupture screening recommendations. Manufacturers are expected to make updates to the device labels on their websites within the next 30 days.

However, the labeling is only "intended to enhance, but not replace" the all-important discussion between the patient and the physician about the risks and benefits that may be unique to each individual patient, the agency clarified.

"Protecting patients' health when they are treated with a medical device is our most important priority," Binita Ashar, M.D., the director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in the news release.

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

Breast augmentation is said to be the most common cosmetic procedure in the U.S., with some 400,000 people getting implants each year, AP News reported. In fact, breast implants are actually considered Class III medical devices, a category that includes devices that sustain human life.

Apart from being implanted under the chest muscle or breast tissue to increase breast size, they are also used to replace breast tissue that has been removed because of cancer or trauma, as well as in revision surgeries to correct or improve previous surgeries.

Authorities have been dealing with concerns regarding breast implants for years, according to AP News. For instance, there were issues surrounding a type of textured implant and its link to a rare cancer. Others also pointed to the implants as the source of their health problems including muscle pain and chronic fatigue.

While the rules were proposed as voluntary measures in 2019, this week's move has turned them into legal requirements for the makers of these medical devices, the outlet noted.