The Food and Drug Administration on Wednesday announced that patients seeking breast implants will have fill out a checklist warning them of the risks of the device before having the surgery. Photo courtesy of FDA/Wikimedia Commons
Oct. 287 (UPI) -- The U.S. Food and Drug Administration on Wednesday announced strengthened breast implant regulations, including a boxed warning informing patients of "significant risks" associated with the medical procedure.
"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 Office of Surgical and Infection Control Devices at the FDA, 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."
Along with the inclusion of the boxed warning, which is the strictest warning applied by the FDA, the federal organization announced the restriction of the distribution and sale of breast implants to only healthcare providers and facilities that provide information to patients with the use of a so-called patient decision checklist.
This checklist, the FDA said, must be reviewed with the patient by a healthcare provider who informs them about the risks and benefits of the implant and it must be signed by both parties.
"The FDA is requiring these restrictions based on its finding that the available information indicates such restrictions are necessary to provide a reasonable assurance of the device's safety and effectiveness," the federal administration said.
According to the American Society of Plastic Surgeons, associated risks of breast implants include anaplastic large cell lymphoma and symptoms commonly referred to as breast implant illness, such as fatigue, so-called brain fog, muscle or joint pain and rash.
The strengthening of the restrictions follows the FDA convening a panel in 2019 to discuss the long-term effects of breast implants after it received complaints about the device.
The panel made recommendations with final guidance issued in September of last year, which was included in the new labelling approved Wednesday, it said.
Other restrictions announced Wednesday include new recommendations for screening silicone gel-filled breast implants for ruptures, a device description with a list of specific materials used and updated labeling for specific brands of breast implants.
"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 said.
The manufactures have 30 days to implement the restrictions.