FDA Releases New Regulations for Breast Implants; Includes Health Risks Checklist for Patients

The U.S. Food and Drug Administration announced new regulations for breast implants.

Back in 2019, a group of women testified during a hearing, saying their doctors did not properly inform them about the potential health issues that may come with having breast implants. This past Wednesday, the FDA said it made a number of changes to breast implant regulations, one of which includes a boxing warning and patient checklist that breaks down all the risks that come with the procedure.

Doctors will also now have to walk patients through the risks, and patients will have to sign off on the checklist that shows that they fully understand and were informed about the risks, CNN Health reports.

Some of the risks or side effects people experience after having a breast implant procedure done include fatigue, joint pain, memory loss and more. The checklist will also note that breast implants have been linked to rare forms of immune system cancer.

“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,” Dr. Binita Ashar, the director of the FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, 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.”