FDA Adds Restrictions and Approves New Labeling for Breast Implants
Posted: Friday, November 5, 2021
The U.S. Food and Drug Administration (FDA) has issued a new warning label to improve safety requirements for breast implants. The new label will restrict sales and distribution of breast implants to health-care providers and facilities that provide information to patients utilizing the patient brochure “Patient Decision Checklist.” The FDA-approved labeling for all approved breast implants will include a boxed warning, a patient decision checklist, updated silicone gel–filled breast implant rupture screening recommendations, a device description with a list of specific materials used in the device, and a patient device card. The FDA’s goal in adding the updated label is to help patients better understand the risks and benefits of breast implants and make informed decisions for their health.
The FDA is basing its updated labeling recommendations on available information that suggests restrictions are needed to allow a reasonable assurance for the device’s safety and effectiveness. This includes recommendations from the General and Plastic Surgery Devices Advisory Panel in 2019. The Panel discussed the long-term benefits and risks of breast implants indicated for breast augmentation and reconstruction. At the meeting, a discussion of breast implant safety involved a potential association with anaplastic large cell lymphoma. Recommendations from the panel included a boxed warning in breast implant labeling, a standardized checklist as part of the informed consent process, MRI screening recommendations for silent ruptures of silicone gel–filled breast implants, and more transparency concerning the materials in breast implants. In addition, a post-approval study released data to help understand the long-term effects of breast implants by providing a status update of all breast implant studies.
The 2019 panel meeting set up the FDA’s final guidance for breast implants, which was issued in September 2020. In addition to the new labeling requirements, the recommendations are a part of the supplemental approval applications submitted by manufacturers.