FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants

The FDA issued the final guidance in order to help improve the information available to patients and health care providers about the risks of breast implants.

The FDA has issued the final guidance for certain labeling recommendations for breast implants in order to help improve the information available to patients and health care providers regarding the risks of breast implants.

The document is titled, “Breast Implants – Certain Labeling Recommendations to Improve Patient Communication.” The draft guidance of this document was issued in 2019.

“As new information has become available about the risks and complications of breast implants, it is critical that women have access to information they need to make informed decisions,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in a press release. “After working with stakeholders, including patients, today we are recommending format and content changes to breast implant labeling so the information is presented in an easy to understand way. It is important that patients discuss the risks and benefits of breast implants with their health care provider and we hope that these labeling recommendations will help in facilitating these discussions.”

The General and Plastic Surgery Devices Advisory Panel was convened in 2019 to discuss the long-term benefits and risks of breast implants indicated for breast augmentation and reconstruction. The meeting covered a variety of important topics on breast implant safety, including characterization of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) incidence and risk factors, as well as methods for assessing systemic symptoms.

The panel then gave recommendations on these topics, including recommending that the FDA require a boxed warning in breast implant labeling and a standardized checklist as part of the informed consent process, revise the MRI screening recommendations for silent ruptures of silicone gel-filled breast implants, and improve transparency regarding materials present in breast implants. Additionally, the panel discussed the role of the patient device card in providing important information about a patient’s breast implant.

The final guidance now provides recommendations for manufacturers to incorporate a boxed warning and a patient decision checklist into the labeling for breast implants to better ensure certain information is received and understood by patients. The guidance also recommends updated and additional labeling information, including updates to the silicone gel-filled breast implant rupture screening recommendations, inclusion of an easy-to-find description of materials, and provision of patient device cards that were recommended at a panel meeting in March 2019.

According to the FDA, these labeling recommendations are intended to enhance, but not replace, discussions between doctors and patients to talk about the benefits and risks of breast implants that relate to individual patients.

In order to provide consistency with these labeling recommendations, the FDA has also updated the guidance, “Saline, Silicone Gel, and Alternative Breast Implants.” The agency indicated it will continue to work with professional medical societies, patient advocacy groups, and women’s health organizations to help ensure that risk information about these devices is properly disseminated to patients.


FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants [news release]. FDA. Published September 28, 2020. Accessed September 29, 2020. https://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-certain-labeling-recommendations-breast-implants

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