FDA Issues Final Guidance on Breast Implant Labeling Requirements

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The U.S. Food and Drug Administration (FDA) issued the final guidance, "Breast Implants - Certain Labeling Recommendations to Improve Patient Communication," as part of the agency's effort to help improve the information available to patients and health care professionals about the risks of breast implants.

"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," said Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. "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."

Over the past several years, the FDA has received new information pertaining to risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and systemic symptoms commonly referred to as breast implant illness (BII) that some patients attribute to their implants, which can include fatigue, "brain fog," muscle or joint pain and rash.

The final guidance recommends manufacturers include 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. This guidance also recommends updated labeling information, silicone gel-filled breast implant rupture screening recommendations, inclusion of an easy-to-find description of materials and provision of patient device cards.

The FDA has also updated the guidance, "Saline, Silicone Gel, and Alternative Breast Implants" to provide consistency with these labeling recommendations. 

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