FDA statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants

Message from the Acting Associate Commissioner

Dear Women’s Health Colleagues,

Today, we are sharing a statement regarding the agency’s continued efforts to enhance safety information available to patients considering breast implants. FDA recommends including a boxed warning and other elements in breast implant labeling in a draft guidance. Please see statement below.

Sincerely,

Kaveeta Vasisht, M.D., Pharm.D.

Acting Associate Commissioner of Women's Health

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The U.S. Food and Drug Administration is taking another significant step in protecting women’s health by helping to ensure patients have complete information about the benefits and risks of breast implants. In a draft guidance issued today, we are providing proposed labeling recommendations to manufacturers of these devices to help ensure women receive and understand information regarding the benefits and risks of breast implants. The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient decision checklist in the device’s labeling, update recommendations for patient screening for device rupture and more.

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