FDA Proposes Boxed Warning for Breast Implants

October 24, 2019 Tags: , , , , , ,

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On Wednesday, the US FDA proposed that breast implant manufacturers use a boxed warning to spell out possible complications from the devices. Patients should be informed of the risk of rare cancers (BIA-ALCL), other symptoms and the need for additional surgeries. These new recommendations are “designed to help inform conversations between patients and health care professionals when breast implants are being considered,” explained FDA Principal Deputy Commissioner Amy Abernethy and Jeff Shuren, director of the agency’s Center for Devices and Radiological Health. The FDA also proposed that plastic surgeons give patients a checklist to guide conversations about the risks and benefits of implants before women pay deposits for their surgeries. 

Read The Washington Post article: https://www.washingtonpost.com/health/2019/10/23/fda-recommends-new-warnings-breast-implants/

Watch The Today Show segment: https://www.today.com/video/new-warning-about-breast-implants-proposed-by-fda-71957573894