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Regulatory News | 28 September 2020 | By Denise Fulton
"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 statement. "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."
Tags: breast implant, FDA, medical device, US