In 2019, women testified that their doctors didn’t properly warn them of the potential health risks of breast implants. This pushed the FDA to restrict the sale of breast implants to only providers who provide patients a standardized checklist outlining the potential complications. Now, two years later, a CNN article reported that the FDA has changed regulations on breast implants, and is requiring new labeling with a boxed warning.
FDA Updates Breast Implant Regulations, Adds Boxed Warning
The agency is working to close information gaps for anyone considering breast augmentation.
Nov 2, 2021
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FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
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