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FDA Updates Breast Implant Regulations, Adds Boxed Warning

The agency is working to close information gaps for anyone considering breast augmentation.

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.

The required warning and checklist will outline symptoms that some patients with implants have experienced including fatigue, joint pain, tiredness, brain fog, and memory loss. It will also outline the potential link between implants and a rare form of immune system cancer known as anaplastic large cell lymphoma. Though it should be noted that textured breast implants are more commonly linked with cancer, specifically the ones produced by Allergan that were voluntarily recalled in 2019. 

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