The new labeling will include a boxed warning, one of the strongest of its kind because of its visibility, informing patients of the significant risks of breast implants, including rupture and the potential for systemic illnesses and a type of cancer.
The FDA is also requiring all patients to review a safety checklist to ensure they are aware of not just the risks of implants, but also when they should and shouldn’t be used, as well as surgical alternatives, especially for mastectomy patients. The hope is that the checklist will provide valuable safety information that patients may never see on the implants’ box, since it’s something that’s opened in the operating room and then thrown away.
The agency will also restrict sales and distribution of implants to only doctors and medical facilities that provide patients with specific safety information.
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