FDA: 36 Dead From Breast Implant-Associated Lymphoma Since 2019, Hundreds Sickened
Agency also verifies Breast-Q module as a tool to help assess women's satisfaction with implanted devices
The US FDA reports the numbers on women globally who've died or been sickened by two types of breast implant illnesses.
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The US agency’s study will look at how the potential cancer risk tied to textured breast implants, as well as other factors, play into how patients decide what type of implants to get.
The US FDA has approved new labeling for all legally marketed breast implants that includes a boxed warning of potential risks. The agency also released updated information on the status of implant manufacturer post-approval studies.
Patients who receive breast reconstructive surgery using some brands of acellular dermal matrix seem to have a higher risk of major complications than those whose surgeries did not use the mesh, says a safety alert from the US FDA.