FDA Wants Stronger Warning on Breast Implants About Risks
Posted: Wed Oct 23, 2019 9:12 amWASHINGTON - U.S. health officials want women getting breast implants to receive stronger warnings about the possible risks and complications.
The Food and Drug Administration said Wednesday that manufacturers should add a boxed warning – the most serious type – to information used to market and prepare patients for implants.
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The recommendations are the agency's latest attempt to manage safety issues with the implants.
In recent years, the FDA and regulators elsewhere have grappled with a link between a rare cancer and a type of textured implant, some of which have been recalled. Separately, the agency has received thousands of reports of health problems that some women attribute to the implants, including arthritis, fatigue and muscle pain.
The FDA will take public comment on the recommendations before adopting them.