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FDA Wants Pelvic Mesh Reclassified as a “High-Risk” Medical Device

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A recent federal proposal would impose stricter safety requirements for the makers of the trouble-prone implants used to surgically repair women's pelvic problems.

The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a "high-risk" medical device. This change is presumably a result of years of reported issues ranging from pain and bleeding to serious infections among women who have received the implants. If adopted, the change would require manufacturers to submit studies demonstrating that their products are safe and effective before they can be sold. 


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