WASHINGTON — Advisers to the Food and Drug Administration say trouble-prone medical products widely used to surgically repair women's pelvic problems need stringent testing for safety and effectiveness.
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It's another case of a problem that wasn't flagged until patients got hurt.
The advisory panel on Thursday urged the FDA to reclassify plastic surgical mesh used to repair pelvic collapse. The consensus recommendation means that, if the FDA agrees, manufacturers would be required to prove the safety and effectiveness of the products.
Consumer groups want a recall, but medical device makers say mesh offers advantages, and the rate of serious complications is low. The FDA said in July it had underestimated the risks, which include pain, bleeding and infection.
The agency often follows the recommendations of its advisers.
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