FDA Advisers Urge Closer Scrutiny of Pelvic Mesh

Trouble-prone medical products widely used to surgically repair women’s pelvic problems need more stringent tests for safety and effectiveness, government advisers recommended Thursday.

In another case of a problem that wasn’t flagged until patients got hurt, a panel of outside advisers to the Food and Drug Administration urged the FDA to reclassify plastic surgical mesh used to repair pelvic collapse.

If the FDA agrees with the consensus recommendation, manufacturers would be required to prove the safety and effectiveness of the products before they could continue to market them. However, the process could take several years.[…]

“If they had done studies on this product in the first place, we wouldn’t be in this situation,” said Diana Zuckerman, president of the National Center for Women and Families, a consumer group for women’s health issues.

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