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Proposed law would give regulators power to order safety studies

January 19th, 2012

New legislation proposed in the Senate would give the Food and Drug Administration the power to order safety studies for products like transvaginal mesh, even after they are approved for sale. The bill would also give the FDA the ability to catalog the failure rate of the surgical mesh and other medical devices.

Senators introduced the bill in attempts to fix current regulations, which allow products to bypass safety testing if a company can prove the device is substantially similar to one already on the market. Transvaginal mesh was approved under this system and has since been found to have an increased risk of severe complications compared to alternative treatments.

Similar to the surgical mesh used to treat hernias, transvaginal mesh was approved without extensive testing to treat pelvic organ prolapse and stress urinary incontinence in women. Data reviewed by the FDA has since found the mesh patch to be no more effective than traditional surgery while increasing the risk of requiring additional corrective surgery.

 

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