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FDA device chief wants to close loophole used to approve transvaginal mesh

March 9th, 2012

The director of the Food and Drug Administration’s Center for Devices and Radiological Health said the agency needs to close a loophole that allows unsafe products to receive approval. Jeffrey Shuren said companies like those that manufacture transvaginal mesh are currently able to receive approval without significant testing if they can prove the product is similar to one that is already on the market.

Shuren stated that many products like transvaginal mesh are based on products that were voluntarily recalled after approval, making them potentially unsafe. Proposed legislation currently in the House of Representatives would close that loophole by allowing the FDA to order additional safety studies on medical devices like surgical mesh before approving them.

Used to treat pelvic organ prolapse and stress urinary incontinence, transvaginal mesh was approved after being compared to surgical mesh used to treat hernias. The FDA has received thousands of complaints from women who allege that the transvaginal mesh caused serious complications, such as organ damage and limited mobility. Hundreds of transvaginal mesh lawsuits have been filed by women who allege that manufacturers released defective devices.

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