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House of Representatives calls for hearings on transvaginal mesh

February 14th, 2012

Democrats in the House of Representatives are calling for committee hearings on medical devices such as transvaginal mesh. The efforts are being led by Representative Henry Waxman, who cites safety concerns as a reason for the Energy and Commerce Committee to take a serious look at transvaginal mesh.

Waxman and colleagues argue that holding hearings and demanding documents from mesh manufacturers such as Johnson & Johnson is a critical step before reconsidering the methods the Food and Drug Administration uses to approve certain medical devices. Pharmaceutical companies are currently able to bypass device testing by proving the product is substantially similar to a device already on the market.

The transvaginal mesh patch was approved without significant testing and has since led to lawsuits alleging that the manufacturers released a defective device. Complications from failed devices include severe pain, damaged tissue, organ perforation and the need for revision surgery.

 

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