U.S. Health Regulators Order Safety Studies for Surgical Mesh

FDA Warning For Transvaginal Surgical Mesh

The U.S. Food and Drug Administration has issued a warning regarding the post-surgical risks associated with transvaginal surgical mesh, which is often implanted in women to repair weakened or damaged tissue, as well as to provide support in cases of pelvic organ prolapse (POP). This type of surgical mesh can also be used to help women suffering stress urinary incontinence.

Federal health regulators issued the order for new safety studies following the FDA’s receipt of more than 1,500 reports of complications related to the mesh, including erosion and infection. The agency also announced it may soon reclassify the surgical mesh devices to a higher-risk category. A reclassification would mean that manufacturers of the devices, such as Johnson and Johnson, and Boston Scientific, would need to conduct clinical studies in people prior to receiving FDA approval.

Given the safety concerns linked to use of these devices, the FDA has issued a letter to thirty-three different manufacturers of medical meshes, asking that they conduct retrospective safety studies on their devices and then provide the results to the FDA for evaluation.

In 2010 alone, approximately 75,000 women have received surgical mesh repairs for pelvic organ prolapse, and more than 200,000 received transvaginal repairs for stress urinary incontinence.

Surgical mesh has been used for decades as a means by which to repair abdominal hernias. However, physicians only began to use the mesh for POP procedures back in the 1990′s and doing so has since become quite popular.

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