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FDA Warns of Transvaginal Mesh Dangers

The dangers associated with Transvaginal mesh are coming under scrutiny within the U.S. Food and Drug Administration's (FDA) after they received over 3,000 reports of medical device injuries or malfunctions between 2008 and 2010. The FDA warned of the increase in women suffering pain and injuries after having Transvaginal mesh inserted during surgery.

Transvaginal mesh is used to repair pelvic organ prolapse, which is a condition where organs like the bladder bulge or prolapse into the vagina. Last year, an estimated 70,000 woman in the U.S. received Transvaginal meshes during prolapsed repair surgery. According to the FDA, Transvaginal mesh used to repair pelvic organ prolapse have several long term risks which include mesh exposure into the vagina, bladder or rectum; pelvic pain, infection, pain during sexual intercourse as well as the need to additional corrective surgeries. Additional risks may include urinary problems, vaginal scarring or shrinkage, recurrent prolapse and neuromuscular problems.

Pain and injuries in females receiving vaginal mesh inserts has led to 270 lawsuits filed against Transvaginal mesh maker Johnson & Johnson, totaling more than 600 lawsuits filed against Johnson & Johnson and other vaginal mesh producers. None of the cases have gone to trial and the plaintiffs need to prove that the companies knew the safety risks and failed to disclose that the product was defective.

An industry group which includes Johnson & Johnson told the FDA that "using mesh in Transvaginal procedures is safe and effective and serious injuries are rare," as reported by Business Week. However, the FDA's Obstetrics & Gynecology Devices Advisory Committee panel agreed with the FDA to reclassify mesh from moderate risk to high risk of harming patients if it fails. The panel also recommended that the FDA require additional studies to determine the product's safety and effectiveness.

Under current FDA guidelines, pelvic organ prolapse surgical mesh products, including Transvaginal mesh, are only required to show that devices are "substantially equivalent" to existing products in the market without preclinical testing.

The panel's recommendation would involve more clinical studies and stricter regulations of surgical mesh products used to treat pelvic organ prolapse. The FDA panel's plan would require premarket approval studies for new mesh products that would be used in procedures to repair organ collapse.

If you or a loved one has suffered pain and other injuries after receiving Transvaginal mesh during surgery, it is important to contact an experienced personal injury attorney to discuss your case.

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