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Committees concerned with transvaginal mesh safety urge caution

March 29th, 2012

Two health committees concerned with the safety and effectiveness of transvaginal mesh have released a joint recommendation urging caution when considering these products. The American Urogynecologic Society and the American College of Obstetricians and Gynecologists recommended only using the surgical mesh in high-risk patients with no alternative options.

The recommendation comes after the Food and Drug Administration warned in July 2011 that women who undergo surgery to repair weakened or damaged tissue with the transvaginal mesh are at an increased risk of debilitating complications from the product. The committees also stressed a need to create a national registry to document the outcomes for patients with transvaginal mesh.

Transvaginal mesh was approved in 2001 to prevent and treat pelvic organ prolapse, a condition in which pelvic organs bulge through the interior walls of the vagina. The mesh was never clinically tested, but instead passed due to its similarity to mesh used to treat hernias. Since its approval, thousands of women have experienced severe complications from the transvaginal mesh patch, including pain, bleeding and organ perforation.

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