FDA Moves Transvaginal Mesh Devices to ‘High Risk’ Category

The U.S. Food and Drug Administration recently submitted a federal proposal to establish stricter safety requirements for transvaginal surgical mesh implants. The devices are often used to repair pelvic collapse in women, and the FDA is reporting they should now be classified as “high risk”.

Three years ago, the FDA concluded that women who receive the transvaginal mesh implants have more subsequent health problems than women who undergo different treatments such as stitches. Many women often experience pain, bleeding and infection requiring additional surgeries after receiving transvaginal mesh implants.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a HealthDay article.

Pelvic mesh has been used for more than twenty years as a way of strengthening the pelvic wall among women with pelvic organ prolapse (POP). This condition occurs when the internal structures that support the bladder, bowel and uterus weaken, allowing the organs to drop below their normal position and bulge into the vagina. This can cause serious pain, urination and defecation problems and disruption in sexual activity.

The lawyers at the Firm have been investigating claims from women who have suffered complications from a transvaginal POP repair with mesh.

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