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Transvaginal Mesh Lawsuit News: FDA May Lower The Boom

For every woman who has filed a transvaginal mesh lawsuit, some vindication may be on its way.

Recently, the U.S. Food and Drug Administration proposed new restrictions on the use of vaginal meshes for the treatment of pelvic organ prolapse. These more stringent safety regulations would move such use of transvaginal meshes from the moderate risk (class 2) to the high-risk category (class 3).

The mesh was originally designed to treat hernia. In the 1990s, medical device manufacturers began marketing them to surgeons as an easier and (most importantly) more cost-effective way to treat women suffering from a condition that causes their internal organs to fall out of place and into the vagina. The many complications that have resulted from these procedures are at basis of every  transvaginal mesh lawsuit.

According to William Maisel, who helps run the science department at the FDA, the agency “has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse.” He adds that the new regulations will “require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness” for the mesh.

This may come a little too late for the plaintiff with the transvaginal mesh lawsuit who is already suffering from injuries due to the device – but it definitely lends weight to plantiff's cases going forward.

If you have received one of these implants and believe you have cause to file a transvaginal mesh lawsuit, contact our offices today for a free, no-obligation case evaluation. 

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