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Transvaginal Mesh

We are presently representing a number of women with potential claims against the manufacturer of Transvaginal Surgical Mesh due to serious complications. The implanting surgeons are not involved in the litigation as it is a claim against the manufacturer only. The FDA recently issued an alert to health care and medical professionals to warn them of complications associated with the placement of surgical mesh in women with Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence. This is an unusual action on the part of the FDA. The action was taken because so many women have been injured by the use of vaginal mesh and there are other surgical procedures to correct these problems that do not include the use of mesh.

In September 2011, the FDA held hearings on the use of transvaginal surgical mesh for the repair of POP and stress incontinence. The hearings resulted in many recommendations that will impact the use of this device in women for POP and urinary incontinence. The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the FDA reached consensus that: vaginal mesh safety in POP repair has not been well-established, it may not be more effective than traditional repair methods, the risk-benefits of mesh are not well-established, and studies are needed to evaluate the use of surgical mesh for POP repair. Use of these products have caused significant pain and disability to patients for benefits that are as yet unproven. We believe this creates a significant and unnecessary risk for consumers.
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