Transvaginal Mesh (TVM) Lawsuits
FDA Reclassifies Transvaginal Mesh as High-Risk Device
On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued an order to reclassify transvaginal mesh products from a class II device, which includes moderate-risk devices, to a class III device. Class III devices are generally the highest risk devices and are subject to the highest levels of regulatory control. Along with the reclassification, the FDA is requiring transvaginal mesh manufacturers to address significant safety concerns like pelvic pain and organ perforation. A chief scientist at the FDA stated that he hoped these requirements will help address the “significant risks” linked to transvaginal mesh
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Transvaginal Mesh Side Effects
Surgical mesh is generally used to repair weakened or damaged tissue. Mesh was originally designed for use in the abdomen to treat hernias. In transvaginal procedures, surgical mesh is implanted to reinforce the weakened vaginal wall and repair pelvic organ prolapse (POP) or support the urethra to treat urinary incontinence. According to the FDA, long term risks of implanted mesh include:
- Organ perforation
- Pain during sexual intercourse
- Mesh Erosion
- Recurrent prolapse
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Are You Eligible for a Transvaginal Mesh Lawsuit?
The Feeney Law Firm is committed to seeking justice for those affected by Transvaginal Mesh surgeries. Fighting to keep people safe from corporate greed and self-interest is our passion. We are here to help make that process as simple as possible for you and your family. Call us now at 1-800-707-7156 for a FREE consultation. Don’t wait; your time to file a Transvaginal Mesh lawsuit may be limited.