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Medical Law -- Pate & Spivey, LLP

Pharmaceutical and Medical Device Litigation

Transvaginal Mesh - Can Cause Complications Such as Chronic Vaginal Damage, Erosion of the Vaginal Tissue and More.


Many experts advise that transvaginal mesh can cause complications such as chronic vaginal damage, low back pain, erosion of the vaginal tissue, urinary problems, perforations of the blood vessels (bladder and bowel), vaginal scarring, painful sexual intercourse and recurrence of urinary incontinence. Pharmaceutical litigation attorneys have ascertained that the manufacturers failed to advise physicians of the risks associated with the mesh product, including serious risk of harm due to retraction and contraction of the mesh often resulting in surgical intervention. Transvaginal mesh implants have a high rate of failure and the medical devices rarely work as intended. 


On Jan. 4, 2016, the FDA issued 2 final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

The orders require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.

Examples of transvaginal mesh include Tyco IVS, Mentor ObTape, Pelvilace, Pelvicol, MiniArc Single-Incision Sling and Bard Avaulta.


Some manufacturers of transvaginal mesh include Coloplast, Boston Scientific, Ethicon, Bard and AMS.

Click here for more info about Tranvaginal Mesh. 

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