TVM (Transvaginal Mesh)
Vaginal mesh devices are marketed toward women who, as a result of childbirth, suffer from stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP). On Oct. 20, 2008, the Food and Drug Administration warned that over 1,000 complaints had been reported in the previous three years for serious complications arising from the use of transvaginal mesh products. These complications included mesh erosion through the vaginal wall and other body parts, infection, extreme pain, urinary problems, prolapse recurrence, bladder-bowel-vessel perforation, scarring, pain during sexual intercourse, and other injuries that significantly decreased quality of life. On July 13, 2011, the FDA warned that mesh should not be used in the pelvic area and that patients and physicians alike should treat any mesh placement skeptically and avoid it if possible. The FDA’s latest announcement against the use of TVM included the statement that reports of TVM failures were not rare occurrences. This statement implicates these manufacturers specifically, since all of their TVM products contain warnings that mesh failures are seldom (failures in the 2 to 5 percent range is what Mentor used at trial), but the actual failure rate is as high as 20 to 50 percent for some products.