Juries have been finding against the manufacturers of transvaginal mesh (TVM) and awarding significant verdicts to women harmed by these products. And now a new study has found there is no added benefit to implanting TVM into women who have surgery to correct pelvic organ prolapse, or “POP.”
A Georgetown University study of thousands of Medicare beneficiaries who had transvaginal mesh implanted to correct POP found there was no variation in cure rates when compared to traditional treatments. The research team was led by Dr. Robert Gutman, and studied more than 7,000 patients.
TVM products have been used to correct pelvic organ prolapse (POP), in which a woman’s pelvic organs drop into the vagina, and stress urinary incontinence (SUI), a condition in which urine is leaked involuntarily.
The FDA issued an alert regarding serious complications from use of the mesh products on October 20, 2008. On July 13, 2011, the FDA issued a stronger warning regarding problems from TVM devices, stating: “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”
According to the FDA’s July 13, 2011 warning, “From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.”
Jurors have rejected TVM device manufacturers’ claims that their products are safe. Last year, a California jury awarded $5.5 to a woman suffering from the ill effects of the device. Earlier this year, a New Jersey jury awarded a woman $11 million, and a West Virginia jury awarded another woman $2 million.
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