A recent study conducted by Dr. Robert E. Gutman and a team of researchers from Georgetown University has revealed no variation in cure rates with or without the use of transvaginal mesh for treatment in repairing vaginal prolapse. The study appears in Obstetrics and Gynecology in the September 6th online edition.
According to NewsDaily, the researchers evaluated the cure rates for 65 women; 33 had received transvaginal mesh to repair vaginal prolapse while the remaining 32 in the study did not receive the transvaginal mesh. The study was cut short due to a 15.6 percent mesh exposure rate. At the time of the three-year follow-up on patients observed in the study, no substantial stage improvement was observed and there were no variations in symptomatic improvements scores.
Researchers cited that the three-year follow-ups on the patients being studied yielded no difference in cure rates when comparing those who underwent traditional surgery to repair vaginal prolapse without the use of mesh to those who underwent vaginal colpopexy with the use of transvaginal mesh.
“Time and again it comes to light that corporations are aware of the risks associated with their product and fail to adequately inform patients and consumers,” commented Daniel Nigh, a transvaginal mesh attorney with the law firm of Levin, Papantonio. “Putting profits ahead of safety, companies that do this will put consumers at risk to make profits.”
Transvaginal mesh was approved through the FDA’s 510(k) process, an expedited approval process where formal safety and efficacy is not required, leading to controversial products to be allowed on the market.
Thousands of women who have suffered from POP have been implanted with transvaginal mesh for treatment. However, due to the transvaginal mesh’s defective design, lawsuits have been filed against the manufacturers of these faulty products.