A newly released study calls into question the safety of transvaginal mesh, after researchers concluded that the placement of vaginal mesh offers no benefits in the treatment of pelvic organ prolapse (POP).
The study was published this week in Obstetrics and Gynecology by researchers at Georgetown University. The team found that there is no increase in positive outcomes for women whose POP is treated with vaginal mesh as opposed to traditional surgical treatments for the condition. In fact, the study had to be called off when too many women suffered serious injury or complications after implantation with the mesh.
In the study, 65 women were monitored. 33 of the subjects had had vaginal mesh implanted to treat POP and 32 of the women studied underwent a traditional surgical procedure for the condition. After three years, the researchers halted the study when 15.6% of the women showed mesh exposure or erosion of the mesh into the vagina.
Three of the women in the study who had a vaginal mesh implant needed additional surgery when their prolapse returned. None of the women who underwent traditional POP surgery had to undergo another operation. Three women in the study died, but researchers did not indicate whether the mesh played a role in these fatalities.
According to researchers, women who underwent the traditional surgical procedure showed no difference in quality of life when compared to the women who had mesh. This, combined with the success rates observed in the study, led researchers to question the benefits of the use of mesh when compared to the risks associated with this potentially dangerous medical device.
In July 2011, the FDA stated that it had received up to 3,000 reports of vaginal mesh complications between January 2008 and December 2010. Common issues associated with the product, also known as bladder mesh, pelvic mesh, or bladder sling, include organ perforation and erosion of the mesh into the vagina. This led to the FDA’s sending a letter to multiple vaginal mesh manufacturers ordering that the companies each conduct additional studies and trials to shed more light on the potential dangers of vaginal mesh.
The number of transvaginal mesh personal injury lawsuits filed in the United States continues to grow as more women suffer painful and debilitating injuries after implantation with the product. If you or a woman you love has been harmed by vaginal mesh, you could be entitled to compensation for medical bills and other damages. For more information on your rights, contact the personal injury lawyers at Berkowitz and Hanna LLC.