In 2010, approximately 70,000 women had transvaginal mesh implanted as a method of treating pelvic organ prolapse (POP) and another 185,000 women had this surgical mesh implanted as a treatment for stress urinary incontinence (SUI). These procedures took place two years after a 2008 FDA warning alerting the public that more than 1,000 complaints had been received about vaginal mesh complications. 
Our New York injury lawyers know that the complications reported to the FDA arose from the use of mesh made by nine different manufacturers. Yet, while it has increasingly become clear that TVM is a dangerous product, it continues to be implanted in women. Now, new studies indicate that not only does TVM increase the risk of serious and painful complications but also that there are no indications patients who have mesh implanted have better outcomes than patients who undergo traditional treatments for pelvic organ prolapse.
POP Patients Do Not Benefit from TVM Use
The study was conducted by Georgetown University researchers, who tracked the recovery and quality of life of 65 patients undergoing treatment for pelvic organ prolapse. A total of 32 of the women in the study had procedures in which TVM was implanted as a treatment method while the remaining women were treated with traditional surgical methods and no mesh.
Researchers studied women who had completed a questionnaire on their quality of life after three years, and who had also undergone a postoperative examination after either two or three years to determine if the status of their POP. After three years, the study had to be cut short because of a 15.6 percent mesh exposure rate. Not all of the patients reported either, as three patients had died and eight patients were not followed up on.
Still, the results, which were included in an article in the September issue of Obstetrics and Gynecology, showed that the use of transvaginal mesh did not significantly improve outcomes for patients. In fact, while both TVM patients and those who did not use mesh experienced the most dramatic improvements in their condition within the first year following the surgery, there was no difference in the improvement scores and no difference in the level of symptom reduction in TVM patients versus patients who had undergone a different method of treatment.
Three of the patients who were involved in the study had also been forced to undergo an additional surgical procedure as a result of their POP. These three women all were in the group that had TVM implanted as part of their initial treatment.
Unfortunately, the data clearly shows that the TVM doesn’t help TVM patients to avoid recurrence or to live a better quality of life. To the contrary, many patients who have transvaginal mesh implanted begin to experience the significant complications that the FDA warned about including erosion of the mesh.
Patients experiencing complications may endure significant pain and may need at least one revision surgery to remove the mesh and treat their POP. These patients deserve to be fully compensated as evidence suggests manufacturers of TVM products both failed to adequately warn patients of risks and also produced products that could not live up to the promises made to consumers.
If you or a loved one is experiencing transvaginal mesh complications, contact the Law Offices of Nicholas Rose, PLLC for a free and confidential consultation. Call 1-877-313-7673.
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