Patients who suffer from pelvic organ prolapse have several treatment options, including conventional surgical procedures as well as a procedure in which surgical mesh is implanted. Transvaginal mesh products were brought to the market under FDA 501(K) clearance rules that allow for approval of medical devices with minimal or no testing, provided that they are substantially similar to other products on the market.
Our Asheville transvaginal mesh lawyers know that many patients had procedures with these mesh products and that many of these patients were unaware that the mesh had undergone only limited testing. The mesh products promised to be a better treatment alternative. But mounting evidence has indicated that mesh products provide no real benefits while causing substantial risks.
Study Shows Mesh Products are All Risk and No Reward
One study providing further evidence that mesh products are a bad choice for patients was conducted by Georgetown University researchers and published in the September issue of the medical journal, Obstetrics and Gynecology. The study tracked the progress of 65 patients who had received treatment for pelvic organ prolapse and who had undergone follow-up exams and surveys on quality of life.
The patients were split into two different groups: those whose treatment included mesh and those whose treatment did not include surgical mesh. In total, there were 32 women who had TVM implanted in order to treat their pelvic organ prolapse and the rest of the patients had undergone traditional treatment without mesh.
The researchers were forced to stop the study after a three-year period of time because of a 15.6 mesh exposure rate. Three patients also died during this time period, while eight were unable to be found for follow-up. The researchers were able to assess the outcomes for the remaining patients and found that the TVM had not lived up to its promises.
Three of the patients had already required a revision surgery or additional operation to treat their pelvic organ prolapse even though just three years had passed since their original surgery. All three of these patients had undergone procedures in which mesh was implanted.
The research revealed that both surgical mesh patients and those who did not have TVM experienced the bulk of their recovery shortly after the surgery. However, there was no significant improvements or differences in outcomes for patients who had undergone procedures with TVM. In other words, the TVM offered no better prognosis than patients who had undergone treatment without the mesh.
Since TVM doesn’t improve treatment outcomes and the FDA has warned of more than 1,000 reports of complications including perforation of the bladder or blood vessels, erosion of mesh in the body, and severe pain, there seems to be little reason for any patient to consider using TVM in the future. Patients who already had mesh procedures should consider taking legal action if they have begun to experience complications because of the mesh use.
If you have suffered complications from transvaginal mesh, contact Grimes Teich Anderson LLP. Call 1.800.533.6845. No Attorney Fees Until You’ve Been Paid, exclusive of case costs.
More Blog Entries:
Carolina Dog Bites Have Authorities Urging Caution & Common Sense, North Carolina Personal Injury Lawyer Blog, October 11, 2012.