Transvaginal Mesh Complications Doctor Survey
It looks like regulatory warnings about transvaginal mesh complications are having an impact on the way doctors treat pelvic organ prolapse (POP). According to results of a survey presented at the 33rd Annual Scientific Meeting of the American Urogynecologic Society, some surgeons are planning to decrease their use of mesh for the vaginal repair of POP.
The survey was designed to measure whether or not the U.S. Food & Drug Administration’s (FDA) July 2011 warning about the high rate of transvaginal mesh complications was having any impact on physician practice. A total of 281 doctors responded to the survey, with 23% reporting that they plan to curtail their use of vaginal mesh for POP repair. Just fewer than 6% said they were not using any vaginal mesh. Just over half (53.7%) reported changing their counseling methods to include more mesh-specific information, while 7.7% said they referred patients to a different provider for assessment of whether to use mesh.
FDA Warning on Transvaginal Mesh Complications
The FDA warning in July 2011 cautioned that reports of transvaginal mesh complications had increased fivefold since 2008. At the time, the agency changed its stance on the use of vaginal mesh to correct POP, stating that complications like vaginal scarring, mesh shrinkage, erosion of mesh into surrounding tissue, infections, chronic pain, and bleeding were not rare. The FDA has since ordered the makers of vaginal mesh used in POP repair to conduct studies to evaluate the safety of their products.
While no transvaginal mesh recall has been issued thus far, Ethicon Inc., a division of Johnson & Johnson, did suspend sales of some its Gynecare vaginal mesh products from the market earlier this year. It also changed the indications for use of its Gynemesh device, stating it should only be used in abdominal procedures. However, the company says the decision was not driven by safety concerns.
Transvaginal Mesh Lawsuits
Thousands of transvaginal mesh lawsuits are currently pending in multidistrict litigations underway in U.S. District Court, Southern District of West Virginia, including claims against Ethicon, American Medical Systems, Inc., C.R. Bard, Inc. and Boston Scientific Corp. Consolidated litigations are also pending in New Jersey Superior Court for Ethicon mesh lawsuits, as well as C. R. Bard claims.
Transvaginal mesh lawsuits have also gone international, with a massive class action complaint filed in Australia earlier this year. The lead plaintiff in the lawsuit claims she suffered “devastating” transvaginal mesh complications, which her doctor compared to the effect of a cheese grater on her vaginal walls. The emotional distress from her ordeal has even caused her to contemplate suicide, the lawsuit claims.
If you suffered similar injuries, you may also be entitled to file a transvaginal mesh lawsuit to obtain compensation for your pain and suffering. Bernstein Liebhard LLP is actively filing cases in the vaginal mesh litigations, and our attorneys provide free lawsuit consultations to victims of these devices. To learn more, please give us a call today, at 1-(888)-217-3033.