More than 8,000 transvaginal mesh lawsuits have now been filed against the makers of vaginal mesh used in surgery to treat pelvic organ prolapse and stress urinary incontinence. According to court records, Johnson & Johnson’s Ethicon unit and American Medical Systems have each been named in about 2,000 transvaginal mesh lawsuits in multidistrict litigations underway in U.S. District Court, Southern District of West Virginia. About 1,000 claims each have been filed against Boston Scientific and C.R. Bard in separate multidistrict litigations pending in West Virginia.

Additional vaginal mesh lawsuits are pending in state courts in Georgia, New Jersey, California, Massachusetts, and Delaware. Similar claims have also been filed overseas, including in Australia, where Johnson & Johnson has been named in at least three transvaginal mesh class action lawsuits.

Transvaginal mesh products are stitched in near the top of the vagina to help the pelvic floor muscles support the internal organs, much like a sling. However, a growing number of women are reporting serious injuries and complications following the transvaginal placement of surgical mesh that in many cases, left them in far worse shape than they had been prior to surgery. According to the U.S. Food & Drug Administration (FDA), the most frequent complications associated with transvaginal mesh include:

  • erosion through vaginal epithelium
  • infection
  • pain
  • urinary problems
  • recurrence of prolapse and/or incontinence
  • bowel, bladder, and blood vessel perforation during insertion
  • pain during sexual intercourse

Transvaginal mesh complications can severely impact a victim’s quality of life, and surgery to remove the mesh does not always eliminate all or even most of a patient’s symptoms, according to the FDA.

The FDA has been reviewing the safety of vaginal mesh devices since 2008. In July 2011, the agency issued a formal warning stating that the use of such devices in pelvic organ prolapse surgery posed a “greater risk” with “no evidence of greater clinical benefit”. The warning followed the publication of a study in the New England Journal of Medicine that found transvaginal mesh kits had “higher rates of surgical complications and post-operative adverse events”.

In the U.S., transvaginal mesh devices for pelvic organ prolapse repair were cleared by the FDA via its 510(k) approval process. This more streamlined protocol does not require that medical devices undergo human clinical trials if a manufacturer can show a product is substantially equivalent to another device that was already granted premarket approval. In September 2011, an FDA advisory panel recommended that the agency reclassify vaginal mesh for pelvic organ prolapse in a higher-risk category, which would make such products ineligible for 510(k) approvals. To that end, the FDA has asked more than 30 manufacturers of transvaginal mesh devices to conduct postmarket studies of their products that address specific safety and effectiveness concerns.

If you or a loved one suffered a serious complication following implantation of surgical mesh, you may be entitled to compensation. To learn more about filing a transvaginal mesh lawsuit, please contact the attorneys of Bernstein Liebhard LLP today by calling 1-877-779-1414 today.

Published November 13, 2012 by