Vaginal Mesh Lawsuits Top 13,000 in U.S., Overseas
Over 13,000 vaginal mesh lawsuits have now been filed against manufacturers whose products have been used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Of that number, court documents reveal that Johnson & Johnson’s Ethicon unit and American Medical Systems have been named in 6,892 vaginal mesh lawsuits pending in multidistrict litigations based in the U.S. District Court for the Southern District of West Virginia, while 3,784 involve vaginal mesh marketed by Boston Scientific and C.R. Bard Inc.
More vaginal mesh lawsuits have been filed in state courts in New Jersey, Georgia, California, Delaware and Massachusetts.
Meanwhile, overseas, similar claims have been brought by plaintiffs who claim to have suffered vaginal mesh complications as a result of being implanted with the surgical material, which is stitched to the top of the vagina to lend support to the pelvic floor muscles and internal organs.
These products have led to thousands of vaginal mesh lawsuits, however, and seem to cause more harm than good. According to the U.S. Food and Drug Administration (FDA), the following side effects are the most common:
- erosion through vaginal epithelium
- urinary problems
- recurrence of prolapse and/or incontinence
- urinary problems
- pain during sexual intercourse
- bowel, bladder, and blood vessel perforation during insertion
Since 2008, the FDA has been investigating the safety of all transvaginal mesh devices. In September 2011, the FDA’s Obstetrics and Gynecology advisory panel recommended that transvaginal mesh be reclassified as Class III, which would require that all future products be approved individually by way of rigorous clinical testing.
Most recently, the FDA has asked more than 30 manufacturers of transvaginal mesh devices to conduct post-market surveillance studies of their devices that investigate specific concerns about safety and effectiveness.