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Thousands of women who had a vaginal mesh or bladder sling implanted to treat pelvic organ prolapse have experienced severe internal injuries, urinary problems and other complications as a result of problems with the medical devices, which may actually provide no real benefit over other methods of treating pelvic organ prolapse.
STATUS OF TRANSVAGINAL MESH LAWSUITS: Cases have been filed throughout the United States by women who experienced complications as a result of the negligent design of a vaginal mesh pelvic support system, and lawyers are continuing to review new vaginal mesh lawsuits.
OVERVIEW: Vaginal mesh, which is also referred to as a bladder sling, hammock or pelvic mesh, is a surgical product that is commonly implanted into the vaginal area to prevent pelvic organ prolapse (POP), which can occur in women after childbirth or surgery. Pelvic organ prolapse causes the womb to fall into the vaginal area, which can also lead to the bladder and bowels slipping out of place and putting pressure on the vagina, causing considerable pain and discomfort, as well as urinary incontinence in some cases.
Lawsuits over vaginal mesh implants allege that negligent designs increase the risk that women may suffer severe complications, physical pain and suffering, deformity and the need for additional corrective surgery. In addition, the FDA acknowledged in July 2011 that there is no evidence that vaginal mesh bladder sling surgery provides any greater clinical benefit than non-mesh surgeries.
VAGINAL MESH PROBLEMS: The FDA issued a statement about all vaginal mesh implants in July 2011, indicating that the agency has received thousands of reports of complications after the bladder sling mesh has been implanted, and also warn of an increased risk of organs being punctured during the surgery to implant the devices. The FDA stated that a review of studies and other literature appeared to show little to no health benefits.
Complications with vaginal sling implants reported by women include:
- Erosion of the mesh into the vagina
- Recurrences of prolapse
- Urinary problems
- Bowel, bladder and blood-vessel perforations
- Injury to nearby organs
- Pain during sexual intercourse
In many cases, transvaginal sling problems have required multiple surgeries to remove the mesh. Even after surgery, women may be left with permanent and disfiguring injuries.
In January 2016, the FDA announced it was reclassifying vaginal mesh as high-risk medical devices and that new and existing vaginal and transvaginal mesh meant to treat pelvic organ prolapse had to go through a premarket approval process.
VAGINAL MESH LAWSUITS: As of October 2015, more than 70,000 complaints had been filed throughout the federal court system involving complications from vaginal mesh or bladder sling products. Most of the cases have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, with the cases centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia for coordinated discovery and early bellwether trials.
Seven different MDLs are currently centralized before Judge Goodwin, including all Bard Avaulta lawsuits, AMS vaginal mesh lawsuits, Boston Scientific pelvic mesh lawsuits, Ethicon Gynecare mesh lawsuits, Coloplast sling lawsuits. Neomedic mesh lawsuits, and Cook Surgisis Biodesign mesh lawsuits.
A series of bellwether trials are being held in each of the MDLs to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. The preparation and outcomes of these early trials are designed to facilitate a possible vaginal mesh settlement agreement that could resolve cases without the need for thousands of trials to be held throughout the country.
While some manufacturers have settled thousands of these cases, tens of thousands more remain unresolved.