Published May 23, 2012 on InjuryBoard
On February 7, 2012, all federal lawsuits concerning transvaginal mesh products were consolidated into one court in the Southern District of West Virginia before Judge Goodwin. Plaintiffs allegedly suffer from injuries from vaginal mesh products made by American Medical Systems, Boston Scientific, Ethicon, and C.R. Bard.
Women implanted with vaginal mesh for the treatment of conditions like pelvic organ prolapse (POP) and stress urinary incontinence (SUI) seek to hold these manufacturers liable for injuries like erosion, bleeding, urinary incontinence, pelvic pain, protrusion of the mesh, infections, and more. On July 13, 2011, the FDA released a safety communication warning health care providers that such complications from transvaginal mesh were not rare, and that multiple surgeries may not always be successful in resolving them.
Vaginal Mesh Products Made Specifically for POP and SUI
Many women, as they age, experience a weakening or stretching of the pelvic muscles and tissues. This is often due to childbirth, menopause, or surgery. These weakened muscles are then no longer able to support pelvic organs like the bladder, urethra, and bowel, allowing these organs to drop (prolapse) or fall into the vaginal wall. Some women suffer no uncomfortable symptoms, but others may experience pressure, pain, urinary incontinence, painful intercourse, and constipation.
Vaginal mesh products created specifically for the repair of POP and SUI appeared on the market in the 1990s. These products were made of surgical mesh, a synthetic polypropylene net-like material, and were used to provide additional support and stabilization for prolapsed organs. The FDA approved the first product specifically designed for SUI in 1996, and the first for POP in 2002. Since then, many new products have come onto the market.
A few years later, however, the FDA began to receive reports of serious side effects associated with transvaginal mesh. Between 2005–2007, they received more than 1,000 such reports, including erosion of the mesh through the vagina, infections, pain, and scarring.
Studies Show High Rates of Complications
In August 2010, researchers published a study in Obstetrics & Gynecology that questioned the value of vaginal mesh for pelvic organ prolapse repairs. In a three-month comparison of women treated with transvaginal mesh and those treated with traditional therapies (that don’t involve mesh), the authors found that at three months, there was a high vaginal mesh erosion rate of 15.6 percent, with no difference in overall cure rates.
In July 2011, the FDA issued their warning after receiving an additional nearly 3,000 reports of vaginal mesh complications between 2008 and 2010. The agency noted that it had conducted a systematic review of the published scientific literature from 1996 and 2011, and concluded that transvaginal POP repair with mesh “does not improve symptomatic results or quality of life over traditional non-mesh repair.” They added they would continue to evaluate study results for SUI surgeries with mesh.
A study appearing in the Journal of Obstetrics and Gynecology Canada the same year stated that until adequate safety and effectiveness evidence becomes available, use of transvaginal mesh devices for prolapse repair should be considered experimental and should be restricted to investigative trials.
Lawsuits Mounting While FDA Asks for More Studies
Submit your claim — as the first bellwether cases prepare for trial, the FDA has asked manufacturers to conduct new safety studies on their products. A Congressional report released in March 2012 also noted that devices like vaginal mesh received FDA approval based on similar devices with problematic safety profiles.References: Defective Medical Device litigation, Transvaginal Mesh