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Amid tens of thousands of vaginal mesh lawsuits filed by women throughout the U.S. who have experienced problems following surgical repair of pelvic organ prolapse or female stress urinary incontinence, a new study indicates that women who experienced problems with pelvic mesh were more likely to have inflammation around the implant.
In a study published this week in the American Journal of Obstetrics & Gynecology, researchers with the Magee-Womens Research Institute in Pittsburgh set out to evaluate reactions among patients undergoing vaginal mesh excision surgery after experiencing complications.
Researchers found that inflammation and concentrations of white blood cells designed to attack foreign material were more commonly found among in women who suffered vaginal mesh complications like extrusion of the mesh through the vagina and other problems than those who simply reported pelvic pain.
In July 2011, the FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products between January 2008 and December 2010. This led to an influx of product liability lawsuits against manufacturers of the devices, with about 100,000 women nationwide presenting claims for injuries and complications allegedly caused by the defective design of the mesh.
Following a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse, and manufacturers of the devices have been ordered to conduct studies to evaluate the safety.
Although the risk of complications from vaginal mesh have been a hot topic within the medical community for several years, researchers in this latest study note that few studies have been performed that focus on how women’s bodies respond to synthetic surgical mesh used for pelvic organ prolapse and stress urinary incontinence.
Researchers looked at 27 mesh-vaginal tissue samples from women who suffered complications and found that macrophages surrounded the implants. They found women who required mesh removal due to exposure, such as when the mesh penetrates the wall of the vagina, had 88.4% higher concentrations of macrophages than those explanted for pain.
“In women with complications, mesh induces a pro-inflammatory response that persists years after implantation, the researchers found. They also determined that the types of white blood cells found in mesh explanted for exposure were associated with degradation, while the types around those removed for pain were more indicative of fibrosis.
Several manufacturers of transvaginal mesh and bladder sling products have agreed to pay several billion in vaginal mesh settlements for women who have experienced problems, and thousands of cases are continuing to move forward through the court system. The transvaginal mesh litigation has been the largest mass tort in the United States over the past decade.