More than 10,000 transvaginal mesh lawsuits have been filed due to complications experienced with American Medical System’s product, which is meant to treat stress urinary incontinence and pelvic organ prolapse.
As of Oct. 8, the number of lawsuits filed in federal court hit 10,633. However, about 30,000 claims have been filed in separate courts against six other vaginal mesh manufacturers. Since 2008, the number of women who have come forward to report adverse events to the transvaginal mesh devices has risen, according to Bernstein Liebhard LLP, a law firm representing a number of the cases.The U.S. Food and Drug Administration warned of transvaginal mesh complications earlier this year, saying the devices can cause serious consequences in its users. The federal health agency said since 2010, it has received more than 1,000 reports from nine surgical mesh manufacturers about patients suffering complications from the devices.
“The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence,” the FDA warned.
Other complications reported to the FDA include perforation of the bowel, bladder and blood vessels during insertion of the transvaginal mesh device. Vaginal scarring and mesh erosion have also led to a significant decrease in quality of life for some patients due to pain and discomfort, the FDA said.
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These complications have caused patients to undergo surgery in some cases. Others have received IV therapy, blood transfusions or developed abscesses.
In its warning, the FDA told doctors they should be “vigilant” for adverse events such as erosion and infection caused by transvaginal mesh devices and to watch for complications that can arise when using the tools to insert the device. Physicians should also be warning patients about the potential for experiencing serious side effects from transvaginal mesh and that some of these complications from the permanent device may not be able to be corrected, the FDA said.