Transvaginal Mesh Patch
The Food and Drug Administration warned in July 2011 that women who undergo surgery to repair weakened or damaged tissue with the transvaginal mesh patch, also known as the bladder sling, are at risk of serious complications from the device.
The transvaginal mesh patch is a permanent synthetic implant designed to treat pelvic organ prolapse or stress urinary incontinence. Versions of the surgical mesh patch are manufactured by American Medical Systems, Boston Scientific, C.R. Bard, Johnson & Johnson and other companies.
According to the FDA’s warning, thousands of women have experienced complications after placement of the transvaginal mesh patch. The most frequent complications include erosion through vaginal tissue, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There have also been reports of bowel, bladder, and blood vessel perforation during insertion. Vaginal scarring and mesh erosion can lead to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia (pain during sexual intercourse).
In the fall of 2010, medical researchers published an article uncovering problems revealed in a clinical study conducted from 2007 through 2009 (Obstetrics & Gynecology: August 2010 – Volume 116 – Issue 2, Part 1 – pp 293-303; “Vaginal Mesh for Prolapse: A Randomized Controlled Trial”; Iglesia, Cheryl B. MD, et al.).
“Patients would have been better off with traditional treatment”, says the article’s lead author, Dr. Cheryl B. Iglesia, director of female pelvic medicine and reconstructive surgery at Washington Hospital Center in the District of Columbia.
“The bottom line is not only were there more complications,” Dr. Iglesia said, “but the mesh didn’t prove any better than traditional surgery.”
In August 2009, researchers conducting the clinical trial of the vaginal mesh products were forced to stop the study before it was completed, because the problems they were seeing in patients were too severe to continue. More than 15 percent of women in the study experienced the dangerous and painful condition known as “erosion” in which the skin splits and the mesh protrudes.
If you or a loved one underwent surgery involving the transvaginal mesh patch and have experienced problems with the device, you may be eligible to file a lawsuit and receive a settlement for your injuries. For a free legal consultation, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form located on this page.
For a free legal consultation, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form located on this page.
For more information on transvaginal mesh lawsuits, visit the Hissey Kientz, LLP transvaginal mesh website.