Attorneys for Beasley Allen Law Firm are currently investigating cases of injury caused by surgical mesh used to repair pelvic floor disorders. Transvaginal mesh is a device used to repair conditions such as stress urinary incontinence and pelvic organ prolapse. The mesh has come under the spotlight recently after an alarming number of complaints to the Food and Drug Administration (FDA) adverse event reporting program, MedWatch.
Transvaginal mesh is made of porous absorbable or non-absorbable synthetic material or absorbable biologic material. In the repair of pelvic floor disorders, the mesh is permanently implanted to reinforce the weakened vaginal wall or to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence, when it is often referred to as a “bladder sling.”
In an October 2008 public health notification, the FDA notified doctors and consumers that the mesh had been associated with “over 1,000” injuries between 2005 and 2007. Since then, between January 1, 2008 and December 31, 2010, the FDA has received an additional 2,874 reports of complications associated with surgical mesh devices used to repair stress urinary incontinence and pelvic organ prolapse, with 1,503 reports associated with pelvic organ prolapse repair and 1,371 associated with stress urinary incontinence.
Complications include pelvic pain, erosion of the mesh into other organs, organ perforation, pain during sexual intercourse, and urinary problems. Some cases involved additional surgeries and hospitalizations.
The FDA says the high number of incident reports with transvaginal mesh makes it an area of “continuing serious concern.” The agency recently ordered an expert review of the device.
Meanwhile, advocacy groups are calling for a ban on the products. And hundreds of women who allege the devices have caused them serious and permanent injury have filed lawsuits against the manufacturers of transvaginal mesh.