It has been three years since the Food and Drug Administration (FDA) issued a Safety Communication warning the public that complications with transvaginal mesh used to treat pelvic floor disorders including pelvic organ prolapse and stress urinary incontinence were not uncommon and could be chronic or life threatening. Since then, lawsuits against manufacturers of the devices have grown exponentially.
Trasvaginal mesh, also known as vaginal mesh, pelvic mesh, or bladder sling, is a type of surgical mesh that is inserted through the vagina to support organs that have dropped due to age, childbirth, obesity or other conditions. The mesh is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.
In 2011, the FDA informed the public that serious complications with the mesh were “not rare,” which was a change from what the FDA had previously reported in 2008. Between 2005 and 2011, the FDA received about 4,000 reports of complications in patients who had the devices.
These problems included pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.
“Many of these complications require additional intervention, including medical or surgical treatment and hospitalization,” the FDA stated.
In recent years, tens of thousands of lawsuits have been filed against manufacturers of transvaginal mesh devices. Plaintiffs allege that the device makers knew the mesh had a high failure rate and could cause serious complications but failed to warn women or their doctors of this risk.