Every surgery has risks, but complications with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) complications have caused serious injuries to thousands of patients. According to the FDA, over 1,000 cases have emerged in the last three years, however there are over 11,000 cases pending against numerous companies. Complications can include erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. Complications during insertion could also include bowel, bladder and blood vessel perforation during insertion.
Treatment of complications can include IV therapy, blood transfusions, drainage of hematomas or abscesses and even surgical revision surgeries to remove the mesh.
Several companies are facing thousands of lawsuits over the transvaginal mesh devices in state and federal courts, as well as in Canada. One company, Endo Pharmaceuticals, Inc., has agreed to pay $54.5 million to settle some of the North American lawsuits and announced the settlement in a regulatory filing with the U.S. Securities and Exchange Commission. In 2010, approximately 300,000 women underwent surgery for pelvic organ prolapse, with roughly one in three using mesh. Approximately 260,000 women underwent surgery for stress urinary incontinence, 80 percent of which involved transvaginal mesh in 2010. More lawsuits are expected to be filed in the coming years.
In 2012, jurors in Bakersfield California awarded $3.6 million in the first case over vaginal mesh devices. They found the plaintiff and her husband were entitled to a total of $5.5 million due to medical expenses, pain, suffering and other damages resulting from her injuries.
In February, a jury awarded a South Dakota woman $3.35 million in compensation for her vaginal mesh lawsuit against Johnson & Johnson and an additional $7.76 million in punitive damages. Her lawsuit was based on failure to warn and product misrepresentation and was the first verdict of the vaginal mesh lawsuits, alleging the product was defective in “design, manufacture, warnings and instructions”. Her injuries led to 18 operations to repair the damage caused by the use of vaginal mesh. Many other trials are scheduled against various manufactures over the next year that will set the parameters for future vaginal mesh settlements.
Patients who have experienced transvaginal mesh side effects may be entitled to compensation and should have their case evaluated by a legal representative knowledgeable about vaginal mesh cases as soon as possible since these cases have time limits which could bar claims not made in a timely fashion.