There are thousands of product liability and personal injury transvaginal mesh complication lawsuits pending nationwide, with estimates of over 100,000 filed cases. Affected and seriously injured women experienced significant vaginal and urinary problems after undergoing surgical repair for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI).
Surgical mesh has been used by gynecologists for the abdominal repair of POP and since the 1990s, for the transvaginal repair of POP. Surgical vaginal mesh is made of biological materials or synthetic materials like polypropylene, polytetrafluoroethylene, polyester fibers or stainless steel. The size, shape, thickness and flexibility vary based on the surgeon’s needs.In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five major manufacturers who are currently marketing this product.Severe Pelvic Pain and Perforation Mesh Side Effects
Over the past six years, there has been a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair.
What is Pelvic Organ Prolapse?
POP occurs when the muscles and tissue of the pelvic floor become stretched, torn or weakened and can no longer support pelvic organs such as the bladder, bowel or uterus; as a result, the organs drop from their normal position and bulge (prolapse) into the vagina.
Women affected with POP experience low back pain or pelvic pressure, painful intercourse, constipation or urinary problems such as leakage or a chronic urge to urinate.
Thousands of Women with Mesh Related Complications
FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair. In 2011, the FDA announced that it had received close to 3,000 adverse event reports involving injuries and devastating complications with vaginal mesh and stress urinary incontinence slings devices between 2008 and 2010. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.
FDA: No Additional Benefit of Mesh
The FDA has found that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse, and manufacturers of the devices have been ordered to conduct safety studies. Unfortunately that is too little and too late for the thousands of injured women.
In 2012, the FDA sent a notice letter to vaginal mesh and bladder sling product manufacturers, demanding that they conduct additional studies to determine the safety of transvaginal mesh products.
As expected, the mesh manufacturers took the easy way out and quit selling the pelvic mesh products for transvaginal repair or pelvic organ prolapse and stress urinary incontinence. Again putting profits before people, the manufacturers did not want to spend a dime to prove how worthless and unsafe these devices were.
The FDA earlier in 2016, announced tighter regulations over mesh inserts after finding they should be classified as higher-risk products when used to treat POP and SUI. This means that any manufacturer who decides to continue selling devices will have to show rigorous testing and safety before approval.
Vaginal Mesh Litigation
Most of the vaginal mesh side effect litigation has been filed in the federal court system, where all cases are consolidated for pretrial proceedings as part of a multidistrict litigation (MDL).
U.S. District Judge Joseph Goodwin in the Southern District of West Virginia is overseeing the litigation since February 2012. Judge Goodwin has presided over more than 100,000 transvaginal mesh and bladder sling lawsuits filed against various manufacturers, including C.R. Bard, Boston Scientific, American Medical Systems, Johnson and Johnson’s Ethicon subsidiary, Coloplast, and others.
Several cases have gone to trial with significant jury verdicts. Thousands of lawsuits have been settled out of court without trials and American Medical Systems, Bard, Caldera and Coloplast have announced settlements. Boston Scientific are in settlement discussions and Johnson & Johnson’s Ethicon subsidiary according to Bloomberg News, settled the first large group of cases, agreeing to pay about $120 million to settle 2,000 to 3,000 of the claims.
Johnson & Johnson is exposed to another 42,400 transvaginal mesh cases, according to a regulatory filing. J&J’s exposure is unknown after those suits are taken off the docket through verdicts, settlements or dismissals because average payouts will vary based on the strength of cases.
Have you been injured or suffered complications from vaginal mesh for treatment of POP or SUI? Help is available.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.
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