Made of strips of surgical mesh for internal use, transvaginal mesh products are intended to repair female stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

However, due to allegedly faulty materials and other issues, seven multidistrict litigations (MDLs) are in process involving more than 60,000 vaginal mesh lawsuits nationwide. The latest addition to a West Virginia vaginal mesh MDL was filed by plaintiff Deborah Crist.

Crist’s complaint against Ethicon and Johnson & Johnson alleges that the Gynecare TVT-Obturator system (TVT-O bladder sling) that was implanted in 2004 was defectively designed and caused her to suffer injuries. Many transvaginal mesh lawsuits involve similar allegations of poor design and use of improper synthetic materials.

Six other companies are facing vaginal mesh lawsuits, including Boston Scientific, C.R. Bard, American Medical Systems, Cook Medical, Coloplast and Neomedic. The thousands of women behind these lawsuits are alleging the bladder slings and vaginal inserts to be defectively designed, causing pain, suffering and more often than not the added affliction of revision surgeries.

With the number of cases in the vaginal mesh MDLs sitting in the tens of thousands, bellwether trials are underway to expedite the process. Bellwether trials are often used in litigation in which many plaintiffs have suffered injuries from the same general cause.

This is often the case in medical device and drug claims. The selected cases are fully prepared and tried before a jury. This gives all interested parties a good idea of how future trials may turn out. Moreover, utilizing an MDL simplifies the process of discovery for the courts and means less court time, fewer potential costs, and no risk of varying outcomes from different judges for plaintiffs.

To date, two of three bellwether trials involving Johnson & Johnson’s subsidiary Ethicon have gone against the defendant, with the last one reporting a jury decision of $3.27 million for the plaintiff. And the bellwether trials aren’t the only ones. In March 2013, Plaintiff Linda Gross was awarded $11.1 million by a New Jersey state court jury due to complications from her Gynecare Prolift mesh. She required 18 surgeries to repair the damages.

Allegations in Crist’s vaginal mesh lawsuit include negligence, manufacturing defect, failure to warn, defective product and design, common law fraud, fraudulent concealment, constructive fraud, negligent misrepresentation, negligent infliction of emotional distress, breach of express and implied warranty, violation of consumer protection laws, gross negligence, unjust enrichment, and punitive damages.

Her Vaginal Mesh Lawsuit is in the MDL In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327, in the U.S. District Court for the Southern District of West Virginia.

What is Transvaginal Mesh?

Transvaginal mesh, whether made of synthetic materials or animal tissue, is a permanent implant. It is used to treat pelvic floor disorders. In the case of POP repair, mesh is used to reinforce a weakened vaginal wall. For cases of SUI, it’s used as a bladder sling to support the urethra or bladder neck. Each of these procedures has unique risks and benefits.

As far back as 2011, the U.S. Food and Drug Administration warned of the serious complications associated with surgical mesh in transvaginal pelvic organ prolapse procedures. In April, the FDA issued two proposed orders to address the health risks associated with surgical mesh used for POP. The goal of these orders was to “reclassify the surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.”