Vaginal Mesh MDL Schedules Three Bellwether TrialsDec 26, 2012
Thousands of women have been implanted with transvaginal mesh, a medical device that has come under increased scrutiny in recent years. In fact, many recipients of these devices have claimed to experience complications related to their defects, including severe pain, erosion of the devices through the skin or tissue, serious infections, and the need for constant revision surgeries to either correct or remove the devices.
Transvaginal mesh is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Complication reports, mounting litigation, and concerns over the lack of clinical testing have raised questions about the devices’ safety. Transvaginal mesh were approved through a fast-track process known as the 510(k), which means that a formal review for safety and efficacy was neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, such as metal-on-metal hip implants, the process has drawn increasing criticism.
Earlier this month, U.S. District Judge Joseph R. Goodwin—the judge overseeing five vaginal mesh multidistrict litigations (MDLs) in the U.S. District Court for the Southern District of West Virginia—called a status conference to announce that the first three bellwether trials are scheduled to begin December 2013. The three trials involve different mesh manufacturers: American Medical Systems (AMS), Ethicon, and Boston Scientific, respectively. The five MDLs involve cases filed against these three device makers and Coloplast and C.R. Bard.
An MDL is a legal vehicle in which lawsuits associated with a particular product may be coordinated under one judge for pretrial litigation. This helps to minimize duplicative discovery and inconsistent rulings and serves to conserve the resources of the parties, witnesses, and the court. When lawsuits are consolidated as an MDL, each case retains its own identity. If the MDL process does not resolve the cases, they are transferred back to the court where they originated for trial. Initial cases are known as so-called “bellwether trials,” and enable involved parties to better understand and predict how future cases will turn out and if their cases should be negotiated in out-of-court settlements.
Transvaginal mesh, allegedly, has a risk of erosion, in which it travels through the body’s tissues, in some cases, embedding in inappropriate areas and requiring multiple surgeries to remove it. In many cases, erosion is so significant and widespread that the mesh cannot ever be completely removed.
Last July, the U.S. Food and Drug Administration (FDA) warned that, contrary to what was initially believed, complications associated with transvaginal mesh are, in fact, “not rare.” The agency also stated that no substantial evidence exists that transvaginal mesh offers significant benefits over non-mesh methods for treating POP and may pose more risks. The FDA has asked 33 manufacturers to conduct post-market safety studies to assess the risk of transvaginal mesh on organ damage and other health issues.
According to an FDA Safety Communication on the matter, the most commonly reported complications associated with transvaginal mesh include mesh erosion through the vagina (exposure, extrusion, protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems.
According to a recent Bloomberg Businessweek report, transvaginal mesh makers face over 650 lawsuits in which plaintiffs claim the devices are defective and cause bodily harm. Some allege that the mesh erodes, meaning it moves from its intended position and cuts into other body parts, such as the colon or bladder. Last summer, the FDA said that, among the thousands of reports received from women since 2005, mesh erosion was one of the most common complications associated with transvaginal mesh.