Women continue to file lawsuits over transvaginal mesh injuries that include vaginal erosion—also known as exposure, extrusion, or protrusion—infection, organ perforation, and chronic pain and/or abscess.
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. The devices 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.
In the first case, the national law firm, Parker Waichman LLP, filed on behalf of a Georgia woman alleging her injuries were caused by Johnson & Johnson, C.R. Bard, and Boston Scientific transvaginal mesh products. The woman was implanted with Johnson & Johnson’s Gynecare Prolift Total Pelvic Floor Repair System, C.R. Bard’s Uretex Sup Pubourethral Sling, and Boston Scientific’s Polyform Synthetic Mesh. The lawsuit alleges that the woman’s injuries resulted from the mesh and names Ethicon, Inc., Ethicon Women’s Health and Urology, Gynecare, Johnson & Johnson, C.R. Bard, Inc., and Boston Scientific Corporation as defendants. The woman received the mesh implants April 2006 to correct her POP and SUI.
Parker Waichman LLP also filed a lawsuit on behalf of a California woman allegedly implanted in July 2005 with the Monarc Subfascial Hammock and Apogee System with Intepro, to treat her POP and SUI. The transvaginal mesh implants are manufactured by American Medical Systems. Among other things, the lawsuit alleges that the defendant failed to warn about the risk of vaginal erosion, infection, extrusion, perforation, chronic pain, and/or abscess and that the woman experienced painful and disfiguring symptoms after being implanted with the transvaginal mesh products, which caused her injuries. The lawsuit holds the defendant, American Medical Systems, Inc., responsible for failing to warn about the dangers associated with the device.
According to the complaint, the mesh is not inert and reacts with the body. This, the suit states, can lead to a host of adverse health consequences. The lawsuit also holds the defendant responsible for exposing women to these risks, especially since it was allegedly aware of such complications.
Both suits allege the mesh caused the women to suffer serious and painful complications leading to significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity, and loss of bodily organ systems.
Parker Waichman filed the lawsuits on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-03156 and Case No. 2:12-cv-03173). The first case is currently pending, alongside many other similar cases, in the multidistrict litigation as part of the In Re: Ethicon, Inc. Pelvic Repair System Products Liability Litigation (MDL No. 2327). The second lawsuit is among the many cases filed into the multidistrict litigation known as the In Re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2325).
According to a report in Bloomberg Businessweek, transvaginal mesh makers face over 650 lawsuits claiming the devices are defective and cause bodily harm. Many lawsuits, such as these, were filed into the multidistrict litigation, overseen by Chief Judge Joseph R. Goodwin. 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 U.S. Food and Drug Administration (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. The agency has asked 33 manufacturers to conduct post-market safety studies on the devices in order to determine their effect on organ damage.
Last July, the agency said that the mesh has no clear advantage over non-mesh methods for treating POP even though it may present additional risks. The FDA went on to say that most POP cases can be successfully treated without transvaginal mesh.
In June, Johnson & Johnson told Judge Goodwin that it will no longer sell four types of transvaginal mesh implants, including the Prolift, Prolift + M, TVT Secur, and Prosima. The company had also asked the FDA to postpone the post-market safety studies.
C.R. Bard recently lost the first personal injury lawsuit to go to trial over transvaginal mesh when a California jury awarded $5.5 million to one couple whose lives were allegedly affected by the Avaulta Plus.