Issues and Litigation of Transvaginal Mesh for the Repair of POP
by: David B. Allen, Attorney
The following is an excerpt from an article written for Indiana Trial Lawyers Association Verdict publication. The full article can be found in the June 2012 edition of Verdict.
Litigation is pending around the country against manufacturers of transvaginal mesh implants that were used to repair the condition of pelvic organ prolapse (POP). Many women suffered great harm by these untested and unsafe products. For the period 2008 to 2010, the most frequent complications reported to the FDA from the use of surgical mesh devices for POP repair included vaginal mesh erosion, pain, infection, urinary problems, bleeding and organ perforation. There were additional reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems. For the same reporting period, there were seven reported deaths associated with transvaginal mesh POP repairs. Three of the deaths were related to the mesh placement (two bowel perforations and one hemorrhage), and four from post-operative medical complications not directly related to the mesh placement.
There are four multi-district litigations, or MDLs, pending in the Southern District of West Virginia against manufacturers, including CR Bard, Inc., Johnson & Johnson/Ethicon, Inc., American Medical Systems, Inc. and Boston Scientific, Inc. These cases are all pending before the same federal judge. The MDLs are moving forward with discovery, and the first trial is expected within the next several months against CR Bard, Inc. See In re Avaulta Pelvic Support Systems Product Liability Litigation, MDL No. 2187, U.S. District Court for the Southern District of West Virginia (and the companion MDLs for the other manufacturers).
The Impact of POP
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic, material or absorbable biologic material. Specifically, in urogynecologic procedures, mesh is permanently implanted to reinforce weakened vaginal walls to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). POP occurs when the pelvic floor which holds the pelvic organs in place becomes weakened or stretched, often as a result of childbirth. The weakened tissues cause the pelvic organs to bulge (prolapse) into the vagina. Some organs will prolapse past the vaginal opening and more than one pelvic organ can prolapse at the same time (the bladder, the uterus, the rectum or the bowel). POP occurs with 30-50 percent of women, with 2 percent becoming symptomatic. POP may negatively impact a woman’s quality of life by causing pelvic pain and/or interference with sexual, urinary and defacatory function. Since 2004, the use of synthetic mesh in vaginal surgery for the treatment of POP has increased. There are growing concerns about the safety and efficacy of the transvaginally placed mesh. See, FDA Public Health Bulletin issued in 2008.
Problems with Mesh
Transvaginal Mesh is typically made of knit or woven polypropylene mesh. The manufacturers claim that polypropylene is inert; however, the medical and scientific literature demonstrates that it is not inert. Unfortunately, manufacturers do not typically test mesh products for degradation, nor do they test the mechanical properties of the mesh, such as tensile strength, elasticity and density at the tissue-mesh interface which causes a mechanical “mismatch.” POP mesh is not compatible with the natural motion of the pelvis because of its rigidity and composition. Mesh has also been shown to shrink in the pelvis, causing undue traction or strain on soft tissues which causes serious complications, including protracted pelvic pain. Furthermore, if the mesh has a collagen component (porcine or bovine), it may create additional problems, including degradation in situ or an inflammatory response in the patient. All of these properties/issues cause substantial problems in women who have had mesh placed transvaginally for repair of POP. The problems are described in detail below.
Unfortunately, complications have been grossly under reported because of difficulties in tracking statistics on complaints and complication rates – which were not tracked when these products were first being used, and have only recently begun to be tracked by order of the FDA. The FDA has acquired some reports and noticed a significant increase in the number of adverse events reported. The FDA conducted a search of the Manufacturer and User Device Experience (MAUDE) database for medical device reports (MDR’s) of adverse events associated with all urogynecologic surgical mesh products received between January 1, 2005 and December 31, 2010. The search identified 3,979 reports of injury, death and malfunction. Among the 3,979 reports, 2,874 reports were received in the last three years (January 1, 2008 – December 31, 2010), and included 1,503 reports associated with POP repairs. The number of MDR’s associated with POP repairs increased by more than 5-fold compared to the number of reports received in the previous three years. FDA stated in its July 2011 Urogynecologic Surgical Mesh Update (The White Paper) that it believes the overall increase in the number of serious adverse event reports is cause for concern.
David Allen is currently serving on the Plaintiff’s Steering Committee for the 4 pending multi-district litigations in the Southern District of West Virginia against manufacturers, including CR Bard, Inc., Johnson & Johnson/Ethicon, Inc., American Medical Systems, Inc. and Boston Scientific, Inc.