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Urogynecologic Mesh: An Overview of Warnings by the FDA The following article will detail the warnings issued by the FDA regarding urogynecologic mesh when used in transvaginal surgery for pelvic organ prolapse. Current Urology Reports, (2012, 13:231-239) in an article titled An Appraisal of the Food and Drug Administration Warning on Urogynecologic Surgical Mesh discusses the fact that surgical mesh has been used for over half a century, although primarily in other applications. In the 1950’s surgical mesh was used in abdominal surgeries to repair hernias. In the beginning, the surgeons would simply cut the mesh to the required shape placing it over the incision. Manufacturers soon picked up on these uses and began developing mesh products which were designed specifically for stress urinary incontinence or pelvic organ prolapse repair. Even surgeons who were not trained in abdominal surgery performed these transvaginal mesh surgeries as they were considered relatively simple procedures and during the 70’s such surgeries became routine. By the 1980’s surgeons had determined that the surgical mesh also had a valid application in the treatment of stress urinary incontinence and mesh “slings” made their first appearance. Although surgeons were routinely using mesh for repair of pelvic organ prolapse and stress urinary incontinence at this point it was not until 1996 that the FDA actually approved a mesh product designed for use in surgical procedures for SUI. Six years later approval came for the synthetic mesh to be used in the surgical repair of pelvic organ prolapse and by 2004 the first manufacturers were cleared to sell mesh “kits” which contained pre-shaped mesh, necessary surgical instruments and specialized tools to complete the surgery. FDA 510(k) Process While over a hundred mesh devices and kits have received FDA approval for the repair of POP, only some twenty percent of those are currently being marketed for use in the United States. The transvaginal meshes and kits were approved under an FDA process known as the 510(k) which only requires that new medical devices or drugs prove they are substantially similar to devices or drugs which have already gained FDA approval. The Current Urology Reports article states that all mesh devices currently used for POP repair gained approval under the 510(k) process based on the mesh application for hernia repair. What this means is that no clinical trials were required for approval and few studies on the safety or efficiency of the surgical mesh when used in transvaginal applications exist. In other words, no scientific evidence is available which can prove that surgical mesh used for pelvic organ prolapse is either safe or performs better than more traditional surgical procedures. The FDA has classified urogynecologic mesh as a Class II device although there are proposals in the works which would change it to Class III status. This status change would mandate premarket manufacturing inspections, clinical trials and post-approval studies. FDA device classifications are based on the intended use as well as the risk the device poses to the consumer. Class III devices are considered to be those with the highest level of risk. As an example, heart valves are classified under the FDA’s Class III devices and because of the potential for surgical mesh to lead to adverse health events, many believe that mesh should be changed to a Class III device. Reports and Notifications from the FDA The 2011 report from the FDA states that “The FDA’s review of these devices has primarily focused on data supporting the adequacy of mechanical performance and material safety…bench and/or animal testing have been used to confirm that engineering specifications are met.” The first Public Health Notification from the FDA was issued in October, 2008 and detailed the potentially serious complications which could arise when surgical mesh was used in a surgical application for pelvic organ prolapse or stress urinary incontinence. At the time that notification was released, there had been over a thousand reports of negative health consequences as a direct result of surgical mesh used in POP or SUI surgery. The FDA concluded in this first notification that while the use of surgical mesh in these applications did generally result in better outcomes surgically, that good surgical outcome could come at a serious cost to the future health of those women. The FDA did stress that “serious complications were rare,” among those who underwent surgical procedures for POP or SUI which used transvaginal mesh. The FDA mentioned specific surgical procedures regarding the use of mesh including anterior or posterior transvaginal POP repair, abdominal sacrocolpopexy and apical repairs known as vaginal vault suspension. Even though surgical mesh has been extensively used as slings in the repair of stress urinary incontinence, the focus of this notification was mesh used transvaginally for POP surgical procedures. Procedures and Various Types of Surgical Mesh Current Urology Reports notes that there are several surgical techniques which are believed to improve the outcome of these repairs including tacking of apical and distal mesh to prevent bunching and rolling and full thickness vaginal wall dissection. Further, this report noted that avoiding a hysterectomy at the time of the surgical mesh repair for POP would also improve the overall surgical outcome although other studies say just the opposite—that a hysterectomy performed at the time the transvaginal POP surgery is done can actually improve the outcome of the POP surgery. While there is a wide assortment of meshes available today-- such as absorbable mesh, biologic mesh and xenografts--most of the older types of surgical mesh have been replaced with a polypropylene mesh which is both softer and more porous. This newer mesh is lighter, has larger pores and an elasticity level between 20% and 35%. Chen et al is quoted in Current Urology Reports as defining the perfect mesh implant as one which is “chemically and physically inert, non-carcinogenic, mechanically strong, sterile, not physically modified by body tissues, readily available, inexpensive and have a minimal risk of infection and rejection.” This would seem to be a difficult standard to reach, particularly in light of the issues surrounding transvaginal mesh. The FDA report notes that erosion is the number one adverse event noted by women who have undergone surgical repair of POP using transvaginal mesh. Pain, infection, bleeding, painful sexual intercourse, organ perforation, urinary problems, neuromuscular issues, vaginal shrinking or scarring and recurrence of prolapse are also reported negative symptoms following the surgery. While there were seven reported deaths associated with POP repair, only three of them related directly to the mesh placement while the other four were tied to post-op complications which were not deemed to be directly related to the surgical mesh placement. The majority of women who submitted adverse event reports following their POP surgical procedure noted more than one negative issue. This article discussed the FDA’s original warnings regarding surgical mesh used in pelvic organ prolapse surgeries. Company Info: Sullo & Sullo, LLP prides itself on being a client-focused law firm. With a reputation for exceptional personal attention, unmatched professionalism, zealous advocacy, and a commitment to the utilization of innovative and interactive technologies, our firm has been able to serve over 140,000 clients for more than a decade. We wish you the best in your pursuits and encourage you to engage our firm for legal representation. For more information to visit our website www.sullolaw.com
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