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This article will detail the FDA’s warnings regarding the use of urogynecologic mesh in the treatment of pelvic organ prolapse and discuss how effective those warnings have been. The FDA first began warning the public and physicians about the potential risks of surgical mesh when used in transvaginal applications in 2008 when they issued a Public Safety Notification after receiving over a thousand adverse reports from women. An article in Current Urology Reports (2012, 13:231-239), An Appraisal of the Food and Drug Administration Warning on Urogynecologic Surgical Mesh, details the fact that mesh kits were initially manufactured to increase both the speed and ease of placement of surgical mesh placed transvaginally. Unfortunately, since the mesh gained FDA approval nearly a decade ago for this particular application, many women have reported adverse symptoms following the surgery, most particularly mesh erosion. The FDA--as well as other groups--continues to emphasize the fact that surgeons using mesh kits and mesh devices must have specialized training which will allow them to both recognize and manage any potential complications which arise from the mesh implants. The present governmental regulations regarding these devices has also come under fire with most groups agreeing that the 510(k) approval process should be changed to require more stringent regulations as well as clinical trials prior to approval. FDAs Reporting Program The FDA currently operates under a reporting program known as Medwatch which gathers information on medical devices and drugs from consumers, hospitals and health professionals. When a serious injury or death is deemed to be directly related to a medical device or drug, it must be immediately reported to the FDA as well as the manufacturer. Within the FDA the Center for Devices and Radiologic Health “approves and collects data on the safety/efficacy of medical devices in the United States.” While it is important that these databases exist, they suffer under certain limitations. Limitations of Current Reporting Programs Surgeons who perform transvaginal pelvic organ prolapse surgeries using mesh are rarely—if ever—the follow-up physician when complications arise. Further, patient complications tend to be seen in referral centers. Surgeons are very unlikely to receive any sort of feedback regarding the surgeries they perform making it difficult to improve surgical techniques. Although software with “significant improvements” over what is currently being used certainly exist, the Current Urology Reports articles states such a program would “demand a tremendous amount of oversight in matters as simple as prevention of duplicates and as complex as the enforcement of mandatory reporting.” What Defines “Successful” Treatment? There are several difficulties involved in defining “successful” treatment for POP. For each woman pelvic organ prolapse symptoms vary widely and the actual degree of prolapse (as determined by a physician) may not correlate with the woman’s report of symptoms. There is an extremely wide range of surgical techniques involved in POP surgeries and the outcomes are very diverse. A “quality of life” study was done on women who had undergone transvaginal POP repair with surgical mesh. Scores were compared between those women whose surgeons considered the surgery an “anatomical success” and those women who suffered recurrent prolapse. Surprisingly,“no significant difference was found,” according to Current Urology Reports. Risk Factors for Complications The same article reports that risk factors for complications of mesh placement include the surgeon’s use of a “T” shaped vaginal incision, the level of the surgeon’s experience, whether a hysterectomy is done at the same time as the POP surgery, the age of the patient and whether or not the patient has a history of tobacco use or diabetes. It does appear that the FDA warnings have been at least partially effective as Drugwatch reports far fewer surgeons using transvaginal mesh implants. The FDA recommends that all potential patients be presented with a written copy of the risks which could be involved with transvaginal POP surgery using a mesh implant. This article discussed the effectiveness of FDA warnings on surgical mesh used in transvaginal POP surgery. 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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