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For the reader with an interest in FDA communications regarding urogynecologic mesh, the following article will provide details regarding those communications. When surgical mesh is used transvaginally for pelvic organ prolapse repair, there may be certain risks associated with the mesh. A Current Urology Reports article, An Appraisal of the Food and Drug Administration Warning and Urogynecologic Surgical Mesh,(2012, 13:231-239) has drawn certain conclusions following over one thousand adverse reports from women who suffered health problems following their transvaginal mesh surgery. The First Public Health Notification from the FDA The FDA released the first Public Health Notification in 2008 following the large number of adverse reports and later issued an update to that report regarding the overall safety of surgical mesh when used transvaginally to repair pelvic organ prolapse. This first notification from the FDA was sent to healthcare practitioners and stated that “the most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems and recurrence of prolapse and/or incontinence…in some cases vaginal scarring and mesh erosion led to a significant decrease in patient quality of life…complications included additional surgical procedures, IV therapy, blood transfusions and drainage of hematomas or abscesses.” In this same notification surgeons were asked to obtain additional training in the correct placement of surgical mesh during pelvic organ prolapse repairs as well as to “inform patients about the potential for serious complications and their effect on quality of life…” The Second Public Health Notification from the FDA Three years later the FDA was issuing an update to the 2008 notification regarding the safety of urogynecologic mesh. The available data and literature were reviewed by the FDA and studies of the overall efficacy of using surgical mesh were also looked at. This 2011 notification contained additional patient information regarding potentially serious complications associated with the transvaginal placement of surgical mesh. At this point in time the FDA noted that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” The FDA further stated that it was unclear whether POP transvaginal repair using surgical mesh was any more effective than older types of mesh repair and could expose patients to a much higher level of risk. The FDA received an additional 2,874 reports of complications associated with the transvaginal placement of surgical mesh from January 1, 2008 through December 31, 2010. The most frequent complications reported during this time period involved erosion of the mesh through the vagina, followed by pain, infection, bleeding pain during sexual intercourse, perforation of surrounding organs and urinary problems. Lesser, but still serious problems included emotional problems, vaginal scarring or shrinkage and recurrent prolapse. Many adverse medical events resulted in surgical treatments and hospitalization. As reported in the Current Urology Reports article several facts were apparent regarding the use of surgical mesh: • Pelvic organ prolapse surgery performed transvaginally and using surgical mesh inherently possessed more risks than traditional surgeries which did not use mesh. • When an abdominal approach using mesh is used in pelvic organ prolapse repairs there appears to be lower rates of mesh complications as compared to transvaginal placement of the surgical mesh. • There is little evidence that using mesh in an apical or posterior transvaginal repair adds any benefit whatsoever. • Although anatomic correction may be increased when mesh is used in anterior transvaginal repair there may be little actual relief of symptoms for the woman who undergoes the surgical procedure. The Current Urology Reports article details that a full third of all surgeries for POP utilize surgical mesh and that roughly 3/4ths of these surgeries are done transvaginally. Over 300,000 women undergo a surgical procedure for pelvic organ prolapse each year in the United States while 260,000 go under the knife to correct stress urinary incontinence. Regarding SUI surgeries the FDA states that over 80% were done transvaginally, using surgical mesh. Further Reports from the FDA As noted in the Current Urology Reports article the FDA essentially sees no added benefits when mesh is used for apical, posterior or transvaginal repairs over more traditional surgical procedures. While mesh kits used during an apical repair might appear initially effective the long-term outcomes are as yet unknown. There is no improved quality of life for women whose surgery included urogynecologic mesh and while there is less recurrence of prolapse during following surgical repair of abdominal apical prolapse, recurrence nevertheless does occur. The FDA believes that as many as 10% of all women who undergo POP surgery with surgical mesh will experience erosion in as little as one year following the surgery. Half of those will undergo a subsequent surgery in order to remove the urogynecologic mesh while the remainder will likely suffer a variety of adverse symptoms. Many women who have had POP surgery with mesh which was performed transvaginally noted complications such as shortening or tightening of the vagina which led to painful intercourse as well as pain, bleeding, and a variety of other side effects. All in all, the FDA believes that when mesh is used in the correction of POP through an abdominal procedure there are far fewer complications and side effects than when the mesh is used transvaginally. Shortcomings of Existing Literature Regarding Transvaginal Placement of Surgical Mesh The article in Current Urology Reports lists several shortcomings regarding the existing literature on the use of surgical mesh used transvaginally to repair pelvic organ prolapse. There were few reports of whether women were actually relieved of their adverse symptoms only reports of whether “ideal pelvic support” had been achieved. The literature does not separate primary surgical procedures from repeat procedures making it very difficult to obtain an accurate picture of which surgery led to additional adverse symptoms. Surgeries for POP were not separated from surgeries for SUI in most of the literature and “many studies are poorly designed and/or conducted, are underpowered, use incompletely documented inclusion/exclusion criteria, have inadequate evaluator masking and fail to account for variable lengths of patient follow-up.” Finally, few studies have followed women who underwent transvaginal POP surgery using surgical mesh for any period longer than two years. Opinions Regarding the FDA Communications The American Urogynecological Society commented that upgrades should be implemented to the FDA’s 510(k) approval process and that in most cases pelvic organ prolapse can be surgically treated using traditional methods rather than surgical mesh, thus greatly minimizing the risks associated with mesh. AUGS further states that when surgical mesh use is warranted only highly trained surgeons should perform the operations and that patients should be thoroughly informed regarding potential risks of surgical mesh. This group also recommends that a national database should be implemented, allowing the FDA to track both positive and negative outcomes of transvaginal surgical mesh placement. Another group, The Society for Urodynamics and Female Urology, while refusing to make blanket recommendations for or against the use of transvaginal mesh also recommended an overall of the 510(k) approval process. They further stated that surgeons who perform this particular surgery should undergo “rigorous training in the principles of pelvic anatomy and pelvic surgery, be properly trained in specific mesh implantation techniques and be able to recognize and manage the complications associated with vaginal mesh.” This article detailed communications by the FDA regarding urogynecologic mesh as well as responses from other groups on those communications. 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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