Mesh Sling in an Era of Uncertainty: Lessons Learned and the Way Forward
Christopher R. Chapple, Shlomo Raz, Linda Brubaker and Philippe E. Zimmern
Published online 4 July 2013
European Association of Urology
For many years, synthetic mesh was avoided whenever possible for surgical treatment of stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP) because of the recognized complications of fibrosis and erosion seen with Mersilene  and Gore-Tex slings .
Petros and Ulmsten  in 1990 and Petros and Papadimitriou  more recently described a fairly simple procedure with tension-free vaginal tape (TVT), during which the surgeon placed a thin strap of polypropylene mesh in a midurethral position. Since the 1990s, the marketing and use of synthetic materials for SUI and POP indications have dramatically increased. This was particularly noticeable after the publication of a randomized controlled trial comparing TVT with colposuspension . A number of similar procedures were subsequently granted marketing licenses with little clinical data from adequately powered randomized studies. This was followed by a series of modifications including transobturator tape (TOT)  and, recently, a wave of single-incision slings, or mini-slings, to prevent passage of trocars through the retropubic space or obturator fossa . Concomitantly, the specialty of female pelvic medicine and reconstructive surgery has witnessed the very rapid growth of larger segments of synthetic material, referred to as mesh, being implanted beneath the vaginal wall to correct POP based on the early data supporting efficacy of TVT and TOT.
More than 40 implants are on the market  and  and are used with little evidence related to mid- and long-term safety and efficacy. Training to place these new implants has often comprised cadaver courses on weekends, review of video procedures, observing “experts” performing implants, and mentorship in institutions by a visiting surgeon. The use of these materials and the surgical techniques have not been limited to subspecialist practice. In 2008, following an escalation in complications reported to the Manufacturer and User Facility Device Experience (MAUDE) database, the US Food and Drug Administration (FDA) issued a first notification to inform the public  that these devices and “kits” had risks, should be used with caution, and might result in nonreversible outcomes . A second FDA notification in 2011 sounded even more alarming  and provoked a chain reaction from patients, physicians, manufacturers, and lawyers. Similar initiatives were under way in the United Kingdom, with recognition of the problem by the Medicines and Healthcare Products Regulatory Agency (MHRA)  and . As the Internet facilitated connection between desperate patients seeking help , television advertisements started to inform the public about issues related to “transvaginal meshes.” A number of Web sites inspired by patients’ experiences identified problems with mesh (eg, TVT Messed up Mesh [TVT Mum], http://www.tvt-messed-up-mesh.org.uk/).
During specialty meetings, many presentations and discussions have focused on mesh or tape complications and their management, specifically, obstruction, pain, dyspareunia, and erosion that may have irreversible consequences despite multiple interventions . In daily practice, patients have begun to inquire more intensely about “mesh” or “tape,” and the regulatory authorities have provided information for patients on this subject. There is a lack of registries to establish the true incidence of the problems with the use of synthetic materials, as has been recognized with the underreporting of these complicated cases to the “optional” MAUDE database  and to the other regulatory bodies such as MHRA in the United Kingdom. Although voluntary registries have been established by professional groups, they do not provide accurate information because registration of all cases would be required and, invariably, existing voluntary registries are prone to selective reporting of cases. To read the full article please click on the links below.
Copyright 2013 European Association of Urology, Published by Elsevier B.V.
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