Complications of transvaginal silicone-coated polyester synthetic mesh sling
ABSTRACT To report a premarket multicenter trial to test the feasibility of a transvaginal silicone-coated polyester synthetic mesh sling in women with anatomic incontinence.
Fifty-one patients in four centers underwent transvaginal placement of a silicone-coated polyester synthetic mesh sling (American Medical Systems) during an 8-month period. Of the 51 patients, 31 were part of a prospective institutional review board-approved feasibility trial in three centers funded by American Medical Systems (group 1) and 20 underwent implantation by a single surgeon and their data were retrospectively reviewed (group 2). The studies were done concomitantly, and all slings were fixed transvaginally with bone anchors. All patients in group 1 were followed up at 4 weeks, 6 months, and 1 year (as applicable) with repeat questionnaires, physical examinations, and pad tests.
In group 1, 20 patients completed 6 months of follow-up. Ten patients (32%) required a second surgical procedure at an average of 183 days (range 68 to 343) postoperatively. Eight patients (26%) had vaginal extrusion of the mesh, one (3%) required sling lysis, and one (3%) required sling removal because of infection. In group 2, 8 patients (40%) underwent sling removal for vaginal extrusion at a mean of 160 days (range 83 to 214).
Transvaginally placed silicone-coated mesh slings used for the treatment of urinary incontinence demonstrated an unacceptably high vaginal extrusion rate in this study. Once identified, this study was immediately terminated, and this product was not marketed for this application in the United States.
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ABSTRACT: We reviewed the incidence, predisposing factors, presentation and management of complications related to the use of synthetic mesh in the management of stress urinary incontinence and pelvic organ prolapse repair. Immediate complications, such as bleeding, hematoma, injury to adjacent organs during placement of mesh and complication of voiding dysfunction are not discussed in this review, since they are primarily related to technique. A PubMed search of related articles published in English was done from April 2008 to March 2011. Key words used were urinary incontinence, mesh, complications, midurethral sling, anterior prolapse, anterior vaginal repair, pelvic organ prolapse, transvaginal mesh, vault prolapse, midurethral slings, female stress urinary incontinence, mesh erosion, vaginal mesh complications, and posterior vaginal wall prolapse. Since there were very few articles dealing with the management of mesh-related complications in the period covered in the search we extended the search from January 2005 onwards. Articles were selected to fit the scope of the topic. In addition, landmark publications and Manufacturer and User Facility Device Experience (MAUDE) data (FDA website) were included on the present topic. A total of 170 articles were identified. The use of synthetic mesh in sub-urethral sling procedures is now considered the standard for the surgical management of stress urinary incontinence. Synthetic mesh is being increasingly used in the management of pelvic organ prolapse. While the incidence of extrusion and erosion with mid-urethral sling is low, the extrusion rate in prolapse repair is somewhat higher and the use in posterior compartment remains controversial. When used through the abdominal approach the extrusion and erosion rates are lower. The management of mesh complication is an individualized approach. The choice of the technique should be based on the type of mesh complication, location of the extrusion and/or erosion, its magnitude, severity and potential recurrence of pelvic floor defect.Indian Journal of Urology 04/2012; 28(2):129-53. DOI:10.4103/0970-1591.98453
International Journal of Urology 07/2012; 19(10):960-1. DOI:10.1111/j.1442-2042.2012.03084.x · 1.80 Impact Factor
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ABSTRACT: The title of this chapter reflects the need to specify anatomical placement when discussing slings. A decade ago, such a distinction was unnecessary as bladder neck positioning was standard. The birth, continued evolution, and success of the midurethral sling have altered the role of the bladder neck sling. This chapter discusses the history, applications, patient selection, technique, materials success rates, and complications of the bladder neck sling.12/2006: pages 131-158;