Page 1 - CUA Mesh Statement 2019
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An update on transvaginal mesh for CUA Members

               Blayne Welk, Duane Hickling, Greg Bailly, Stephen Steele, Richard Baverstock, Jacques Corcos,
               Kevin Carlson

               On April 16 2019, the United States Food and Drug Administration (FDA) published an update to
               its previous statements on transvaginal mesh.  The FDA ordered all manufacturers of surgical
               mesh systems for transvaginal repair of anterior compartment prolapse to stop selling and
               distributing these products immediately. The FDA also advised those who have received a prior
               transvaginal prolapse repair with mesh that “there is no need to take additional action if you
               are satisfied with your surgery and are not having any complications or symptoms.” At this time
               there has not been any additional guidance from Health Canada on transvaginal mesh since

               The updated FDA statement is in keeping with the 2017 CUA statement on transvaginal mesh,
               which states that the routine use of transvaginal mesh for prolapse repair does not appear to
               be supported by the current evidence, and its use should be restricted to specialized pelvic
               floor surgeons and specific clinical situations.  The concern regarding the use of mesh for pelvic
               organ prolapse (POP) stems from the increased complications and minimal difference in
               functional and anatomic outcomes compared to traditional native tissue repairs.   There has
               been a significant decrease in the utilisation of transvaginal mesh for prolapse since the initial
               FDA warnings , and the number of companies manufacturing prolapse mesh systems has also
               decreased significant. With the new FDA statement, it is likely that the availability of
               transvaginal mesh systems for prolapse will be limited in the future.

               Unfortunately, despite the clear differences in the indication, complications, and intensity of
               clinical study, midurethral slings (MUS) for stress urinary incontinence (SUI) are often
               inappropriately drawn into the dialogue about transvaginal mesh for prolapse. The situation is
               similar this time, with recent media reports inappropriately stating for example: “FDA Pulls All
               Vaginal Mesh Products Off the Market”.  It should be emphasised that the FDA’s most recent
               statement does not apply to sacrocolpopexy mesh, or midurethral slings.

               The CUA is committed to promoting excellence in surgical care for women with SUI.
               Midurethral slings continue to be a well-studied, and appropriate option for many women with
               stress incontinence. Surgeons offering midurethral slings should counsel patients on the various
               treatment options for SUI, and their expected outcomes.  If MUS is an appropriate option, then
               the surgeon should review the potential complications of this procedure and be prepared to
               diagnose and manage them.  In cases were a patient does not wish to have a midurethral sling,
               the patient should be offered alternative non-mesh-based procedures.
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