Key Points
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The effectiveness of synthetic midurethral slings (SMUS) is comparable to the time-honoured gold standards—the autologous fascial sling and Burch colposuspension
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At least 15% of women with SMUS experience a serious adverse outcome and/or recurrent sphincteric incontinence
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A subset of women sustain refractory, lifestyle-altering complications that are unique to women with a SMUS
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SMUS-associated complications are under-reported
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The overall quality of the published evidence is currently low with respect to assessing SMUS safety and SMUS-associated complications
Abstract
Implantation of a synthetic midurethral sling (SMUS) is the most commonly performed anti-incontinence operation in women worldwide. The effectiveness of the SMUS is comparable to that of the historical gold standards—autologous fascial slings and the Burch colposuspension. Much controversy, however, has evolved regarding the safety of this type of sling. Overall, the quality of the studies with respect to assessing risks of SMUS-associated complications is currently poor. The most common risks in patients with SMUS include urethral obstruction requiring surgery (2.3% of patients with SMUS), vaginal, bladder and/or urethral erosion requiring surgery (1.8%) and refractory chronic pain (4.1%); these data likely represent the minimum risks. In addition, the failure rate of SMUS implantation surgery is probably at least 5% in patients with stress urinary incontinence (SUI). Furthermore, at least one-third of patients undergoing sling excision surgery develop recurrent SUI. Considering the additional risks of refractory overactive bladder, fistulas and bowel perforations, among others, the overall risk of a negative outcome after SMUS implantation surgery is ≥15%.
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Change history
24 August 2015
In the legend of Figure 6, Figure 6b was incorrectly labelled in the originally published version of this article. This error has been corrected in the HTML, PDF and print versions of this article.
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All authors made a researched data for this article, J.G.B., M.S.B., G.M., R.B. and V.I. contributed to discussions of content, J.G.B., R.S.P., M.S.B., G.M., R.B. and V.I. wrote the manuscript and J.G.B., R.S.P., M.S.B., R.B. and V.I. made a substantial contribution to reviewing and/or editing of this manuscript prior to submission.
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V.I. and J.G.B. have provided opinions as medico-legal expert witnesses in mesh litigation cases. J.G.B. has acted as a consultant for Astellas Pharma and is a shareholder in P Square Medical and is a shareholder and co-owns intellectual property with LLC and Symptelligence Medical Informatics. The other authors declare no competing interests.
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Blaivas, J., Purohit, R., Benedon, M. et al. Safety considerations for synthetic sling surgery. Nat Rev Urol 12, 481–509 (2015). https://doi.org/10.1038/nrurol.2015.183
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DOI: https://doi.org/10.1038/nrurol.2015.183
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