Sandra Elmer1,2, Janelle Brennan3,4, Rebecca Mathieson3, Briony Norris5,6, Marcus Carey7,8, Caroline Dowling6,9. 1. Department of Urology, Royal Melbourne Hospital, 300 Grattan Street, Parkville, VIC, 3050, Australia. drsandraelmer@gmail.com. 2. Department of Urology, Austin Health, 145 Studley Road, PO Box 555, Heidelberg, VIC, 3084, Australia. drsandraelmer@gmail.com. 3. Department of Urology, Bendigo Health, 100 Barnard Street, Bendigo, VIC, 3550, Australia. 4. Bendigo Health Clinical School, University of Melbourne, Parkville, VIC, 3010, Australia. 5. Department of Urology, Royal Melbourne Hospital, 300 Grattan Street, Parkville, VIC, 3050, Australia. 6. Department of Urology, Eastern Health, 5 Arnold Street, Box Hill, VIC, 3128, Australia. 7. Department of Urogynaecology, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC, 3052, Australia. 8. University of Melbourne, Parkville, VIC, 3010, Australia. 9. Eastern Health Clinical School, Monash University, Wellington Road, Clayton, VIC, 3800, Australia.
Abstract
PURPOSE: In this review, we explore the evidence behind mid-urethral sling (MUS) surgery, review the rising reports of complications and the subsequent US Food and Drug Administration (FDA) and society statements, and evaluate risk perception and communication with patients, doctors, governing bodies, manufacturers and insurance companies. Our aim was to explore the pitfalls in communication that may be contributing to the decline in MUS use, and develop strategies to make MUS surgery safer. METHODS: We searched the English language literature using PubMed for articles related to the management of stress urinary incontinence (SUI), MUS, safety and monitoring of transvaginal mesh (TVM), and reviewed all online FDA publications and international position statements regarding MUS for SUI. RESULTS: Polypropylene mesh has been used in MUS since the 1990s, with robust evidence to support its use. There has been a decline in the use of MUS ever since the FDA notifications. In response to the controversy surrounding TVM, position statements have been released portending the safety of, and advocating for the continued use of, MUS for the management of SUI. CONCLUSIONS: MUS is a viable, effective and safe treatment for SUI management. Physicians should obtain and document informed consent, be adequately trained, and monitor and report their outcomes using registries. With publication of registry results and ongoing health advocacy, the perception of the safety of MUS can improve and MUS can still be offered as a treatment option for SUI.
PURPOSE: In this review, we explore the evidence behind mid-urethral sling (MUS) surgery, review the rising reports of complications and the subsequent US Food and Drug Administration (FDA) and society statements, and evaluate risk perception and communication with patients, doctors, governing bodies, manufacturers and insurance companies. Our aim was to explore the pitfalls in communication that may be contributing to the decline in MUS use, and develop strategies to make MUS surgery safer. METHODS: We searched the English language literature using PubMed for articles related to the management of stress urinary incontinence (SUI), MUS, safety and monitoring of transvaginal mesh (TVM), and reviewed all online FDA publications and international position statements regarding MUS for SUI. RESULTS:Polypropylene mesh has been used in MUS since the 1990s, with robust evidence to support its use. There has been a decline in the use of MUS ever since the FDA notifications. In response to the controversy surrounding TVM, position statements have been released portending the safety of, and advocating for the continued use of, MUS for the management of SUI. CONCLUSIONS: MUS is a viable, effective and safe treatment for SUI management. Physicians should obtain and document informed consent, be adequately trained, and monitor and report their outcomes using registries. With publication of registry results and ongoing health advocacy, the perception of the safety of MUS can improve and MUS can still be offered as a treatment option for SUI.
Authors: Paul Abrams; Karl-Erik Andersson; Apostolos Apostolidis; Lori Birder; Donna Bliss; Linda Brubaker; Linda Cardozo; David Castro-Diaz; P R O'Connell; Alan Cottenden; Nikki Cotterill; Dirk de Ridder; Roger Dmochowski; Chantal Dumoulin; Mandy Fader; Christopher Fry; Howard Goldman; Philip Hanno; Yukio Homma; Vik Khullar; Chris Maher; Ian Milsom; Diane Newman; Rien J M Nijman; Kevin Rademakers; Dudley Robinson; Peter Rosier; Eric Rovner; Stefano Salvatore; Masayuki Takeda; Adrian Wagg; Todd Wagner; Alan Wein Journal: Neurourol Urodyn Date: 2018-08-14 Impact factor: 2.696
Authors: Daniel Altman; Tapio Väyrynen; Marie Ellström Engh; Susanne Axelsen; Christian Falconer Journal: N Engl J Med Date: 2011-05-12 Impact factor: 91.245