Birds of a feather?

Abstract

The complications of using vaginal mesh for pelvic organ prolapse are well known. SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), NHS England Mesh working Group and the Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women all published reports in 2016. Their conclusions have overlapping themes, with an emphasis on the need for robust clinical governance, multi-disciplinary team working, thorough audit, and recording and reporting of adverse events. Adequate patient information and informed consent is a fundamental principle underlying all healthcare management. The midurethral synthetic sling is made of the same type 1 macroporous material as vaginal prolapse mesh and so slings have been included with mesh in adverse publicity with a consequent decline in their use, with resurgence of fascial slings and more complex surgery such as colposuspension. The impact of this has been particularly evident in Scotland, where patients have been refusing to have a synthetic sling. As recently as 2011, it was common practice to inform patients that a synthetic sling was the procedure of choice and it was acceptable to give this as the sole option. This is now in violation of the Montgomery ruling of the UK Supreme Court (Montgomery v Lanarkshire Health Board [2015] UKSC 11), which requires a thorough discussion of pros and cons and alternatives. However, complete cessation of use, as has been the case with vaginal mesh, would equate to throwing the baby out with the bathwater. The price would be paid by the patient, who would end up with more complex surgery, with greater overall risks (apart from the risks of any synthetic material, i.e. extrusion and erosion, which are low in the case of sub-urethral slings). Some patients would likely be denied treatment altogether on the grounds of obesity or other comorbidities which make them unsuitable for an abdominal procedure. The midurethral sling is no longer a ‘new’ device and has reassuring 17-year follow-up data with a 90% objective continence rate and no serious long-term tape-induced adverse effects (Nilsson et al. Int Urogynecol J 2013;24:1265-9). So at what point is a prosthesis considered well established in clinical practice? In the history of implantable devices, defective/faulty ones will usually be identified within 10 years of market launch. Examples include trocar-guided meshes for prolapse, PIP breast implants, and Pinnacle Hip implants. On the other hand, the full extent of complications with synthetic slings such as extrusion and erosion may not yet be apparent. In the UK, we need to centralise the management of mesh-related complications in specialist units to allow the development of the expertise needed for successful remediation. With patient groups such as TVT MUM clamouring for a total ban on the product, there is an urgent need for the development of agreed clinical decision-making tools to enable patients to make fully informed choices in the management of their urinary incontinence. None declared. Completed disclosure of interests form available to view online as supporting information. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.