Transvaginal mesh: let's not repeat the mistakes of the past

Over the last decade the premature introduction of transvaginal meshes for the surgical treatment of pelvic organ prolapse has had a negative impact on women who have experienced unexpected suffering and morbidity. The resulting litigation has seen the voluntary removal of most of these products from the market1 and several international regulatory bodies, including the Food and Drug Administration (FDA),2 the Medicines and Healthcare Products Regulatory Agency,3 the Scientific Committee on Emerging and Newly Identified Health Risks, (a committee that advises the European Commission),4 an Independent Scottish review committee5 and the New Zealand Accident Compensation Corporation,6 issuing cautions regarding use of transvaginal mesh for the management of pelvic organ prolapse. This has led to women not only questioning the efficacy and safety of transvaginal meshes for prolapse but also questioning the highly effective midurethral slings for the management of stress urinary incontinence, as well as the competence and trustworthiness of us as clinicians. It is imperative that pelvic floor surgeons take a leadership role that ensures the mistakes of the past are not revisited. From 2003 transvaginal mesh was introduced into treatment pathways for pelvic organ prolapse without adequate evaluation of their safety or efficacy.1 Initial confidence in these products was extrapolated from the success of synthetic mesh for hernia repair,7 sacral colpopexy for vault prolapse8 and midurethral slings for urinary stress incontinence.9 There was no evidence from comparative trials of either the safety or the efficacy of any of the transvaginal mesh products until seven years after they were brought into treatment pathways.10 By this time is had become evident that, due to the properties and function of the vagina, mesh had unpredicted complications when used in the vagina, specifically pain and dyspareunia due to mesh contraction and high rates of mesh exposure.1,11 After transvaginal mesh placement, one in ten women undergo reoperation for mesh exposure.12 The number who undergo reoperation for, or live with, chronic pain is poorly defined. We do know that pain and/or dyspareunia were the leading causes of adverse events reported to the FDA and that in a series reporting on reintervention after transvaginal mesh, pain and dyspareunia are the leading indicators for reoperation at a rate higher than mesh exposure.13 It has been argued that a proportion of the blame for this high complication rate can be assigned to the fact that transvaginal meshes were so quickly uptaken by pelvic floor surgeons regardless of their surgical experience, volume or procedurespecific training.14 However, highvolume, experienced surgeons who sought out procedurespecific training have also reported high complication rates with transvaginal meshes. Maher et al.15 reported a reoperation rate of 22% at two years and a mesh exposure rate of 25% was reported by Balakrishnan et al.16 at 12 months. Thirteen years on, there is now an emerging body of evidence beginning to articulate the limited role for transvaginal mesh in reconstructive pelvic surgery. The 2016 Cochrane review12 on transvaginal meshes found that although synthetic mesh reduces the rates of awareness of recurrent prolapse, objective prolapse and reoperation for recurrent prolapse when compared to native tissue repairs, it results in a twoandahalffold increase in overall reoperation rates for either prolapse, stress urinary incontinence or mesh exposure and a higher rate of de novo stress incontinence. There is higher morbidity with transvaginal Conflict of interest: Neither author has conflicts of interest.