{'fraction_non_alphanumeric': 0.017364657814096015, 'fraction_numerical': 0.008988764044943821, 'mean_word_length': 5.442105263157894, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 1, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
The way forward after the transvaginal mesh decade

When transvaginal mesh was first approved for use in the treatment of vaginal prolapse in 2002, the gynaecology community was receptive to a change in the existing treatment paradigm. Many clinicians were frustrated with the high rates of recurrent prolapse after traditional native tissue repairs for prolapse, and at the same time impressed with the efficacy of synthetic mid-urethral slings (MUS) for stress urinary incontinence (SUI) and abdominal mesh for vault prolapse. However, 15 years later it is clear that while the transvaginal mesh was successful in correcting prolapse, unforeseen adverse events such as mesh exposure and vaginal pain were not insignificant and frequently difficult to treat. Despite the introduction of the transvaginal mesh for prolapse largely complying with the suggested framework for the evaluation of interventional therapy as recommended by the IDEAL (Idea, Development, Exploration, Assessment, Long-term Follow-up, Improving the Quality of Research in Surgery) Collaboration in 2009, the general public are frustrated that neither clinicians nor the regulatory authorities had the basic governance processes in place to protect patients from unforeseen adverse outcomes. To address these concerns, regulatory authorities around the world have up-classified transvaginal mesh from a class IIb product to class III, requiring more rigorous premarket evaluation. Recently we have seen the Therapeutic Goods Association (TGA) in Australia remove from use all transvaginal mesh for prolapse. In response to the unexpected complications, a very public conversation in the form of litigation, class actions and multiple government enquiries has taken place throughout the western world. While the independent expert reviews have all reported concerns with transvaginal mesh for prolapse, they also found MUS for SUI and abdominal mesh for prolapse to be safe and effective. Despite the evidence-based literature and formal enquiries being supportive of MUS for SUI and abdominal mesh for vault prolapse, the message resonating with women is that all mesh is possibly problematic. Given the lack of clarity regarding the safety and efficacy of mesh products, women in Scotland are electing to suffer an impaired quality of life rather than seek treatment. In 2010–11, approximately 1400 continence interventions were performed annually and by 2015–16 this number had reduced by 86% to approximately 200. During the same time period, all prolapse interventions (not just transvaginal mesh) reduced by 37% from 1100 to approximately 700. Unfortunately, it seems that the role of educating the public on these devices has been assumed by journalists in the general media, lawyers in litigation and special interest groups on social media. Going forward, we need to reestablish the community’s confidence in the ability of the medical profession to treat female pelvic floor dysfunction in an open and transparent manner, while also being able to safely introduce and monitor new innovations. To achieve this goal, three broad areas of change are discussed. Firstly, the gynaecological community needs a clear pathway for the introduction of new innovations that serves to balance the need for timely innovation with reducing the risk to the community of unexpected poor outcomes. This will require clinicians, manufacturers, regulatory bodies and ethics committees to work together during the innovation and introductory phase of new interventions. Professional representative colleges and international educational bodies are well positioned to lead in this domain. Secondly, at an individual level and in line with recommendations from most national reviews, we need to demonstrate a robust informed consent process for surgery and the reporting of adverse events to regulatory authorities. Auditing of interventions (both novel and established) in an anonymised manner on national databases is to be actively encouraged while a wider conversation regarding the practicalities of the ideal form of audit is finalised. In 2017, the Royal College of Obstetricians and Gynaecologists (RCOG) produced an excellent patient information leaflet on prolapse surgery, which is an important adjunct to an improved informed consent process. Thirdly, while accepting that transvaginal mesh for prolapse is a problem, we need to ensure that the safe and effective MUS for SUI and abdominal mesh for vault prolapse are not discarded. Both of these interventions have demonstrated efficacy and safety in the peer-reviewed literature, but this message is not being enunciated clearly to the public. One solution is to develop evidence-based treatment pathways that are simple, interactive and accessible by the general medical community and the public. Achieving this is a significant challenge to our profession and while the