The Scottish Independent Review urges a suspension of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women.
Following discussions with campaign groups, NHS Scotland urged all Scottish Health Boards to suspend transvaginal mesh procedures pending the outcome of a Scottish Independent Review. Although awaiting the publication of further pieces of work to inform the final report, the main programme of work has been completed and an interim review has been published. No date for the release of the final report has yet been announced.
Information for members
The interim review reached eight main conclusions. In summary these are:
- Robust clinical governance must surround treatment, the decision to use mesh and the surgical approach used. To support decision making, management of the individual patient should take place in the context of multi-disciplinary team assessment, audit and review. The use of a comprehensive information system will underpin this. The Expert Group should address this with NHS planners, including an assessment of any administrative support required for the clinical teams.
- Evidence of involvement in multi-disciplinary team working, engagement in audit activity and recording and reporting of adverse events should be an important part of consultant appraisal and thus statutory revalidation of medical staff. The Expert Group should work with Medical Directors as Responsible Officers to include this in the conduct and supervision of appraisal. In addition the Scottish Government should consider the alternative methods for the capture of adverse events set out in chapter 8 to determine further the most effective way to ensure complete notification.
- Informed consent is a fundamental principle underlying all healthcare. There has been extensive work done by the Expert Group which preceded the establishment of the Independent Review, with leadership by both patients and clinicians. This has resulted in an SUI information leaflet and consent form. Following on from this, the Independent Review concluded that additional work is required to include pelvic organ prolapse (POP) procedures and that the SUI leaflet is reviewed in the light of this work and other recent developments. This should be addressed by the Expert Group as a matter of urgency. Other points highlighted by the Independent Review include the provision of adequate time for discussion and reflection. Patients should be provided with information enabling them to report adverse events if these occur.
- The Independent Review does not consider that current research studies on safety and effectiveness will provide evidence on long term impact of mesh surgery. The lack of extended long term follow up and related outcome data, including information on quality of life and activities of daily living, should be addressed. The Independent Review recommends the Expert Group highlights this knowledge gap to funders of health research and the research community. Opportunities for routine audit should be explored by the Expert Group in conjunction with NHS Scotland.
- Good information […] is essential to good patient care. The experience of the Independent Review has been that there are many gaps although there is information both in a professionally led database (the BSUG database) and routine NHS information (SMR01 and SMR00). It is recommended that the Expert Group works with ISD, BSUG and others to ensure that an information system is developed which is universal, robust, clinically sound and focused on fostering good patient outcomes. Work already underway on consistent coding by ISD will be vital to this endeavor.
- The Independent Review expressed serious concern that some women who had adverse events were not believed, adding to their distress and increasing the time before any remedial intervention could take place. Improving awareness of clinical teams of the possible symptoms of mesh complications together with good communication skills, (including good listening and empathy) is an essential part of good clinical care. The Independent Review concluded that the Expert Group should review the training and information available to clinical teams and find ways of incorporating patient views in multi-disciplinary working. It should also continue oversight of the mesh helpline.
- A review of the different sources of evidence available to and considered by the Independent Review (patient experience, clinical expert opinion, research evidence and epidemiological evidence from routine information) led to an expression of concern in the Interim Report at the use of the transobturator rather than the retropubic approach for routine surgery for stress urinary incontinence using mesh. The clinical governance arrangements recommended in the interim report will allow an individual case to be considered in the context of a multi-disciplinary assessment, including patient views. The authors of the report await the final publication of key research reports but wish to register these concerns and to recommend that the Expert Group explore further appropriate pathways to ensure the techniques chosen take the differential patient and clinical experience, as well as research evidence into account in the final report.
- Similar concern is expressed, both for effectiveness and adverse events, at the use of transvaginal mesh in surgery for pelvic organ prolapse. The clinical governance arrangements […] recommended will allow an individual case to be considered in the context of a multi-disciplinary assessment, including patient views. The authors of the report await the final publication of key research reports but wish to register these concerns and to recommend that the Expert Group explore further appropriate pathways to ensure the techniques chosen take the differential patient and clinical experience, as well as research evidence into account in the final report.
The interim report notes that the Expert Group has produced a new Patient Information and Consent booklet for stress urinary incontinence which sets out the risks associated with this procedure and the alternatives available.
The interim report also notes that regarding surgery, NICE produced guidance in their interventional procedures programme which includes a range of procedures from 2005-2009 for both SUI and POP. In addition, NICE published a detailed clinical guideline in 2013 on urinary incontinence management in women. The professional societies including British Society of Urogynaecology (BSUG), the British Association of Urological Surgeons (BAUS), and RCOG provide specialist training and professional guidance, plus a method of recording activities and patient information and consent information.
 These include: Opinion of the European Commission and its Scientific Committee on Emerging and Newly Identified Health Risks Opinion (SCENIHR) and PROSPECT (PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials).
 The Expert Group was formed in December 2013 to review current clinical practice and make recommendations for change. It developed from the original Transvaginal Meshes Working Group (TMWG) and had greater clinical representation.
The interim report suggests that there may be a way by which surgery can again take place, but that a number of actions, outlined in the conclusions above, must be ensured. These include:
- Informed consent is obtained using approved processes and information
- An approved clinical pathway is followed
- Information, including adverse events, is recorded in a universal and robust way
- Patient treatment and audit is considered as part of a clinical network involving all practitioners
- The Expert Group develops a pathway for the retropubic approach in SUI as the routine mesh procedure with any variation considered as part of the multi-disciplinary team
- The Expert Group develops a pathway for the treatment of POP where transvaginal mesh is not used routinely. Any variation in the future is considered in light of the awaited results of the PROPSPECT study and follows discussion within the multi-disciplinary team.
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