Transvaginal mesh implants independent review: interim report

Executive Summary

This report outlines the work of the Independent Review (IR) of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. It is an interim report as the publication of further pieces of work are awaited, including: 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). However as the main programme of work has been completed the IR has been able to draw conclusions and make recommendations.

The work has taken several months and is the product of individuals with a range of skills and interests including patients, clinicians, statisticians, public health experts, researchers, regulators, scientists and legal advisers.

The deliberations of the IR have been based on considering published evidence, patient stories and the opinion of clinical experts. In addition an epidemiological study has been conducted using routinely reported Scottish hospital inpatient data.

The IR meetings have also assessed verbal evidence from different experts, including patients, to reach consensus conclusions. It is expected that these will improve the quality of care in a field that crosses primary, secondary and specialist care and can have lifelong effects on women's quality of life.

Some conclusions are specific to improving care in the use of transvaginal mesh. Others are intended to benefit patients in general. All conclusions are described below:

Conclusion 1

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.

Conclusion 2

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.

Conclusion 3

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 concludes that additional work is required to ensure that this work is extended to include 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.

Conclusion 4

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.

Conclusion 5

Good information, as stated before, 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 endeavour.

Conclusion 6

The Independent Review expressed serious concern that some women who had adverse events found they 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.

Conclusion 7

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) has led us to express concern in this 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 that we have recommended will allow an individual case to be considered in the context of a multi-disciplinary assessment, including patient views. We await the final publication of key research reports but wish to register these concerns and to recommend that the Expert Group in the following months before the publication of the final report explore further appropriate pathways to ensure the techniques chosen take the differential patient and clinical experience, as well as research evidence into account.

Conclusion 8

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 that we have recommended will allow an individual case to be considered in the context of a multi-disciplinary assessment, including patient views. We await the final publication of key research reports but wish to register these concerns and to recommend that the Expert Group in the following months before the publication of the final report explore further appropriate pathways to ensure the techniques chosen take the differential patient and clinical experience, as well as research evidence into account.