Transvaginal mesh implants independent review: final report

Executive Summary

This report sets out the concluding findings and recommendations 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 the final report and supersedes the earlier interim report which was published in October 2015. As such this final report draws on new information that was not available when the interim report was published, including:

The Scientific Committee on Emerging and Newly Identified Health Risks ( SCENIHR) Opinion on " the safety of surgical meshes used in urogynecological surgery" 3 December 2015 http://ec.europa.eu/health/sites/health/files/scientific_committees/emerging/docs/scenihr_o_049.pdf

" Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials" ( PROSPECT)
http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(16)31596-3.pdf

The Medicines and Healthcare products Regulatory Agency commissioned study " In vivo response to polypropylene following implantation in animal models: a review of biocompatibility"
https://www.gov.uk/government/news/interrogating-research-to-protect-public-health

The report 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 the consideration of 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, updated and published in the Lancet on 20 December 2016. From the information provided the IR has reached consensus. It is expected that the recommendations within this report will improve the quality of care in a field that crosses primary, secondary and specialist care, and will have lifelong effects on women's quality of life.

Conclusion 1

Fundamental to the treatment of patients with SUI and POP is patient-centred care which should include patient choice and shared decision making supported by robust clinical governance. To support shared decision making, management of patients must take place in the context of a multidisciplinary team ( MDT), supported by a quality assurance framework. In addition, the Scottish Government should consider the alternative methods for the capture of adverse events set out in chapter 8 to determine the most effective way to ensure complete notification.

Conclusion 2

Evidence of involvement in MDT working; engagement in all relevant local and national audit activity; and the mandatory recording and reporting of adverse events, in line with GMC guidance, should be necessary parts of consultant appraisal and thus statutory revalidation of clinical staff. The Expert Group should work with Medical Directors and Responsible Officers to ensure this is included in the appraisal of all relevant staff.

Conclusion 3

Informed consent is a fundamental principle underlying all healthcare interventions. Extensive work was carried out by the Expert Group prior to the establishment of the IR, with leadership by both patients and clinicians. This has resulted in an information leaflet on Synthetic Vaginal Mesh Tape Procedure for the Surgical Treatment of Stress Urinary Incontinence in Women and consent form. Following on from this, the IR concludes that additional work is required to ensure that this work is extended to include all appropriate SUI and POP procedures and that the existing 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 IR include the provision of adequate time for discussion and reflection. Patients should be provided with the information they need in order to make informed choices. Patients also require appropriate information, which must include device identification, to allow them to report adverse events if these occur.

Conclusion 4

The IR does not consider that current research studies on safety and effectiveness provide sufficient evidence on long-term impact of mesh surgery. The lack of long-term follow up and related outcome data, including information on quality of life and activities of daily living, should be addressed. The IR recommends the Expert Group highlights this knowledge gap to the research community and those that fund health research. Opportunities for routine audit should be explored by the Expert Group in conjunction with NHSScotland.

Conclusion 5

Good information is essential to good patient care. The experience of the IR has been that, although data on the provision of SUI and POP surgery is held both in professionally-led databases and routine NHS activity data, the information derived from such sources could be improved. It is recommended that the Expert Group works with key stakeholders to address information gaps and ensure that available information is used as effectively as possible to support safe and effective care. The IR notes that, as an important first step towards this, ISD has already secured the creation of new data codes that will allow more precise recording of mesh surgery and any subsequent mesh removal/revision within routine NHS activity data records.

Conclusion 6

The IR expressed serious concern that some women who had adverse events felt they were not believed, adding to their distress and increasing the time before any remedial intervention could take place. Improving awareness amongst 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 IR concluded that the Expert Group should review the training and information available to clinical teams in primary and secondary care and find ways of incorporating patient views in MDT working. The importance of developing pathways for the treatment of complications is emphasised, ensuring involvement of clinicians with the appropriate skills to take forward the personalised and holistic care necessary in these situations.

Conclusion 7

In the case of surgical treatment for SUI, a review of the different sources of evidence has led us to recommend that women must be offered all appropriate treatments (mesh and non-mesh) as well as the information to make informed choices. Management of patients must follow agreed care pathways and the importance of multidisciplinary assessment is emphasised. When surgery involving polypropylene or other synthetic mesh tape is contemplated, a retropubic approach is recommended. The Expert Group must develop appropriate pathways, including one for management of those suffering complications. Work with Medical Directors and Planners will be required to ensure their smooth implementation.

Conclusion 8

In the surgical treatment of POP, current evidence does not indicate any additional benefit from the use of transvaginal implants (polypropylene mesh or biological graft) over native tissue repair. Transvaginal mesh procedures must not be offered routinely. The Expert Group must develop appropriate pathways to meet clinical needs and also for the management of those suffering complications. Work with Medical Directors and Planners will be required to ensure their smooth implementation.