The interim report from the NHSE has been produced in response to questions about the safety and efficacy of surgery using mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
It has been produced by the Mesh Working Group who were set up by NHSE with the support of the Department of Health, and the Medicines and Healthcare products Regulatory Agency (MHRA). As it may be another two years before the results of studies and evidence can be fully assessed, the decision was made to produce an interim report. A list of the most prominent studies yet to report are listed within the interim report, together with web links to those studies.
The report explains the context in which the work was undertaken, presents the debate surrounding ongoing use of mesh, and provides recommendations for the work necessary to optimise care for women undergoing treatment for SUI and POP.
 The list of mesh working group members, and the members of the three sub groups can be found in the interim report.
Patient members of the Working Group adversely affected by mesh believe that mesh should not be used for either SUI or POP, and that the use of mesh devices should be suspended pending establishment of a clearer case for their safety and efficacy.
Clinical members believe that there is an acceptable risk profile for these procedures and that they should be continued. For them, the consenting process is the key, with prospective patients given the information they need to make an informed choice.
The Working Group identified three main areas of concern:
- Clinical quality
- Data and information
- Informed consent
A number of recommendations appear under each of these areas (see Appendix 1, below).
An Oversight Group (OG), who will meet every six months, will oversee recommended activities. The lead organisation for each recommendation will determine timescales in agreement with the OG.
Clinical Quality Recommendations
- Use trust appraisal system to ensure surgeons: are appropriately trained and current in their practice; adhere to clinical guidance; comply with national data requirements; and report complications
- NICE to produce a Clinical guideline that describes, holistically, care for women with POP
- NICE to review current Clinical Guideline for Urinary Incontinence
- NICE to review guidance on complications arising from surgery for SUI and POP
- A nurse helpline service for mesh-injured women to be established, modelled on a service being piloted in Scotland
- GP awareness of treatment options for SUI and POP to be improved through the introduction of an e-learning package, to include:
- Mesh procedures and their alternatives
- How to deal with possible complications
- Non-surgical interventions
- Alternative surgical options and their possible complications
- Information on continence nurse service for mesh injured women
An e-learning package should be developed by the RCOG that improves GP awareness of mesh-related clinical issues, leads to improved clinical outcomes for patients and ensures patients feel empowered by their GPs to raise any concerns.
Data and Information Recommendations
- Stronger clinical leadership is needed to promote awareness amongst all health care professionals/surgeons undertaking procedures which involve implanting mesh of the importance of returning all the necessary data associated with their activities. The relevant Royal Colleges should be asked to consider identifying an individual/or individuals to provide this leadership.
NHS (Trust) employee appraisal systems should ensure surgeons adhere to clinical guidance, comply with national data requirements and report complications. A section of the appraisal should ask surgeons performing these procedures if they are:There are no specific HES OPCS-4.7 codes to classify full or partial removal of vaginal mesh for POP. Therefore the group recommends that new OPCS codes should be developed to reflect complications which result in full or partial mesh removal and the reason for this. A small working group should be established to look at this issue for both POP and SUI and advise on what requests need to be made to HSCIC to introduce new codes in future versions of the OPCS to address this.
- Following NICE guidance
- Reporting the procedure on a national database e.g. BSUG/BAUS database
- Appropriate reporting of serious adverse incidents to MHRA, including reporting retrospectively, regardless of whether they carried out the original procedure.
- There is considerable disparity between published evidence in academic/medical literature and experiential evidence from patients on the nature and extent of problems with these devices. A better understanding of the true nature and extent of the complications with these devices needs to be established and more independent rigour brought to discussions. The following actions are needed to address these issues:A cost/benefit analysis of establishing a registry for these procedures should be undertaken at the earliest opportunity.
- MHRA should continue to raise awareness amongst clinicians about the mechanisms that are in place for reporting/registering adverse events relating to mesh procedures. Emphasis should be placed on the fact that reports could be made retrospectively
- Patient support groups and MHRA, liaising where appropriate, should work to:
- Encourage those women who have experienced adverse events to report them, ensuring they understand that adverse events can be reported retrospectively and;
- Ensure women are aware that patient identifying details will only be passed on to manufacturers if women give permission for this to be done.
- A one-off information gathering exercise on patient outcomes should be conducted. This exercise should be independent, retrospective, take full account of patient experience and have buy-in from patient groups. It should include a sufficient time frame to detect the long term complications which may not arise for years after the surgery.
Informed consent recommendations
- Consistent information to be given to patients on mesh tape procedure for SUI and procedure for treatment of POP through the use of the leaflets that have been developed in line with national guidance in collaboration with clinicians, professional bodies and patient support groups in Scotland, England and Wales and Northern Ireland.
- Good practice in obtaining legally informed consent is where discussions between the clinician and patient takes place about the procedure itself, alternatives, recommendations and questions/understanding and this has been recorded. Reasonable time should be allowed between giving the patient the information leaflet and giving the patient time to ask questions before signing a consent form. The information leaflet can provide the opportunity for the patient to sign to say this has been completed by additional text at the end. The consent form to be kept separate from the information leaflet and not to follow a predetermined template. The GMC guidance should be followed when obtaining consent.
- Once finalized RCOG, BSUG and BAUS should recommend the use of these SUI and POP leaflets by all its members including those operating in the private sector. A letter to be written by Sir Bruce Keogh, Medical Director, NHS England to the Trust Development Authority (TDA) and Monitor to ask them to ensure Trusts are using the leaflets.
- The professional bodies take ownership and aim to have regular and timely (every two years) review of the SUI and POP mesh leaflets through collaboration and coordination with the four nations. The review will take into account further evidence as it is made available, to ensure that it is a reflection of best practice in the UK.
- The SUI and POP leaflets carry the relevant national NHS logo along with logos from RCOG, BSUG and BAUS with reference that the other nations will be using the same information.
- BSUG and BAUS will aim to review their information leaflets for all SUI and POP procedures and update them in due course.
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