Transvaginal mesh short-life working group: report

Findings

The Short Life Working Group on management of mesh complications

In March 2019, the Cabinet Secretary for Health and Sport asked that a short life working group (SLWG) be established to examine the course of care for women who experience mesh complications. The SLWG was chaired by Mr Terry O'Kelly, Senior Medical Officer at the Scottish Government, and membership consisted of the Accountable Officers from each territorial NHS Board, a clinician identified by the Scottish Mesh Survivors Group to represent their views, plus representatives from the Scottish Government, the Transvaginal Mesh Oversight Group, the Health and Social Care Alliance Scotland and national NHS boards (Appendix 1). All members of the SLWG declared their interests and these are published on the Scottish Government website along with the minutes of the group (https://www.gov.scot/groups/transvaginal-mesh-short-life-working-group/). The first meeting of the SLWG took place on 5 April 2019.

The SLWG's remit, published on the website, specified that the group:

• considers the physical and psychological needs of women who experience complications following vaginal mesh surgery
• considers sharing experience, techniques and learning with colleagues in Europe, the USA and elsewhere. For this to be successful it is important that surgeons and clinical teams engage with counterparts of proven merit and who are regarded by the professionals as leaders and innovators in their field
• reviews the course and organisation of care for patients suffering complications in Scotland with a broader UK perspective
• examines the complex education and training requirements we must have to ensure a sustainable and resilient high quality service, and
• identifies the resource requirements to provide the service our patients need.

This report describes the progress made by the SLWG in respect of its remit. A glossary of terms is included in Appendix 2.

Remit area 1: The physical and psychological needs of women who experience complications following vaginal mesh surgery

The SLWG received two reports addressing the physical and psychological needs of women who have experienced complications following vaginal mesh for SUI or POP. The first report was presented by the Scottish Mesh Survivors Group.^[3] The second report was commissioned by the SLWG from the Health and Social Care Alliance Scotland.^[4]

The Scottish Mesh Survivors Group report describes the experience of the mesh complication service as reported by a sample of the mesh-injured women in Scotland. The sample of 51 women was derived from responses to a service evaluation form circulated during the meeting with Baroness Cumberlege in April 2019 and by email to members of the patient support group. Key findings of the report were:

• Almost half of respondents did not undergo any mesh removal surgery, despite suffering from chronic pain and pain during sexual intercourse
• Respondents found conservative management not a very useful alternative to surgery
• Of the respondents who had surgery, a high majority had partial (rather than total) mesh device removal
• All respondents who had a partial removal describe their current condition as worse/much worse, even those who felt initial improvement. Only half of those who had total removal felt better.

The report made a number of recommendations, which are summarised below and included in full in Appendix 3:

• Consider postponing all non-urgent highly-complex 'total' mesh removal surgery for women with chronic pain until our surgeons are trained by the US surgeons who are more experienced in this type of surgery and obtain high patient satisfaction
• Stop partial mesh removal surgery in local units
• Facilitate second opinion from another unit in the UK or overseas - a reciprocal agreement
• Develop and implement national patient care / treatment pathways for mesh injured women
• Mandate the use of a national database to record the details of the mesh removal surgery, report adverse events to MHRA and audit the outcome in patients' own terms of success and failures
• Facilitate psychological support for the mesh-injured women
• Raise awareness among social care professionals that pelvic mesh complications can be a direct cause of serious disability and provide adequate and timely social support, during initial assessment and subsequent decisions.

The Health and Social Care Alliance Scotland used a mixture of one to one interviews, an online survey and a number of pop up cafes in order to maximise participation across the whole of Scotland.

Forty six women from across Scotland took part in the Alliance's research. All shared their experience of living with complications following transvaginal mesh surgery and described the impact these complications have had on their lives. Without exception, the participants reported the impact as being moderate to negative and for many extremely debilitating. The desire to be listened to, and have the impact mesh has had on their lives acknowledged, was a prominent message and holistic, person centred care with women being involved in all decisions featured in many responses.

The overarching themes that emerged from the research were: impact on physical health; impact on mental health; impact on relationships; impact on finances and impact on confidence in Healthcare systems.

The report presented the following key messages from women who have experienced complications associated with vaginal mesh insertion. It is recognised that not all of these issues are within the remit of NHSScotland:

• Full removal of mesh for those who still wished it
• Permanent ban on transvaginal mesh implants in Scotland
• Recognition of the impact mesh has had on their lives
• Clear and coordinated care pathways with easy to access services, with some women emphasising the importance of people with lived experience being involved in what these might look like
• Awareness of mesh related complications amongst all healthcare professionals
• To have a choice of surgeon and treatment centre
• Clear information on treatment options
• Improved communication between primary and secondary care
• Recognition of their disabilities and access to support services/resources as appropriate to their needs
• Easy access to advice and financial support from DWP
• To be symptom free and able to return to normal life
• Access to Pain Clinics and specialists, particularly for those women who are deemed unsuitable for mesh removal.

The SLWG welcomed the findings of both the Scottish Mesh Survivors and the Alliance reports and noted the similarity of findings across both reports. The SLWG agreed that cognisance must be taken of the findings when planning and delivering services for women affected by mesh complications and consideration should be given to how the system can be provided with assurance that this is happening.

Remit area 2: Sharing experience, techniques and learning

In order to ensure that women in Scotland receive the highest quality care following complications associated with vaginal mesh, it is vital that best practice from Scotland, the wider UK, and overseas continues to be reviewed, shared by clinicians, and incorporated into NHSScotland clinical practice.

Urogynaecology has evolved as a subspecialty particularly over the past two decades. Through audit and published research, Scotland now trains subspecialists in the field and attracts scientific meetings and clinical visitors who wish to learn and develop services.

Techniques for the management of complications of vaginal mesh are evolving quickly. Until recently the professional view was that removal of the vaginal portion of the transvaginal mesh implant was sufficient to alleviate symptoms, but more extensive surgery has now become usual practice in certain super-specialised centres. The surgeons in Scotland's specialised centre aim for total removal if possible. This is not standard practice across the world, where many continue with the partial removal, as the total removal requires longer operating and recovery time with all attendant potential complications. It is important that outcome data are collected, reviewed and published to ensure that practice is evidence based and harm is minimised.

To support learning from colleagues in the United States, the SLWG recommended a study visit be undertaken to the USA. The Chief Medical Officer and NHSScotland clinicians visited Dr Goldman at Cleveland Clinic, Ohio, and Dr Veronikis at Mercy Hospital, Missouri in November 2019. Both visits proved very worthwhile and clinical teams were very generous with their time and sharing of knowledge. Dr Veronikis confirmed that the techniques used for complete mesh removal in Scotland's specialised centre are similar to those he employs at Mercy Hospital.

A reciprocal visit by Dr Veronikis is intended for Spring 2020. The aim is to further share and compare surgical experience of mesh removal, to build professional relationships and to identify how Dr Veronikis can complement the Scottish service. The SLWG recognised the need to build confidence in some of the mesh-affected women and inclusion of Dr Veronikis will help to address this.

Remit area 3: Reviews the course and organisation of care for patients suffering complications in Scotland with a broader UK perspective

a) Current service provision

Pathways of care for women experiencing mesh complications

The SLWG considered pathways in place across NHSScotland for the management of women experiencing mesh complications (Appendix 4). Seven NHS Boards and a consortium of the five West of Scotland NHS Boards described the pathways they use for management of complications. The island Boards do not have their own pathways, but follow the associated service/ referral NHS Board.

There is variation in the timing of elements of the pathways across NHSScotland, but all pathways share a common spine. Key aspects of all the pathways reviewed include investigations, MDT discussions, notifications to Accountable Officer, MHRA or IRIC, criteria for referral to the national mesh centre and follow up.

Recommendation

In order to help ensure all women receive the same high standard of care around all aspects of their mesh complication journey, the SLWG recommends the development of a standard core pathway, with local variation only where this is clinically appropriate. All Boards will be expected to ensure their pathways are transparent and open to review through clinical and care governance processes.

b) Guidelines

NICE guidelines on the management of urinary incontinence and pelvic organ prolapse in women^[5] were published in 2019. These provide up to date, evidence-based recommendations for the whole pathway of care for women with SUI and POP. The SLWG reviewed practice in each NHS Board against the NICE recommendations pertaining to management of mesh complications.

Differences were found in the implementation across NHSScotland of several of the NICE recommendations, including variation in:

• terms of reference, group constitution, cases referred and overall processes within local and regional MDTs
• the use of decision aids
• the provision of information on any surgical products used
• follow up processes after surgery.

The SLWG also received a report on waiting times and staffing levels for specialist physiotherapy services across Scotland. This report showed that in most boards referral to specialist physiotherapy is an established part of the patient pathway, but there is significant variation in waiting times for access to these services.

Recommendations

To reduce variation across NHSScotland:

• there should be greater standardisation of key MDT processes (both local and regional), taking account of the fact that this is likely to significantly increase the number of women being considered by MDTs
• national work should be undertaken:
  • to agree the use of a common decision aid
  • to develop consistent, accessible and quality assured patient information materials
  • to agree a more standardised follow up for women to be incorporated into existing pathways, and
  • to review the capacity and demand for access to appropriately skilled physiotherapists and address gaps to ensure timely access.

The SLWG noted the work already undertaken by the TVMO to quality assure existing patient information materials in NHSScotland. A quality assured leaflet on potential complications of transvaginal mesh, has been developed by NHS Lothian and has been shared across NHSScotland.

Remit area 4: Examines the complex education and training requirements we must have to ensure a sustainable and resilient high quality service

Following the halt in mesh procedures for SUI, alternative forms of surgery are being used to meet patient needs. These include procedures where surgeons may not have recent experience, such as open or laparoscopic colposuspension, a complex procedure with recognised complications and failures. Such procedures are subject to high vigilance scrutiny.

The British Society of Urogynaecology (BSUG) has published guidance on a mentorship scheme for colposuspension and autologous fascial sling procedures. The scheme is being adopted as the "standard" in NHS England and is intended to be completed by Consultant Gynaecologists who wish to (re)introduce one, or both, of these procedures into their practice for primary stress urinary incontinence.

The SLWG has reviewed arrangements for training in non-mesh surgery in NHSScotland. Information received from NHS Boards found the BSUG scheme to be clear and data collection straightforward and all NHS Boards undertaking such surgery have local arrangements equivalent to BSUG guidance.

In response to the views and experiences of women expressed in the reports from the Scottish Mesh Survivors and The Alliance, including comments about empathy and shared decision making, the SLWG recognised the need for on-going training in effective communication, including listening skills and empathetic behaviours. The Effective Communication for Healthcare Programme (EC4H) currently provides such training for clinicians in seven NHS Boards.

Recommendation

All urogynaecology services review and provide training in effective communication and empathetic behaviours for all clinical staff.​

Remit area 5: Identifies the resource requirements to provide the service our patients need

Proposal for a Scottish National Complex Pelvic Mesh Removal Service

The SLWG has supported the development of the proposal for a pelvic mesh removal service sited within NHS Greater Glasgow and Clyde (NHS GG&C). This service would replace the current services provided collaboratively in NHS GG&C and NHS Lothian, formally allow the pooling of specialist expertise with a view to ensuring equitable access to healthcare, long term follow up and the potential to improve outcomes and meet the needs of patients. The proposed service will be in line with the service specification for the development of specific centres of expertise in England to treat this group of woman under consultation in NHS. The proposal for this service will be presented to Board Chief Executives in March 2020.

Implementation of recommendations for best practice

There are implications associated with the implementation of the recommendations of the SLWG. These are described in the following table.

Recommendation	Responsible	Implications
In order to help ensure all women receive the same high standard of care around all aspects of their mesh complication journey, the SLWG recommends the development of a standard core pathway, with local variation only where this is clinically appropriate.	Scottish Government	Establishment of a multidisciplinary group, including both clinicians and those with lived experience, with the authority to commission / undertake the work to develop a standard core pathway
All Boards will be expected to ensure their pathways are transparent and open to review through clinical and care governance processes	NHS Boards	Review and oversight of pathways via clinical and care governance processes
To reduce variation across NHSScotland: there should be greater standardisation of key MDT processes (both local and regional), taking account of the fact that this is likely to significantly increase the number of women being considered by MDTs	NHS Boards	High likelihood of resource implications associated with this recommendation, which will vary by NHS Board according to current practice. These include: medical staff planned activities (PAs) to cover MDT participation medical staff PAs to cover displaced non urogynaecology and on call workload within Job Plan admin staffing to coordinate meetings primary and secondary care nursing staff and allied health professionals (AHPs) to attend MDT nursing staff and AHPs to cover displaced non urogynaecology workload
National work should be undertaken: to agree the use of a common decision aid to develop consistent, accessible and quality assured patient information materials to agree a more standardised follow up for women to be incorporated into existing pathways	Scottish Government	Establishment of a multidisciplinary group, including both clinicians and those with lived experience, with authority to commission / undertake the work
To review the capacity and demand for access to appropriately skilled physiotherapists and address gaps to ensure timely access.	NHS Boards	High likelihood of resource implications associated with this recommendation, which will vary by NHS Board according to current practice.
All urogynaecology services should review and provide training in effective communication and empathetic behaviours for all clinical staff	NHS Boards	High likelihood of resource implications associated with this recommendation, which will vary by NHS Board according to current practice. These include: time to review skills and training needs time to attend, reflect on and implement training cost of training, licences etc

Future direction

The SLWG was established with a specific remit. It will continue to exist until the Scottish National Pelvic Mesh Removal Service has been established. Thereafter, it is important that a new group is established with appropriate representation, from both clinicians and those with lived experience, and authority to provide oversight of the delivery of improvements in services and review implications for Scotland of external reports and should complement the work to deliver the forthcoming Women's Health Plan. This group requires a clear remit, timeline and agreed outcomes at each step.

Conclusion

The SLWG has undertaken activities across the five areas of its remit and has made a number of recommendations which will seek to address the issues highlighted in both the Scottish Mesh Survivors and the Alliance reports. The SLWG will continue to exist until the mesh removal service is established and a new oversight group is established.