Transvaginal Mesh Case Record Review

Chapter 6 - Alternative approaches: International experiences and perspectives*^[112]

6.1 In its introduction, this Report acknowledged that the concerns expressed by women following transvaginal mesh surgery are not confined to Scotland or indeed the United Kingdom. For the purpose of this chapter we have considered the work that has been undertaken in Australia and New Zealand, some of which we believe could potentially be adapted to enhance and support the provision of mesh services within a Scottish context.

The wider Australian response

6.2 The Queensland Government estimate that 150,000 women across Australia have received pelvic mesh implants in their treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) within the past twenty years.^[113] This estimation gives rise to two points. First, it implies that a significant number of women across Australia have received a transvaginal mesh implant. Second - and arguably, more importantly - the percentage of those 150,000 women who may have experienced complications, remains unknown. This lack of certainty surrounding data capture was the catalyst for the Parliament of Australia to set up an Inquiry into the, ‘Number of women in Australia who have had transvaginal mesh implants and related matters,’ launched on 15 February 2017.^[114]

6.3 On the 28 March 2018, the Senate Affairs Reference Committee’s Report was published, comprising five chapters and 13 recommendations.^[115] The Senate Report acknowledged the complexities of this area of healthcare and suggested some ways in which they could be addressed - with Senator Rachel Siewert stating:

A Lack of Data

6.4 A significant finding was the lack of available data regarding the exact number of women who received a transvaginal mesh implant in Australia and how many also experienced complications.^[117] A lack of data is not an issue isolated to Australia. We consider Scotland’s challenges with regard to this in Chapter 9 of this Report.

6.5 Queensland acknowledged the difficulties that a lack of or incomplete data represented when developing and providing resources to meet what is an unknown number of women’s needs.^[118] In response to initially very little and inconsistent information being recorded, in early 2020, letters were sent to every woman residing in Queensland who had undergone surgery involving transvaginal mesh since 2000.^[119] Whilst this may be seen to have merit, it did not have the anticipated outcome. Rather than providing clarity in terms of data capture and/or reassurance, this process led to a substantial increase in the number of women who raised concerns around their surgery and the possibility of complications. As a result, the whole process became unmanageable and “...outstripped the capacity...”^[120]

6.6 Accurate data is vital to inform and shape responses. To address the lack of data, several measures were recommended. This included implementing a mandatory reporting system for women who experienced an adverse event,^[121] the establishment of a national register of medical devices,^[122] and broadening the sources of potential data to include private insurance companies, hospital databases, and patient records.^[123]

Informed Consent and Information Disclosure

6.7 It is widely acknowledged that informed consent and information disclosure are vital components of good clinical care.^[124] The Senate Report^[125] found that while many women received detailed information and counselling,^[126] others received little to no information.^[127]

“The committee is dismayed by reports that some women were not advised that a transvaginal mesh implant was being used as part of their treatment.”^[128]

6.8 Australia and Scotland share a particular commonality with the Scottish Health and Social Care Alliance in their project, ‘My Life, My Experience - Capturing Lived Experiences of Complication Following Transvaginal Mesh Surgery’, finding 36 of 46 women who participated reported experiences of being given minimal information about treatment they received^[129] and conversations with our Review participants highlighted similar concerns.^[130] Arguably, a contributing factor to the lack of informed consent in both jurisdictions is the confusing nature and inconsistency of the terminology utilised by clinicians when discussing transvaginal mesh implants. Again, just as the Review had heard, transvaginal mesh implants were often described to women in Australia as a ribbon, tape, or sling - the connotations of which do not immediately imply a polypropylene device to non-medically trained individuals.

6.9 In response, the Senate Report provided a list of recommended points to be raised during discussions between healthcare professionals and patients to ensure full understanding of what is being discussed. Recommendations included providing full details of the proposed treatment and a clear rationale for such treatment, including alternative options and a final confirmation that the patient fully understands their treatment plan.^[131]

Care pathways

6.10 The need for effective care pathways was highlighted by the Senate Report. By using bespoke referral pathways, the patient’s clinical needs could be addressed.^[132] In an attempt to streamline this process, the Australian Commission on Safety and Quality in Health Care (ACSQHC) are developing a surgical pathway,^[133] which will be based on a ‘traffic light approach’. In effect, this is triage system based on the priority of patients’ clinical needs.^[134]

6.11 Whilst this could potentially be an effective measure, the Panel recognise the need for support mechanisms for women who are waiting to be referred.

6.12 Whilst several recommendations were made by the Senate Report, Recommendation 13^[136] provides a comprehensive and integrated list of services to be established. These include information and helplines for women, specialist counselling programs, multidisciplinary units, and guidance for medical professionals on the importance of data capture for surgical procedures.

6.13 A range of services have been introduced across Australia. Starting in September 2017, Western Australia established a confidential free telephone line as well as a Mesh Register to aid data capture. In December 2017, the State of Victoria established a mesh information service and helpline,^[137] as well as specialist programs to address reported complications following mesh surgery.^[138] At the same time, the Government of New South Wales are issuing Safety Notices, regularly updated, regarding transvaginal mesh implants outlining what patients should do if they have concerns following surgery.^[139] In January 2018, the Australian Capital Territory directly contacted women who were identified as having a mesh implant within the last ten years. In conjunction they developed a dedicated phone line and established an email where patients could register their concerns.^[140] The Panel found these initiatives impressive and informative.

6.14 In 2019 a Progress Report highlighted that Recommendation 13 has been acted upon in most Australian jurisdictions, with services being created for the removal of mesh and provision of support.^[141]

6.15 The Panel see the merit in additional support mechanisms being put in place for GPs and practice teams for when women raise concerns with them. We have included a link below to the template which is a resource for GP’s and explains the possible symptoms and signs of women presenting with pelvic mesh-related conditions and if required, where to signpost them for further help.^[142] It is also vital to provide patients with access to dedicated online information and support services which can be regularly updated.

6.16 The Panel recommend additional support mechanisms being put in place for GPs and practice teams to aid understanding and address concerns women may raise with them following a transvaginal mesh surgery.

6.17 Australia have recognised the importance of data capture with a Mesh Register becoming a key tool, not only to collect data, but to regulate how transvaginal mesh is utilised in clinical practice.

6.18 It is recommended that Scotland maintains a Mesh Register which records surgery in Scotland, as well as surgery which has occurred in other parts of the UK and overseas.

Queensland’s Pelvic Mesh Service

6.19 One of the most prominent responses to the recommendation for a comprehensive approach was with the establishment of the Queensland Pelvic Mesh Service, located at Varsity Lakes Day Hospital on the Gold Coast.^[143]

“The Queensland Pelvic Mesh Service is committed to partnering with women, providing multidisciplinary care and treatment through their recovery journey in a mutually respectful, transparent and supportive environment.”^[144]

6.20 The service focuses on a ‘partnership’ between women and healthcare professionals,^[145] suggesting that the service promotes a collaborative approach to clinical care. Focusing on a ‘partnership’ in this context builds trust and empowers the patient as the decision-maker.

6.21 Adequate resourcing of any such service remains critical. The Queensland Pelvic Mesh Service is funded by Queensland Health with a 2022-23 budget allocation of $3.14 million.^{[146] [147]} It remains to be seen whether this will be a sufficient resource to meet the aims of the service.

6.22 It is recognised that the waiting time to access complex mesh services in Scotland,^{[148] [149]} and throughout the UK, continue to raise concerns.^[150] As a way of attempting to manage and allocate resources, the Queensland service has adopted a triage approach. Category 1 is allocated to the most severe complications, and Category 3 being those who experience milder physical symptoms. Every woman, irrespective of how mild or severe her complications may be and what category that places her into, undoubtedly wants to see the medical team as soon as possible. Considering the wait times associated with each category, Category 1 are those currently being seen by the medical team; Category 2 are those who wait between four to six months on average; those in Category 3 are currently not receiving appointments.^[151]

6.23 Between April 2019 and April 2021, it was found that 484 women were treated by the medical team, 257 underwent cystoscopy, 91 underwent mesh revision surgery, 65 had complete excision and 25 had a partial excision and one sling division. 180 women were discharged.^[152] Notably, the 484 women who received treatment account for just over half of the eligible referrals that the service received.^[153]

6.24 A final point to note is that initial services tended to focus upon the provision of revision surgery.^[154] However, the Queensland Government concluded that this approach may be misplaced.^[155] They argued that whilst surgery may bring the psychological relief of having had mesh removed, it may not resolve other clinical matters, including the physical symptoms which were the reason for the initial surgery. This is something that the Panel have also recognised in their conversations with participants and will be discussed further in Chapter 9.

New Zealand – a restorative justice approach?

6.25 In 2017, New Zealand became the first country to ban the use of all surgical mesh products for transvaginal POP repair and a single incision mini-sling for the treatment of SUI, following regulatory action from New Zealand’s Medicines and Medical Devices Safety Authority (MEDSAFE).^[156]

6.26 New Zealand operate what is referred to as a ‘no-fault system’ – a different legal mechanism to the adversarial system that is used to resolve litigation in Australia and across all four jurisdictions of the United Kingdom. Since 1974, New Zealand has operated a scheme which provides assistance with the cost of treatment and rehabilitation for all personal injuries, regardless of fault.^[157] Specifically, The Accident Compensation Corporation (ACC) is charged with the responsibility of compensating victims of harm under this system. As of the 30 April 2019, it was estimated that the ACC paid $23.6 million NZ dollars on 959 claims.^[158] 63% of such claims were associated with POP or SUI repair.^[159] The ACC have strict eligibility criteria which must be satisfied for a successful compensation claim to be made. Specifically, evidence of harm must be present, the injury caused must have been a direct result of the treatment provided, such injury must be as a result of failure and finally, a list of exclusions is provided ranging from injury as a necessity of treatment, to treatment which failed to reach the desired outcome.^[160]

6.27 It is important to understand this legal background since it provides the context in which the New Zealand response has been made.

6.28 Whilst the extent of reported adverse events appears to be broadly similar to that of Australia and Scotland, there have been some innovative approaches in an attempt to acknowledge these in New Zealand. Of particular interest for this Review, New Zealand have also conducted a project to address concerns over potential harm specifically through a restorative justice approach.^[161]

6.29 Regarding New Zealand’s wider response to address adverse events following mesh surgery, some recurring themes between Australia and New Zealand are recognisable, including the challenges of a lack of data capture and acknowledging the need for a collaborative approach. Unlike Australia which sought to provide solutions on a state-by-state basis, New Zealand’s response encompassed the whole of New Zealand. It comprised a project, a workshop, and two reports – which, when considered together, aimed to provide comprehensive measures to address and resolve issues by way of an integral provision of healthcare services.

6.30 The starting point for New Zealand’s approach can be traced back to the Ministry of Health’s 2019 project, launched with the aim of hearing directly from patients who had experienced adverse consequences following mesh surgery. Designed with an underlying framework of restorative justice,^[162] the project was undertaken between August and October 2019 and involved 600 people who were affected by mesh.^[163] They were invited to share their individual experiences through ‘Learning Circles’ and online ‘Story Databases’.^[164] The majority of participants were women and also included those who had been indirectly affected. By involving participants with diverse perspectives, the project’s objective was to assess the

6.31 After collating the responses gained through the project, a workshop was conducted on the 20 November 2019. Attendance included the Ministry of Health, the organisation ‘Mesh Down Under’,^[166] and The Health Quality & Safety Commission.^[167] The workshop provided a platform upon which the findings of the project could be openly discussed. As noted already in chapter 2, the outcomes from both the workshop and the restorative project were summarised in 2020 in a report which outlined the benefits which could be derived from adopting a restorative approach.^[168] Its conclusion also considered the preventative future measures through six key areas, namely;

• the credentialing^[169] of surgeons;
• the creation of multidisciplinary mesh services;
• mechanisms used to maximise the principle of ‘informed consent;
• harm should be acknowledged;
• a culture of safety in healthcare systems and;
• responding to mesh concerns in the present and the future. ^[170]

6.32 The success of the project was founded on a collaborate approach to capture people’s stories. Participants were invited to share their experiences through a range of diverse forums.^[171] This suggests that access and getting the right environment are key to a restorative justice approach. The Panel recognises that not all women feel comfortable sitting in close proximity with someone who was closely involved in their care or to discuss medical issues that are very intimate. By utilising databases and online platforms, it removed that proximity and instead provided alternative methods of engagement. Individuals could access and share information of their choice at any given time.

6.33 The restorative element focused on enabling the women to share their experiences. This was found to provide a “...nuanced understanding of events”,^[172] suggesting that discussing such matters in a carefully considered environment may be of benefit not only for the participants themselves but to allow others to gain an understanding.

6.34 The New Zealand project produced 19 points of action.^[173] Some of these are parallel to those produced within the Australian report, however, New Zealand provides some notable additions including:

• the potential need to provide counselling to those experiencing mesh complications;
• the need to recognise the complexity and sensitivity of the issues involved;
• the need to reiterate the importance of informed consent and provide training to support and uphold information disclosure and understanding; and
• the requirement to update the law to ensure it is in-keeping with modern medical device regulation.

6.35 In conclusion, Australia and New Zealand share much in terms of approach, not only with each other, but with Scotland and throughout the UK. The Panel particularly favoured the collaborative approach seen in New Zealand, with responsibility for care shared and managed amongst a number of healthcare agencies including complex mesh services, health providers, patients and government initiatives. Each country made good use of online information services which appear to be regularly updated. Patient involvement is integral to both Australia’s and New Zealand’s approach.

6.36 There is a degree of commonality about the issues of concern raised across all countries:

• the need for data capture;
• effective review of data capture to inform future initiatives for care;
• clear processes for information disclosure and consent;
• pathways for referral and treatment need to be created;
• credentialing for clinicians performing revision surgery;
• patient involvement;
• process to promote sharing of best practice for all of the above; and
• effective use of websites to collate and share all this information.

6.37 The Panel were supportive of the practical and integrated response proposed by the New Zealand review and suggest that Scotland should reflect with a view to adopting similar initiatives.