Hearing and Responding to the Stories of Survivors of Surgical Mesh: May 2020 update

Since the release of the report Hearing and Responding to the Stories of Survivors of Surgical Mesh in December 2019, the Ministry of Health, in collaboration with other health sector agencies, has been working to progress the agreed actions and support those who have been affected and minimise future harm.

An update on each of the actions detailed in the report is provided below. Unfortunately, and understandably, some resources have been reassigned to respond to the COVID-19 pandemic and this will cause some delays, but we remain committed to delivery of the actions.

Actions

1. The severity of the harm from surgical mesh should be acknowledged when the report is released publicly.

The Ministry of Health supported the release of the report in December 2019 with the press release Report highlights severity of harm from surgical mesh. The Ministry’s Chief Medical Officer Dr Andrew Simpson and Chief Nursing Officer Margareth Broodkoorn also spoke to this during an interview with Radio New Zealand.

The severity of harm was also acknowledged in press releases by the Royal Australasian College of Surgeons, the Royal Australasian College of Obstetricians and Gynaecologists and ACC.

• Royal Australasian College of Surgeons press release
• Royal Australasian College of Obstetricians and Gynaecologists press release
• ACC press release

Future communications will continue this recognition.

2. The Ministry of Health was identified as the coordinating agency for each workstream.

The Ministry has taken responsibility for overall coordination of the surgical mesh work programme and workstreams. 

3. A collaborative approach is required to respond to harm from surgical mesh, and groups that should collaborate were identified for each workstream.

A collaborative approach is being taken with broad representation involved in each workstream. 

4. The HDC will promote the visibility of their national advocacy service.

The Nationwide Health and Disability Advocacy Service is a free service that operates independently from all health and disability service providers and agencies. They have a freephone 0800 555 050 and website.

5. Attendees will share the final report with their professional members/within agencies.

The report has been widely shared across the health sector by health professionals and health organisations, including internationally.

It was intended that the Ministry’s Chief Medical Officer Dr Andrew Simpson and lead researcher from Victoria University Jo Wailling, along with a representative from Mesh Down Under, would present the report at an international patient safety symposium in Europe in June. Unfortunately the symposium has been postponed due to the pandemic, but there may be another opportunity in the future.

6. The surgical mesh round table is considered an appropriate group to oversee the delivery of the workstreams. To restore trust, there was an expectation of transparent reporting and regular public updates to communicate progress.

The Surgical Mesh Roundtable is responsible for providing oversight and monitoring of the surgical mesh work programme, including the actions and recommendations arising from the Health Committee and Restorative Justice reports. The group also provides advice and recommendations to the Ministry of Health. Terms of Reference for the Roundtable are available at Surgical mesh: Terms of reference. 

The Surgical Mesh Roundtable met on 6 March 2020 and agreed to meet every two months to review and advise on progress. Unfortunately, the May meeting is unable to go ahead as anticipated due to Covid19, but planning is underway for the Roundtable to meet again virtually. 

This update is the first of intended regular public updates to communicate progress on the surgical mesh work programme and workstreams.

7. Consumers will be reimbursed when participating in the co-design of each workstream.

This has been established and is clear in the Terms of Reference of the groups established to date.

ACC has signed letters of agreement with the consumer members who are working alongside them.

8. Specialist multi-disciplinary centre(s) are required. A group will meet in January 2020 to advise: the number of specialist centres required to ensure equity of access, the model of care and team required. This may be informed by learning from successful models elsewhere.

A specialist services group was convened in January and met early February. The Specialist Services Group are tasked to advise on a model of care, the expertise required, and the number and location of specialist multidisciplinary centres for those who experience mesh complications. Terms of Reference, including membership of this group, are available at Surgical mesh: Terms of reference.

Data and information regarding the number and complexity of current referrals, alongside waiting times for treatment, is being collated for the Specialist Services Group. This will go some way to inform the immediate need for speciality services and where the majority of referrals come from.

It is acknowledged, however, that given evidence that many women have limited access to current services and are ‘unknown’, it will be difficult to fully estimate unmet need initially.

Contact has also been made with an existing specialist service in Queensland to see what can be learnt from their experience.

The northern region of New Zealand has already commenced work on a regional specialist service model so this will also inform the work of the Group.

The Specialist Services Group will, in time, advise the Ministry of Health on whether different models of care and services are required for managing complications resulting from different mesh use.

9. Establish a credentialing committee by the end of January 2020 to recommend national standards for individual practitioners and services commencing with urogynecology procedures. Minimum standards for insertion, renewal, repair and removal surgery and native tissue repair will be included.

A Credentialing Committee was convened in December 2019 and met in January 2020. Terms of Reference, including membership of this group, are available at Surgical mesh: Terms of reference.

As a first step, the credentialing committee has convened a panel to review and understand the process followed by DHBs (and some private providers) to assess their surgeons undertaking urogynaecological surgical mesh procedures against credentialing guidance developed by the Australian Commission on Safety and Quality in Health Care. This action was requested by the Director-General of Health in September 2018 (see the Letter sent to DHBs: Surgical mesh devices and ensuring patient safety [PDF, 3.3 MB]).

This will aid in the development of a long-term, sustainable credentialing framework. 

The panel was due to meet in early May 2020, however, this has been delayed due to COVID-19.

10. The Ministry of Health will lead, supported by ACC, interdisciplinary education and build the capability of the required technical skills to prevent future harm and reduce the severity of existing harm. This action intends to also support the provision of removal surgery.

The Ministry of Health and ACC are working together to scope and design an interdisciplinary education programme. This activity will also support other actions relating to credentialing and provision of specialist services.  

An initial proposal has been reviewed by the Surgical Mesh Roundtable and will be refined further by a small group comprising of ACC, a Consumer and MoH prior to wider consultation. It is intended that this work will continue as far as possible within the limits of COVID 19 contact recommendations (eg, due to the likely ongoing restrictions on travel and gatherings as a result of Covid-19, alternative ways to deliver such a programme are being considered).

11. Professional colleges will inform and educate their members about their role in preventing and reducing harm from surgical mesh.

The colleges are involved in all work to date with representatives on each of the groups as well as the Roundtable. They are expected to keep their college members up to date and informed on all work being undertaken.

12. ACC will partner with consumer representatives to design an approach for looking back through declined mesh-related treatment injury claims. Recognising those claim outcomes may not change; the process will also aim to learn where improvements can be made to the consumer experience.

ACC and consumer representatives designed the three phase programme: ‘Look Back’. ACC has now completed phase one of the look back and is moving onto the next phase.

A sample of more than 40 claims have been identified as part of phases 2 and 3. These will be looked at when ACC has finalised its updated decision-making guidelines for cover assessment.

ACC established an Expert Advisory Group. This group is continuing to work on updated decision-making guidelines for ACC cover assessment.
A literature review has been completed by the University of South Australia which will also inform the cover guidelines.

During each phase of the look back ACC is continuing to identify ways to improve its approach and processes for people injured by surgical mesh and other types of treatment injuries. They have also started a piece of customer research that will help identify further improvements across the treatment injury process.

The next meeting is scheduled for this month.

13. ACC will explore the potential to provide support services, such as counselling, while cover decisions are pending.

ACC’s Policy Team are investigating support options available outside of ACC that might be available to people while cover decisions are being made. They are also more broadly reviewing pre-cover support for complex claims.

14. ACC recognizes the complex and sensitive nature of mesh claims and intends to use an approach that ensures mesh injured clients are matched to case owners with an appropriate background, experience, and skills.

ACC is currently rolling out a new case management system that includes improvements to claim triaging and capability streaming to case owners with appropriate experience for that claim. 

A separate piece of customer insight and research has also been commissioned in parallel to identify further improvements throughout the cover process, and these will also be applied as appropriate.

15. ACC will continuously improve the collation and sharing of information on injuries caused by surgical mesh with key stakeholders and agencies under its Risk of Harm reporting framework to support prevention of future harm.

ACC is currently refreshing its risk of harm reporting process and is working alongside the Ministry of Health, DHBs and registration authorities to make sure the information that we gather through the claim decision process is provided to the authority responsible for patient safety for that treatment.

From 1 March 2020 ACC started capturing data in a new way and are working on how to provide this information to the right parts of the health sector to promote a learning culture and support safer treatment.

16. National standards of practice and the code of rights for informed consent are already in place. Credentialing and training will support these to be embedded in everyday clinical work.

Work to develop a credentialing framework will be informed by the interim credentialing process and will clearly outline the expected competencies for female pelvic medicine and reconstructive surgery. This includes the appropriate processes to ensure informed consent and choice is provided to patients/consumers.

17. National information resources for mesh-related procedures should be created with consumers and include informed consent processes. Information should incorporate the product safety profile, outcomes and risks, alternative treatments available, and the informed consent process.

Information is available at Considering Surgical Mesh to Treat Stress Urinary Incontinence? on the Ministry of Health website. This information was co-designed by Mesh Down Under and the professional colleges.

Waitemata DHB has also, with consumers, developed patient information booklets on treatment options for stress urinary incontinence and pelvic organ prolapse, as well as managing complications. These have been shared with some DHBs and those who have asked for the resource. They are available on the Waitemata DHB website.

Further opportunities to improve national information resources will continue to be considered.

18. The Ministry of Health and Medsafe will support the Government in modernising the regulation of medical devices in New Zealand, including the development of new legislation (Therapeutic Products Bill) to improve device safety.

The New Zealand Government is working on a new and comprehensive regulatory regime to regulate therapeutic products in New Zealand, which will replace the Medicines Act 1981 and its Regulations.  As well as replacing and modernising the regulatory arrangements for medicines, the regime will provide regulation of all therapeutic products. This includes medical devices (including mesh products) and cell and tissue therapies which are currently not fully regulated in New Zealand.

As part of the development of the Therapeutic Products Bill, the Ministry of Health consulted on a draft of the Bill during early 2019.

This work is ongoing and updates are available at Therapeutic products regulatory regime on the Ministry website.

19. The Ministry of Health will identify the actions and supports required to meet the need for a collaborative approach to safety systems and culture.

The Ministry is collaborating with other health sector agencies to ensure that the lessons from surgical mesh inform wider improvements to safety systems and culture.

Next steps

An evaluation of the restorative approach to hear and understand the stories of those harmed by surgical mesh, which informed the report, will commence in May 2020. The evaluation will be led by researchers from the Diana Unwin Chair in Restorative Justice, Victoria University of Wellington.

The Diana Unwin Chair in Restorative Justice research team will be evaluating participants experiences of the project that aimed to:

• listen to the impact of surgical mesh use in New Zealand
• understand the Ministry of Health’s responsibilities
• inform action.

More information about the project can be accessed on the Restorative Health website.

Participants that consented to be contacted will receive an invitation to complete a survey from the researchers in May 2020.