Surgical mesh

Surgical mesh statement from Director-General of Health

Director-General of Health, Dr Diana Sarfati, has supported, effective 23 August 2023, a time-limited pause on the use of surgical mesh for stress urinary incontinence.

The use of surgical mesh to treat stress urinary incontinence will be paused while steps are taken to minimise harm linked to the procedure. The Surgical Mesh Roundtable (MRT), an oversight and monitoring group chaired by Manatū Hauora | Ministry of Health, has been investigating a pause since earlier this year. The MRT’s assessment is that the balance of benefit and harm from the procedure will be improved by a set of additional agreed measures, and it recommended a pause until those measures are in place.

Specific conditions to be met 

The recommendation is that a time-limited pause is in place until specified conditions taken to minimise harm linked to the procedure for women are met to lift the pause. It is strongly recommended all cases using this technique are postponed immediately if clinically safe to do so. 

The four specific conditions are:

  1. mandatory credentialling of clinicians to the National Credentialling Framework Pelvic floor reconstructive, urogynaecological and mesh revision and removal procedures (2022),
  2. setting up a mesh registry for female pelvic floor procedures including mesh,
  3. a structured informed consent process using a patient decision aid and
  4. patient case discussion at a multi-disciplinary meeting.

These conditions are also part of the 19 actions from the restorative justice process (outlined in Hearing and Responding to the Stories of Survivors of Surgical Mesh). 

Mesh Roundtable recommendation 

The decision to support a time-limited pause has been made by the Director-General of Health on the recommendation of the Surgical Mesh Roundtable (MRT) – an oversight and monitoring group overseeing the surgical mesh work programme – that includes representatives from Manatū Hauora | Ministry of Health, Te Whatu Ora | Health New Zealand, New Zealand Private Surgical Hospitals Association, the Royal Australasian College of Surgeons, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, ACC, Health and Disability Commissioner (HDC), Te Tāhū Hauora | Health Quality and Safety Commission and mesh injured consumers.

The MRT recommendation is supported by Te Aka Whai Ora. The Medical Council of New Zealand Te Kaunihera Rata o Aotearoa has actively engaged with the Manatū Hauora to support the process to affect the pause.

Affected patients being contacted 

Women who are directly affected by this decision, including those currently waiting for a stress urinary incontinence mesh procedure which may include mesh insertion, have been, or will be shortly contacted by Te Whatu Ora to discuss their ongoing management plan. Those receiving treatment in a private facility can expect to be contacted by their clinician. Each plan is likely to be different depending on individual circumstances but could range from additional non-surgical management (eg, pelvic floor physiotherapy), a different surgical procedure.

Exceptions and high-vigilance processes to be implemented  

For some women using pelvic mesh will be the only available procedure to manage their stress urinary incontinence. A process will be in place to review these cases before any mesh insertion surgery is done.

We recognise the need for a ‘high-vigilance’ process to mitigate and manage the risk that while there is a pause on mesh insertion for stress urinary incontinence procedures that there could be a shift to non-mesh stress urinary incontinence procedures

We will continue to work closely together across the health sector. We are all committed to providing choice and the best treatment options to women and to helping address the serious concerns raised by women who have experienced mesh complications.

Read more - Interim High Vigilance Guideline for Non-Mesh Stress Urinary Incontinence Surgery

Questions and answers

1. On what grounds will the use of mesh be paused?

There is no legal or regulatory mechanism to enforce the pause. A decision to ‘pause’ is based on collective agreement by members of the MRT and is only enforceable through disciplinary action from employers or responsible authorities (such as the Medical Council of New Zealand).

2. How will the pause be implemented? 

A voluntary pause in the use of stress urinary incontinence mesh has been accepted by agencies and organisations represented in the MRT. Other non-mesh stress urinary incontinence procedures will be subject to an agreed ‘high vigilance’ process. 

3. Does the pause mean pelvic mesh to treat stress urinary incontinence cannot be used at all?

We recognise that for some people, mesh may be the only suitable option for management of stress urinary incontinence. A process will be in place to review these cases before any mesh surgery is done.

4. How many people will be affected by this pause? 

As of 16 August, we are aware of 84 people on Te Whatu Ora’s waitlist for a stress urinary incontinence procedure. Not all of them will need a mesh procedure. Te Whatu Ora has, or is, contacting these people with advice and support needed for their individual situation. There may also be patients scheduled for private surgery, these patients have or will be contacted by their surgeon.

5. How long is the pause? 

This is a time limited pause. It will be lifted when a set of specified conditions are in place. Those conditions are: credentialling of surgeons, the establishment of a mesh registry, structured informed consent using a patient decision aid, and patient case discussion at a multidisciplinary meeting.

6. Are there any plans to pause other procedures that use mesh for example, hernias?

There are no plans to pause other procedures that use mesh.

7. Is mesh safe in other procedures? Why only this procedure?

Surgical mesh is used in a number of surgical procedures. Whilst no surgery is without risks it has been identified that the use of surgical mesh for stress urinary continence is associated with more complications than when it is used in other procedures. Therefore, a number of additional safeguards are being implemented to ensure that when it is used for stress urinary incontinence preventable complications can be avoided.

8. Which procedures will be included in the pause?

The pause affects only the procedure that uses mesh to treat female stress urinary incontinence. These procedures are known as ‘transvaginal tape’ or ‘mid-urethral sling’. Additional information can be found at Considering Surgical Mesh to Treat Stress Urinary Incontinence?.

9. Who was consulted to consider the pause?

The MRT is a cross-agency oversight and monitoring group with the role of overseeing surgical mesh work programme. The MRT includes representation from mesh-injured consumers, ACC, the relevant surgical colleges, Te Tāhū Hauora Health Quality & Safety Commission, the Health and Disability Commissioner, and Te Whatu Ora. Additionally, we have consulted the Medical Council of NZ and Te Aka Whai Ora. More information can be found at About the use of surgical mesh.

10. How are you informing people about this decision?

Communications are being prepared for affected stakeholders such as patients on waiting lists, public and private hospital service providers, clinicians and their professional colleges.

11. Can a person still opt to have the procedure if they prefer or chose?

No, a person cannot choose or opt to have mesh inserted as part of their stress urinary incontinence treatment. This is by exemption only. We have established an ‘exceptions pathway’ that ensures there is appropriate oversight of a decision to use stress urinary incontinence mesh during the pause. Your surgeon will be able to provide further information on this process.

12. I am on a waiting list to have surgery – am I still able to have this? What support will be offered? 

If you are already on the waiting list or have been given a date for your surgery, your hospital/surgeon will discuss with you a plan for your ongoing care.

13. I recently had mesh inserted to treat stress urinary incontinence, and I am not experiencing complications – should I get it removed?

The decision to use mesh would have carefully been considered and was likely to have been the most appropriate option. Most patients have had successful stress urinary incontinence mesh procedures without complications. If you are not experiencing complications, there is no need to take any action.

If you become concerned that you have symptoms which could be related to your mesh you should follow up with your medical practitioner. More information about pelvic mesh complications and the symptoms can be found on The New Zealand Female Pelvic Mesh Service. A referral to the NZ Female Pelvic Mesh Service run by Te Whatu Ora is an option to you if you are experiencing any problems that could be related to previous pelvic mesh surgery.

14. Will I still be able to have a mesh procedure if I understand and accept the risks? 

No. Surgeons will not be able to insert mesh in this circumstance. There will be exceptions for specific clinical reasons and procedures will be undertaken as part of a high vigilance process. 

15. How will you ensure the pause is being adhered to?

We have comprehensive sector-wide agreement that there should be a time-limited pause on the use of stress urinary incontinence mesh. Additionally, agencies that hold regulatory and complaint management powers, such as the MCNZ and the HDC (an independent agency with responsibility for protecting the rights of consumers who use health and disability services), are also supportive of a pause. 

16. Will there be public consultation? 

Whilst we are not seeking public feedback mesh injured consumers/patients are represented on the Mesh Roundtable and play an important part in our processes.

17. Will ACC continue to support people who have had injuries because of surgical mesh?  

Yes. ACC will continue to support clients if they have or in the future receive cover for an ACC treatment injury (including injuries sustained due to surgical mesh). More information can be found at Pelvic mesh injury on the ACC website.

18. Why did this take so long?

We acknowledge this work has taken some time and we need to ensure that the system settings are correct. The pause will give us the necessary time to ensure the correct safety procedures are in place, in particular surgeon credentialling, structured informed consent, a registry of procedures and multi-disciplinary meetings. The 2019 restorative justice process (described in Hearing and Responding to the Stories of Survivors of Surgical Mesh) made 19 recommendations around the use of surgical mesh. The MRT has been leading the work programme implementing these recommendations. While most of these recommendations are now in place, we regret the amount of time that this has taken. 

19. What happens to surgeons who have already been credentialed?

All surgeons who implant mesh in the treatment of stress urinary incontinence have been expected to ‘self-credential’ against the Australian standard, since 2018. A small number of surgeons have been credentialled against the NZ National Credentialling Framework for Tier 2 procedures including mesh insertion when they were being assessed for more complex Tier 3 mesh removal procedures. 

Because we need to make sure the system that these clinicians are working in is safe the pause applies to all surgeons including those credentialled for mesh insertion. 

20. What happens if a practitioner still performs stress urinary incontinence mesh procedures?

The MCNZ and HDC take recommendations to the sector on best practice seriously. Where a practitioner continues to perform stress urinary incontinence mesh procedures, outside of the ‘exceptions process’ this could be considered by the MCNZ and/or HDC as part of a complaint assessment.

21. Are there plans to ensure the competency of clinicians is maintained when mesh is reintroduced?

We anticipate that a drop in capability for clinicians using stress urinary incontinence mesh would be relatively low, as this pause is time limited. All surgeons using mesh for stress urinary incontinence will have been through a rigorous credentialing process.

22. What support is available for clinicians? 

Clinicians are being supported through their professional colleges (RACS and RANZCOG). 

23. What other services or procedures are available for management of stress urinary incontinence? 

There are non-surgical and other surgical procedures available for treating stress urinary incontinence. Multi-disciplinary health services are still available to support people, for example allied health and pain services. This tool can give you an idea of the options for managing stress urinary incontinence: Surgery for stress urinary incontinence: Patient decision aid (PDF, 976 KB). Although this tool refers to the NHS in the UK it provides a good overview of stress urinary incontinence options while we develop our own tool here in Aotearoa-NZ.

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