Surgical mesh statement from Director-General of Health

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).

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.

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.

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.

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.

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

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.

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?.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.