Director-General of Health recommends a time-limited pause on the use of female pelvic surgical mesh products to treat stress urinary incontinence.
The 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 has 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 patients 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 process1
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, the Accident Compensation Corporation (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
Patients 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 nonsurgical management (e.g., pelvic floor physiotherapy), to a different surgical procedure.
Exceptions and high-vigilance processes to be implemented
For some patients 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 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, and to helping address the serious concerns raised by people who have experienced mesh complications.