It's been one year since the Director-General of Health, Dr Diana Sarfati, supported a pause in the use of surgical mesh to treat stress urinary incontinence (SUI) on the recommendation of the Surgical Mesh Roundtable (MRT).
Specific conditions need to be satisfied before considering lifting the pause. Those conditions are:
- mandatory credentialling of clinicians to the National Credentialling Framework Pelvic floor reconstructive, urogynaecological and mesh revision and removal procedures (2022),
- setting up a registry for female pelvic floor procedures including mesh,
- a structured informed consent process using a patient decision aid, and
- patient case discussion at a multi-disciplinary meeting.
Progress across the four conditions
There has been considerable progress made across the four conditions required to lift the pause.
Credentialling
The Ministry completed two rounds of Tier 1 and Tier 2 credentialling for pelvic floor reconstructive, urogynaecological and mesh procedures earlier in the year.
Credentialling is a structured process that verifies that surgeons are competent to perform specific procedures to a high quality. Surgeons are credentialled against the National Framework for pelvic floor reconstructive, urogynaecological and mesh revision and removal procedures.
Health New Zealand is now leading the process with another round of Tier 1 and Tier 2 credentialling scheduled for November 2024.
A group of national and international experts and local consumers form the panel assessing surgeons.
In 2022, the credentialling round focused on Tier 3. Tier 3 are the most complex procedures involving mesh removal.
National Pelvic Surgical Procedure Registry
Health New Zealand is progressing the pelvic floor registry and is finalising an agreement with an Australasian vendor. It's expected that work will begin with public and private sites to have the registry operating in the early half of 2025.
Informed consent process
The Health Quality and Safety Commission has produced two patient decision guides to support informed decision making about managing SUI.
As part of the consent process, patients should be fully informed of treatment options, potential benefits, and risks of complications.
The guides explain the surgical and non-surgical options for SUI management and are designed to be read and discussed between patient and doctor to determine which is the right treatment to take.
Both guides were developed with health care professionals and independent consumers, some of whom have lived experience of stress urinary incontinence. The guides are published on the Health New Zealand website.
SUI Multidisciplinary Team Meetings
The roll out of regional Multidisciplinary Team Meetings (MDMs) will start before the end of the year. MDMs are deliberate, regular meetings where health professionals with expertise in a range of different specialities discuss the options for patients' treatment and care.
A project working group of gynaecologists, urologists, urogynaecologists, nurse specialists and pelvic health physiotherapist has developed an MDM process that will ensure consistency in monitoring and reporting across New Zealand.
High-Vigilance guidelines
When the pause was announced, it was recognised, based on international experience, that there would be a need for a high-vigilance guideline for non-mesh SUI procedures. An interim high-vigilance guideline is now in place to provide assurance that other procedures used instead of mesh are appropriately delivered. The guideline is used to ensure risks to patients are considered and managed. The guideline has been developed collaboratively across the sector.
Mesh exceptions process
For some women, using pelvic mesh will be the only clinically appropriate procedure that will best manage their SUI. For the remaining duration of the pause, an exceptions process is now in place with a National Mesh Exception MDM reviewing all applications for mesh insertion and ensuring that all potential treatment options have been considered. The MDM is an opportunity for surgeons to discuss the case with a panel of practitioners who are experts in diagnosing and managing SUI, the full range of treatment options and management of potential mesh complications.
Patient preference for mesh over other treatment options considered suitable by the surgeon or MDM, will not be a sufficient reason for seeking an exception.
A process check by the Ministry as the final step will ensure the process is being followed correctly.
The MRT, which includes people from across the health system including Health New Zealand, professional colleges, The Health and Disability Commissioner and consumers, continue to actively monitor progress and help address the serious concerns raised by women who have experienced mesh complications.
