Mesh exception process

Following on from the announcement of a pause in the use of mesh for stress urinary incontinence in August 2023, a process to consider exceptions to the pause has now been finalised. This has been developed by Health New Zealand | Te Whatu Ora’s New Zealand Female Pelvic Mesh Service (NZFPMS) at the request of the Mesh Roundtable and work has involved representatives from both RANZCOG and RACS.

To be considered for an exception to the pause and the use of mesh for SUI, cases need to be considered by a specifically constituted multidisciplinary team meeting (MDM), this MDM will be led by the NZFPMS. The MDM will consider cases carefully and is the substantive part of the decision-making process.

MDM attendance:

• Chair Dr Hazel Ecclestone (Urologist, Taranaki District Hospital)
• 1 NZFPMS Tier 3 credentialled surgeon
• 1 Tier 2 credentialled surgeon Gynaecologist
• Presenting (requesting) surgeon
• CNS Incontinence
• Pelvic Health Physiotherapist
• MDM Coordinator
• Radiologist, Stoma Nurse invited as required

After the MDM there will be a process check by the clinical team at Manatū Hauora Ministry of Health who hold the secretariat for the Surgical mesh Roundtable. This step will not re-examine clinical aspects of the case but will ensure that appropriate process has been followed.

There will not be an ‘appeal’ process as the MDM has the comprehensive knowledge and skills required to make decisions. There will be opportunities to present new or updated clinical information on a given patient via the MDM process.

All surgeons undertaking female SUI procedures in New Zealand can refer and present a case to the Mesh Exception MDM. Criteria are:

• Patients for whom there is evidence of harm (defined in a patient centric manner) from delaying surgical treatment until the pause is lifted, or surgeon and referring MDM advice is that a non-mesh procedure may carry additional risks
• Patients who have been discussed according to the interim high vigilance guideline for non-mesh SUI surgery and it was agreed that requesting an exception for mesh is appropriate
• At this time, patient choice for use of mesh over other treatment options, where the responsible surgeon and MDM consider the other treatment options suitable, is not an accepted reasons for seeking an exception.

For more information about the MDM process see the Terms of Reference for the Mesh Exceptions MDM.

Surgeons can request MDM consideration of an exception for the use of mesh using this guideline and form.

• MDMs to consider mesh exception will commence on 1 August and run four-weekly
• Each MDM will be able to consider up to 3 cases
• You need to let the MDM Coordinator know at least 10 days prior to the MDM meeting that you plan to submit a mesh exception request NZFPMSNationalMDM@waitematadhb.govt.nz

Please use the following text in the subject line Attention MDM Coordinator – Mesh Exception Request

• Completed forms need to be sent to the MDM Coordinator at least 7 days prior to the MDM meeting

There is a guide for patients on the MDM process.

Following your application for a mesh exception, on approval or endorsement, you will receive 2 forms within 5 working days of the meeting. You will need both forms to confirm that you have the requisite authority to place SUI mesh:

1. MDM outcome form with endorsement (substantive part of the decision)
2. Process check form the Ministry of Health (procedural part of the decision)

Both forms are required before you proceed with SUI mesh placement and our advice is that these forms are lodged within the patient notes and made available to the surgical facility at (or before) the time of surgery.

The Ministry of Health will retain a log of all patients and referring surgeons who have received a mesh exception.

• Referral and outcome form (DOCX, 57KB)
• Patient information guide (PDF, 148KB)
• Terms of reference (PDF, 293KB)