This has been developed by 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 RACS and RANZCOG. We are sharing this information with members on behalf of Manatū Hauora Ministry of Health.

 

Exceptions process

To be considered for an exception to the pause in the use of mesh for SUI, cases need to be considered by a specifically constituted multidisciplinary meeting (MDM) that is 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 office off the Chief Clinical Officers at Manatū Hauora Ministry of Health. 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.

 

Criteria for mesh exceptions

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.

 

How to refer a case for an exception

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

  • MDMs to consider mesh exceptions will commence on 1 August and run four-weekly.
  • Each MDM will be able to consider up to three cases.
  • You need to email the MDM Coordinator at least 10 days prior to the MDM meeting to let them know that you plan to submit a mesh exception request.
  • The form must be sent to the MDM Coordinator at least seven days prior to the MDM meeting.

There is a patient guide to the MDM process.

 

How will you receive the mesh exception?

Following your application for a mesh exception, on approval or endorsement, you will receive two forms within five 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 from 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.

 

Next MDM meeting

If you would like a mesh exception considered at the meeting on 1 August, please email the MDM coordinator as soon as possible. You will need to provide a completed referral form by Friday, 26 July. The next MDM will be on Thursday, 29 August, with referral forms due Thursday, 22 August.

Future meetings will be held as follows:

 

Meeting date Notification to MDM coordinator Referral form due 
 29 August Monday 19 August Thursday 22 August 
 26 September Monday 16 September Thursday 19 September 
 24 October Monday 14 October Thursday 17 October 
 21 November Monday 11 November Thursday 14 November