Kia ora koutou
Please see the below information re: female pelvic mesh products announced by Manatū Hauora yesterday. Health Pathways has been advised and changes will be made appropriately.
Please see attached below for FAQs and patient facing comms.
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 (potentially 12-18 months) 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 process.
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 non-surgical management (e.g., pelvic floor physiotherapy), to a different surgical procedure.
Exceptions and high-vigilance processes will be implemented for those patients where pelvic mesh is the only option.
Barbara Stevens |Tumu Whakarae/CEO