23 Aug 2023

Health Ministry recommends temporary halt on surgical mesh use for urinary incontinence

6:27 am on 23 August 2023

The Health Ministry said the temporary ban would not be lifted until the measures were introduced to reduce the harms associated with the insertion of mesh - expected to occur within 12 months. Photo: 123RF

The Ministry of Health is calling for the use of surgical mesh to treat urinary incontinence to be suspended until further notice.

The use of mesh has been controversial after hundreds of women suffered irreversible complications that left them with severe or chronic pain.

Director-General of Health Dr Diana Sarfati said the Surgical Mesh Roundtable has been investigating a pause since earlier this year.

She called for a temporary halt to mesh use, effective from Wednesday, to allow steps to be put in place to reduce the harms linked to the procedure.

Diana Sarfati

Director-General of Health Dr Diana Sarfati. Photo: RNZ / Samuel Rillstone

They include implementing a registry to monitor patients post surgery, a detailed, informed consent process, that ensures that women have a good understanding of all the different options available to them, the establishment of multidisciplinary teams to help establish the best treatment options and a credentialing process, to ensure the surgeons performing the procedure are able to do so safely.

Ministry of Health chief medical officer Dr Joe Bourne said it was important to acknowledge that harm had occurred to women who had mesh inserted for stress urinary incontinence.

Between 3 and 4 percent of those who had the procedure experienced some harm with it.

Bourne said there was nothing "intrinsically wrong" with the mesh itself, given that for many it was successful.

While the Ministry of Health had recommended its use be suspended until further notice, it was not legally enforcable.

"There isn't really a mechanism through which we can ban the mesh, because we don't have evidence that says the mesh in itself is harmful, it's everything around the mesh that needs to be in place in order for it to be able to be used safely."

The decision was based on a collective agreement across the healthcare sector, which included the the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Royal Australasian College of Surgeons.

"This has been a challenging area for many of the surgeons involved who who purely want to be able to do the best they can for women who are presenting with stress urinary incontinence.

"Although not life threatening, it can have a really profound impact on people's quality of life."

Bourne said it would work with employers and the Medical Council of New Zealand to undertake enforcement action if needed.

"We're optimistic, we have that buy in from the surgeons themselves, we've already noticed a considerable reduction in the use of this product since there has been more evidence presented around the harm that's associated with it."

Bourne said there remained other surgical and non-surgical treatment options for those who suffered from stress urinary incontinence.

"We're pleased with some measures that have already been established and that includes the recent launch of a specialist service for the removal of mesh where complications have occurred, delivered by Te Whatu Ora.

He said the temporary ban would not be lifted until the measures were introduced to reduce the harms associated with the insertion of mesh - which he anticipated would occur within 12 months.

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists Aotearoa New Zealand committee Te Kāhui Oranga ō Nuku chair Dr Susan Fleming said there was industry agreement on the safety measures that should be introduced.

"As clinicians devoted to women's health, we want to keep the risk of an adverse outcome as low as possible and that's largely what this initiative is focused on, reducing preventable harm. We can't eliminate complications entirely for this procedure, or indeed for any other it is the nature of an intervention."

Fleming said RANZCOG had asked all of its members to comply with the recommendation.

"We are really aware of the pain and distress that has been suffered by New Zealand women who've experienced complications from pelvic mesh implants and so this pause allows the system as a whole to come together and address those things."

Fleming said there was agreement on that the safety measures that the Ministry of Health plan to implement were necessary in ensuring that the use of surgical mesh was as safe as it could be.

She said the organisation was pleased that despite the suspension, there was a pathway for those women who had really significant stress urinary incontinence symptoms to still have surgical mesh inserted, when other treatment options did not offer the best care.

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