Director-General of Health Dr Diana Sarfati has recommended a pause on the use of surgical mesh to treat urinary incontinence in women.
The move comes after dozens of complaints of injury caused by the product over the past decade as well as a petition urging for the procedure to be stopped.
Female pelvic surgical mesh is used in the treatment of stress urinary incontinence, which is when physical movement puts pressure on the bladder, causing it to leak urine.
Alternative treatments can include surgery without the use of mesh, and non-surgical interventions.
The Health and Disability Commissioner has reported 64 complaints about mesh being used in the surgery in the past 10 years. There is a 3.6% injury rate for procedures involving mesh, based on ACC figures over the past 17 years.
In June, Parliament's Health Committee recommended the Ministry of Health investigate a pause in the procedure after it considered the petition of mesh-injured woman Sally Walker.
The Surgical Mesh Roundtable (MRT), an oversight and monitoring group, has been investigating a pause since that time.
The recommendation by the Director-General of Health comes after dozens of complaints over the past decade and a petition earlier this year. (Source: 1News)
Recommendations
The group's assessment is that there is likely to be less harm from the surgery if a series of measures are implemented. It recommends a pause until those measures are in place.
“After considering the MRT’s assessment, I have decided to support a pause to allow the following steps to be put in place to reduce the harms linked to the procedure as much as possible,” Sarfati said.
Those steps are:
• specific training and certification for surgeons performing the procedure
• creating a registry of all public and private patients who could benefit from it
• reviewing patients and the decision to carry out the procedure with a range of experts from physiotherapists to surgeons
• using a structured and guided informed consent process for patients.
“No surgery is without risks, and it’s important to remember that this particular procedure has changed the lives of many people for the better,” Sarfati said.
“However, we recognise it has caused ongoing pain and lessened the quality of life for some people, and we therefore need to act to minimise these outcomes.
“We also acknowledge the process has been slow at times and that has potentially added to the frustrations of those who have suffered harm from surgical mesh.”
A significant factor behind the decision to put the use of mesh on pause is due to the length of time it is expected to put those measures in place.
Exceptions
Sarfati said there may be exceptions, as the procedure is paused, not banned.
"The procedure might be carried out during the pause if a multi-disciplinary team agree there is no viable alternative. Any use would only happen after extensive consultation and review.
“We acknowledge that this pause may cause additional uncertainty for patients awaiting treatment, and concern for those who have recently had it. However, we need to make sure that patients are given treatment that appropriately limits the risk of harm for as many people as possible, and we believe this move will help us achieve that.”
The Royal Australasian College of Surgeons (RACS) said it supported the move to create patient safety systems.
Spokesperson and Christchurch urologist Dr Sharon English said: “We see this as a win for patient safety and look forward to a resumption of the use of mesh sling to treat SUI within a solid safety system as soon as possible."
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists has also advised its members to comply with the Director-General’s recommendations.
It said it would work with health authorities to "ensure the credentialing of all surgeons in this space and that training and mentoring pathways are put in place as quickly as possible, to see the pause lifted so women can again have the full range of treatment options for stress urinary incontinence available to them,” Committee Chair Dr Sue Fleming said.
In a statement, Urological Society of Australia and New Zealand female urological advisory group deputy chair Sandra Elmer said the society supported the decision to immediately pause using mesh in surgery in the best interests of patient safety.
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