Calls for immediate halt of the use of surgical mesh
Independent Review calls for immediate halt of the use of surgical mesh for stress urinary incontinence in England. Should New Zealand Follow?
An English Independent Safety Review has concluded that there must be an immediate suspension and pause in the use of surgical mesh for the treatment of stress urinary incontinence (SUI). The NHS agreed.
Baroness Julia Cumberlege, Chair of the Review said: “We strongly believe that mesh must not be used to treat women with stress urinary incontinence until we can manage the risk of complications much more effectively. We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications.”
She has advised the Department of Health and Social Care and NHS England that surgical mesh should not be used for the treatment of stress urinary incontinence until a set of conditions to mitigate the risks of injury are met. Baroness Cumberlege has said that these conditions should be met by March 2019. The Department and NHS England have accepted the recommendation.
In December 2017 Medsafe used the
provisions in the Medicines Act 1981 to request safety
information from four suppliers of surgical mesh products in
New Zealand. The Act permits the Director-General of Health
to request safety information from a supplier should there
be reason to believe a medical device is unsafe.
Medsafe reviewed information supplied and concluded that strengthened warnings or limited indications for some products were appropriate for them to remain on the market.
A working group comprised of members of Mesh Down Under as well as representatives of the surgical colleges RANZCOG and USANZ have been close to finalising a patient information document which warns patients about the potential risks and benefits of polypropylene plastic mesh implants for the treatment of female stress urinary incontinence.
“The New Zealand document is based
on the UK National Health Service’s (NHS) own patient
information booklet, with localised content” said Mesh
Down Under co-founder Carmel Berry. “We’ve been working
to verify some specific facts and, just like the English
Independent Safety Review, we just aren’t finding enough
evidence of safety or likelihood of complications in
In 2014 campaigners from Mesh Down Under petitioned the New Zealand Health Select Committee to commission a full independent inquiry into the use of surgical mesh in New Zealand.
Whilst that didn’t happen, the committee made a number of recommendations to the Government which were all accepted on 25 August 2016.
Then Health Minister Jonathan Coleman said “The Ministry of Health will consider and consult on options for a registry to record the use of surgical mesh.”
“But the reality is that now, almost 2 years later, the Ministry is still ‘consulting on options’ and work on an actual registry has not even begun” said Berry “And now both the Australian Senate Inquiry and the UK Independent review are demanding local registries and mandatory reporting as well”.
“If the registry had been established in 2014 when we asked for it, we would have at least 4 years of robust New Zealand data to refer to in creation of the patient information document assisting health professionals in gaining patients informed consent. Instead we have been relying on the NHS material” said Berry.
Carl Heneghan, professor of evidence based medicine at Oxford University, told UK Sling the Mesh Campaign leader and journalist Kath Samson “The ban on mesh for stress urinary incontinence reflects the inadequate evidence-base that let risky mesh devices onto the market, the lack of long-term evidence to inform their use and the inadequate response of health professionals to emerging harms.
“We now need to learn some serious lessons and not repeat the mistakes of the past. Including listening to patients when health care goes badly wrong and ensuring healthcare is based solely on high-quality research evidence.”
Patricia Sullivan of Mesh Down Under has written to the Minister of Health advising him of the development in England. “We fully support a similar suspension/ pause in the use of polypropylene plastic mesh for the treatment of SUI in New Zealand until a similar list of conditions is met” she said. “This announcement from England is timely as the cost benefit analysis requested by the MOH for a surgical mesh registry is now overdue due and we are concerned that once again the urgency of data collection for this female issue will be sidelined”.
1. Surgeons should only undertake
operations for SUI if they are appropriately trained, and
only if they undertake these operations regularly
2. They report every procedure to a national database/ registry.
3. A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery
4. The reporting of complications via ACC and Medsafe is linked to the register, and are mandatory
5. Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh.