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
published research”.
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”.
Conditions:
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.
ENDS.
http://immdsreview.org.uk/