New Zealand ban controversial vaginal mesh procedures
New
Zealand has become the first major country in the world to ban all vaginal
mesh procedures, which have been called “the biggest health scandal since
thalidomide”.
The New Zealand Medicines
and Medical Devices Safety Authority (Medsafe) declared it would remove
from supply and limit the use of surgical mesh products.
According
to its statement, most suppliers in New Zealand have indicated that by
January 2018, medical companies will "be taking the same steps to limit
supply as they are in Australia”.
It
comes just two weeks after the death of Chrissy Brajcic, prominent
anti-mesh campaigner, developed an antibiotic resistant infection due to
mesh complications, which led to sepsis.
It also
follows the decision by the Australian Therapeutic Goods Administration (TGA) to ban single-incision minislings and transvaginalmesh
implants specifically for
treating pelvic organ prolapse.
In contrast, the health
minister of New Zealand, Julie-Anne Genter, told companies they are not
permitted to supply surgical mesh for any pelvic operations – including both
urinary incontinence and prolapse.
Ms Genter said: “This is an important step to
preventing more women from being put in the potentially harmful situation too
many New Zealand women have already experienced.”
Surgical
mesh will still be available for other conditions, such as hernias. Such
treatments have also courted
controversy.
Kath
Sansom, founder of campaign group Sling the Mesh, told The
Independent: “We are thrilled that New Zealand is leading the way
in stopping the devastation caused to women by pelvic mesh implants.
"Full credit must go to
campaigners Carmel Berry and Charlotte Korte, who have successfully made
political leaders realise the serious harm caused by these devices.
“For some women, problems do
not cut in until years later – which means the mesh is merely a ticking time
bomb with an unknown future for all those who have it.
She added: “It is now time for
Westminster and governments globally to do the right thing and ban all pelvic
mesh. It is a huge injustice to women whose lives have been shattered for two
decades, in this profit-before-patient safety, money-making tragedy.”
In
October, Ms Sansom and Labour MP Emma Hardy took a cross-party campaign to
Westminster to push for a suspension and full inquiry into the scandal.
However, minister for care and
mental health Jackie Doyle-Price maintained that the risks were associated with
clinical practice, not the mesh implants themselves, and ruled out a suspension
or inquiry.
The Urological Society of Australia and New Zealand (USANZ) has
condemned the decision, saying it left women in New Zealand without options.
A spokesperson said: “The Australian TGA decision to ban
transvaginal mesh for pelvic organ prolapse is accepted by the urological
community in Australia and New Zealand, but our health minister’s decision to
ban all forms of mesh for incontinence as well as prolapse in women in New
Zealand is more far-reaching than the Australian decision.
“This will leave women without effective surgical options for
these debilitating conditions.”
One of the products
specifically targeted by the New Zealand ban is the Johnson & Johnson
“Gynecare TVT” device.
A BBC Panorama documentary on
the vaginal mesh scandal, “The Operation that Ruined my Life”, revealed that the Gynecare TVT was only trialled on 31 women –
and some sheep.
It also discovered that Ethicon, a wholly-owned subsidiary of of Johnson &
Johnson, failed to update doctors with the full extent of risks associated
with the device.
There has been significant
backlash to the suggestion in the documentary that only a minority of the women
implanted with a mesh device experienced chronic and debilitating side
effects.
Based on the available data and
testimony from device experts, gynaecologists and policy organisations
including the Food and Drug Administration, the US regulatory body, the risks
of such effects are estimated between 10 and 40 per cent.
MP Owen
Smith, chair of the All-Party Parliamentary Group on surgical mesh implants,
said one in 10 women suffering due to the implants was not “a minority issue”.
This
Friday, the National Institute for Health and Care Excellence(Nice) will
publish updated guidelines on the procedures. They are expected to recommend a
full ban on vaginal mesh.
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