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Holyrood committee calls for a ban on mesh implants MSPs call for ban on mesh implant use
(about 11 hours later)
The use of mesh implants by the NHS in Scotland should be banned, a parliamentary report has concluded. The use of mesh implants by the NHS in Scotland should be completely banned, MSPs have said.
A review into the controversial procedure last year set out new conditions on its use but the findings were criticised by campaigners. The Scottish government called for the use of mesh implants to be suspended four years ago while an independent safety review was carried out.
Holyrood's petitions committee said it had "serious concerns" about the review's credibility and urged ministers to take stronger action. But about 500 women have had the controversial procedure in Scotland since then.
The Scottish government said a number of steps were being taken. A report by Holyrood's public petitions committee has urged minsters to take stronger action.
It said "serious consideration" would be given to the findings and health boards were expected to implement the committee's recommendations. And it said the committee had "serious concerns" about the credibility of the safety review, which laid out strict criteria for use of the procedure but did not recommend an outright ban.
Over the past 20 years, more than 100,000 women across the UK have had transvaginal mesh implants, which are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), often after childbirth. Prof Alison Britton is currently carrying out a review of the review, and is due to report later this year.
The mesh, usually made from synthetic polypropylene, is intended to repair damaged or weakened tissue. The Scottish government's chief medical officer, Dr Catherine Calderwood, defended the continued use of mesh implants, which she said were now only given to a very small number of women whose symptoms were such that there was no better alternative.
While the vast majority of women suffer no side-effects, others have reported chronic and debilitating pain, with some being left unable to walk. Dr Calderwood also said medical research had shown that the implants could be used safely in certain circumstances, and that the procedure was only carried on women who were aware of the potential side-effects.
Concerns were first brought to the attention of the Holyrood's petitions committee in 2014 by campaigners who complained that complications were frequently under-reported by doctors. Last month, the NHS in England announced it was following Scotland's lead in stopping the use of mesh implants - although it too said "carefully selected patients will continue to have access in discussion with their consultant."
Guidance ignored What are mesh implants?
The Scottish government urged all health boards to stop using the procedure until more evidence was gathered - and set up an independent review to look into safety concerns. Concerns were first brought to the attention of the Holyrood's petitions committee in 2014 by campaigners who complained that complications were frequently under-reported by doctors.
But the guidance was widely ignored - BBC Scotland revealed in December 2016 that hundreds of operations had been carried out since the "suspension". The Scottish government urged all health boards to stop using the procedure until more evidence was gathered and set up an independent review to look into safety concerns.
And the final draft of the safety review, published in March 2017, was itself mired in controversy. But the guidance was widely ignored, with BBC Scotland revealing in December 2016 that hundreds of operations had been carried out since the "suspension".
While it laid out strict criteria for use of the procedure, it did not recommend an outright ban. The final draft of the safety review, published in March 2017, was itself mired in controversy.
Campaigners, including Elaine Holmes and Olive McIlroy, who lodged the original petition with the parliament on behalf of the Scottish Mesh Survivors campaign, branded it a "whitewash". Campaigners, including Elaine Holmes and Olive McIlroy - who lodged the original petition with the parliament on behalf of the Scottish Mesh Survivors campaign - branded it a "whitewash".
They resigned from the review, as did expert clinician Dr Wael Agur.They resigned from the review, as did expert clinician Dr Wael Agur.
Holyrood's petitions committee said it was worrying that an interim draft of the safety review report was modified before the final version was published. MSPs on the petitions committee said it was worrying that an interim draft of the safety review report was modified before the final version was published.
"We have serious concerns about the credibility of the final report as a basis for informing both clinicians and patients to make fully informed decisions," it said in a report published on Tuesday. They said: "We have serious concerns about the credibility of the final report as a basis for informing both clinicians and patients to make fully informed decisions".
The committee said its preference was for "the use of mesh devices to treat SUI and POP to cease in Scotland". The committee criticised the continued use of mesh procedures, and said its preference was for "the use of mesh devices to treat SUI and POP to cease in Scotland".
The report criticised the continued use of the procedure in Scotland despite the request for a moratorium. Its deputy convener, SNP MSP Angus MacDonald, called for stronger guidance from the Scottish government.
The Scottish government said the total number of mesh operations had fallen considerably since it requested that health boards suspend the use of transvaginal mesh in 2014. He said: "The committee expects a positive response from the Scottish government, particularly given we're awaiting the review of the review from Prof Alison Britton which will hopefully shed some more light on this extremely upsetting saga".
It said the number of operations for SUI in the six months to March 2018 was at 5% of the previous rate. Dr Calderwood told the BBC's Good Morning Scotland programme that the procedure had been carried out 50 times in the first six months of this year - which she said was just 5% of the figure prior to a moratorium being called for.
Deputy convener Angus MacDonald called for stronger guidance from the Scottish government. She added: "It is only under very specific circumstances, where there is no other choice and a woman's symptoms are such that she says 'I understand the risk of this procedure but I want to go ahead because I'm not able to live with my symptoms'".
"The committee expects a positive response from the Scottish government, particularly given we're awaiting the review of the review from Professor Alison Britton which will hopefully shed some more light on this extremely upsetting saga," he said. Dr Calderwood referred to medical studies that had shown "there are circumstances under which the mesh can be used safely and the risk of complications is low".
Designated centres Best option
A Scottish government spokesman said the chief medical officer would develop designated centres able to treat the "very few" women who have no choice but procedures using a mesh, while also overseeing an audit of all procedures in Scotland in future. And she said there was a lack of alternative procedures for some women, which meant that mesh would be the best option for them.
The Scottish government pointed out it had no power to enforce a ban the use of mesh, which is a matter for the Medicine and Healthcare products Regulatory Agency (MHRA). A Scottish government spokesman said the chief medical officer would develop designated centres which were able to treat the "very few" women who have no choice but to have a mesh procedure, while also overseeing an audit of all procedures in Scotland in future.
"The MHRA is the regulator of medical devices across the UK, and responsibility for the agency is reserved to Westminster. The spokesman also said the Scottish government did not have the power to ban the use of mesh, which was a matter for the Medicine and Healthcare products Regulatory Agency (MHRA), which is the regulator of medical devices across the UK and is the responsibility of Westminster.
"The Scottish government cannot therefore ban mesh. We have, however, repeatedly raised concerns about mesh with the MHRA when they have been brought to our attention and, were the agency to issue a medical device alert in relation to it, health boards would be fully expected to act on it." He added: "All health boards are fully expected to implement the recommendations of the independent review.
The spokesman added: "All boards are fully expected to implement the recommendations of the independent review.
"The Scottish government's request that they suspend use of transvaginal mesh will remain in place until the chief medical officer is satisfied that they have been implemented, and all necessary safeguards are in place.""The Scottish government's request that they suspend use of transvaginal mesh will remain in place until the chief medical officer is satisfied that they have been implemented, and all necessary safeguards are in place."
Mesh implants - timelineMesh implants - timeline