MSPs call for ban on mesh implant use
The use of mesh implants by the NHS in Scotland should be completely banned, MSPs have said.
The Scottish government called for the use of mesh implants to be suspended four years ago while an independent safety review was carried out.
But about 500 women have had the controversial procedure in Scotland since then.
A report by Holyrood's public petitions committee has urged minsters to take stronger action.
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.
Prof Alison Britton is currently carrying out a review of the review, and is due to report later this year.
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.
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.
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."
What are mesh implants?
- 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.
- The mesh, usually made from synthetic polypropylene, is intended to repair damaged or weakened tissue.
- While the vast majority of women suffer no side-effects, others have reported chronic and debilitating pain, with some being left unable to walk.
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.
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.
But the guidance was widely ignored, with BBC Scotland revealing in December 2016 that hundreds of operations had been carried out since the "suspension".
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".
They resigned from the review, as did expert clinician Dr Wael Agur.
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.
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 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".
Its deputy convener, SNP MSP Angus MacDonald, called for stronger guidance from the Scottish government.
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".
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.
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'".
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".
And she said there was a lack of alternative procedures for some women, which meant that mesh would be the best option for them.
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 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.
He added: "All health 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."
Mesh implants - timeline
- April 2014 - Campaigners lodge a petition at the Scottish Parliament, calling for a suspension of mesh implant surgery.
- June 2014 - Women, some of them in wheelchairs, give evidence to Holyrood's petitions committee about the debilitating consequences of their surgery. Health secretary, Alex Neill asks Scotland's health boards to suspend the use of mesh while an independent review is carried out.
- October 2015 - New health secretary, Shona Robison, apologises to women affected and says the suspension will remain in place.
- December 2016 - Figures obtained by BBC Scotland reveal that 404 women have received mesh and tape implants since the health secretary called for the suspension in June 2014.
- March 2017 - Patient representatives Olive McIlroy and Elaine Holmes resign from the independent review group, claiming its final report has been watered down. The review says the procedure should not be used routinely for pelvic organ prolapse cases, and for incontinence, women should be given full information about the risks before making their decision.
- May 2017 - Shona Robison asks Prof Alison Britton of Glasgow Caledonian University to conduct a review of the independent review
- July 2018 - NHS England says the use of mesh implants will be "paused" until strict new conditions are met but will remain as a treatment of last resort for some patients