The use of mesh implants by the NHS in Scotland should be banned, a parliamentary report has concluded.
A review into the controversial procedure last year set out new conditions on its use but the findings were criticised by campaigners.
Holyrood’s petitions committee said it had “serious concerns” about the review’s credibility and urged ministers to take stronger action.
The Scottish government said a number of steps were being taken.
It said “serious consideration” would be given to the findings and health boards were expected to implement the committee’s recommendations.
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 – BBC Scotland revealed in December 2016 that hundreds of operations had been carried out since the “suspension”.
And the final draft of the safety review, published in March 2017, was itself mired in controversy.
While it laid out strict criteria for use of the procedure, it did not recommend an outright ban.
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.
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.
“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.
The committee 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.
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.
It said the number of operations for SUI in the six months to March 2018 was at 5% of the previous rate.
Deputy convener Angus MacDonald called for stronger guidance from the Scottish government.
“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.
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.
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).
“The MHRA is the regulator of medical devices across the UK, and responsibility for the agency is reserved to 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.”
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.”
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