Mesh implant campaigners 'betrayed' by report publication

Patient representatives Olive McIlroy and Elaine Holmes resigned from the review group earlier this month

Two campaigners against mesh implants say they are "dismayed and disgusted" at the publication of an independent report into their risks and use which they claim has been "watered down".

Olive McIlroy and Elaine Holmes, who resigned from the mesh implants review group, said they felt "utterly betrayed" by the publication.

It was claimed that parts of the final report had been removed.

The Scottish government said it had accepted the recommendations in full.

The report said mesh implant procedures must not be offered routinely to women with pelvic organ prolapse.

The expert group concluded that patients should be offered a range of treatments - mesh and non-mesh - and must be given the information to make "informed choices".

Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.

• What's the issue with mesh implants?

Ms McIlroy, from Renfrew, and Ms Holmes, from Newton Mearns, both suffered severe complications following mesh implant surgery.

Following their resignations earlier this month, it emerged that a consultant also quit the expert group over concerns about the final draft of the report.

The consultant claimed that an entire chapter, which highlighted concerns about the use of mesh in some procedures and contained tables displaying the risks of treatment, had been taken out.

That chapter has been published but only as an attachment to the final report, and table two from that chapter - which highlights the risks of mesh implants - is still missing altogether.

What the report says:

• Mesh must not be offered routinely to women with pelvic organ prolapse

• Reporting of all procedures and adverse events should be mandatory

• Extra steps to ensure patients have access to clear, understandable advice to help them make informed choices

• Calls for improved training and research

• All treatments should be made available to treat incontinence - including mesh

The final report states: "It is clear that a number of women have suffered serious, life-changing complications following transvaginal mesh implant surgery.

"It is also evident that many women have benefited from these procedures.

"However, due to the way these procedures are coded, it is not possible to provide accurate data on the number of mesh procedures where complications have occurred.

"This lack of information, allied with the fact that adverse events have been under-reported, has led to opinion being divided on the safety of transvaginal mesh procedures."

The Scottish government said it would now set up an oversight group to ensure the recommendations were implemented.

Former health secretary Alex Neil described the decision to publish the report without investigating claims of a whitewash to be "totally unacceptable".

'Not in our name'

In a joint statement, Ms McIlroy and Ms Holmes said: "We are dismayed and disgusted that the Scottish government have seen fit to publish this tainted report despite all the concerns raised by us and the expert who resigned in protest over missing vital evidence and safety warnings on mesh.

"We are furious that our name has not been removed from a report which we believe is nothing more than a whitewash and a betrayal of every one of the hundreds of Scottish women who have had their lives devastated by the injuries caused by mesh implants, and their families.

"We are seeking legal advice on the matter as we have repeatedly told both the head of the review and Health Secretary Shona Robison that our names must be removed from this report, and any input we have had be withdrawn.

"The report as it stands is most certainly not in our name."

They added: "Almost 100 MSPs have signed a pledge promising there will be no whitewash on mesh. We are taken aback that Shona Robison has chosen to ignore everyone who has raised concerns.

"Every single women who is injured in the future can now lay the responsibility squarely at the door of Shona Robison. We feel utterly betrayed."

Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants but some have suffered painful and debilitating complications.

There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.

Suspension request

In 2014, campaigners gave evidence to the Holyrood Petitions Committee. Several of them were in wheelchairs, unable to walk because of surgical complications.

As a result Alex Neil, the Scottish government's health secretary at the time, wrote to health boards requesting a suspension in the use of mesh implants by the NHS in Scotland, pending the review group's investigation into their safety.

An interim report was delivered in October 2015 with the final report now published.

Alex Neil said the allegations should be fully investigated

Mr Neil - who is now a backbench MSP - said: "This is totally unacceptable if they have published and accepted this report without these allegations being fully investigated. If there has been a cover-up, then this needs to be investigated. There now needs to be an independent review of the process."

Dr Catherine Calderwood, Scotland's chief medical officer, said: "I want to thank this independent review for their hard work over a lengthy period of time. This is a highly complex and technical subject area and they had a wide range of evidence to consider.

"The group included a wide range of people with differing views and all of their contributions have been very valuable.

"On behalf of the Scottish government I am today accepting the conclusions of the review group. It is vital that women are given all the available information before they decide whether to go ahead with a mesh procedure. It is also right that all adverse events are properly reported so that we can continue to improve safety and positive outcomes."

'Final stages marred'

She added: "We must remember that this review came about because of the tireless campaigning of women who have been negatively impacted by mesh procedures. It is right that we recognise the courage of these women, which has brought us to this point today.

"I want patients to have the best and most up-to-date information on which to base their decisions - in discussion with their clinicians. I will be looking for the newly-formed oversight group to ensure this happens."

Tracey Gillies, chairwoman of the independent review, said: "The final stages of completion of the review have been marred by suggestions that evidence has been destroyed or is missing,

"I am confident that is not so and have written to the cabinet secretary for health and sport setting out the approach taken. The material presented by one group member and not included in the final report is available on the website with the declarations of interest from group members."

She added: "I have no doubt that the implementation of the conclusions in this report will provide benefit to women across Scotland, and will provide clinicians with additional tools to support their engagement with realising realistic medicine, allowing better decisions to be made jointly with patients."

Labour MSP Neil Findlay said the review was "every bit the establishment stitch-up the Scottish mesh survivors said it would be".

"Essential information has been omitted, reports overlooked and data hidden to ensure the review presents what I suspect was a predetermined position from day 1 in favour of continuing to implant mesh which has caused so many women long-term, life-changing damage to their health."