Mesh expert voices concerns over patient safety

BBC Dr Wael AgurBBC
Dr Wael Agur said he believed mesh implants should only be used in exceptional circumstances

The expert at the centre of a review group looking at the safety of mesh implants in Scotland has spoken for the first time about why he resigned.

Dr Wael Agur told BBC Scotland he believed patient safety was being put at risk.

He said mesh should only be used in exceptional circumstances due to the risk of "irreversible" damage.

The Scottish government said no evidence had been deleted or hidden from the review group's report.

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.

Mesh implant surgery 'decimated my quality of life'

Over the past 20 years, more than 100,000 women across the UK have had transvaginal mesh implants - including more than 20,000 in Scotland.

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.

In 2014, former Scottish Health Secretary Alex Neil called for the suspension of such procedures, and an independent review group was set up to look at safety issues.

Dr Agur, a consultant urogynecologist, was a member of the review group but said he was forced to step down earlier this year after an entire chapter of the final report was removed and put in the appendices.

It followed the resignation of two patient representatives on the group who claimed the report had been "watered down" and that it was ultimately "a whitewash".

At the time, Health Secretary Shona Robison said no evidence would be hidden in the group's final report.

mesh

Dr Agur said he reviewed the most up-to-date research in the UK and internationally and concluded that non-mesh surgical procedures were safer, but said that such conclusions were removed or changed.

He told BBC Scotland: "It was so important that we got this right. Not just for women in Scotland but for women around the world. Scotland was the only country where an independent review was running to look at the benefits and risks of these procedures.

"I believe the report has left the door slightly open for some procedures to be performed and that should not have happened."

Dr Agur said he believed mesh use should be avoided in future in all but the rarest circumstances because of the risks of "acute" and "irreversible" damage.

Asked if he believed the final report by the review group was a whitewash, he said: "Whitewash is a political term and I am not a politician. I'm a clinician and a researcher and a surgeon and I can tell you that I looked into the evidence that compares all these procedures and I concluded that they should either not be performed at all or restricted to clearly defined situations where not a single surgeon but a group of surgeons nationally should decide."

Based on the evidence gathered, he said he expected the review group to conclude that mesh use should not continue and that the suspension should remain in place.

He said that ultimately the report gives surgeons in Scotland and globally the impression that its use should continue.

'Different format'

On Thursday, Dr Agur will give evidence to the Petitions Committee at the Scottish Parliament.

In his written submission, he stated: "The report did not adequately warn surgeons and patients against the serious risks with the transobturator mesh tape (the type most commonly used in Scotland).

"The report ignored the best evidence on mesh-related adverse events that described the prevalence of a negative outcome to be as frequent as 15% (1 in 7).

"On interpreting the evidence tables comparing safety of surgical procedures, I came to the following conclusions: Non-mesh procedures are safer than mesh procedures for incontinence. Transobturator tape is too risky to be offered, except in very rare circumstances. Prolapse mesh has no benefit and is too risky to be offered."

His submission to MSPs added: "As the chapter was deleted, its evidence did not inform the recommendations of the final report."

Scotland's Chief Medical Officer, Dr Catherine Calderwood, said she had "fully accepted" the recommendations made by the independent review and had been clear that the suspension of the use of mesh implants should remain in place until she was satisfied they had been implemented.

She added: "The cabinet secretary met with the chair of the independent review, who informed us that some evidence has been presented in a different format to that of the interim report, but that no evidence has been deleted or hidden.

"The interim report is available to read on the independent review's website and the final report builds on that.

"The clinician who resigned from the review group drafted an alternative version of one chapter which was not agreed by the rest of the group, but in the interests of transparency was published on the Scottish government website.

"A review is being carried out into the process of the independent Review, which will make recommendations about the conduct of future similar reviews and will report back next year."‎