Mesh implant removal inquiry finds Scots women 'misled'

Women were left with horrific side effects after having mesh implants implanted through the vagina to treat stress incontinence and pelvic organ prolapse including persistent pain and nerve damage that has left some reliant on wheelchairs.

Scotland's health boards were told to "immediately halt" the use of transvaginal implants altogether in surgery in 2018 following the death of Eileen Baxter, 75.

Multiple organ failure was said to have led to Mrs Baxter’s death, with sacrocolopexy mesh repair – an implant to fix a pelvic organ prolapse – noted as an underlying cause.

Eighteen women who have had implants were interviewed for a review, which was commissioned by the then Health Secretary Jeane Freeman in 2021, amid concerns that a previous government inquiry into their use was flawed.

It found that the amount of mesh tape removed by surgeons in Scotland was dependent on the procedure that was carried out but many women were unaware this was the case.

One woman recalled waking up from the anaesthetic and seeing the surgeon giving her a "thumbs up" and saying it had "all gone". She later discovered this was not the case.

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Another woman who thought she had had a full removal described telling a friend she had had a full removal who had then asked to see the "groin incisions".

She did not have any because the procedure had been carried out vaginally, which meant that only part of the mesh had been taken away.

She said: "It was confirmed that I had a partial removal and my world just fell." 

The review was critical that the type of surgery carried out was not made "explicit" to the women.

"Failing to do this means that the patient does not have all the material information and cannot make an informed decision," the review said.

Some of the case records documented decisions where the participant was incorrectly advised that it was not possible to remove all of the mesh.

One woman said: "Every time I saw [the surgeon] who said, 'Well I'm not really sure how much is left' I said, "My discharge letter says about 1mm and [the surgeon said] 'Well no. We had 6cm from the right side and 4cm from you left.'

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The review was led by Alison Britton, Professor of Healthcare and Medical Law at Glasgow Caledonian University, who said in the report: "All of these women described their euphoria in believing that all of their mesh had been removed and their profound disbelief and dismay when they found out it was not the case."

In the cases reviewed some of the women continued to experience side-effects after the removal surgery. 

Some women said they had requested information regarding their treatment and had been given notes that were "significantly redacted".

"The redactions were not confined to one or two sentences but in some cases entire sentences had been blacked out" leaving women feeling upset and confused as to why this had occurred."

When many of the earlier surgeries took place it was common practice to use a generic consent form that did not detail the risks and complications specific to that procedure. 

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The review found that the devices that caused women to suffer horrific side-effects including groin pain were described as a "miracle cure" by some medics.

One woman spoke of having a "procedure" with no explanation that it involved any sort of implantable device.

Women told of hearing the word "tape" and imagining something "completely different" to the 23cm of polyproylene mesh that was commonly used.

"A wee bit of tape didn't sound too bad," one said.

Another said: "I never got anything that said this was a permanent implant."

None of the women involved in the review were shown an example of the device that was going to be used.

All of the participants reported having urinary incontinence and 16 out of 19 said mesh surgery was described to them as a "gold standard" treatment that would alleviate their symptoms.

Out of the 18 women who were interviewed, six had proceeded with revisionist surgery.

"The numbers weren't huge but I think a lot of the ladies who have chosen not to have surgery so far are anxious," said Prof Britton.

"They don't feel as if they have had enough information.

"The language that was used to explain their potential treatment and the potential outcome of that treatment was inaccurate and in some cases misleading.

"The case records we saw, some women were told it had been removed in its entirety, there has been a full removal.

"The problem is that so much hope is placed on getting the device out of your body. 

"If a lady is told 'we've been successful' 'we've got it all' she is understandably going to think 'bloody marvellous, that's it all out."

The Scottish Government is now funding corrective treatment at specialist centres in the United States, where many discovered they had only had part of the mesh removed.

She said mesh removal "has its place" because for some women it did alleviate their symptoms but for others it did not.

She said: "Unfortunately if there has been nerve damage, some are using wheelchairs, some are in constant pain, taking away a mesh device may not alleviate those symptoms."

Prof Britton said she hoped today's report, which is the culmination of two years of in-depth interviews, would go some way to making amends to the women whose "voices had not been heard."

The report makes a significant number of recommendations, most critically, improvements in communication and consent procedures.

She said: "We need good communication, clear unequivocal communication in commonly understood language so there can be no doubt that if someone says, 'I have removed all of your mesh' that everybody understands what that means.

"Prior to getting the initial surgery none of the women actually saw a piece of mesh and only one of the 18 was informed that it was a device designed not to be removed."

Women’s Health Minister Jenni Minto said:“We have received Professor Britton’s report and we are fully considering its 21 recommendations around improving healthcare services for women experiencing mesh complications.

"I would like to thank all the women who took part and shared their experiences."