'We're absolutely appalled' say mesh campaigners over NICE decision - ITV news Apr 2019

Sly Saint

Senior Member (Voting Rights)
Campaigners fighting to ban the use of vaginal mesh to treat incontinence, say they're 'absolutely appalled' by a decision by NICE not to ban the procedure.

Kath Sansom from March in Cambridgeshire has been campaigning since 2015 after she was given a mesh implant to treat incontinence after childbirth and suffered complications.

Kath says the decision by the National Institute for Health and Care Excellence disregards the experiences of thousands of women.

NICE says it recognises there is 'public concern about the use of mesh procedures' and that there is "some evidence of benefit" for using surgery - including mesh to manage stress urinary incontinence or pelvic organ prolapse. But that there is "limited evidence" on the long-term harms. "In particular, the true prevalence of long-term complications is unknown," it said.
"We are appalled that despite political campaigns and the obvious suffering of many women, these guidelines are no different from what was published in 2003. They are so weak, they clear the way for the next generation of women to be harmed. We told our stories and Nice ignored us."

the problem of lack of recording of harms again a problem
https://www.itv.com/news/anglia/201...lled-say-mesh-campaigners-over-nice-decision/
(the story is also in various papers)

see also this thread:
https://www.s4me.info/threads/healt...-of-medical-treatment-issues.2553/#post-46645


eta: this was the poster for the review, am looking for the results.
https://www.gov.uk/government/news/...t-medicines-and-medical-devices-safety-review
 
Last edited:
this is the review website:
http://www.immdsreview.org.uk/


Statement on the use of surgical mesh following publication of the NICE guideline
02/04/19

Baroness Cumberlege CBE, Chair of the Independent Medicines and Medical Devices Safety Review said:

“We will examine the NICE guideline published today.

Our position is very clear. Last July, we recommended, and NHS England and the Department of Health & Social Care agreed to, an immediate pause in the use of mesh for stress urinary incontinence. We made the recommendation because we had already by then heard from many women, all of whom had suffered terribly following their mesh procedures, and continue to do so. Since then, we have met many hundreds more women across the country who face the same situation. The scale and intensity of this tragedy is truly shocking, lives have been ruined.

We set five conditions that would need to be met before the pause could be lifted and the use of mesh could be contemplated. Those conditions have not yet been met, and it is clear to us that it will be some considerable time before they are. This means that now and for the foreseeable future mesh should not be used to treat stress urinary incontinence either in the NHS or the independent sector.

A restriction in the use of vaginally inserted mesh for pelvic organ prolapse has also been put in place. Abdominally inserted mesh to treat pelvic organ prolapse has, since the introduction of the pause, been subject to an NHS high vigilance regime to address safety concerns. We expect both the restriction and the high vigilance regime to continue.

We are in the midst of our Review and expect to publish our report with recommendations later this year.”

The NICE guidelines are availale to view here: https://www.nice.org.uk/guidance/ng123
 
'We're absolutely appalled' say mesh campaigners over NICE decision

I'm absolutely appalled too. This is NICE telling women everywhere to piss off because their experiences and their quality of life is of no interest and of no importance to the NHS. Saying there is "limited evidence on the long-term harms" just means that nobody has thought it important enough to listen to women and record their experiences of mesh surgery. It wouldn't be that difficult to collate the necessary evidence, but clearly there was no real medical or political will to do so.
 
Very appalling, but no longer surprising, as commerce seems to come before health and safety with governments and industry.

As Dr. Nancy Klimas said in Unrest, "Let me be a feminist here", (paraphrased), and say why do manufacturers and governments think it's OK to implant potentially damaging metal and plastic medical devices into women's urogenital organs?

Canadian Class Action Lawsuit re damages from transvaginal mesh implantation:
https://www.siskinds.com/class-action/transvaginal-mesh/

Health Canada warning re this mesh (not banned):
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/39475a-eng.php

Canadian Urological Association position on this; patients should be made aware:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5461136/
 
Last edited:
'We're absolutely appalled' say mesh campaigners over NICE decision

I'm absolutely appalled too. This is NICE telling women everywhere to piss off because their experiences and their quality of life is of no interest and of no importance to the NHS. Saying there is "limited evidence on the long-term harms" just means that nobody has thought it important enough to listen to women and record their experiences of mesh surgery. It wouldn't be that difficult to collate the necessary evidence, but clearly there was no real medical or political will to do so.

There has been some ‘political will’ as heard in the Debate
‘Safety of Medicines & Medical Devices’ in House of Lords 28.2.2019

(Moved by Lord O’ Shaughnessy) who said, in his opening words:


“Thirdly, and related to the previous point, all these women had been campaigning for years to have their voices heard, their pain and suffering recognised, and it had often fallen on deaf ears. In this respect, the parallels with scandals like the one at Mid-Staffordshire could be seen: a system that too often turns its back when criticised, rather than offering a compassionate and understanding face that seeks to help those affected and prevent the problems occurring for others. It was this insight—that there were common themes that warranted further explanation—that led to my suggesting to the then Health Secretary, Jeremy Hunt, whose abiding principle was that patient safety should always come first, that we needed an independent review into our medicine and medical device safety regime. I was delighted when he and the Prime Minister supported the proposal, and even happier when my noble friend Lady Cumberlege was appointed to lead it. It is fantastic that she is able to speak in the debate today. The work she is doing is so important, and I believe that the way she has engaged patient groups around the country through her review has been truly exemplary. She has already made a big difference, because it was on her recommendation that a pause was instigated on certain mesh procedures in England.”


Then, pay particular attention to Baroness, Lady Cumberlege at 1.50pm in

https://hansard.parliament.uk/Lords...FBE6225E54/SafetyOfMedicinesAndMedicalDevices

So, even with an independent review already started, NICE has made an appalling decision.

Glad to see that Baroness Cumberlege is continuing the fight as shown in @Sly Saint ’s post above.
 
There has been some ‘political will’ as heard in the Debate
‘Safety of Medicines & Medical Devices’ in House of Lords 28.2.2019

Thanks for the hansard link. I'm glad there are some people in parliament with a heart. I still think there are plenty of politicians who had theirs excised at some point in their lives, but that could just be my own prejudice.
 
I agree it's very worrying. It's not only a feminist issue, there is also a problem of mesh used in hernia operations which affects men as well.

BMJ news, September 2018:
Hernia mesh complications may have affected up to 170 000 patients, investigation finds.

https://www.bmj.com/content/362/bmj.k4104

I know a young man in the UK who had a mesh hernia op 10 years ago, luckily without complications so far, but when he needed the other side done, he wanted it without mesh and his local hospital in a big UK city had no surgeons who knew how to do the op without mesh, so he travelled to Germany to have it done and the NHS says it will pay most of the cost of the operation.
 
I agree it's very worrying. It's not only a feminist issue, there is also a problem of mesh used in hernia operations which affects men as well.

BMJ news, September 2018:
Hernia mesh complications may have affected up to 170 000 patients, investigation finds.

https://www.bmj.com/content/362/bmj.k4104

I know a young man in the UK who had a mesh hernia op 10 years ago, luckily without complications so far, but when he needed the other side done, he wanted it without mesh and his local hospital in a big UK city had no surgeons who knew how to do the op without mesh, so he travelled to Germany to have it done and the NHS says it will pay most of the cost of the operation.

I’ve been disappointed with how the problems have been framed. There seems to be an issue with implants in general and a lack of testing and trials. The media focus is very narrow in my opinion.
 
"limited evidence on the long-term harms"
this is what could easily happen with the ME/CFS NICE review re CBT/GET which means that any argument to remove them from the guidelines will need to be carefully phrased in particular to counter the argument that 'the treatments help some people'.
If they deem that there is 'insufficient evidence of long-term harm' (which there will be if they only go by trial results) then there must be a stronger argument with almost indisputable evidence as to why CBT/GET should not be included as specific 'treatments' for ME/CFS.

@Keela Too
@adambeyoncelowe
@Jonathan Edwards
 
he wanted it without mesh and his local hospital in a big UK city had no surgeons who knew how to do the op without mesh, so he travelled to Germany to have it done and the NHS says it will pay most of the cost of the operation.
I developed a serious "hidden" hernia early last year. Five months and 7 NHS doctors later, they still hadn't found it and suggested that my pain was imaginary, or that I had constipation (like I wouldn't know!).

I privately sought out the German hernia surgeon who repairs hernias without mesh (presuming we are talking about the same person), and was lucky to get an appointment with her in London. She found my hernia easily by dynamic ultrasound within 5 minutes of meeting, which the NHS could have done I'm sure, if only they had believed me in the first place.

Unfortunately, I was not well enough to fly to Germany for surgery, which the NHS would pay most of the cost for, and had to foot the entire bill to have it done by her in the UK (absurdly, the NHS will only offer financial aid if the operation is done abroad). I may be very much the poorer, but I was determined not to have mesh surgery if it could be avoided.

The majority of NHS hernia surgeries in the UK are performed on men and virtually all are done using mesh. Although the number of women receiving this surgery is small in comparison, they have a far higher rate of post-surgery complications, largely due to their differing anatomy and greater susceptibility to auto-immune issues.

The German doctor gave me her telephone number/email address and told me to contact her at any time if I have any concerns in the future regarding my recovery. I had to do so last month and, true to her word, she offered her advice freely at no additional charge.

Did my ME diagnosis influence how the NHS treated me? I cannot say, but I was discharged from our local hospital, still in acute pain from an undiagnosed hernia, clutching only a box of unnecessary laxatives . . .
 
I privately sought out the German hernia surgeon who repairs hernias without mesh (presuming we are talking about the same person), and was lucky to get an appointment with her in London.
Probably not, since the surgeon in the case I know of was male! It's not just UK that has a problem. He met another patient having the same op the same day who was from Ireland and had flown to Germany to have the op without mesh.
 
Probably not, since the surgeon in the case I know of was male!
Possibly from the same team, though. They see many patients from outside of Germany for revision of hernia mesh procedures gone wrong, or hernia repair. The surgeon that I saw comes to the UK once a month to operate here, but her male colleague works almost exclusively from the German hospital.
 
this is what could easily happen with the ME/CFS NICE review re CBT/GET which means that any argument to remove them from the guidelines will need to be carefully phrased in particular to counter the argument that 'the treatments help some people'.
If they deem that there is 'insufficient evidence of long-term harm' (which there will be if they only go by trial results) then there must be a stronger argument with almost indisputable evidence as to why CBT/GET should not be used.

I have addressed this specifically in my memorandum to the committee, and repeated it in my summary. The argument aboit helping some people needs to be evidence based. Some people getting better is not evidence.
 
There is also porcine mesh, which is used for some hernia operations. It's supposedly more biocompatible. I don't know how well this works; I would think it is not as strong, but I don't really know:https://www.sages.org/wiki/biologic-mesh/

This mesh is I believe, more expensive than the synthetic. I don't know if it causes health problems.

As @Diluted-biscuit says, there seem to be issues with all implant devices. I would add bone grafts to that. One's own bone is hopefully exempt from that. But allografts, and xenografts don't necessarily work for everyone, no matter how many supportive scientific studies are written.

Titanium dental implants are suspect by holistic dentists, whom I understand advise these implants can make people sick. I don't know if they have an evidence base on this.

Although, what choice would someone with a shattered hip have? They need it replaced; unless I'm wrong, some form of metal needs to be used - hopefully more biocompatible metals.

There are now zirconia implants on the market - however, there is a concern with this material fracturing: https://onlinelibrary.wiley.com/doi/full/10.1111/prd.12180
https://onlinelibrary.wiley.com/doi/full/10.1111/prd.12180

And, there are the issues of breast implants causing illness, as well Essure, a permanent birth control device that has caused life-changing pain for many, many women: https://www.s4me.info/threads/canad...tigation-of-medical-devices.7033/#post-126749
 
There are issues with implants, just S there are issurs with drugs, cars, kettles and lawnmowers. But it wpuld be a mistake to generalise. Titanium is excellent for dentistry and no good for hip replacements.

The central problem is treatment for profit. That drives huge numbers of unnecessary operations. If surgeons were paid a standard wage to select the best treatment or, equally, no treatment people might be a lot healthier.

There is also a laxity of regulation in terms of evidence requirement fpr surgery just as there is for therapies.
 
There are issues with implants, just S there are issurs with drugs, cars, kettles and lawnmowers. But it wpuld be a mistake to generalise. Titanium is excellent for dentistry and no good for hip replacements.

The central problem is treatment for profit. That drives huge numbers of unnecessary operations. If surgeons were paid a standard wage to select the best treatment or, equally, no treatment people might be a lot healthier.

There is also a laxity of regulation in terms of evidence requirement fpr surgery just as there is for therapies.


Yes, titanium is excellent for dentistry. I forgot to mention that point. I don't know what is used for hip replacements, but will defer to your knowledge.

I have found one can Google till the cows come home looking up all kinds of peer reviewed articles about various medical devices, and treatments, but what may be concluded in these articles still may not fit the individual. And yes, unfortunately I have seen the drive for profit all too often. Especially in dentistry - there is no universal dental care in Canada.

@Jonathan Edwards, thank you very much for your research re ME/CBT/GET issues, and your work with the NICE committee. I watch from afar in Canada, but with the knowledge that what is decided will effect hundreds of thousands in Canada as well. We are glad to have you in our corner.
 
blog on BMJs website by Carl Henegan
Carl Heneghan
Editor in Chief BMJ EBM, Professor of EBM, University of Oxford

NICE’s committee discussed making research only recommendation for POP. However, they considered it would be doubtful that any suggested research would be conducted, as it would be inappropriate to blindly randomise women to mesh surgery. This I find puzzling: surgery is virtually always open-label and not blinded. The way to get around this, and to minimise bias, is to use objective outcomes and to ensure other aspects of the trials (such as the outcome assessors) are blinded.
https://blogs.bmj.com/bmjebmspotlight/2019/04/04/what-a-mesh/
 
Back
Top Bottom