Thousands suffer in silence

  • Mesh Report does not look into mesh safety.
  • At least one in 11 women have complications.
  • Hundreds more suffer in silence as six in ten surgeons don’t log problems.
  • Women who go to doctors or outpatients are not logged in mesh risk statistics.
  • More than 126,000 mesh tape implants used in England alone in last decade.
  • More than 4,800 mesh tape implants have been removed and 1,200 adverse events logged in England in the past decade but because of under-reporting, the real figure will be much higher.
  • Pelvic mesh been used in NHS for 20 years.
  • Patient reps and leading mesh removal surgeon not invited to mesh report meetings for 18 months.

Women are outraged after realising the NHS never intended to investigate mesh implant safety despite undertaking a three-year mesh review costing thousands of pounds.

A long-awaited report was never given funding to look at the mesh product itself. The review began in 2014 and involved experts and patient representatives. It only commissioned to look at patient leaflets, under-reporting and how to deal with women who suffer mesh complications.

Labour MP Owen Smith, who has set up an All Party Parliamentary Group into mesh, said: “Mesh-injured women will be deeply disappointed by the outcomes of the final NHS England review, which seems to have made little progress since its interim report came out over a year ago.

“This was an opportunity for the NHS to take a lead and recommend a pause in the use of mesh until we know precisely how many women have been adversely affected by the product. Instead, they appear content to allow mesh to be widely used despite growing, international concerns about its potential ill effects.

“The only people pleased with this report will be the medical device companies who marketed mesh so diligently and who now fear mass litigation. Many companies have already taken their mesh products off the market, that alone should tell us something is not right with these devices.”

Surgeon Wael Agur said: “If we cannot obtain accurate figures on the true risks in real life, we cannot continue offering these procedures in the future. The UK mesh group did not plan to comment on safety of mesh procedures in comparison to the alternatives. Recording these procedures on a national database and reporting adverse events to watchdogs must be made mandatory.”

Kath Sansom, of campaign group Sling The Mesh, said: “They might as well park an ambulance at the bottom of a cliff and wait for women to fall in. They should have looked at product safety, not at ways to fix women once things have gone wrong.

“How can a major study of mesh not look at mesh safety. It is a whitewash. The NHS paid lip service to patient reps. Mesh implants are the only operation done blind, using large hooks to put in plastic that can then shrink, twist or degrade inside the body. But nobody has explored that.

“We want a full investigation and audit into how many women are suffering from mesh implants. While that takes place, we want a mesh suspension. We want a national register and NICE to urgently bring its SUI guidelines forward from 2019.”

Life-changing pain

David Golten, partner and head of litigation at City law firm Wedlake Bell, leading the group legal action for Sling The Mesh, said: “The suffering of women affected by surgical mesh implants is immense. They live not only with life-changing pain, but they also have to accept they will never again be the people they once were. The emotional impact of that for them and their families is appalling, and all for an operation that was supposed to improve their quality of life.

“We are putting together a team of leading legal experts from around the globe to represent these women to make sure they receive the redress they deserve.”

Surgeon Suzy Elneil, of UCLH, said: “The complexity of mesh surgery, no matter where it is placed, is not in the putting it in-situ, but in the preparation of the patient. This includes taking a proper history, investigating appropriately, instituting non-invasive measures such as physiotherapy, and offering the patient options of all available therapies. All of this requires informed consent, including the pros and cons of every procedure being discussed at length.

“In addition, should complications arise, there should be a defined pathway of care. But, above all the patient must be listened to and supported by us in the profession. To do otherwise would be harmful at all levels.”

Retired surgeon John Osborne said: “Undoubtedly many women have been helped by the TVT operation, but the complication rate seems to have been under-reported. My feeling is too many women have had this procedure as a quick fix when the symptoms did not justify the risk.”

Jemima Williams of Welsh Mesh Survivors said: “Wales has been ignored for years. This is the tip of a huge global iceberg that needs to be addressed now. Mesh should be suspended until an investigation is made into the adverse effects. No other life should be destroyed.”

Jackie Harvey of Northern Irish mesh support group, said: “Over 200 mesh-injured women in Northern Ireland have joined the local support group within the past four weeks. Heartbreaking stories of going to seek help with pain and infection only for many of them to be fobbed off or told they are the only one. The realisation is now dawning that they are unlikely to get the treatment they need in Northern Ireland, so are increasingly turning to England and choosing to pay for private treatment by mesh complication experts there.”

Scottish Mesh Survivors said: “Patients should not have had to campaign for years to highlight the suffering mesh implants have caused and to get basic safety measures in place. It is no longer acceptable for surgeons to assume that if a device has made it onto an NHS shelf it is safe.

“We have been let down badly by pro-mesh health professionals who cannot fix us when serious complications occur, and we have been let down by the MHRA who regurgitates the claim that the ‘benefit [of mesh] outweighs the risk’ without having necessary data to back up this up.

“We need the Government to step up to the mark and take responsibility for what is arguably the biggest health scandal ever and stop these procedures now!”

Resignations

Four of seven patient reps resigned from the NHS review as they claimed they were not listened to and were not invited to meetings for the past 18 months.
Teresa Hughes said: “This final report was made without patient members being on the oversight group and having no input. We were treated disgustingly, no communication for months.”
 
Jill Lott, patient rep who resigned, said: “We were nothing but a pawn to allow them to say patients were part of the process.”
 
Ann Boni said: “Patients were invited to these meetings as a box-ticking, lip service exercise on behalf of NHS England and the Department of Health. We have been treated as little more than an annoyance. They failed to listen to us.”
 
Ingrid Hardacre said: “While I welcome the much-needed addition of giving GPs more information, including 18 mesh specialists centres, this report has changed nothing, as it is till pro-mesh. Patients will continued to be harmed by dangerous, blind mesh procedures.”

‘Key areas of action’

A spokesman for NHS England said the interim report “recognised three key areas of action and made recommendations on what should be done to tackle them”.

It said: “These focused on improving clinical quality and practice to achieve good outcomes consistently, better data and information, and informed consent. It has not been NHS England’s role to set the direction of the work: the expertise and experience in this field lie with the clinicians and patients.

“The working group’s role has been to identify issues causing concern in the treatment of SUI and POP, particularly surrounding use of mesh devices, and make recommendations to the health system to address them.”

For the mesh report, the NHS commissioned and provided funds to look at:

  • Encouraging surgeons to report problems. Six in 10 don’t.
  • New patient information leaflets.
  • How to deal with women suffering. Within that 16 hospitals in England and Scotland have become specialist mesh problem centres. There are none in Wales or Northern Ireland. Surgeons at some centres have no comprehensive mesh removal experience and many are known to have told women they are mystery mesh patients.

The NHS relies on NICE guidelines into mesh. However, the last major review of incontinence mesh was 2013. It was revised in 2015. The next major review is 2019. For prolapse mesh, a study, called PROSPECT, shows there are no benefits to using mesh and carries risk for at least one in ten women.

Watchdog body the MHRA said the mesh causes serious complications for a minority of women, but it remains an effective treatment option. It said the benefits of vaginal mesh implants outweigh the risks.

Some of the English group patient reps resigned due to not being listened to. They were made oversight members 18 months ago and have not been invited to any meetings in that time.

The Guardian reported the MHRA tried to limit media attention on mesh.

Westminster meeting

Members of Sling the Mesh held a packed meeting with Mr Smith on July 18 in Parliament where women and their families wept as they gave harrowing accounts of traumatic complications suffered from mesh implants.

At the meeting Carl Heneghan, professor of evidence-based medicine at Oxford University, said mesh was like the thalidomide scandal – except with that you could see the injuries. With mesh, problems are hidden.

Politicians in Scotland called for a suspension of mesh use in 2014; however the material is still widely used in England, Wales and Northern Ireland.

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15 thoughts on “Thousands suffer in silence

  1. I am male and had a mesh inserted to repair a hernia in January 2014. Since day 1 following the operation I have been in pain daily, which for some unknown reason is horrendeous from teatime onwards. I have been passed from pillar to post to try and find out what is causing it. Since no one can come up with an answer I was told in December 2017 by a consultant that no further action would be taken and so I am now left to deal with this on my own. The problem is none of the pain medications work. I am convinced it’s caused by an immune reaction to the mesh but can’t find a practitioner to support me. As I live in Northern Ireland I don’t have an MP I can complain to, as the Local Assembly is currently defunct.

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    1. Hi Ray, I too had a mesh repair. However, mine was 2009 and like you, I have been in pain since day one!

      I have gone through the several nerve blocks and nothing really takes the pain away. I also find the more I try to do the more I hurt, which is often worse later on in the day because of that. My wife is now my carer (which is awful, mentally).

      I too have been pushed and pulled about resulting in different diagnoses. For instance the surgeon I have seen recently told me I did not have a hernia, but a lipoma!

      He sent me for an MRI. Which ended up being 2 MRIs, the first (I was told) was not good enough resolution (their fault not mine) and I needed another, which isn’t easy to do when in pain and you have to be absolutely still.

      My research suggests that nerves and the mesh are nearly impossible to see with MRI scans.

      After, I met with the surgeons registrar who said the MRIs showed nothing (no surprise), but she did confirm that nerves etc are impossible to see. after that I asked her about a lipoma and said ‘not really a lipoma just a few fatty cells’ … and my pain is just hyper sensitivity… mind boggling, was there even a need for the mesh!

      I was originally told by the original surgeon back in 2010 that I have scar tissue. And eventually told nerve damage, which i have been under the impression since the hyper sensitivity diagnosis in 2017.

      However, I have pushed for a mesh removal, which they said they would do (but your head be it type of thing)… but I have discovered that a mesh removal can make things worse or not even improve on the pain but the nerve being cut in unison would offer better results… yikes ! That is a serious thing right? And therefore more risk?

      The NHS has taken 6 years to even contemplate an op now it’s got be more involved than expected.

      I am now having to attend another MRI too as I am going back to the surgeon … maybe they will set it to 1080p full HD this time LOL!!! This is after months of contemplation and I want them to do an exploratory op to find out what the hell is going on. But now I fear with further cuts they will probably deem an op not viable, but would of splashed out on x3 MRIs!

      I have therefore taken upon myself to further my options and to not risk myself under the NHS, so I wrote to the London hernia hospital (private and not sure if something like this exists in NI) who have said in hearing my story that I should see one of there consultants at £150 without tests or diagnostics… jeez! God knows how much it will be to have an op with these guys.

      However, there is the Bistish Hernia (charity based, I think) who I am also going to email to see if they are willing to give a consultation. I really want an outside opinion on my hernia repair as anything I have come against in the NHS is protect their own and hide behind statistics .

      Good luck and I hope you can decipher any helpful points within my waffle!

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      1. In this part of France the system is part privatised and so I was on the conveyor belt to a private hospital. They did not want to answer my questions even before an operation and my anxiety resulted, not in some counseling about all my options, but in the cancellation of the operation, and no further responses, except for a letter to my gynecologist, copy to me, addressed to my dearest colleague and describing a difficult patient with no name. When I finally saw my gynecologist, three months later she asked me what the sad death of Christine Brajcic had to do with me. And why would I worry about ‘just one’ death!

        The NHS has many faults and needs some serious changes to improve it, but there are a couple of things to really value
        1 Continuity of care. Private hospitals don’t have the same obligation.
        2. Responsibility and a centralised system. The NHS takes responsibility for each patient.
        3 Compassionate and individualised care.
        4.From what I’ve read the NHS has now responded to the global crisis, even if its taken ages in your lifetime. The NHS does seem to disucss individual choices, it does update its guidelines regularly and has set up some specialist centres. to deal with mesh problems.

        Here its business as usual, the patient information sheets are not regularly updated and all complications are glossed over.and called rare or exceptional, when global evidence suggests the opposite.

        In the states, some people it seems cannot even get enough pain medication.

        So the NHS may yet be your best friend.

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  2. Dear Duncan
    The issue is close to my heart on two counts. I have just slipped out of the lion’s cage; my op for prolapse has been canceled at the last minute and since then I’ve become fully aware of the issues. I’m not going back. What was proposed would have filled me with mesh. I’m saved. But I regret that I did not takes my son’s worries seriously enough when he had mesh implanted five years ago.

    There are lots of issues: the regulation which is so lax that I’m gobsmacked; the appalling complications and the danger and difficulty of removing the mesh; ignorance about the long term consequences; the fact that this is not just mesh but a series of kits making millions for the biotech industry. All apply equally to men and women and I agree with you.

    However there are a few things, I think that add extra injustices to women’s suffering, such as the total disregard of the importance of women’s sexuality. Add to this the fact that the mesh goes in ‘blind’ threaded in with big hooks, though the most delicate parts of a woman’s anatomy. And from this is the issue of informed consent. You never get to see the kits, so from the tiny bit of ‘bio-compatible’ mesh in the surgeon’s drawer there is no way that you can imagine what is really involved. The horror and barbarity of what is done (see UTube) is so shocking that I find it hard to imagine how any one ever thought it up.

    Take heart Duncan, this issue will snowball and the truth will come out. You are not and will not be alone. I hope you are not still feeling shattered. Take care.

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    1. I should also like to add as a man my sexual ability is too affected as well as every aspect of daily life. I left with additional pain after the op in areas that never hurt like constant pain in my testicles, and isn’t it a funny coincidence that when surgeons place the mesh (open surgery) they have to move a bunch of nerves out of the way… why should surgeons hide behind statistics of the mesh when negligence is sometimes obvious!

      My family in many ways has lost a father!

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      1. Dear Duncan
        Its really important that every part of every ones suffering is documented because only then can those on the outside (looking on in horror at this unfolding catastrophe), begin to understand. From what you say its just as hard for a man as for a woman. That is an important message. Pain is pain and crippling pain is not gender specific. I empathise with you even though I cannot imagine it.

        From my own internet research, I’m not sure that this is necessarily surgeon negligence; rather that the global medical profession has become driven by first the pharmaceutical industry and now the biotech industry. I looked on one web site making prosthetics, and there were 68,000 products! Its massive.

        These operations are carried out all over the world and it has become the accepted gold standard. But if the products are faulty or importantly cause inflammation, or changes in nerve cells or if they move or if the additives causes a reaction, then there will be massive suffering even when the surgeon is competent and correct.

        Its vital that every one knows which product they have inside them, the material and batch number.

        I wonder if there are any alternative therapies that would help to calm the nerves and inflammation, just to make life easier.

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    1. I had this operation last April my step mother had the same two weeks before and was home the next day . Unfortunately I ended up in hospital home fore 4 and back again for a week . I have started weeks and weeks ago severe tummy cramps pain when I urinate and make bowel movements incontinence pain in kidney and lower back area they havnt offers a scan to even see if the tape is still in place . So upset by it all I’m a single mum with 5 kids and it really affects me mentally and physically.

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      1. I am so very sorry to hear about all the complications and pain that many people like Lisa are suffering. Its hard to know what to say, words may be of some comfort, but its precious little.
        Here in France, I did not have the operation because I asked too many questions and was struck off the list, so I still have a prolapse, but no mesh inside me.
        Here, in France it seems there have been no complaints and there seem to be no support groups which gives the impression that there are no problems, but I think this is perhaps because there is no one to complain to.
        If there is anything to take heart from in the UK and English speaking counties it is the culture of mutual support.
        It seems that all of this plastic in our bodies is one great big experiment and note that the plastic in our bodies mirrors that in the oceans, and also now in our fields. Plastic is not living and it is harming humans and the ecosystems alike.
        Keep posting, keep documenting, keep connecting to each other, and I shall keep hoping and praying that you all get better, and that this ghastly pollution of our lives and our planet will come to an end.
        By the way I seem to have become sensitive to mobile phones, headaches, nausea, severe bloating, violent hot flushes and sweating.
        Keep as much modern pollution as you possibly can out of your lives and try to keep as well as you can.

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      2. Hi
        I thought I’d post a couple of things on risk:
        Russian roulette, the chance of being shot is 1 in 6 or 16.666%
        Not something we’d chance for a minor issue like stress incontinence, though we might take that same risk if we thought that we were going to die anyway.
        What if the Russian roulette ‘game’ were replaced with a forfeit in which the consequence would be inconsequential, we might join that game. So we have two dimensions to risk and as far as I can see the NHS has good documents on this.

        Absolute risk
        Something very common is 1/1 to 1/100
        Common is 1/10 to 1/100 (same order as Russian roulette)
        Rare is defined as 1/100 to 1/10,000 etc

        A risk matrix defines absolute risk with consequences and is given a score. 1 is very low risk and low consequences, high is 5, high risk and severe consequences.

        What I find shocking is that research reveals that many procedures have a common risk and fairly severe consequences, like for example having to self Catheterise for long periods or even forever, And yet the procedures are still routinely carried out in many countries. What I found shocking in France was that there was no real discussion of risk and further words like ‘rare’ were used to describe complications that elsewhere in the world are common.

        It is pure luck that I found out about the very serious risks, because the surgeon glossed over them, ‘very rare’, ‘nothing to worry about’, and initially I put my trust in him. But in reality surgeons will be paid whatever the outcome and if it generates extra work for complications they’ll be paid a second time. Zero risk for them, unless they are truly negligent.

        Anyone who is considering an operation must be given a chance to think this through thoroughly. What value is put on constant pain? for me its a serious consequence and for me unless the complication rate was very rare, ie less that 1 in 100,000 I would not consider it, unless I would die without treatment or unless my condition was very disabling.

        How many of those suffering were really given the chance to consider all the risks and all the other options available, including no treatment?

        Liked by 1 person

    2. i have autoimmune disorder and have had tvt and when that failed tvt but also had burch colsuspension and bladder reconstruction after all those.

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      1. Hi Again
        In addition to my comments on risk I’ll add this.

        Personalised risk assessment
        If you dye your hair it is recommended that you do a test and wait 24 to 48 hours to see if there is a reaction.
        We are all different, some of us are allergic to some antibiotics and medics take careful note of this.

        But what happens with mesh implants? I was told that the proposed polypropylene was ‘bio-compatible’ It sounded reassuring,

        But how do we know that we can all tolerate it in the same way? why do some people react to hair dyes and some do not? If one persons body reacts adversely, but the majority do not, does this mean that it does not matter or that it cannot be true?

        Why is there no test done before an operation to see if the implant will be tolerated? There are many different types with different pore sizes and in addition they have additives put on them to them to make implantation easier.

        In my own case I was never shown the exact ‘prosthese’ or product. I imagined that it would be a special piece of material and would be cut on the day of the surgery to fit my individual body, as one might cut a bandage or plaster; I did not know it would be a pre-made kit.

        We do not know how these products will perform in the long term. The body, like the sea is a hostile environment for plastic; will it decompose, will it change? Even if the product remains stable our own bodies will change, muscles and skin will lose elasticity and become more fragile as we age. Organs can descend. Will the implant and the body change in harmony with each other over 30 or 40 years?

        The Future

        I hope that in the future both objective risk assessments will be done as well as a personalized risk assessment. In the meantime there are only after the event studies. In the long term, epidemiological studies will show the true picture.

        I hope also that it will become mandatory for all patients to be given a certificate showing the exact model, batch and manufacturer of any product that it put inside their bodies. We have these same rights with respect to food, we have the right to know who makes it and with what, why not with medical products?

        I hope these thoughts are of some help.

        Liked by 1 person

  3. I have been offered this mesh procedure, after reading and hearing from women who have been in pain and can no longer void naturally. They have to self Catherine. This was a requirement from the surgeon that I saw. He wants to see I can easily self Catherine. He made a point of that befor informed consent. Ummmm not good I’m finding out so much. Against even doctors only four out of ten adverse problems are not reported. These women are being abused, not reporting the true findings is so misleading as the figures are not true at all so they look good with the amount of women having so called ok good outcome procedures. Terrible. We trust our doctors we must be carefull. It’s sad.sad.sad.

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  4. I am saddened to read your story however I am sure there are other men that have suffered. So many women are only just speaking out after years of pain and suffering. I only found out about this recently from the Facebook group maybe you should consider that too a place where men can also speak about their own experiences without shame or embarrassment good luck .

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  5. Hi, I have followed the mesh case for women closely as I too have had a mesh implant, and since the operation I have endured pain on a daily basis.

    However, I am a man who underwent a hernia repair in 2011. I have seen much on cases where woman have suffered as a result of mesh implants. Yet the mesh is not gender specific and men are indeed suffering too and globally by my own research.

    Therefore this needs to be made more aware of, as to strengthen the case against the mesh and to show that all suffer. I have only noted one other story regarding a man in the uk.

    After pushing for surgical help I have discovered that in actual fact I did not have hernia, however the surgeon saw fit to place one within me…I went in with pain to the groin and gained additional pain in different areas afterwards!

    Personally, my life has been shattered and am seeking help in fighting for some sort of recognition and answers to an obvious problem, that’s left me victimised.

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