THE VAGINAL MESH SCANDAL
Published in The Mail on Sunday on
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Published in The Mail on Sunday on
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They were questioned, doubted, ignored and sidelined - often by the very doctors they begged for help.
But now, thousands of women who have suffered life-changing injuries as a result of vaginal-mesh operations are set to be vindicated by a landmark inquiry.
Many suffered crippling chronic pain, infections and nerve damage following the procedure, commonly used by surgeons as a quick fix for urinary incontinence and other gynaecological problems.
In some women, the mesh - a netlike material made of plastic that's meant to support muscles and organs in the pelvis - cut through the vaginal wall or pierced the bladder. Some patients were left barely able to walk, as a result of complications. Sex was made unbearable, and relationships and marriages were ruined.
But for years, women's concerns were dismissed, and campaigners trying to highlight the problem were branded 'hysterical' - with many surgeons insisting vaginal-mesh procedures were completely safe.
Now, finally, the voices of those who have suffered have been heard. This week, a long-anticipated report into the use of pelvic mesh will be published by the Independent Medicines And Medical Devices Safety Review. The Mail on Sunday has learnt it will reveal alarming stories of how women's complaints were handled, and suggests their concerns were not properly addressed.
The women affected now hope the publication will mark a shift in attitudes, and end scepticism among some parts of the medical profession about their claims.
It comes as a new group legal action - involving more than 250 vaginal-mesh claims - is launched in England against surgeons, private hospitals, NHS trusts and manufacturers. Thompsons Solicitors, which is representing the group, says many women were not adequately informed about the risks of the surgery beforehand and were not told about less invasive options that could treat their condition, such as physiotherapy.
Medical firm Johnson & Johnson, the main manufacturer of the mesh used in England, has already agreed to pay a reported £50million settlement to women in Scotland who say they were left in agony by the implants. It is hoped there could be a similar payout in England.
Kath Sansom, 52, from Cambridge, is one of those eagerly awaiting the findings of the independent review. The mother-of-two had mesh implanted on the NHS to treat stress urinary incontinence, brought on by childbirth, in March 2015.
For Kath, a fitness fanatic who enjoyed mountain biking, high-board diving, boxing and swimming, the pain began immediately after surgery. At first she assumed this was a normal part of the recovery process. But a week later, severe pain in her legs meant she was barely able to walk.
'It was a sharp, stabbing pain - like a cheese-wire was inside me,' Kath recalls. 'It felt as if there was barbed wire around my feet and legs.'
It was only when Kath searched online for more information about her operation that she realised she was far from alone. Around the world, thousands of women had reported similar experiences - with symptoms sometimes emerging only years after mesh surgery.
'I suddenly realised I wasn't going mad,' Kath says. 'I was so angry as I had gone from super-fit to only just being able to shuffle the dog down the road - and even that left me in agony. I went back to my surgeon and he completely denied it was anything to do with my mesh implants. He tried to blame it on a back problem. But I'd never had a back problem in my life.'
Kath stood firm - and launched campaign group Sling The Mesh, to highlight patients' concerns.
'So many women tell us doctors have denied their symptoms are anything to do with their operation and made them feel silly - that is standard,' Kath says. 'Many surgeons dismiss our problems as just a niggling pain, but it isn't. There are women who can't have sex because it hurts so much. We have men who have been cut by the mesh while they were trying to have sex. These are life-altering, irreversible complications. It's just heartbreaking.'
Thanks to campaigners such as Kath, in July 2018 NHS England put an immediate pause on the use of vaginally inserted surgical mesh for the treatment of stress urinary incontinence and prolapse.
It followed a recommendation from the independent review, which suggested the procedure should not be carried out until strict conditions are met. This included the setting up of a national database, where details of all mesh operations would be reported, and the establishment of centres dedicated to removal and helping those adversely affected by the procedure.
Two years later, these conditions have not been met. As a result, it is widely expected the suspension will remain in place when Baroness Cumberlege, chairman of the inquiry, makes her findings public. But one uncomfortable question remains. Just why did it take so long for these women to be heard - and believed?
Mesh - also known as tension-free vaginal tape, or TVT - was introduced in the 1990s, as a surgical method to treat stress urinary incontinence. The condition, which affects millions of women in the UK, causes urine to leak out of the bladder involuntarily.
For some, this can be just a few drops, triggered by a cough, sneeze or some forms of exercise. But others can find their whole bladder emptying without warning. The problem is usually the result of a weakening of, or damage to, the network of muscles inside the pelvis that are involved in urination. This is common after childbirth.
The operation involves inserting a piece of mesh, normally made from a kind of plastic, through a small cut in the vagina. It is placed under the urethra, the tiny tube that carries urine from the bladder to outside the body, and is meant to support the weakened muscles and improve control.
A similar operation can also be offered to treat prolapse - when organs in the pelvis slip down from their normal position and bulge into the vagina, causing pain and discomfort, which is also a knock-on effect of childbirth. In these cases, the mesh is placed inside the pelvis and used to prop up the organs.
Before mesh became available, doctors usually recommended physiotherapy to women affected by prolapse and incontinence. This involved regular, at-home exercises to strengthen the pelvic floor muscles. But it was certainly not an easy solution, requiring weeks, months or even years of strict adherence to the regime.
'It works for some people, but not others,' says Clive Spence-Jones, consultant obstetrician and gynaecologist at The London Clinic and the Whittington Hospital in North London. 'Unfortunately, there is no test you can do beforehand - you can't tell who will benefit. It's also clear from studies that if you stop the physiotherapy, the benefit will drift off over a few months.'
There were other surgical options, too, involving complex cutting, repositioning and stitching of internal muscles and tissues. However, these procedures were not done lightly, with recovery sometimes taking up to six weeks. Mesh offered a faster alternative.
'It was seen as a quick fix,' says Dr Wael Agur, a consultant urogynaecologist and honorary senior clinical lecturer at the University of Glasgow. 'If you have it, you don't have to do pelvic-floor exercises. You have the surgery and everything is hunky dory.'
But this, it turned out, was not quite true. Over time, more and more women began reporting chronic pain, nerve damage, difficulty with walking and pain during sexual intercourse. Studies now suggest as many as one in ten patients may suffer these complications, and the figure is estimated to be as high as 40 per cent for mesh inserted to treat prolapse.
Data on vaginal-mesh surgery has been a source of controversy among the medical profession. Some experts argue a lack of high-quality, long-term research makes it difficult to understand the true extent of the problem.
But in 2018, after the suspension on the use of vaginal-mesh surgery was announced, the British Society of Urogynecologists said it strongly opposed the decision to suspend its use for the treatment of incontinence, citing evidence that 95 per cent of women remain free from complications afterwards. Last week, there appeared to have been a change of heart.
'The period of high vigilance on mesh has provided an opportunity to reflect on how to improve these treatment options for women,' said its chairman, Dr Swati Jha.
Some patients' problems are now known to be caused by incorrect placement of the mesh. The procedure is done 'blind', meaning surgeons can't see exactly where they are operating and making it easy to put the implant too close to other body parts. And if a surgeon mistakenly hits a nerve, it can result in severe, long-term pain.
'You are passing a needle through tissues, but you can't physically see where the needle is going,' explains Mr Spence-Jones. 'It is inevitable that sometimes the needle tip will go somewhere it shouldn't do. Nobody deliberately puts it in the wrong place.'
Dr Agur adds: 'There is no way for any surgeon to find out if they have hit a nerve or not during surgery. There are instructions from manufacturers on where to place it, and how to avoid nerves. But every woman is different.'
Nerve damage can also emerge later, if the mesh becomes embedded in surrounding tissue, along with other complications. The mesh can, for instance, dig into nearby structures such as the bladder or vagina. The area around the mesh is also prone to infection - both after surgery and years later.
Other women report less well understood symptoms, such as chronic fatigue and psoriasis - a condition that causes red, scaly patches on the skin. It has been suggested these could be triggered by the immune system reacting to the presence of a foreign body. But research in this area is so far limited.
Yvette Greenway, 56, founder of support group Mashed Up By Mesh, was initially pleased with her mesh operation.
The mother-of-two, who last year married leading QC Michael Mansfield, 78, developed urinary incontinence after the birth of her youngest child. The problem grew worse, eventually getting to the point where her full bladder would empty spontaneously.
'It built up gradually,' she says, 'until it became unmanageable - a succession of embarrassing accidents in the swimming pool, for example, or at the theatre. I was using incontinence pads - I was still in my 30s - but there's a limit to how much they can absorb if you suffer a full urination.'
At 45, Yvette had a mesh implanted on the NHS to treat her incontinence and a hysterectomy to resolve her prolapse.
'I was told it was the gold-standard treatment for stress urinary incontinence and that my problems would go away,' she says.
And for eight years they did, until August 2017, when she suffered sudden excruciating pain in her lower right abdomen, which radiated down her leg. Her vagina also started bleeding.
The pain was so severe she couldn't contemplate penetrative sex, or even use a tampon. But it was not until February that she finally had the implant removed by a private surgeon in Bristol.
'By the beginning of this year, I was seriously unwell,' Yvette says. 'A lot of the time I felt I'd been hit between the legs with a block of concrete. I had to sit on the edge of a chair to avoid putting any weight on the vaginal area. When I was opened up, it was discovered that the mesh had fused with the pelvic bone on the left-hand side of my vagina.'
Yvette believes, as do many other patients, that she was not fully informed of the risks.
'There are alternative procedures to counter incontinence,' she says, 'but none of these options was explained to me.'
Mr Spence-Jones stresses that vaginal-mesh implants can work and be problem-free.
'For some women, it has been truly wonderful,' he says. 'They are no longer a slave to leaking urine.'
Looking back, Kath Sansom believes her 'minor' incontinence problem did not warrant surgery.
'It only happened when I did my boxing classes or jumped around at gigs,' she says. 'The operation was given out too freely, to too many women who just didn't need it.'
Her mesh was removed in October 2015, just seven months after the initial procedure. But even today she suffers chronic pain, and struggles to run, cycle or even sit without discomfort.
'It wasn't in long, but it was enough to cause a lot of damage,' she says. 'None of us goes back to the women we were.'
Dr Agur believes there may still be a place for mesh - as a 'last resort when everything else has failed', and only if the patient is well aware of the potential risks.
However, he adds: 'But offering it to everyone, without any alternatives I don't think we will ever go back to that.'