THE BIGGEST MEDICAL SCANDAL OF OUR TIME?
Take a look at the image on the right. This tiny piece of plastic has become synonymous with a scandal so devastating and far-reaching, doctors are calling it ‘bigger than thalidomide’. WH reports on the female health crisis of our time
It looks innocuous, but a small piece of mesh is ruining lives
Doctor Sohier Elneil is having a hectic morning. The urogynaecology consultant is striding through the corridors of University College London Hospital where, for 16 years, she has performed complex vaginal surgery. A typical day might involve the delicate and difficult removal of a genital growth or helping to restore bladder control in victims of female genital mutilation. She’s also one of the few specialists in the UK with the skills to extricate small pieces of plastic from vaginas, rectums and bladders. And right now, she is busier than ever. ‘This week, we’ve removed nine,’ she tells WH, stepping out into a corridor to take our call. She is talking about polypropylene netting. Mesh. You’ve probably never imagined what sensation a cheese grater would cause if it were inserted somewhere in your lower abdomen. Or how it might feel to sit on razor blades. Or to take every step carefully, wary of disturbing a jagged piece of glass lodged somewhere deep inside your vagina. Yet that inconceivable, goosebumps-just-thinking-about-it pain is what thousands of British women are living with right now. The term ‘mesh scandal’ – as it’s become known in the press – fails to convey the everyday agony and the path of destruction that these pieces of plastic have wreaked. They have shattered self-confidence, careers, marriages. They’ve ruined lives. The story begins in the early 2000s when gynaecologists started implanting TVT (tension-free vaginal tape) meshes into the vaginas of women struggling with incontinence following childbirth. ‘Before this, surgeons’ standard procedure was a “hitch and stitch” operation; where stitches are made either side of the vagina, lifted and then stitched to the bone to stop the bladder from moving when a woman coughs or sneezes,’ explains Dr Wael Agur, urogynaecologist and clinical senior lecturer at the University of Glasgow. The highly technical procedure could be personalised to fit the needs of each woman,
but it cost an overstretched NHS time – and money. The newer mesh procedure? Four could be done in the time it took to perform one hitch and stitch. ‘Using keyhole surgery, surgeons make a small incision inside the vagina and thread a piece of plastic tape around the tube carrying urine out of the body,’ explains Dr Agur, who fitted meshes for over a decade. ‘The middle of the tape holds the urethra up in the correct position and the two ends are threaded through two small incisions in the lower abdomen or the groin.’ The end goal was that the female body would naturally produce scar tissue around the area, holding everything in place. Patients were able to forgo hitch and stitch recovery times of up to six weeks, the first three days of which would need to be spent in hospital, for a turnaround time of mere hours; women had the mesh inserted mid-morning and would be sleeping in their own beds that night. Early evidence suggested that mesh worked – and the procedure soon became surgeons’ default. It was a similar story with pelvic organ prolapse (a bulge in the vagina caused by sagging of pelvic muscles and organs after childbirth). ‘Prolapse procedures work in much the same way as those for incontinence, except that a larger sheath of mesh is used,’ explains Dr Agur. ‘To repair prolapse in the front, the mesh is positioned underneath the bladder. Prolapse in the back requires the mesh to be fitted between the back wall of the vagina and the rectum, to keep it in place.’ By 2010, mesh procedures accounted for a quarter of all prolapse operations. Mesh was a safe, practical, efficient answer to some of the most common gynaecological problems affecting adult women. Until it wasn’t.
As the number of operations grew, so too did reports of complications – a word that is, in fact, one hell of an understatement. Infection, urinary problems, pain during sex – in some cases, the mesh was reported to have cut so far through the vagina that it sliced the penises of women’s partners during intercouse. In November 2017, a Canadian woman died from sepsis which she attributed, via a social media post in her final days, to complications with TVT mesh. It was a procedure billed as safe, simple and cost-effective – so what happened? ‘Surgeons thought the mesh would be fine, as similar products had been used to treat hernias for years. But when you’re treating a hernia, you’re aiming to stop an organ protruding – it’s a bit like blocking a door,’ Dr Elneil explains. ‘Vaginas are different. They are fibrous, muscular tubes, which things move in and out of. They require flexibility, and what we know now is that these meshes induced non-flexibility.’ Indeed, while data suggests meshes don’t move once in the body, they can contract in on themselves, something that wasn’t taken into account when the procedure was soaring in popularity. ‘Think about what happens to a plastic bag if you put it next to an oven for a few days,’ Dr Elneil explains. ‘It becomes brittle and starts to shrink in on itself. In some women, that’s what happens with the mesh.’ She believes that the widespread use of mesh was problematic because it failed to account for how different women’s bodies might react. ‘Doctors didn’t consider that introducing a prosthetic material could induce a chronic inflammatory response, causing pain, discomfort, recurrent inflammation and infection.’ It’s still unclear just how far-reaching the fallout is. NHS data reveals that 92,000 women have had vaginal mesh fitted in England alone. But reports on the scale of the damage vary hugely. While the Medicines & Healthcare Products Regulatory Agency has put the complication rate at just one to three per cent, doctors aren’t legally required to report every issue, and leading experts we contacted estimate that the number is much higher.
THE REAL DEAL
But as the true scale of this crisis unfolds in the headlines, women are living through this nightmare – and the reality is horrifying. Kate Langley, a 42-year-old former recruitment consultant from East Sussex, had a TVT mesh implant inserted in 2012 to treat the stress incontinence she suffered after the birth of her second child. ‘My surgeon described it as a quick fix: a sameday operation, safer than any of the “oldfashioned” procedures they used to do,’ she recalls. But Kate’s mesh eroded through her vaginal wall and urethra and is now embedded in her bladder. Six years and 50 hospital admissions later, the bitter irony of this breezy consultation isn’t lost on her. ‘I’m at the mercy of the pain; it can hit at any time, and when it does, it can be so severe I have to call an ambulance. I take a cocktail of painkillers, suppositories and antidepressants just to get through the day, and I can’t have sex with my husband without triggering stabbing pains, which can last weeks. I grit my teeth and smile most days. But the mesh has ruined my life.’ Kate’s reaction, naturally, was to get this thing the hell out of her body. Her surgeon managed to remove the majority of the mesh, but is now struggling to find a way to extricate the final piece lodged inside Kate. She believes it is dangerously close to major veins and arteries – which, if cut, could be fatal – and is cautious about removing it. She has called on the expert opinion of another surgeon, who has won awards for his bomb shrapnel removal in Syria and Iraq, and who could be Kate’s last hope. Now all Kate can do is wait, knowing that, even if they do manage to get it out, the permanent nerve damage already caused by the implant could mean her pain is a lifelong reality.
‘I CAN’T HAVE SEX WITHOUT TRIGGERING STABBING PAINS THAT CAN LAST WEEKS’
Such is the case for Kath Sansom. Before being fitted with a TVT mesh for incontinence in March 2015, Kath could often be found high-board diving or mountain biking. Two weeks after the operation, she was bent double over the bathroom sink at work, the pain in her groin and legs so unbearable she couldn’t stop crying. After googling ‘TVT gone wrong’, she uncovered so many stories that she returned to her doctor and asked that the mesh be removed. Seven months later, it was – but the damage was far from undone. ‘I’m better than I was before and, compared with so many women, I am fortunate. I can still walk, I can still do my job,’ she explains. But her voice begins to crack as she recalls her former life. ‘Exercise used to be my therapy. But the amount of damaged scar tissue means the pain is irreversible. I can’t cycle for more than a mile on a flat road without triggering the pain. I’ll never be the woman I was before the mesh.’
It seems strange that a story with so much visceral, toe-curling detail took so long to break. Why, if thousands of women were mutilated by a ‘simple’ operation, did they take years to speak up? One word comes up often in accounts of the victims: shame. Especially the kind we attach to the complicated internal system that shoulders the messy business of being a woman. Data from gynaecological cancer charity The Eve Appeal reveals that nearly a fifth of women have delayed seeing a doctor about symptoms of gynaecological cancers such as abnormal vaginal bleeding – a third of whom said they did so because they deemed their symptoms ‘not serious enough’. When you consider this, the slow, muffled way in which the wider public became aware of such complications starts to make sense. Stephanie Mills*, 40, from Staffordshire, recalls her shame all too well. The mother of two lived with a persistent ‘tugging’ sensation after her first mesh operation for uterine prolapse in 2012, during which a mesh sling was fitted from her coccyx to her cervix to hold up her uterus. Because it wasn’t out-andout painful, she accepted it as ‘one of those things’. But 12 months ago, Stephanie was informed that her bowel and bladder had also prolapsed and that she would need another operation. In 90 minutes, a second piece of mesh was fitted to hold up her bladder, and a third to support her bowel. ‘The discomfort never went away after the operation. It feels as though a sharp pin is being scratched along the side of my… [she pauses, uncomfortable] vagina.’ One year on, the pain has become so debilitating that Stephanie can no longer work. And yet, she is still second-guessing herself. ‘I’m worried that if I go back to my GP, they’ll think I’m exaggerating or jumping on some media bandwagon.’ But stigma is only part of the story. The message from countless women we spoke to isn’t just that they feared their pain would be dismissed, but that it actually was. Kate recalls telling ambulance staff that something was cutting her from the inside, only to be later told by a doctor that she was ‘being silly’. And on a separate occasion, when she raised similar concerns with a surgeon, she was told to ‘avoid hysterical women on the internet’. This feedback isn’t just anecdotal; it’s a wider conclusion drawn by a 2017 report from the All Party Parliamentary Group on Women’s Health. MPS found that 40% of women needed to visit their GP 10 times before they were diagnosed with common gynaecological complaints. And this appalling situation isn’t just a UK problem. In a landmark review of studies in this area, The Girl Who Cried Pain, University of Maryland researchers found that, compared with men, women were more commonly prescribed sedatives instead of painkillers after an operation, and more likely to have their pain characterised as ‘emotional’ or ‘psychogenic’.
We know doctors aren’t monsters; they’re medical professionals with their patients’ best interests at heart. So why are reports from devastated women stacking up against the NHS? ‘I denied that their pain could have anything to do with the mesh,’ says Dr Agur. ‘I even performed a hysterectomy on a woman who didn’t need one because there was no other explanation for her symptoms. Of course, I regret it now. But there was no mention of chronic pain as a side effect on the instruction leaflet, so as far as I was aware, any complications were unrelated to the mesh.’ Indeed, mesh manufacturers have faced legal challenges that they didn’t test the implants rigorously enough before bringing them to market. Meanwhile, the regulatory framework has also come under fire; EU legislation dictates that medical devices must have clinical trials or ‘equivalence’ –
similarity to an already-approved device – in order to be used on patients. Which essentially means that to be approved as medical devices – even when they’re designed to go inside your vagina – they don’t necessarily need to be tested. ‘The device doesn’t even have to be seen by the people who approve it as fit for purpose. All they approve is technical documentation – the same as you would for a wheelchair,’ explains Dr Carl Heneghan, director of the Centre for Evidence-based Medicine at Oxford University, who has likened the use of mesh to the thalidomide birth defects scandal in the 1960s and is calling for a registry of all devices going forward to match the system we have with drugs. ‘I originally made the analogy between vaginal mesh and thalidomide because the latter marked a turning point in drug regulation requiring clinical trials. And I think the damage done by vaginal mesh implants could see a similar shift in how invasive devices are regulated.’
While the politics play out, British women are still giving birth, their pelvic floor muscles are still slackening and their wombs are still prolapsing. So what now? The medical community is divided. Some surgeons dismiss the notion that meshes in particular cause harm by pointing out that all gynaecological surgeries carry risk. Dr Agur isn’t convinced. ‘In the absence of long-term clinical trials comparing the impact of treatments with and without mesh, we can look only at the numbers available to us. In Scotland, where I practise, 500 people have sued after having mesh procedures. For non-mesh procedures, the number is zero. The women themselves are the evidence in this case, and they need to be listened to.’ They’re beginning to be. At the time of writing, the Government has promised to carry out a full audit of how many women in England have suffered complications as a result of vaginal mesh implants. Draft guidance from the UK’S medical watchdog NICE has recommended that routine mesh operations for prolapse be banned. This doesn’t go far enough for Kath. After she had her mesh removed in 2015, she founded a campaign group called Sling The Mesh, and is working with a crossparty group of MPS with the aim of banning the use of all pelvic mesh implants. Sling The Mesh also aims to empower women to talk freely about stigmatised issues like incontinence and prolapse. ‘If I’m proud of anything, it’s that over the past six months “vagina” has been said so frequently on daytime television that it no longer sounds shocking,’ she says, laughing. ‘The taboo women feel about their own bodies may be just one part of this scandal, but it’s a toxic one that we need to change.’ Stealing a moment before she performs another mesh removal surgery, Dr Elneil finds cause for hope. ‘I feel heartened by the fact that there is a strong group of galvanised women who are not going to have their pain explained away,’ she says. ‘Many of the women I see have never viewed themselves as feminists, but now those ideals are driving them on. They’re not afraid to speak out about their bodies – and they’re not going to stop.’