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

Women's Health (UK) - - CONTENTS - words ROISÍN DERVISH-O'KANE

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.

IT’S COM­PLI­CATED

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.’

KEEP­ING QUIET

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’.

BRO­KEN SYS­TEM

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.’

NEXT STEPS?

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.’

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