IS THIS THE BIG­GEST HEALTH SCAN­DAL TO HIT BRI­TISH WOMEN?

All you need to know about vag­i­nal mesh

Good Housekeeping (UK) - - Contents -

At Lon­don’s Univer­sity Col­lege Hos­pi­tal, Dr So­hier El­neil is hav­ing a hec­tic morn­ing. The urog­y­nae­col­ogy con­sul­tant is one of the few spe­cial­ists in the UK able to ex­tri­cate small pieces of plas­tic from vagi­nas, rec­tums and blad­ders. ‘On Mon­day, we re­moved nine,’ says Dr El­neil. She is talk­ing about polypropy­lene net­ting.

The term ‘mesh scan­dal’, as it’s be­come known in the press, fails to con­vey the

on­go­ing pain these pieces of plas­tic have caused – or the con­fi­dence, ca­reers and mar­riages they’ve wrecked.

The story be­gan in the early 2000s, when gy­nae­col­o­gists started im­plant­ing TVT (ten­sion-free vag­i­nal tape) to treat in­con­ti­nence. Be­fore this, the stan­dard pro­ce­dure was to lift and hitch the blad­der neck up by in­sert­ing stitches ei­ther side of the vagina to stop in­vol­un­tary leaks when a woman coughed or sneezed. This tech­ni­cal op­er­a­tion could be per­son­alised to fit the needs of each woman, but the mesh method was cheaper, quicker to per­form and had a faster re­cov­ery time.

‘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,’ says Dr Wael Agur, a urog­y­nae­col­o­gist and clin­i­cal se­nior lec­turer at the Univer­sity of Glas­gow, who fit­ted meshes for over a decade. ‘The mid­dle part of the tape holds the ure­thra in place and the two ends are threaded through

two small in­ci­sions in the lower ab­domen or the groin.’ The mesh be­came the de­fault op­tion. It was a sim­i­lar story with vag­i­nal pro­lapse (when one or more or­gans in the pelvis slip from their po­si­tion and bulge into the vagina). By 2010, mesh pro­ce­dures ac­counted for a quar­ter of all pro­lapse op­er­a­tions.

IT’S COM­PLI­CATED

As the num­ber of op­er­a­tions grew, so too did re­ports of com­pli­ca­tions – in­fec­tion, uri­nary prob­lems, and pain dur­ing sex. For a pro­ce­dure billed as safe, sim­ple and cost ef­fec­tive, what hap­pened? Dr El­neil says 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.’

A re­port by NHS Dig­i­tal re­veals that sur­geons have per­formed at least 500 re­moval op­er­a­tions in Eng­land ev­ery year since 2008. But re­ports on the scale of the dam­age vary. The Medicines & Health­care Prod­ucts Reg­u­la­tory Agency (MHRA) has put the com­pli­ca­tion rate at just 1-3%. Doc­tors are re­quired to re­port com­pli­ca­tions, but ac­cord­ing to a 2017 NICE re­port there ap­pears to have been un­der-re­port­ing.

BRO­KEN SYS­TEM

We know doc­tors have pa­tients’ best in­ter­ests at heart, so why are re­ports from women like Kate (see right) stack­ing up? ‘I de­nied 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.’

Mesh man­u­fac­tur­ers have faced le­gal chal­lenges stat­ing they didn’t test the im­plants rig­or­ously enough. Mean­while, the reg­u­la­tory frame­work has also come un­der fire: EU guid­ance al­lows med­i­cal de­vices to be ap­proved on an ‘equiv­a­lence’ ba­sis if they are sim­i­lar to an al­ready ap­proved de­vice – so 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 a tech­ni­cal doc­u­men­ta­tion,’ says Dr Carl Heneghan, di­rec­tor of the Cen­tre for Ev­i­dence-based Medicine at the Univer­sity of Ox­ford.

SO, WHAT NEXT?

In Fe­bru­ary, Dame Sally Davies, Eng­land’s chief med­i­cal of­fi­cer, re­vealed she had re­ceived heart­break­ing let­ters from women who have been af­fected. She said that al­though the treat­ment was ap­pro­pri­ate for some women, not enough had been made aware of the pos­si­ble risks. Shar­ing her own in­con­ti­nence prob­lems af­ter the birth of her first child, she said: ‘We women, af­ter we’ve had ba­bies, can be dam­aged so that we get in­con­ti­nence, and ac­tu­ally af­ter my first child I could walk three yards be­fore I peed in my pants. I’m still not as I would wish to be. So I have ev­ery sym­pa­thy with these women.’

The gov­ern­ment has an­nounced a re­view into the scan­dal, while guid­ance from NICE, the UK’S med­i­cal watch­dog, has rec­om­mended that rou­tine mesh op­er­a­tions for pro­lapse be banned. How­ever, this doesn’t go far enough for some, who have set up cam­paign group Sling The Mesh. They are work­ing with a cross-party group of MPS to ban the use of all vag­i­nal mesh im­plants – as New Zealand has done. The fig­ures also make stark read­ing in Scot­land, where Dr Agur prac­tises. ‘Five hun­dred women have sued af­ter hav­ing mesh pro­ce­dures for in­con­ti­nence,’ he says. ‘For non-mesh pro­ce­dures, the num­ber is zero. The women them­selves are the ev­i­dence in this case, and they need to be lis­tened to.’

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