IS THIS THE BIGGEST HEALTH SCANDAL TO HIT BRITISH WOMEN?
All you need to know about vaginal mesh
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.
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.
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.’