* Kimberly Vallis was given implant to improve bladder function after childbirth
* But the former estate agent had a ‘foreign body response’ to the plastic mesh
* She suffered a miscarriage after two years of pain and constant infections
* She asked doctors to remove the plastic mesh but they refused
* Her nightmare only ended when she paid for a private operation
Within days of an operation to insert a mesh support to improve her bladder function after childbirth, Kimberley Vallis, knew something was very wrong.
She couldn’t move her left leg properly — ‘I had to use my hand to move it’, recalls the 31-year-old special needs teaching assistant from Yate, near Bristol.
It was the start of two years of agony and urinary tract infections that culminated, she says, in her next pregnancy ending in a miscarriage. Kimberley had had a ‘foreign body response’ to the plastic mesh.
‘I kept asking them to take the mesh out, but they wouldn’t,’ she says.
‘Eventually I had a miscarriage. The baby died at six weeks, though I didn’t actually miscarry until 12 weeks. I’ve no doubt this was because of the infection set up by the mesh implant.’
Her nightmare only ended when she spent £4,500 on private surgery to remove the surgical mesh ‘ribbon’.
‘I just couldn’t bear the pain and constant infections,’ says Kimberley who gave birth to her second son, Adam, 11 weeks ago.
She believes she was a victim of a procedure to tackle a taboo problem: the fact that many women never regain full bladder control after childbirth.
The stigma around incontinence has meant vast numbers of women suffer in embarrassed agony because of the disintegration of the polypropylene material used to support the bladder or womb after childbirth.
Fragments of the mesh, which is inserted like a hammock to support the bladder, can burrow deep into tissue like tiny shards of glass, causing excruciating pain and infection that has left some women unable to walk or even facing kidney removal. Others report pain during sex.
Studies have shown that the longer the mesh is left in, the more likely it is to ‘erode’, embedding itself into tissue in a way that it cannot be removed.
A study published in The Lancet last December showed women given mesh implants were roughly three times more likely to suffer complications and twice as likely to need follow-up surgery compared with the traditional version of the surgery, where stitches are used to provide support.
It has also been ordered to pay £10 million in two other cases, and is facing a further 35,000 lawsuits in the U.S., with claims from at least nine other countries including class actions from Australia and New Zealand.
At least 800 women in England are taking legal action, it was reported by the BBC last week. But despite cases first coming forward back in 2011, authorities in the UK have so far insisted there is no problem.
In fact there are concerns about the current, official investigations. Last month an inquiry in Scotland published its report on over 1,500 women who have been affected, concluding that despite the problems, the mesh should still be available.
However before the report’s publication, four of the 20-strong inquiry team resigned, including chairman and leading public health specialist Lesley Wilkie, Wael Agur another top clinical lecturer from Glasgow University, and patient representatives, Elaine Holmes and Olive McIlroy.
Meanwhile, an NHS England investigation has dispensed with input from five other patients and reformulated itself as a mesh ‘oversight group’ dominated by officials.
In the meantime, countless women in the UK have been left with dreadful side-effects.
An estimated 92,000 women in England alone have received a mesh implant in the last 10 years, and two million worldwide.
It was first introduced in the mid-Nineties as a cheaper, quicker way for less experienced doctors to do pelvic repairs which previously involved highly skilled stitching.
As the Mail first highlighted five years ago, problems with nerve damage, pain, infection and sexual difficulties were initially reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2011.
NHS England set up an investigation in 2014, but it has yet to produce a final report and none of the five patient representatives originally invited to participate has been invited to recent meetings Good Health has discovered.
Leaked minutes from its meeting last October discussed the need to ‘avoid media attention on mesh’. An MHRA spokesman told Good Health this referred to a need to ensure balanced reporting. He insisted that the mesh is safe but refused to comment further, bizarrely citing pre- election purdah.
Olive McIlroy, 60, and Elaine Holmes, 52, the two patient representatives who resigned from the Scottish investigation, have expressed fury about the report. Elaine had the mesh inserted in 2011, waking after surgery in excruciating pain as the mesh had sliced through her urethra. She can no longer walk or drive.
Olive had the operation in 2008 and two years later woke up unable to move because of apparent nerve damage. Neither was well enough to talk to Good Health, but in a joint statement said vital evidence and safety warnings had been ignored, and they were ‘dismayed and disgusted the Scottish government has seen fit to publish this tainted report’.
Kath Sansom, 49, a journalist in Cambridgeshire, set up Sling the Mesh, a campaigning group for victims, two years ago after she, too, was left with nerve damage by the procedure in 2015. She now has 1,600 members demanding the mesh is banned.
‘The Government just isn’t listening to patients. The Scottish report is clearly a whitewash and we fear the NHS England one will be similar,’ she told Good Health. An NHS England spokesman said: ‘Many women have been treated successfully using transvaginal mesh implants, however, we do recognise that a number of women have suffered complications or poor outcomes.
‘We have listened carefully to their concerns… and made a number of recommendations in December 2015 to improve the quality of care and information available. Strong progress has been made in completing these recommendations, and a final report setting out the action taken will be published later this year.’
The women who have been affected fear many others will suffer before the medical establishment recognises the level of damage caused.
Sallie Booth, of solicitors Irwin Mitchell, represents nine women who have claims against Johnson & Johnson. ‘It’s an embarrassing, awful condition,’ she says. ‘It’s difficult to gauge how many there are because for a long time people haven’t realised that the awful effects are shared by others.’
Part of the problem is that many women are still being told by doctors their problems are unique. Teresa Hughes, 65, from St Helen’s, Lancashire, whose case was among the first to be highlighted by Good Health, was told the pains in her legs and lower body were ‘nothing to do with the mesh’ she had implanted in 2006.
‘Then I was told I was among a handful of unlucky people the product didn’t suit,’ she says. ‘I had no idea there were thousands of women with the same problem.’
Sohier Elneil, a gynaecologist at University College Hospital in London, who has developed an expertise in removing fragments of mesh, says the material was given a licence ‘on the basis it’s similar to hernia mesh’.
‘Over a period of seven years, this mesh fragment removal work has gone from 10 per cent to 60 per cent of my practice,’ she says.
Another gynaecologist, speaking on condition of anonymity, said the mesh was being promoted to save money. ‘It costs about £1,000 to do a surgical repair but a mesh procedure is £268 cheaper,’ he said.
‘That may not sound much, but if you’re doing thousands of operations a year, it adds up. They’re trying to keep the lid on it because of the possibility of the terrifying cost of litigation: claims could run into many millions.’
A spokesperson for Johnson & Johnson said: ‘Ethicon is vigorously defending litigation concerning the use of our pelvic mesh products. We believe the evidence shows the devices are safe.’
Kimberley says one thing is clear: ‘We’ve got to get the message out that incontinence is pretty normal and there are other less risky ways of dealing with it.’