Controversial vaginal mesh implants should be banned, NICE says.
The health watchdog recommends the ‘gold standard’ implants should not be routinely offered for treating organ prolapse but instead just used for research or after patients are made aware of the risks, according to the BBC’s flagshipVictoria Derbyshire show.
One expert said it is highly likely the NHS will take up NICE’s recommendation, which will be published next month, however, it is not obligated to do so.
The verdict from NICE comes after the Government released its three-year investigation into the mesh scandal and rejected calls for a widespread ban on the implants last September.
More than 800 women are suing the NHS and the implants’ manufacturers after complaining of crippling pain.
The NHS has even been accused of sweeping such complications under the carpet in an effort to dodge media attention.
After previously denying their implants were causing women discomfort, mesh manufacturer Johnson & Johnson paid out $57 million to a sufferer from Philadelphia last month after a jury found the company to be negligent and its product defective.
Many women who have been fitted the mesh implants have complained of being in such severe agony they are unable to work, walk or have sex, with some even being on the brink of suicide.
Julie Gilsennan was told she would need up to six weeks off work after having the mesh fitted, however, she has been unable to return to work as a paramedic and instead works from home processing complaints to the ambulance service
Angela Young (pictured), a 47-year-old hairdresser from Stockport, described the pain of a vaginal mesh as: ‘It’s as if you have a handful of needles shoved between your legs’
Controversial vaginal mesh implants (pictured) should be banned, according to NICE
WHAT ARE VAGINAL MESH IMPLANTS?
Vaginal mesh implants are devices used by surgeons to treat pelvic organ prolapse and urinary incontinence in women.
Usually made from synthetic polypropylene, a type of plastic, the implants are intended to repair damaged or weakened tissue in the vagina wall.
Other fabrics include polyester, human tissue and absorbable synthetic materials.
Some women report severe and constant abdominal and vaginal pain after the surgery.
In some, the pain is so severe they are unable to have sex.
Infections, bleeding and even organ erosion has also been reported.
Ban comes too late for many
In a series of documents about vaginal mesh implants to be published in December, NICE said that ‘evidence of long-term efficacy is inadequate in quality and quantity’.
It added that ‘when complications occur, these can be serious and have life-changing consequences’
Yet, NICE also said most women do not report complications after being fitted with such implants.
The health watchdog only commented on organ prolapse and not urinary incontinence or hernias, which implants are also used for.
Current recommendations state the procedure ‘should only be used with special arrangements for clinical governance, consent and audit or research’.
And doctors wishing to undertake this surgical repair should ‘ensure that patients understand that there is uncertainty about the long-term results and there is a risk of complications, including sexual dysfunction and erosion into the vagina, which would require additional procedures’.
Professor Carl Heneghan, an expert in the subject from the University of Oxford, said NICE’s comments are an admission that health services had ‘got this wrong’, but said a potential ban comes to late for many sufferers, the BBC reported.
Action from the Department of Health and the Medicines and Healthcare products Regulatory Agency is required before a ban can come into place.
Liz Adelanwa, digital media manager at NICE told MailOnline: ‘Our official guidance on the use of vaginal mesh is not due out until 20 December. NICE’s remit means we cannot ban treatments or procedures’
The NHS declined to comment.
Mother-of-two Denise Davis (pictured), 52, from Gorsley, Herefordshire, says she considered suicide because of the pain after she had the mesh implanted in 2010 for incontinence
Ella Ebaugh (pictured), 51, was awarded $57 million after her vaginal mesh implant caused her extreme pain and burning. Johnson & Johnson is under fire for selling multiple implants
Sylvia Litchfield (pictured before the surgery in 2014), 61, claims the only reason she is still alive today is because her three cats and grandchildren gave her a purpose to live for
‘A public health scandal’
Sharon Hodgson MP, Labour’s Shadow Public Health Minister, said: ‘Mesh implants have left women in permanent pain, unable to walk, and unable to work. This is an ongoing public health scandal and the Government need to do much more to support those affected.
‘Mesh implants should be taken off the market now until we know more about the threat they pose to women’s safety.
‘The Government have failed to answer big questions about the extent of this public health scandal, including how many women have been affected and why a product with such terrible risks was allowed into the market in the first place.
‘I’VE BEEN ON THE BRINK OF SUICIDE. MY KIDS KEPT ME GOING’
Janette Nelson, 43, was on the brink of suicide after suffering agonising pain from a vaginal mesh implant she had fitted
A mother-of-three has revealed she was on the brink of suicide after suffering agonising pain from a vaginal mesh implant she had fitted.
Janette Nelson, 43, from Newtownards, Northern Ireland, said the only think that kept her going was her children, but she still battles guilt every day as she depends on them to help her wash, dress and even catheterise after the procedure left her unable to control her bladder.
The former hairdresser also blames her implant for the breakdown of her relationship as her boyfriend left her when the pain was too severe for her to have sex.
Unable to work, her career has also been destroyed.
‘My children lost their mummy’
Ms Nelson had the most common type of mesh, known as TVT, fitted in March 2012 in an attempt to cure her urinary stress incontinence.
She said: ‘Immediately once my tape was fitted I woke up with excruciating pain in my groin; its indescribable.’
Just one week later, Ms Nelson wet herself while out with her children and now relies on her eldest daughter to help her catheterise every day.
Due to the excruciating pain of the mesh, Ms Nelson has been forced to rely on her mother and sister to help her raise her children.
She said: ‘My children lost their mummy. I’ve been on the brink of suicide.
‘My kids kept me going. I was useless as a mum but I’m still their mum. It’s all been about me for the past few years.’
Ms Nelson, 43, pictured with her daughters Bryanne (bottom), 17, and Zofie, 12
‘My boyfriend left me because of it’
As well as affecting her as a parent, Ms Nelson also blames the implant for the loss of her love life and career.
She said: ‘I had a boyfriend when this started but the sex was excruciating, neither of us could cope with it. My boyfriend left me because of it.
‘I used to work as a hairdresser; always on my feet, always very confident, but now I can hardly walk and I can’t control my bladder so I can’t work. It’s really knocked my confidence.’
NHS DODGING MEDIA ATTENTION
The NHS tried to dodge media attention over the vaginal mesh implants that left hundreds of women in agony, it was revealed in April.
The procedure cut into women’s vaginas and left many in discomfort so severe they have been left unable to work, walk or have sex.
It emerged the NHS actively sought to avoid courting headlines over the matter after minutes from an NHS meeting in October were leaked.
The minutes showed an agreement to ‘take the press element out of’ a campaign for women experiencing complications from the devices.
Seen by the Press Association, the minutes outlined the Medicines & Healthcare products Regulatory Agency’s (MHRA) yellow card campaign, which targets under-reporting of mesh complications.
Officials said they should ‘look into taking the press element out of the mesh yellow card campaign’ and ‘investigate whether there can be a general yellow card campaign, of which mesh is one element, to avoid media attention on mesh’.
Government previously rejected a ban
Last September the Government released its three-year investigation into the mesh scandal and rejected calls for a widespread ban on the implants, which can shrink, twist and curl at the edges, leading to nerve damage.
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with bodies accepting up to 40 per cent of women may experience side effects.
Some studies, published in an array of scientific journals, have shown that pain, erosion and perforation from the surgery can affect up to 75 per cent of women.
The alarming evidence prompted officials in three US states to suspend the practice and saw them call for an urgent review into its safety.
Previously suspended in Scotland
Mesh implants continue to be used in Scotland despite calls from the health secretary for their suspension.
The mesh, introduced 20 years ago, was promoted as a quick, cheap alternative to complex surgery for incontinence. It was dubbed the ‘gold-standard’ treatment.
Due to it not requiring specialist training to implant, outraged women have since called for tougher regulations in order to conduct such surgery.
More than 10,000 women a year have the procedure. Some 7,800 have suffered lacerations and nerve damage from the mesh breaking into tiny fragments.