Many mesh implants used by the NHS 'have no safety evidence'

NHS hospitals are using more than 100 different hernia mesh implants – ‘even though many have NO safety evidence and have only been tested on animals’

• Investigation found English and Scottish hospitals have bought dozens of types
• There is ‘no chance’ they’ve all had their safety tested thoroughly, an expert said
• Many women are left crippled by nerve damage caused by the medical devices
• They are surgically implanted to repair hernias and prolapses in women and men

More than 100 types of mesh surgical implants are being used by the NHS and many have no scientific evidence to prove they’re safe, an investigation has found.

Mesh is a small, solid, net-like device which is implanted to hold parts of the body in place if someone has a hernia or prolapse.

But it’s controversial because many women have been left in constant pain and even disabled by nerve damage caused by the implants, branded barbaric by some campaigners.

Hospitals in England and Scotland have now revealed that they use more than 100 types of different mesh devices.

One expert said there haven’t even been that many proper trials to test the devices, so many are likely being used without any safety guarantees.

Six years ago Karen Preater was an active and confident mother with a successful career, working as an account manager for Yellow Pages. Now aged 42, Ms Preater takes a cocktail of 19 pills a day and relies on a walking stick to get around because of complications after a mesh implant procedure

Professor Carl Heneghan, from the University of Oxford, told BBC’s Victoria Derbyshire programme the manufacturer tests which are done on mesh implants are ‘completely inadequate’.

Sometimes, he said, they’re only tested on animals such as rabbits for a few days before being sold to be used in people, who keep them in for years, or decades.

Companies look only to see whether the mesh provokes an immune system reaction, but are unable to test for pain in these situations.

Professor Heneghan said there was ‘no chance’ that all the implants being used by the NHS had been proven to be safe and said it should stop using them immediately.

The medical device expert’s comments come after a BBC investigation found that, between 2012 and 2018, hospitals had bought dozens of different mesh types.

This was discovered through Freedom of Information requests, to which 56 out of 159 NHS hospital trusts replied.

Tens of thousands of mesh implants are performed each year to repair either hernias or incontinence and vaginal prolapse – both are common after childbirth.

But increasing numbers of women are coming forward about the operations destroying their health.

The hard edges of the mesh can dig into sensitive nerves in the pelvis and cause constant pain or other symptoms like incontinence and difficulty walking.

Karen Preater, from Rhyl in North Wales, was left in crippling pain by a mesh operation to treat mild incontinence five years ago.

She had to quit her job, can’t have sex with her husband, struggles to look after her children and spends every day in pain and reliant on a walking stick to get around.

She told MailOnline last year: ‘It was like a sharp pain which was constant and got worse whenever I moved.’

The pain spread from her left thigh, where it started immediately after the surgery, to her groin and hip and she has numbness and a ‘crawling ants’ sensation on her back.

‘I would rather live with incontinence,’ she said. ‘It was manageable, I just wanted to find out how to stop it getting worse. 

‘They sold mesh to me and made it sound fantastic. I wouldn’t want this to happen to anybody else.’

MOTHER LEFT UNABLE TO WORK AFTER AGONY OF MESH COMPLICATION

Seven years ago Karen Preater was an active and confident mother with a successful career, working as an account manager for Yellow Pages.

But, just one day after being given a vaginal mesh implant to treat her mild urinary incontinence six years ago, her life was turned upside down.

The mother-of-three quit her job within a month because she didn’t know if the pain would ever stop, and couldn’t drive herself or her children anywhere.

Now, Ms Preater, who is in her early 40s, takes a cocktail of pills a day to cope with the excruciating pain caused by the device and relies on a walking stick to get around.

And she has heartbreakingly revealed she is in constant pain, can’t urinate normally or have sex, suffers from depression and is racked with guilt over the person she has become.

‘This [mesh] has definitely changed me as a person,’ she told MailOnline last year. ‘I live in a nice area of North Wales and the long walks with the dog or swimming with the children just don’t happen any more.

‘The intimate side of my life is totally destroyed. We did what we could but I would be in massive amounts of pain for days afterwards so it wasn’t enjoyable for either of us.

‘The weight of guilt is the worst thing, over how my children’s lives have been affected – they have to help me so much but I get annoyed and cry easily.’

As soon as she came out of the operating room in 2014 Ms Preater, from Rhyl, knew something was wrong because she had excruciating pain in her left thigh.

Mrs Preater, pictured with her son, said: ‘I would rather live with incontinence. I just wanted to find out how to stop it getting worse. They sold mesh to me and made it sound fantastic’

‘It was like a sharp pain which was constant and got worse whenever I moved,’ Ms Preater said, adding she couldn’t walk because it was unbearable to put any weight on my leg.

Despite expecting a quick recovery, Ms Preater spent eight nights in hospital laying in agony and being given morphine while doctors tried to find a painkiller suitable to send her home with.

The pain has now spread to her hip, thigh and groin. And she revealed she also suffers numbness in the top of her leg and a ‘crawling ant sensation’ all over her back.

One doctor has admitted her agony is down to nerve damage caused by the mesh, which was attached too tightly to her bladder and in the wrong position on one side.

Removing it would be ‘extremely high risk’, may not work and could even make it worse, something Ms Preater said is ‘not an option’. So she must live with it.

‘I would rather live with incontinence,’ she told MailOnline. ‘It was manageable, I just wanted to find out how to stop it getting worse. They sold mesh to me and made it sound fantastic.

‘I wouldn’t want this to happen to anybody else. The new guidelines are not fit for purpose and they just haven’t listened to any of us.’ 

The use of vaginal mesh is no longer permitted for most women while an official review is carried out into its safety.

The results of the review are expected in the spring this year and could transform the rules for surgeons operating on people with hernias and prolapses.

NHS commissioner the National Institute for Health and Care Excellence (NICE) has said mesh should now only be used as a last resort and women must actively choose to have it put in – many have complained they didn’t know what was happening.

Government health minister Jackie Doyle-Price said last year the conversations women were having with their surgeons about mesh were ‘utterly inadequate’

A Department of Health spokesperson told the BBC: ‘On the rare occasion where a patient has suffered as a result of a mesh procedure, we are taking steps to improve patient safety – including improving how we listen to patients and how the system learns when concerns are raised.’

WHAT ARE VAGINAL MESH IMPLANTS? THE CONTROVERSIAL DEVICES THAT HAVE BEEN COMPARED TO THALIDOMIDE

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.

Vaginal mesh implants are devices used by surgeons to treat pelvic organ prolapse and urinary incontinence in women

WHAT ARE THE DIFFERENT TYPES OF MESH? 

Mini-sling: This implant is embedded with a metallic inserter. It sits close to the mid-section of a woman’s urethra. The use of an inserter is thought to lower the risk of cutting during the procedure.

TVT sling: Such a sling is held in place by the patient’s body. It is inserted with a plastic tape by cutting the vagina and making two incisions in the abdomen. The mesh sits beneath the urethra.

TVTO sling: Inserted through the groin and sits under the urethra. This sling was intended to prevent bladder perforation.

TOT sling: Involves forming a ‘hammock’ of fibrous tissue in the urethra. Surgeons often claim this form of implant gives them the most control during implantation.

Kath Samson, a journalist, is the founder of Sling The Mesh

Ventral mesh rectopexy: Releases the rectum from the back of the vagina or bladder. A mesh is then fitted to the back of the rectum to prevent prolapse.

HOW MANY WOMEN SUFFER?  

According to the NHS and MHRA, the risk of vaginal mesh pain after an implant is between one and three per cent.

But a study by Case Western Reserve University found that up to 42 per cent of patients experience complications.

Of which, 77 per cent report severe pain and 30 per cent claim to have a lost or reduced sex life.

Urinary infections have been reported in around 22 per cent of cases, while bladder perforation occurs in up to 31 per cent of incidences.

Critics of the implants say trials confirming their supposed safety have been small or conducted in animals, who are unable to describe pain or a loss of sex life. 

Kath Samson, founder of the Sling The Mesh campaign, said surgeons often refuse to accept vaginal mesh implants are causing pain.

She warned that they are not obligated to report such complications anyway, and as a result, less than 40 per cent of surgeons do.   

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