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Hernia Mesh End of Day Update
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Hernia mesh complications could affect 100,000 as MPs warn of 'another scandal', analysis claims
| Independent
By Alex Matthews-King
Mesh implants widely used to repair hernia may have left 100,000 people in pain or with other complications that require the procedure to be reversed or redone, a new analysis shows. -
Controversial hernia mesh procedures may have left up to 170,000 people in England unable to walk and even suicidal
| Daily Mail
By Alexandra Thompson
Up to 170,000 people who have had hernia mesh implants in England over the past six years could be battling agonising complications. -
Hernia mesh complications 'affect more than 100,000'
| BBC News
By Anna Collinson and Jessicai Furst
Up to 170,000 people who have had hernia mesh implants in England in the past six years could face complications, the BBC's Victoria Derbyshire programme has found. -
170,000 Hernia Mesh Patients in England Could Be at Risk of Life-Changing Complications
| Huffington Post
By Rachel Moss
Almost 200,000 people in England who have undergone hernia mesh surgery could be at risk of severe complications such as being unable to walk, according to a new report.
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Hernia mesh complications could affect 100,000 as MPs warn of 'another scandal', analysis claims
| Independent
By Alex Matthews-King
Mesh implants widely used to repair hernia may have left 100,000 people in pain or with other complications that require the procedure to be reversed or redone, a new analysis shows.
NHS figures show that over the last six years around 570,000 people have had the implants for hernia, a common issue where surgery or a tear in the connective tissue or muscle causes the organs to push through the wall of the cavity in which they normally reside.
British regulators regard the procedure as less risky than recently banned vaginal mesh implants, which has left manufacturers facing lawsuits involving thousands of women with life changing injuries, or worse.
However, surgical experts are now claiming that complications occur in as many as 30 per cent of hernia mesh surgeries, and that these can be every bit as harmful as with vaginal mesh.
MP Owen Smith, who heads the All Party Parliamentary Group on Surgical Mesh warned that the UK “could potentially have another scandal on its hands” if complications proved correct and said that regulators were not listening to patient experiences.
Jen Coles, 34, spoke to the BBC's Victoria Derbyshire programme about her experiences following a mesh implant in January 2017 which left her in debilitating pain.
“I was hunched over and walking as though I was elderly and I couldn’t stand up straight and it hurt all the time,” she said. “I had a cane because I just felt really unsteady on my feet.”
Her family paid for her to have two large implants removed over fears of how long it would take to get the procedure on the NHS. But while the pain has decreased she still struggles to do simple tasks.
“Sometimes I just want to scream," she said. "It’s maddening."
She added that before the mesh implant she "was so active – running around commuting, kayaking, and now I can’t pick up a sock from the floor.”
Mesh implants can be flexible or rigid, but can degrade under repeated stress in the body and cut into the internal tissues.
Recent studies have shown that a loophole in licensing laws let manufacturers bring out multiple mesh products made from different materials or in different designs by stating it is similar to an originally licensed version.
Mr Smith said: “It reflects the flawed system we have in place, neither the regulators or the manufacturers have to follow up on problems. Companies ultimately have to take some responsibility for this. It’s not good for them to give this to the NHS and then they walk away with the NHS carrying any liability.”
The Medicines and Healthcare Products Regulatory Agency (MHRA) which licenses drugs and medical products for use in the UK told the BBC it has “not had any evidence which would lead us to alter our stance on surgical mesh for hernia repairs or other surgical procedures for which they are used.
“The decision to use mesh should be made between patient and clinician, recognising the benefits and risks,” it added.
The Royal College of Surgeons said the implants remain “the most effective way” to treat hernia, though private surgeons told the BBC that they prefer to suture the wound closed.
https://www.independent.co.uk/news/health/hernia-mesh-implant-vagina-pain-symptoms-wheelchair-victoria-derbyshire-surgery-a8555396.html
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| Daily Mail
By Alexandra Thompson
Up to 170,000 people who have had hernia mesh implants in England over the past six years could be battling agonising complications.
Between 12 and 30 per cent of the 570,000 people who have had the procedure have been left in such severe pain they are unable to walk or work.
Experts said on the BBC's flagship Victoria Derbyshire show that some patients of the common procedure have even been left suicidal.
This follows the vaginal mesh scandal, which has left thousands of women around the world unable to have sex and dependent on wheelchairs to get about.
Tireless fights by campaigners were rewarded earlier this year, when officials declared a temporary ban on the brittle material being used to treat incontinence.
However, regulatory body the MHRA continues to back the use of hernia mesh - despite the high complication rates.
One in 10 people will develop a hernia, with the most common treatment being a doctor pushing the bulging tissue back into the body and covering it with surgical mesh.
Up to 100,000 of these operations have taken place every year in England since 2011-to-2012.
Leading surgeons have warned the 12-to-30 per cent complication rate may mean between 68,000 and 170,000 patients have been left with life-changing side effects in the past six years.
But the number may be much higher due to mesh being used for hernia operations since the 1990s.
NHS trusts in England have no consistent guidelines on how best to treat hernia patients.
But the Medicines and Healthcare products Regulatory Agency (MHRA) backs the use of mesh.
THE MAN LEFT IN AGONY AFTER BEING GIVEN A SURGICAL MESH IMPLANT TO REPAIR A HERNIA
Mario Spacagna is eternally grateful for the surgery that removed his kidney tumour.
But he fears he will pay the costs of his survival for the rest of his life as a result of a secondary operation following the cancer surgery.
‘I am in constant pain, day and night,’ explains the 75-year-old from Southampton.
‘I can be walking down the street and my legs will suddenly fold up under me. I can’t breathe and I can’t speak.
‘Sometimes it is a general ache and other times it is a sharp stabbing sensation like having a knife stuck in my side. Anyone who saw me would think I was having a heart attack.’
Mr Spacagna has had a large, 10-inch square sheet of plastic surgical mesh placed internally.
This was done to repair the damage caused by the partial removal, in October 2013, of one of his kidneys, which was affected by a large cancerous tumour.
‘I was left with a bulge in my side where the kidney surgery had left a gap in the muscles holding everything together,’ he says.
‘It was about half the size of a football after the operation. A small mesh was put in to hold everything in place.
'It didn’t work so in October 2015 they went back. They couldn’t take out the original mesh so they put another huge piece of mesh over the top. It didn’t work either.’
Quite apart from the ongoing pain, he says he still has ‘this huge bulge — clothes don’t fit me properly and I’m very self-conscious about it’.
Labour MP Owen Smith, who chairs the All Party Parliamentary Group on Surgical Mesh Implants, argues the MHRA's job is to ensure medical devices are safe.
He adds the agency is not listening to the experiences of affected patients.
'Companies ultimately have to take some responsibility for this.
'It's not good for them to give this to the NHS and then they walk away with the NHS carrying any liability,' he said on the Victoria Derbyshire show.
The MHRA argues there is insufficient evidence to discontinue the use mesh for hernias. The Royal College of Surgeons agrees the device is the 'most effective way' to treat the condition.
But the private hernia surgeon Dr Ulrike Muschaweck is urging for medics to use the suture technique rather than mesh. This involves using strips of surgical adhesive tape to close wounds.
Unfortunately, the technique is rarely taught to young surgeons, she adds.
Dr Muschaweck claims she has removed 3,000 meshes due to patients suffering chronic pain, of which only went on to be free of any discomfort.
Consultant urogynaecologist Dr Suzy Elneil, who was a fierce campaigner in the bid to ban vaginal mesh on the NHS in England, estimates treating a patient with hernia mesh complications comes to at least £25,000.
This is due to the costs associated with removing the mesh, a further operation to treat the hernia and follow-up care.
The vaginal mesh scandal came to light in April 2017, when the NHS tried to dodge media attention over the implants that left hundreds of women in agony.
Vaginal mesh has been the subject of various legal proceedings across the world, with figures suggesting more than 100,000 are suing the manufacturers of the devices.
This comes after hundreds of private surgeons were accused of being 'cash-hungry' by pushing women to undergo barbaric vaginal mesh surgery.
Campaigners unearthed data last July that revealed urogynaecologists can 'double their salaries' by offering the controversial procedure in their own clinics.
Calculations by the prominent group Sling The Mesh show surgeons can earn an extra £125,000 by giving four women mesh each week privately.
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.
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.
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.
Hernia mesh complications affect up to 170,000 people in England
https://www.dailymail.co.uk/health/article-6209441/Hernia-mesh-complications-affect-170-000-people-England.html
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Hernia mesh complications 'affect more than 100,000'
| BBC News
By Anna Collinson and Jessicai Furst
Up to 170,000 people who have had hernia mesh implants in England in the past six years could face complications, the BBC's Victoria Derbyshire programme has found.
In that time, there have been about 570,000 such operations and the complication rate is said to be 12-30%.
Some patients have been left unable to walk or work, others left suicidal.
The Medicines and Healthcare products Regulatory Agency continues to back the use of hernia mesh.
One in 10 people will develop a hernia.
The most common treatment involves a doctor pushing any bulging tissue back into the body and covering it with a piece of surgical mesh.
There have been between 90,000 and 100,000 hernia mesh operations in England each year since 2011-12.
And leading surgeons believe the complication rate is 12-30% - which means between 68,000 and 170,000 patients could have been adversely affected in the past six years.
Mesh has been used for hernia repairs since the 1990s, so the total number who have experienced complications since its introduction is thought to be much higher.
But NHS trusts in England have no consistent policy for guidelines on treatment or follow-up with patients.
After Jen Coles, 34, had a mesh implant in January 2017, following her hernia, the operation left her with chronic pain.
"I was hunched over and walking as though I was elderly and I couldn't stand up straight and it hurt all the time," she said.
"I had a cane because I just felt really unsteady on my feet."
She has since had a repair operation to remove two large pieces of mesh.
Her family paid for the operation because they feared it would take years on the NHS.
Her overall mobility has improved, and the pain decreased, but she still struggles to do certain tasks.
"Sometimes, I just want to scream. It's maddening," she said.
"[Before the mesh implant] I was so active - running around commuting, kayaking, and now I can't pick up a sock from the floor."
Labour MP Owen Smith, who chairs the All Party Parliamentary Group on Surgical Mesh Implants, said he feared the UK could "potentially have another scandal on our hands".
He said the Medicines and Healthcare products Regulatory Agency (MHRA), whose job it is to ensure medical devices are safe, was not doing enough to listen to the experiences of patients affected.
"It reflects the flawed system we have in place," he said. "Neither the regulators or the manufacturers have to follow up on problems.
"Companies ultimately have to take some responsibility for this.
"It's not good for them to give this to the NHS and then they walk away with the NHS carrying any liability."
The MHRA told the BBC it had "not had any evidence which would lead us to alter our stance on surgical mesh for hernia repairs or other surgical procedures for which they are used".
"The decision to use mesh should be made between patient and clinician, recognising the benefits and risks," it added.
The Royal College of Surgeons said mesh implants were the "most effective way" to deal with a hernia.
Dr Ulrike Muschaweck, a leading hernia surgeon in the private sector, said she used a suture technique - instead of mesh - for most hernia operations but this method was dying out because young surgeons were rarely taught it.
She said she had performed 3,000 mesh removals because of chronic pain - after which only two of the patients had not gone on to become "pain-free".
Dr Suzy Elneil, a consultant urogynaecologist who was a leading voice in the successful campaign to halt the use of vaginal mesh on the NHS in England, estimated treating those who had experienced complications with hernia mesh could cost a minimum of £25,000 a patient.
This includes:the removal of the mesha further operation to treat the herniafollow-up care
It is similar to the predicted cost for those treated for vaginal mesh complications.
https://www.bbc.com/news/health-45604199 link to video: https://www.youtube.com/watch?v=MMGJvHGJcQY
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170,000 Hernia Mesh Patients in England Could Be at Risk of Life-Changing Complications
| Huffington Post
By Rachel Moss
Almost 200,000 people in England who have undergone hernia mesh surgery could be at risk of severe complications such as being unable to walk, according to a new report.
Experts told the BBC’s Victoria Derbyshire show that 570,000 people in England have had hernia mesh surgery in the past six years. They estimated the risk of complications is between 12 and 30 per cent, meaning as many as 170,000 people could be affected.
HuffPost UK previously heard from 12 people who’ve experienced life-changing complications due to hernia mesh, two of whom required treatment in intensive care. Some patients reported being unable to work long after their operation due to severe pain, while others said complications led to suicidal thoughts.
Hernias occur when an internal part of the body pushes through a weakness in the tissues that hold muscles together. Hernia mesh is a synthetic material similar to nylon that is inserted into the body to “patch” up the weakened area.
Gayle Devlin, 43-years-old, from Falkirk, Scotland, underwent hernia mesh surgery in 2009 but was still experiencing pain three years later. After a number of visits to her GP, she was rushed to hospital in intense pain, where a CT scan revealed the mesh had slipped and cut into her small bowel.
The NHS nurse and mum-of-two developed sepsis and spent the next seven days being treated in intensive care. Her family were told to prepare for the worst.
Although she has now recovered physically, when Devlin spoke to HuffPost UK in April, she said the ordeal has had long-term implications for her mental health.
“I feel very angry and distressed and I get anxiety now,” she said. “When I get a sore stomach at all now, I feel very anxious that something else is going to happen. It has left me a different person.”
The new figures on hernia mesh come in the wake of the vaginal mesh scandal, where hundreds of thousands of women worldwide reported severe complications, such as being unable to walk or have sex. In July the Department of Health suspended the use of mesh to treat stress urinary incontinence. Campaign group Sling The Mesh, which originally formed to petition the use of vaginal mesh, is now calling for further investigation into hernia mesh.
Despite the new figures, the Medicines and Healthcare Products Regulatory Agency (MHRA), which regulates medical devices in the UK, said it has “not had any evidence which would lead us to alter our stance on surgical mesh for hernia repairs or other surgical procedures for which they are used”.
“The decision to use mesh should be made between a patient and clinician, recognising the benefits and risks in the context of the conditions being treated and in line with National Institute for Health and Care Excellence guidance,” a spokesperson told HuffPost UK.
“Patient safety is our highest priority and we recognise some people develop complications after surgery, but these have been mitigated by the development of newer surgical techniques such as laparoscopic approaches to some types of hernia surgery.
“We encourage anyone, patient, carer or healthcare professional, who is aware of a complication after a medical device is implanted, to report to us via the Yellow Card scheme, regardless of how long ago the implant was inserted.”
https://www.huffingtonpost.co.uk/entry/170000-hernia-mesh-patients-in-england-could-be-at-risk-of-life-changing-complaications_uk_5bab80f4e4b0f143d10f0ee9
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