Controversial vaginal mesh will no longer be used on thousands of women with stress urinary incontinence, officials declared today.
Outraged campaigners have fought against the use of the ‘barbaric’ implants for years as thousands have been maimed by the procedure.
They have welcomed the ‘incredible news’ that the government has accepted an immediate suspension on the procedure, common after childbirth.
It is not a complete ban, but a halt to implementing mesh until a list of five strict conditions laid down by ‘appalled’ reviewers have been met.
Bu victims hope it sets the groundwork for an outright ban, as the review has so far found no evidence the benefits of mesh outweigh the severity of human suffering.
The full recommendations of the review, announced by Health and Social Care Secretary Jeremy Hunt in February, is expected to be publicised next year.
Sling The Mesh hopes that Baroness Julia Cumberlege, who led the review, adds rectopexy mesh – used for rectal prolapse – to the suspension
Kath Sansom, founder of campaign group Sling the Mesh, which represents those affected by mesh implants, said: ‘This is incredible news.
‘It is testament to people power. Our members have written, emailed, attended Parliament and lobbied to get this result and I am delighted.
She added it was ‘vindication’ for the 6,100 members of the group, ‘who have been maimed by this operation and then ignored, some for years’.
‘MailOnline has been key in this suspension with the regular stories, telling of the devastation of the lives of women and their families.
‘This has contributed to making the NHS, and other regulatory bodies, accountable for an operation sold to us as low risk.’
Sling The Mesh hopes that Baroness Julia Cumberlege, who led the review, adds rectopexy mesh – used for rectal prolapse – to the suspension.
Ms Sansom said: ‘This is even more taboo and more embarrassing than urinary incontinence. Women suffer the same grave, life changing complications.’
Brittle plastic that can curl
Vaginal mesh implants, made of brittle plastic that can curl, twist and cut through tissue, have been branded the ‘biggest medical scandal’ since thalidomide.
Thousands of women have been maimed by mesh across the world and have been left on the brink of suicide, unable to work and reliant on wheelchairs.
Tireless fights by campaigners, backed by MailOnline, and ‘meshed up’ victims have led to internal investigation by the NHS and debates in the House of Commons.
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.
Mr Hunt announced the Government would look into vaginal mesh implants back in February, alongside two other public health scandals.
Baroness Cumberlege today called for the immediate suspension of mesh for stress urinary incontinence – caused by the weakening of pelvic muscles.
What did Baroness Cumberlege say?
She said: ‘We strongly believe mesh must not be used to treat women with SUI until we can manage the risk of complications much more effectively.
‘We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications.
‘I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families.
‘We had to act now. My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries.’
She added: ‘At this stage in our review we are not recommending a ban, but a halt to procedures until the conditions we have laid down are met.’
Baroness Cumberlege described the ordeal of hundreds of women who were brave enough to speak out about their mesh ordeal as ‘compelling’.
Both the Department of Health and Social Care and NHS England have accepted her recommendations.
Baroness Cumberlege listed five criteria needed to be met for the pause to be lifted, including reporting every procedure to national database.
The All Party Parliamentary Group on Surgical Mesh Implants (APPG) also described Baroness Cumberlege’s decision as ‘wonderful news’ and ‘long overdue’.
WHAT ARE THE CONDITIONS FOR LIFTING THE PAUSE OF SURGICAL VAGINAL MESH?
The conditions of lifting the pause in the use of surgical mesh, which should be met by March 2019, are as follows:
1. Surgeons should only undertake operations for SUI if they are appropriately trained, and only if they undertake operations regularly;
2. They report every procedure to a national database;
3. A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery;
4. Reporting of complications via MRHA is linked to the register;
5. Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh.
Owen Smith, chair of the APPG, said: ‘It is also a complete vindication of all those women who have campaigned tirelessly to suspend mesh.
‘Baroness Cumberlege should be applauded for making this definitive statement just days after her review began taking evidence from women affected by mesh injury.
‘She has obviously been left in no doubt – as those of us who have listened to women injured by mesh are in no doubt – that the risks far outweigh any benefits.
‘Of course the reality of the situation is surgeons have already recognised that fact which is why the use of mesh has declined so precipitously over recent years.’
The ‘right thing’ to do
Carl Heneghan, professor of evidence-based medicine at Oxford University, said: ‘The ban is the right thing to do as it prevents further unnecessary injuries.
‘However, it has come too late for many thousands of women who face lifelong disabling complications.’
He continued: ‘We now need to learn some serious lessons and not repeat the mistakes of the past.’
Health watchdogs Nice already announced the controversial surgery should only be banned for prolapse – when organs fall out of place, and not incontinence.
Campaigners attacked the decision, revealed in December, as they estimate around three quarters of women were given vaginal mesh to treat SUI.
How many women have had mesh?
NHS Digital data shows nearly 130,000 patients have undergone a mesh procedure for incontinence or prolapse in the past decade.
A Government audit in April delved into the effects of mesh – but Sling The Mesh argued at the time it didn’t show the ‘true scale of the disaster’.
The risks of complications from mesh were shown to be around the 45 per cent mark – unlike NHS assertions it is no more than three per cent.
The dangers of mesh for prolapse and incontinence, common medical issues after childbirth, were almost equal, despite Nice only recommending a ban on the former.
Action around the world
It came after the Government released its three-year investigation into the mesh scandal last September. It rejected calls for a ban at the time.
All forms of pelvic mesh were banned in New Zealand back in December, and a similar move against prolapse has been made in Australia.
The Scottish government put in place a suspension in the use of mesh for SUI in 2014 following years of campaigning by outraged victims.
Vaginal mesh has been subject of various legal proceedings across the world, with figures suggesting more than 100,000 are suing manufacturers of the devices.
Despite the risks, widely publicised over the past year, most women experience no problem and doctors are adamant the procedure is beneficial.
When did the scandal come to light?
The scandal came to light last April, when the NHS tried to dodge media attention over the implants that left hundreds of women in agony.
Senior doctors immediately called for a public inquiry into the controversial mesh, with some claiming the scandal could be akin to thalidomide.
At the time, 800 women were suing the NHS and device manufacturers. However, it is unsure how many women are now looking to take action in Britain.
WHAT ARE THE RISKS OF VAGINAL MESH?
Mesh, introduced 20 years ago and dubbed ‘gold-standard’, was promoted as a quick, cheap alternative to complex surgery for incontinence and prolapse.
Because it did not require specialist training to implant, victims of the procedure have since begged for tougher regulations to conduct such surgery.
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 injury.
Some studies, published in an array of scientific journals, have shown that pain, erosion and perforation from the surgery can strike 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.
Scottish officials asked for it to be suspended in Scotland in 2014 pending a similar review, but hundreds of women are still believed to be having the surgery.
Leading mesh manufacturer Johnson & Johnson was forced to pay out $57 million last September to a woman fitted with the implant.
Ella Ebaugh, 51, from Philadelphia, was awarded the eight-figure sum after a jury found the company to be negligent and its product defective.