Thousands of women have been forced to suffer unbearable pain because of their controversial vaginal mesh implants, an audit today confirmed.
However, while campaigners today welcomed the damning decade-long review, they stressed it ‘doesn’t show the true scale of the disaster’.
Health officials today urged the country’s top medics to respond to the new report, which delved into data about mesh implants in England and revealed:
- The risks of complications from mesh are around the 45 per cent mark – unlike NHS assertions it is no more than three per cent
- Hundreds of women are undergoing surgery each year to have their vaginal mesh implants removed
- The risk of mesh for prolapse and incontinence are almost equal – despite health watchdogs recommending a ban on one
- The number of vaginal mesh operations for incontinence each year have halved since 2008 and have been slashed by 13 per cent for prolapse
The All Party Parliamentary Group for Surgical Mesh demanded the audit into the implants, in the hope of creating a ‘clearer’ picture of the scandal.
Furious experts have already dubbed the ‘barbaric’ procedure akin to the thalidomide scandal of the 1950s and 60s, as it has maimed thousands of women across the world.
Owen Smith, MP and chairman of the group, said: ‘Mesh is proving itself unsafe and ineffective in many women and the doctors are therefore stopping using it.
‘That, in itself, shows that the Government, NICE and the MHRA have been wrong to repeatedly defend the use of mesh.’
He added: ‘These data show the campaign against mesh has been totally justified in our claim that large numbers of women have been damaged by mesh.
‘Government has previously, repeatedly claimed that mesh was “safe” and that just one to three per cent of women suffer serious complications after surgery.
‘However, their own statistics now shows that around 40 per cent of women treated with mesh are subsequently undergoing outpatient treatment.’
Outraged victims of the ‘barbaric’ vaginal mesh procedure argued the statistics downplay the true risk of the scandal-hit devices (pictured: a new material revealed by experts at Sheffield University, who said it would be better than the current one used)
Sling The Mesh, a campaign group that has almost quadrupled in size since the mesh issue came to light last year,
Kath Sansom, its founder, who has battled tirelessly against the use of vaginal mesh, told MailOnline the audit was purposely confusing.
She said: ‘It seems desperately unfair that campaigners have to go through so much effort to raise awareness and are then faced with picking through audits like this.
‘Every step of the way campaigners fight hard to have our voices heard and taken seriously, while juggling jobs, pain and, in many cases, children.’
Commenting on the results, she said: ‘The Government have selectively used figures in a bid to make mesh risk look low.
‘[They] have presented it in such a confusing way that to a non-experienced reader they will think mesh is not a problem.
‘It has not included private patients or women going to GPs for pain medication or antibiotics to treat painful urinary infections.’
Ms Sansom stressed the audit, published by NHS Digital, contained ‘no information on the devastating social and psychological impact on women’.
She added: ‘Officials have gone through a lot of trouble to come out with this 43-page report, but it doesn’t show the true scale of the disaster.
MOTHER CLAIMS HER PARTNER DUMPED HER BECAUSE HER MESH IMPLANT SLICED HIS PENIS
Theresa Bartram, from East Sussex, is one of thousands of women who have been tainted by the scandal-hit vaginal mesh procedure
A 51-year-old mother last month claimed her partner dumped her because her controversial vaginal mesh implant sliced his penis during sex.
Theresa Bartram, from East Sussex, had the scandal-hit device removed following the incident – only to end up single two months later.
The former health worker battled post-traumatic stress disorder and was unable to work after undergoing the ‘barbaric’ procedure.
She is one of thousands of women who have been tainted by vaginal mesh. Many have been on the brink of suicide or left in wheelchairs.
Before the decision for the removal of the brittle plastic, which can curl, twist and cut through tissue, she also experienced unbearable pain and infections.
Like hundreds of other victims, she was told the agony was all in her head and was offered anti-psychotic drugs. Her own family dismissed her concerns.
What did the audit show?
The investigation, published today, showed nearly 130,000 patients had undergone a mesh procedure for incontinence or prolapse in the past decade.
It dwarfs previous NHS estimates, which suggested 100,000 women had been given mesh for both procedures since it was introduced in the 1990s.
Both procedures to implant mesh, which is made of brittle plastic and can curl, twist and cut through tissue, are common after childbirth.
Up to 44 per cent of women fitted with tape, or mesh, for incontinence will attend an appointment with trauma and orthopaedic surgeons, the audit suggests.
While this figure was even higher (46 per cent) for women fitted the vaginal mesh devices for prolapse, when organs slip out of place because of weakened muscles.
The data on prolapse comes months after health watchdog, Nice, recommended a ban on inserting the controversial devices in women with the condition.
Opened a ‘can of worms’
But, the statistics, which technically show more complications from mesh used in prolapse than continence, have ‘opened a can of worms’.
Ms Sansom, 49, who also happens to be a journalist, based in Cambridgeshire, said: ‘The report opens up a huge can of worms.
‘It shows the risks of mesh for prolapse and incontinence is roughly the same – despite a recommended ban against one type of prolapse mesh.’
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.
The number of operations to implant vaginal mesh in women with incontinence have almost halved in the past decade, the audit revealed.
While only a 13 per cent reduction was noted for mesh used in treating prolapse. The procedure is expected to take a hit next year.
And, in each year since April 2008, surgeons have performed at least 500 removal operations for tape or mesh, the audit showed.
Between 2008 and 2017 there were 5,374 total or partial removal procedures – but this could include any women who have been forced to undergo more than one surgery.
When was the audit announced?
The Department of Health and Social Care declared it would conduct an audit into vaginal mesh at the end of January.
The move, welcomed by campaigners at the time, was hoped to create a ‘clearer’ national picture of patients who have had mesh implants.
Health Minister Lord O’Shaughnessy today asked for the leading medics, NHS bodies and patient groups to report back to him ‘within a month’.
The APPG on surgical mesh implants demanded the audit, which was expected to be completed by the end of this month April.
WHAT WAS THE THALIDOMIDE SCANDAL?
Thalidomide was the medication given to pregnant women to combat morning sickness between 1958 and 1961.
It was withdrawn after doctors noticed an increase in the number of deformed babies born to mothers who had been on the drug.
After a long battle, the families affected received total of £28 million in compensation, paid out by manufacturer Diageo during the 1970s.
Chiefs have remained adamant that only three per cent of patients will experience complications of vaginal mesh, which can curl, twist and cut through tissue.
However, an array of trials into mesh – made of brittle plastic – have revealed the true rate of serious side effects is likely to be nearer the 10 per cent figure.
At least 4,800 women have suffered lacerations and nerve damage from the mesh in England, but only 1,000 have reported it to the MHRA.
However, campaigners stress these are just the tip of the iceberg and that actually there are thousands more – but they have been kept silent.
Despite the risks, which have been widely publicised in recent months, most women experience no problem and doctors are adamant the procedure is beneficial.
A recommended ban
Nice’s recommendation for a ban on mesh used in prolapse was announced back in December.
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.
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.
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 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.