A company owned by a multi-billion pound pharmaceutical failed to fully inform doctors of how dangerous vaginal mesh can be, a BBC Panorama investigation has found.
The programme, airing tonight, will also reveal how an implant made by Ethicon was only tested on 31 women and in sheep before being used in patients.
The company, owned by Johnson and Johnson, sells its scandal-hit products in the UK under the brand name Gynecare TVT.
An investigation reveals how a director at the company asked for the wording to be changing in the safety leaflets for mesh implants to recognise the dangers – but her request was ignored.
It comes amid mounting pressure for the ban of controversial vaginal mesh implants, which have left thousands of women on the brink of suicide.
The revelation follows the death of a prominent vaginal mesh campaigner, who reportedly died from sepsis triggered by her implant.
Christina Brajcic, 42, from Ontario, Canada, passed away on Thursday following a four-year battle with persistent infections – as a result of her mesh
Christina Brajcic, 42, from Ontario, Canada, passed away last Thursday following a four-year battle with persistent infections – as a result of her mesh.
Her death last week followed landmark moves by English and Australian health officials to recommend the controversial implants should no longer be used.
It is expected that the NHS will follow the guidance from Nice, the Government’s healthcare adviser – despite not being obliged to do so.
The verdict comes after the Government released its three-year investigation into the mesh scandal last September. It rejected calls for a ban at the time.
Australian watchdogs also banned the use of vaginal mesh implants for prolapse last week after a review found ‘the benefits do not outweigh the risks’.
‘I’M MORE OF HER CARER THAN I AM HER LOVER’
The scathing comments come as MailOnline spoke to John Sharman (right), who revealed his beloved wife Lynne (left) was left suicidal from the implant
A 65-year-old grandfather has slammed the controversial vaginal mesh procedure that has destroyed the life of his beloved wife and left her contemplating suicide.
John Sharman, from Reading, revealed Lynne’s heartbreaking account of the scandal-hit surgery, which left her in unbearable pain and unable to have sex, following the emergence of hundreds of similar stories.
He decided to tell MailOnline of her painstaking ordeal from a man’s point-of-view, which is often forgotten amid the scores of outraged women who have spoken, in an attempt to raise awareness about the topic which, up until now, has been swept under the carpet.
The father-of-three he has sometimes thought about leaving Mrs Sharman, who he has been married to for 43 years, due to the effect the mesh has had on their marriage.
Mr Sharman, who met his wife at a chess club, told MailOnline: ‘It does impact your relationship and now I’m more of her carer than I am her lover and a husband.
‘She has been left in constant pain which has totally altered our sex life, social life and the way we operate and what we do.’
However, vaginal mesh remains a viable option in both countries for surgeons operating on women suffering from incontinence.
The BBC Panorama investigation reveals that Ethicon produces ‘Instructions for Use’ (IFU) leaflets to accompany mesh products to explain how doctors should insert them.
They also explain the ‘adverse reactions’, or risks, associated with surgery to help surgeons explain these to patients.
But in 2009 an associate medical director at Ethicon warned that the statements about side effects in the IFU leaflets for mesh products were not sufficient.
At the time the leaflets said that side effects were ‘transitory’, the BBC Panorama investigation will reveal.
THE DIFFERENT TYPES OF MESH
Different types of mesh implants include:
- 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.
In an email in January 2009 the associate medical director wrote about three Ethicon Gynecare TVT mesh implants suggesting that the wording be changed.
She wrote: ‘From what I see each day, these patient experiences are not “transitory” at all.’
However, Ethicon did not update them to remove the word ‘transitory’ at the time. The company’s latest IFUs, updated in 2015, say some effects may be permanent.
Ethicon, who spoke to Panorama as part of the investigation, confirmed it did not change the wording of the IFUs at the time.
It concluded: ‘The wording in the IFU was appropriate for the intended users – trained pelvic floor surgeons.’
Dr Wael Agur, a consultant urogynaecologist, told BBC Panorama the IFUs are very important.
He said: ‘It’s so important for me as a surgeon to understand full the risks of a medical device I’m about to implant during a surgical procedure and my first resource would be the IFU.
‘I would expect the manufacturer to have a comprehensive list of the adverse events and the risks within the instructions for use so I fully understand these and communicate them.’
Ethicon launched the TVT-Secur implant in 2006 worldwide. It was intended to be the company’s safest and most effective pelvic mesh product.
The product, which Johnson & Johnson has since paid one sufferer who became reliant on a walking stick $57 million, was withdrawn from the market in 2012.
Ethicon told Panorama: ‘While we empathise with those who have experienced complications, the vast majority of women with pelvic mesh see an improvement in their day to day lives.
‘All surgical pelvic floor procedures – with and without mesh – come with the risk of developing complications.’
The MHRA, the UK medical devices regulator, told Panorama it recognises some women develop serious complications.
It said: ‘Currently, from a regulatory perspective these devices are acceptably safe when used as intended and as part of an appropriate treatment pathway.’
The Panorama investigation follows the warning that there is inadequate regulation for vaginal mesh products which has exposed women to unnecessary harms.
THE INADEQUATE REGULATION OVER VAGINAL MESH IMPLANTS
Professor Heneghan has now launched a fresh attack on mesh, asking for them to be given temporary licences that restrict them solely to use in clinical trials – and not in humans.
Professor Heneghan and colleagues argue evidence from large trials over the safety of mesh did not emerge until 20 years after the first products were introduced.
Writing in the BMJ Open, they suggest they can’t be considered safe as they didn’t undergo scrutiny in scientific studies with a follow-up of at least five years.
The attack on regulation was made after looking at 61 mesh devices given marketing clearance in the US when they were previously deemed lower risk.
Only two of the original devices were approved under close scrutiny, with the rest being given clearance for being ‘equivalent’ to the already approved ones.
The results show no evidence of any new clinical trial data at the time of device approval for all of these 61 devices, Professor Heneghan warned.
They argue changes in design ‘should have alerted regulators’ to differences in the characteristics of the mesh that should have negated the use of equivalence.
The findings also show a lack of long term data to inform the use of vaginal mesh devices – an argument campaigners have long pointed to.
And when longer term evidence did emerge, it identified serious concerns – which many officials have since ignored, implied Professor Heneghan and colleagues.
They also recommend a patient registry should be established for all implantable devices to enable long term follow-up and surveillance.
This has received the backing from Sling The Mesh, a campaign group which has quadrupled in size since the scandal made headlines in April.
Kath Sansom, founder of the 4,600-strong group, welcomed Professor Heneghan’s comments, and said there ‘virtually is no regulation’.
She told MailOnline: ‘Carl is a respected leader in the field of evidence based medicine and lays bare the farce of supposed medical device regulation.
‘Patient safety in this country is shocking – devices permanently implanted into people with no trials and without the proper studies to back it up.
‘People trust that those in power to control patient safety are doing their job. Carl has fully exposed just how woefully poor regulation is.
‘The Government and the MHRA should be ashamed of themselves. First PIP, then metal hips and now mesh.
‘How many more disasters before they realise medical devices should all be tracked on a national register.’
Ms Sansom, a Cambridge-based journalist, said the cost would be low compared to the cost of thousands of patients being left with life-changing injuries.
Writing in the BMJ Open, Professor Carl Heneghan said they can’t be considered safe as they didn’t undergo scrutiny in properly conducted scientific studies.
The professor of evidence-based medicine at Oxford University has previously described the mesh scandal as akin to thalidomide.
The controversial implants, which can shrink, twist, curl and cut through tissue, have left thousands of women on the brink of suicide, unable to work and even walk.
They have been used since the late 1990s to help women overcome incontinence and pelvic organ prolapse – often two major issues of childbirth.
Despite the risks, which have been widely publicised in recent months, most women experience no problem and doctors are adamant the procedure is beneficial.
The scandal came to light in April, when the NHS tried to dodge media attention over the implants that left hundreds of women in agony.
Vaginal mesh implants (pictured) have left women wheelchair bound and unable to have sex
Senior doctors immediately called for a public inquiry into the controversial mesh, with some saying the scandal was comparable to thalidomide.
Figures estimate 100,000 women across the world are looking at taking legal action against the device manufacturers.
Mesh, introduced 20 years ago and dubbed ‘gold-standard’, was promoted as a quick, cheap alternative to complex surgery for incontinence and prolapse.
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.
Because it did not require specialist training to implant, outraged women 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.
More than 10,000 women a year are fitted with mesh in the UK – but around 4,800 have since come forward to reveal they have been left in agony from the mesh.
However, campaigners stress these are just the tip of the iceberg and that actually there are thousands more – but they have been kept silent.
Leading mesh manufacturer Johnson & Johnson was forced to pay out $57 million in 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.
In her first UK interview, she told BBC Panorama: ‘The pain that I have I will have to live with for the rest of my life. There’s nothing they can do to help me.’
BBC Panorama: The Operation That Ruined My Life to air on BBC One, 7.30pm, Monday 11th December
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.
Yet, 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.
According to Kath Samson, head of the Sling The Mesh campaign, surgeons often refuse to accept vaginal mesh implants are causing recipient’s pain, and are not obligated to report such complications anyway.
She said: ‘Less than 40 per cent of surgeons report vaginal mesh implant side effects.
‘In last 10 years, 126,000 mesh and tape implants have been fitted in England alone.
‘In that period around 7,800 women have gone into hospital with a mesh complication, but the number reported to the MHRA is just over 1,000.
‘Many more women would have experienced pain but never gone to hospital.’