Regulation over vaginal mesh implants is inadequate

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.’

It comes as a leading expert has warned there are inadequate regulation for vaginal mesh products which has exposed women to unnecessary harms.

Carl Heneghan, professor of evidence-based medicine at Oxford University, has previously described the mesh scandal as akin to thalidomide.

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. 

Writing in the BMJ Open Professor Heneghan and colleagues argue the implants can’t be considered safe as they didn’t undergo scrutiny in scientific studies with a follow-up of at least five years.

The implants, which can shrink, twist, curl and cut through internal tissue, have left women on the brink of suicide, unable to work and even walk. 

The scathing comments come as MailOnline spoke to John Sharman (right), a 65-year-old grandfather, who revealed his beloved wife Lynne (left) was left suicidal from the implant

Mr Sharman added:’It’s something she will have for the rest of her life, there is no possibility of getting a pain-free life back. That’s so frustrating.

‘Sometimes I wonder whether if it’s worth staying together, you can’t help it because our relationship has changed.

‘It has to change because your wife isn’t the same one that you married.

‘We’ve been together for long enough that I care enough about her, but you can never say never. But at the moment it isn’t an issue.

Their sex life has been shattered

He revealed how the couple’s sex life has been scuppered, going from twice a week to barely engaging in any activity beneath the sheets.

The issue arose when he felt something in the way as they had intercourse a few years ago. He could see it was hurting her.

Since then, Mr Sharman constantly worries about causing her pain.

He said: ‘Even if she isn’t in pain I’m always worried about hurting her if we try.

Vaginal mesh implants (pictured) have left women wheelchair bound and unable to have sex

Vaginal mesh implants (pictured) have left women wheelchair bound and unable to have sex

‘She’s not in the mood for manual or oral stimulation either. Your sex life goes out of the window. Both of us in terms of libido have totally gone.’

‘It [the mesh] probably means you don’t have fun anymore at all. You’ve got to look after your wife.’

Now I’m more of her carer than I am her lover and a husband

John Sharman, 65

Her timeline of events

Mrs Sharman, 61, had the vaginal mesh surgery at Berkshire Independent Hospital in 2011 due to her mild incontinence – triggered by childbirth.

Pain almost immediately followed.

But she was not given any warnings about any possible life-long side effects other than it might perforate her bladder.

John Sharman (pictured), 65, from Reading, revealed Lynne's heartbreaking account of the scandal-hit surgery following the emergence of hundreds of similar stories

John Sharman (pictured), 65, from Reading, revealed Lynne’s heartbreaking account of the scandal-hit surgery following the emergence of hundreds of similar stories

The former counsellor, who had three children, then had it partially removed at the John Radcliffe Hospital, Oxford, a year later.

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.

It followed a year of tireless pleas to the surgeon who put in the implant, who was unable to determine what was causing her pain.

A full removal followed a year later, but the delay in removing the mesh has left her plagued by a lifetime of pain.

Mr Sharman said: ‘She has contemplated it [suicide], I guess if she hadn’t been a teenage counsellor then she might have had the inclination to do so.

‘If she hadn’t recognised in herself how to deal with it and if I hadn’t been behind her then she might have gone through with it.’

Struggles to cuddle her grandchildren

The pain has impacted on Mrs Sharman’s ability to be a grandmother, meaning she often struggles to cuddle her five grandchildren.

Mr Sharman said: ‘It’s difficult to tell a four-year-old that nanny can no longer pick them up and give them a cuddle anymore because she isn’t capable.’

He said attempting to pick the youngsters up will have a detrimental effect on her, leaving her to spend the next day in bed recovering.

The couple have long campaigned for an end to vaginal mesh procedures, such as this one which has made Mrs Sharman reliant on painkillers.

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.’

Mr Sharman added: ‘I know of nobody who has had a successful removal who hasn’t been left with some form of pain, which is normally quite chronic.

‘We are applauding all of the actions going on at the moment. It’s really appalling, but hopefully we’re getting somewhere.’

The couple purchased a narrowboat a few years ago. It’s easier for Mrs Sharman to walk around in and gives them both an interest.

The father-of-three sometimes thinks about leaving Mrs Sharman, who he has been married to for 43 years, due to the effect the mesh has had on their marriage

The father-of-three sometimes thinks about leaving Mrs Sharman, who he has been married to for 43 years, due to the effect the mesh has had on their marriage

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.

Mr Sharman, who met his wife at 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'

Mr Sharman, who met his wife at 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’

Figures suggest more than 100,000 women around the world are suing mesh manufacturers after developing serious complications from the brittle implants. 

Tiresome fights by campaigners, backed by MailOnline, has since led to Australian and English health officials calling for a ban to some of the procedures.  

Professor Heneghan’s latest comments add fuel to the fire as outraged sufferers seek a House of Commons debate over the safety of vaginal mesh.

The comments follow the death of a ‘courageous’ vaginal mesh campaigner who passed away from sepsis triggered by her implant, it was reported.

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.

Christina Brajcic, 42, from Ontario, Canada, passed away last Thursday following a four-year battle with persistent infections – as a result of her mesh.

During her final few months, she posted an array of videos detailing her struggle with the scandal-hit devices on her Facebook page. 

Ms Brajcic’s death 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 obligated 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’.

However, vaginal mesh remains a viable option for surgeons operating on women suffering from incontinence in both countries. 

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.

Senior doctors immediately called for a public inquiry into the controversial mesh, with some saying the scandal could be akin to thalidomide.

At the time, it was reported that at least 800 women were suing the NHS and device manufacturers. However, it is unsure how many women are now looking to take action in Britain. 

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 on Thursday following a four-year battle with persistent infections – as a result of her 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, outraged women have since begged for tougher regulations to conduct such surgery. 

NICE RECOMMEND IT SHOULD BE BANNED

Controversial vaginal mesh implants should be banned, Nice said last week.

The health watchdog recommends the ‘gold-standard’ implants should not be routinely offered for treating organ prolapse but instead just used for research or after patients are made aware of the risks. 

In a series of documents about vaginal mesh implants to be published in December, Nice said that ‘evidence of long-term efficacy is inadequate in quality and quantity’.

It added that ‘when complications occur, these can be serious and have life-changing consequences’ 

Yet, Nice also said most women do not report complications after being fitted with such implants.

The health watchdog only commented on organ prolapse and not urinary incontinence or hernias, which implants are also used for.   

High-risk device in the US 

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. But only 4,800 have suffered lacerations and nerve damage from the mesh breaking into tiny fragments.

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.



Read more at DailyMail.co.uk