The scandal of women who STILL aren't told the risks of bladder operations
22:56 GMT, 3 September 2012
'The problems started immediately,' said Teresa Hughes of her bladder operation
Teresa Hughes had been delighted to be offered a solution for stress incontinence.
The 61-year-old mother of two had suffered for more than a decade before being told she would be suitable for a new treatment called transvaginal tape (TVT) — a mesh implanted under the bladder like a hammock to support damaged pelvic organs after childbirth.
Today, however, Teresa considers it one of the worst decisions she ever made.
TVT tape is known to have a devastating design fault — a tendency to break up in the body, causing small fragments to cut their way into surrounding tissue.
This is described as the ‘cheesewire effect’, because of the excruciating pain it causes.
Teresa is one of thousands of women suffering internal lacerations from the procedure that, in some cases, has left victims with difficulty walking.
They also suffer repeated pain and infection, worse incontinence and the end of their sex lives.
The issue was highlighted by the Mail a year ago — yet extraordinarily, TVT is still in regular use in Britain, and women are being recommended for the surgery without being warned of the risks.
The scale of the problem is also much worse than originally thought.
Previous official figures had recorded 107 complications with TVT between 2006 and 2011.
But figures from the Department of Health have revealed that NHS hospitals in England recorded 2,659 attempts to remove defective transvaginal or transobturator tape, as it is also known.
The latest NHS figures also show the number of affected women is rising by more than 500 a year, indicating that about one in 20 of the 13,500 operations a year to insert the material goes disastrously wrong.
After the TVT scandal broke a year ago, government regulators agreed to a safety review of the product, but the results have been delayed.
‘This is a big problem and not enough is being done about it,’ says Dr Vincent Argent, a gynaecologist and former member of the National Institute for Health and Clinical Excellence’s women’s treatment guidelines review group.
He compares the situation to the scandals surrounding other defective medical products — metal-on-metal artificial hips and breast implants made from industrial grade silicone.
In each case, criticisms were levelled at the government body that approves medical products in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA).
'I've been told I will need four more operations to try to repair permanent damage to the bladder and urinary tract,' said Teresa
‘What we need is a compulsory national register of all mesh insertion and removal operations, and outcomes including patient satisfaction, cure rates and complications,’ says Dr Argent.
The doctors who remove the tape are rarely the same ones who inserted it, so information about the rising number of disasters is not being made known.
‘It’s easy to put the mesh in, but extremely difficult to get it out. There is no requirement for surgeons to report complications and they are not keen to tell anyone when things go wrong.’
Though Teresa, who had her operation six years ago on the NHS, repeatedly complained to her GP and her hospital, she was told her problems were nothing to do with the mesh or she was one of a small number of unlucky patients unsuited to the product.
‘The problems started immediately,’ says Teresa, who lives with her husband David, 65, a glazier, in St Helens, Lancs.
‘I have had pains in my legs and abdomen, and repeated surgery to remove plastic fragments of the product that had dug through into my bladder.
‘My incontinence is worse than ever and I’ve been told I will need four more operations to try to repair permanent damage to the bladder and urinary tract, with no guarantee they will work.’
So far, no doctor has been willing to offer her the surgery.
‘I have finally been referred to a surgeon in London, but I am worried because he won’t tell me how many other meshes he’s taken out and what results he’s had,’ she says.
Teresa has had to give up her job as an auditor because of her health.
She is leading a group of women who are campaigning for the tape to be banned or for women to be given the facts about its risk before they have the operation.
Earlier this year, she delivered a petition to Downing Street calling for the number of victims to be made public.
‘So far we have only the number of NHS patients in England,’ she said.
‘There will be many more in the private sector.’
The MHRA has admitted there are problems in the system for approving medical devices, which is nowhere near as rigorous as the licensing system for drugs — these have to complete many years of clinical trials to prove they are safe before they can be prescribed.
A spokesman said: ‘The EU directives that regulate medical devices are under review by the European Commission, and the MHRA is playing a leading part in that review.’
The MHRA has also commissioned an investigation by experts from York University’s healthcare consortium, looking at reports of problems with the incontinence tape from around the world, and advising on what should be done.
Teresa is campaigning for transvaginal tape (TVT) to be banned or for women to be given the facts about its risk before they have the operation
Dr Susanne Ludgate, clinical director of the MHRA, said: ‘We sympathise with the concerns that many women have.
‘We are urgently gathering independent evidence that will give us important information about the use and potential problems associated with vaginal tapes and vaginal meshes. We will publish the findings as quickly as we can.’
A spokesman for Ethicon in the UK, owned by the pharmaceutical giant Johnson & Johnson, and one of the leading suppliers of the tape, says the company ‘continues to have confidence in the safety and efficacy of its products for the treatment of pelvic disorders, and has no plans to make changes to the materials used in products on the market’.
However, the Food and Drug Administration, which regulates medical products in the U.S., warned last year that ‘serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare’.
After reviewing years of evidence, it concluded 10 per cent of women suffer problems with the mesh breaking up.
It’s not clear if this is because of problems with the mesh itself or poor insertion technique.
Lawyers say cases are hard to fight. A loophole in the law means if a doctor has caused a pre-existing problem to be worsened, it is harder to make a claim.
Liverpool solicitor Christian Beadell has investigated around 300 claims against a local urogynaecologist who was barred by the General Medical Council in 2009 from doing any more vaginal tape insertions due to poor technique.
‘There are a lot of women shopping around for someone to remove it and it is difficult to find surgeons able to do it,’ he says.
Marcus Drake, a urologist at Southmead Hospital, Bristol, says TVT tape can cure incontinence, but the procedure is often carried out by badly trained doctors.
‘Perhaps a body should be created to weigh up the safety and efficacy of products and guarantee the training of doctors using them.’
Teresa Hughes agrees.
She says anyone being recommended to have the tape should ask questions — most importantly, what to do if they end up among the unfortunate 10 per cent of patients for whom the operation does not work.
Last week, Londoner Christine Doppelt, 70, who first highlighted the TVT problem to the Mail, said she had just endured her fourth stay in hospital to remove fragments of the tape from her urinary tract.
‘It is as excruciating as being cut by cheesewire,’ she says. ‘It is time something was done to stop more women suffering in this way.’