It was a simple implant to cure an embarrassing problem… The incontinence operation that’s ruining women’s lives
Thousands of women have been left severely damaged as a result of an implantable ‘sling’ operation to treat problems following childbirth.
Up to 40,000 women in the UK are believed to have received the treatment — an implantable plastic mesh known as trans-vaginal tape (TVT), which is intended to support the pelvic organs to prevent incontinence.
Now it’s been found that in an estimated 10 per cent of cases the mesh disintegrates within months of being implanted.
The tiny fragments, measuring only a few millimetres, migrate and become randomly embedded elsewhere, triggering inflammation and infection.
Women can also be left in intractable pain and their sex lives can suffer.
Although some women have undergone ten or more operations to attempt to remove the mesh, surgeons say it is impossible to get it out completely.
As a result, the sling procedure is no longer recommended in America — the Food and Drug Administration (FDA) there has warned that it causes far more complications than previously thought, and is exposing women to unnecessary risk.
In Britain, the Medicines and Healthcare Products Regulatory Agency is currently investigating reports of widespread problems and is due to issue guidance soon on whether doctors should stop using the operation.
The problem with TVT highlights a continuing dangerous anomaly in medicine. While drugs have to pass many years of exhaustive clinical trials before being approved for use on patients, new medical devices can be introduced with minimal testing and do not need to go through patient trials.
As well as breast implants, there have been problems with some artificial hip joints and pacemakers, which came to light only after thousands received them.
The sling procedure was developed to tackle a common long-term problem associated with childbearing, as well as the menopause and hysterectomies.
Up to two in five women suffer incontinence, or prolapse, when the ligaments supporting the womb are stretched and become ineffective. This means the womb and other organs can press on the bladder.
Doctors frequently recommend pelvic-floor exercises to improve muscle tone, but often they do not work.
Some women are too embarrassed to consult a doctor and simply suffer in silence.
Traditional surgical treatment has involved holding up the womb by stitching it into surrounding tissue — this prevents it pressing on the bladder, but the procedure often doesn’t work and involves up to two weeks in hospital.
The advent of TVT in America in 2002 seemed to provide a better solution, and it quickly became available on the NHS as well as privately.
Since then, however, lawyers have investigated hundreds of complaints from distraught women who say their lives have been ruined.
One victim is Christine Doppelt, 69, a psychotherapist who lives with her husband in Fulham, South-West London.
A mother of three adult children, she started having ‘very mild’ problems with urinary incontinence about ten years ago, and was recommended TVT following a consultation with a private gynaecologist in 2006.
‘I couldn’t afford to take the time off work for the standard “stitching and lifting” operation, and I was sold the tape procedure on the basis it was a 20-minute process under local anaesthetic,’ she says.
‘However, it hasn’t worked at all. I have been in constant pain. I feel as if I’m passing acid when I go to the loo. I was not informed of the risks of it not working, I have been back again and again, and it seems nothing can be done. I am furious.
‘It keeps disintegrating a bit at a time. I have infection after infection and have been more or less permanently on antibiotics since I had the operation, as well as having various operations to try to remove the fragments.’
Christine says the device now feels ‘like a cheesewire’ is inside her.
‘If I had known about the risks, I would never have had it done,’ she adds.
‘Although I am otherwise fit and healthy, I feel doomed. I have been told the only solution might be a complete urethral reconstruction to remove the affected area and all the mesh at the same time, but even that might not work.’
Mrs Doppelt is a far from unique case. A support group called Messed Up Mesh in Bristol has more than 140 members.
‘Some women are having up to 12 operations to get this stuff out of their bodies,’ said Lorraine Evans, who started the group after suffering the same problems. ‘We are hoping to launch a group legal action.’
Mrs Doppelt has so far been told that she would be unlikely to be successful in a legal action against the consultant who inserted the mesh, because there is no evidence the procedure was done wrongly or any established evidence that the mesh is defective.
All that may be about to change. In America, the Food and Drug Administration has just taken the rare step of revising a 2008 advice document saying problems with the mesh were ‘rare’.
After reviewing years of evidence, it has concluded one in ten operations goes disastrously wrong.
Its advisers originally assumed the mesh would not present problems because it is similar to a material which has been used in men since the Fifties to repair hernias — gaps in muscle wall which can trap sections of an organ.
The mesh was approved in 2002 for use in female prolapse, where the bladder or womb slips down into the vagina. However, it seems to behave differently in gynaecological use because there is less tissue to support it.
Despite protests from affected women, the U.S. authorities have not recommended complete withdrawal of the treatment.
Instead Food and Drug Administration is holding a meeting next month to discuss how to find better ways of identifying patients who will not react badly to the tape.
Meanwhile, here, the Medicines and Healthcare Products Regulatory Agency has launched an investigation.
‘We are planning to publish our findings soon,’ a spokesman said. ‘If people are experiencing problems with a device, we would encourage them to report this to our adverse incident centre.’
Christian Beadell, of Goodmans solicitors in Liverpool, says his firm has received more than 400 complaints about the mesh.
‘The most common problem was the mesh failing to bond in place. Instead, it works its way through the vaginal wall, causing infection, urinary difficulties and pain during sex.’
Marcus Drake, a consultant urologist at Southmead Hospital, Bristol, is one of a number of senior specialists who have raised concerns about the use of the TVT.
He has operated on many women who have suffered problems after the mesh disintegrated and points out that, unlike drugs, there isn’t a proper system for reporting problems.
‘As a result we have absolutely no idea of what the total number might be, but I regularly get requests to remove these tapes from women who are struggling with chronic pain, inability to pass urine naturally, or whose tape has eroded. All regret having had it placed.
‘It is unacceptable that drugs have to go through protracted testing and trials, but devices are put on the market with minimal experience of how they perform in real patients.’
Vincent Argent, another specialist gynaecologist based in Eastbourne, Sussex, says there should be a national register of patients as there is for those with breast implants, pacemakers and hip joints.
This would mean that if anything goes wrong with a particular device, doctors can rapidly stop using it, and affected people can be recalled to have it replaced.
‘There are about 25 different manufacturers of this mesh,’ says Dr Argent.
‘They are all broadly similar, but there is no way of highlighting the ones that fail. We know use of this operation has grown rapidly, and there are undoubtedly large numbers of women affected.’
One of the major brands of the tape is manufactured by Ethicon, a subsidiary of U.S. healthcare giant Johnson & Johnson. A spokesman said:
‘Patient safety is our primary concern and we support the FDA’s efforts to review and assess data regarding the safety and efficacy of surgical mesh products.’
Read more: http://www.dailymail.co.uk/health/article-2026354/It-simple-implant-cure-embarrassing-problem–The-incontinence-operation-thats-ruining-womens-lives.html#ixzz1VNsIJmTg
- FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process (earlsview.com)
- Medtronic’s InterStim Therapy Continues to Show Encouraging Results at 3-Year Follow Up (medgadget.com)
- Stress Incontinence (via IncoStress) (femaleincontinence.wordpress.com)
- A Feminine Approach to Incontinence (nytimes.com)
- Women face several forms of urinary incontinence (seattletimes.nwsource.com)
- Women face several forms of urinary incontinence (medicalxpress.com)
- Incontinence in men: 14 must-know facts (cbsnews.com)
- Risky pelvic mesh highlights worries about FDA (msnbc.msn.com)
- Pelvic Mesh for Incontinence May Carry Added Risk for Women (nlm.nih.gov)
- FDA: pelvic mesh for women riskier than thought (seattletimes.nwsource.com)