A report into the safety of an operation to cure women’s incontinence, carried out regularly in hospitals in Cambridgeshire, has used evidence that is “high risk” for bias.
The Cochrane Report, published this week, says the TVT mesh sling is successful in eight out of ten cases, but the authors have used 13 trials that they admit are at high risk of bias.
An independent panel studied 81 trials but only two pieces of evidence were considered to have a “low risk” of bias.
A further 66 are “unclear” about whether they are objective, by, for example, the authors having links to mesh manufacturers.
Cambs Times reporter Kath Sansom launched awareness campaign Sling The Mesh after suffering since having the operation four months ago.
Around 40% of women incontinence after natural childbirth which weakens pelvic floor muscles.
Kath said: “Most of the trials carried out since the sling was introduced 18 years ago focus on if it has cured the incontinence or they compare two different styles of operation - the TVT or the TVTO.
“There are no robust trials over a long time that show the potential painful complications that women can suffer.
“The operation may be a success by curing incontinence, but for some women it can be a massive fail by dramatically reducing quality of life.
“Until there is more unbiased research or a National Register where it is mandatory for surgeons to report complications, there will be no clear picture of the risks or how long it takes for them to cut in. For some it can be years later.”
Within a month of launching Sling The Mesh more than 600 people have joined Kath’s Facebook support group with problems of leg pain, hip pain, groin pain, difficulty going to the toilet or unable to have sex again due to mesh cutting into vaginal walls.
Some are in wheelchairs or struggle to walk far due to nerve damage or the mesh pressing on nerves.
Joseph Ogah, consultant gynaecologist, who the report says ‘is sponsored to attend workshops by Johnson and Johnson’, said: “We need to know more about what happens to women in the long term. This review found 35 trials carried out more than five years ago.
“If all the women in these trials were followed up we would know much more about how long the operations last and, crucially, whether they had developed late but important side effects.”
Cochrane Report lead author, Abigail Ford, from Bradford Teaching Hospitals said: “This is a very significant review informing women about the minimally invasive surgical options available for the treatment of this very debilitating condition.
“It helps to clarify the pre-existing evidence on the effectiveness of these approaches and their side effects in the short term, as well as introducing longer term evidence of efficacy and safety. It helps to give women more information to make an informed choice.
“As all surgery carries some risk women must weigh up carefully how much they are troubled against taking a small chance that things may go wrong.”
The report says problems have led to “many court actions worldwide, with cases already under way in the UK, USA and Canada.”
Co ordinating editor of the Cochrane Report, Cathryn Glazener, who is involved in overseeing the first human trials of mesh slings, said: “Safety concerns about slings have made international headlines in recent months. Independent reviews of the evidence for efficacy, effectiveness and safety have already been conducted or commissioned in Australia, Denmark, the European Commission, France, the Netherlands, New Zealand, the UK, and the USA.”
She added: “Women have reported serious and debilitating problems following surgical treatment for stress urinary incontinence…using vaginal mesh implants.
“The number of reports to MHRA is low compared to the overall use of these implants, there is some evidence of under-reporting and there are concerns that MHRA is not aware of all women who have experienced problems.”
But despite that the MHRA insist the risks outweigh the benefits.
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