Women are duped into believing the most common mesh operation is safe, campaigners say
- Credit: Archant
The NHS have duped thousands of women into believing the most common incontinence mesh operation is safe, by not adding loss of sex life into its risk figures, campaigners say.
The move keeps figures low so surgeons can reassure women that it is a safe day case operation.
The discovery is buried in a report from five years ago, and when questioned on it, the MHRA, tasked with making sure implants are safe for patients, passed the buck and blamed the report authors.
The revelation comes after a debate in Westminster, where health minister Jackie Doyle Price said there was not enough evidence to suspend the plastic implants and quoted a risk of one to three per cent.
However, those figures were blown out of the water just weeks before the debate in a landmark study using the NHS’s own hospital re-admission figures which show TVT mesh tape risk is at least 10 per cent.
Campaigners say even that is not a reflection of the true scale of the mesh disaster because it does not take into account women going to doctors for pain medication or those suffering in silence.
David Golten, senior partner of Wedlake Bell, leading a group action for campaign group Sling The Mesh, said: “This is yet another example of the devastating damage these products and procedures have done to women and of the suppression and manipulation of evidence which is becoming a hallmark of this case.
“The government must act straight away to suspend these procedures pending a full enquiry.”
For five years the MHRA, has failed to take notice of risk statistics for dyspareunia - a medical term for painful or loss of sex life.
Yet at least half the women on Sling The Mesh suffer this distressing after effect.
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A report, commissioned by the MHRA, shows as many as one in seven women lose their sex life after a mesh implant.
But this figure is ignored and instead, they only add up the risk figures of pain and erosion - a condition where the plastic mesh slices into flesh and nerves.
A spokesman for Sling the Mesh, which has quadrupled to 4,200 members in six months, said: “This is statistically misleading. Leaving out dyspareunia risk figures is unscrupulous, unethical and a basic human rights issue.
“If this was happening to men these operations would have stopped years ago.
“The emotional impact for women and their partners is devastating.”
Campaigners say that despite a three year mesh working group, which says consultants must give women fully informed consent, surgeons across the country are still telling women that risk is low after the most commonly used mesh implant called a TVT.
Some tell women it is mesh media hype, while others deny it is mesh and insist it is a tape.
Instructions for use for surgeons that come with TVT kits, use the word “mesh” more than 30 times within the literature, making it abundantly clear that the TVT tape is made of mesh and is described as such in paperwork from the manufacturers, campaigners say.
WHERE DID THE ONE TO THREE PER CENT FIGURE COME FROM?
The MHRA, commissioned a study called the York Report in 2012 to find out complication rates for mesh implants.
They picked a range of studies and produced a table to clearly highlight risks.
In it, the most popular mesh sling implant to treat incontinence, a TVT tape, made of plastic mesh, shows the highest risk for women losing their sex life is 13.5 per cent with an average risk of 9.3 per cent.
Even that table is incorrect, campaigners say, as the highest risk study referred to, by author Marszalek, is actually 14.5 per cent risk.
None of the loss of sex life statistics were included in final calculations, which campaigners say was done deliberately to make it look as if the operation is safer than it is.
When questioned, the MHRA said they did not include loss of sex life as it was not in the “general risk” range.
An MHRA spokesman said: “The York report was a literature survey carried out in 2012 and represents the available scientific / medical views from five years ago.
“The figures used to inform the general range of one to three per cent are highlighted in yellow whilst the nine per cent figure is highlighted in blue.”
THE MHRA PASSES THE BUCK
The MHRA - responsible for ensuring patient safety - then passes the buck and blames the omission on the report authors.
The spokesman said: “MHRA commissioned the report from the Health Economics Consortium of York University, reviewing the published literature on the most frequently reported adverse events.
“MHRA did not compile the report.
“For further info on the details you’re encouraged to get in contact with the authors of the document.”
In a report from 2013 the MHRA admits that: “The resources available for the Devices Division within the MHRA have been diminishing over the years due to austerity measures.
“It is proving to be increasingly challenging. It has also been difficult to recruit to vacant clinical posts within the Devices Division.”