Women who have agreed to be guinea pigs for one of the first human trials into an operation for incontinence are not being listened to when they suffer extreme pain, it has emerged.
The news comes after a mum of three, who signed up for the trial, leaked documents to reporter Kath Sansom after seeing her Sling The Mesh campaign on Facebook, to show the research is not properly monitoring the 305 women involved.
The woman told her surgeon that she was suffering chronic pain in November 2014.
Eight months later, however, she has still not been treated. More worrying is that trial leaders insist there have been no complications so far.
The woman said: “I am supposed to be part of a carefully monitored trial but nobody is taking notice.
“Pain is so bad that at night I can’t lie on one side, I have constant stomach pains like period cramps, it sometimes takes my breath away, I have hip pain, sex is too painful. I was fit and active before, not anymore.
“The sling only worked for eight weeks. When I went back to the surgeon I hoped he could offer something to fix this but I was told if it isn’t working we might as well leave it in.
“He offered to put another sling in, inject me with botox to cure the incontinence or give me abdominal surgery. I signed up to the SIMS trials feeling I would be looked after, it is not the case at all. The pain has been ignored.”
SIMS trials have been taking place in 11 hospitals across the country since July 2014 and are designed to compare mini slings with the TVTO mesh.
The woman said she was sent a £15 love to shop voucher as a thank you for participating.
By comparison surgeons are encouraged to find the 650 women needed for the trial with the lure of prizes such as a trip to Rio de Janeiro and laptops, which was exposed in an investigation led by Scottish journalist Marion Scott earlier this year.
Mohammed Abdel Fattah, the surgeon leading the SIMS trials, based at Aberdeen University Hospital, said in 2011 that evidence did not support the use of mini slings.
He now heads up the trials and on his CV says that he receives travel sponsorship from sling makers, Ethicon. A spokesman said he was currently on annual leave and not available for comment.
The mum in the trial sent Kath a copy of the 19-page questionnaire sent five times over three years, to show that questions had been selectively worded to concentrate on a woman’s “urinary problem” and not give space to properly detail post operative pain or complications.
“The questions all focus on if your urinary problem is affecting your life.
“They are cleverly worded so you cannot answer saying you are in pain. This is wrong as it does not give space for women to detail terrible complications that can happen, so the reality of risks goes unrecorded” she said.
A spokesman for the SIMS trials said: “The independent Data Monitoring Committee review safety data and, to date, have reported no concerns with data they have reviewed.
“Mr Abdel-Fattah’s paper in European Urology was a review of the literature published on SIMS and Standard Midurethral Slings (SMUS) – the trials reporting on the use of the SIMS technique were considered sub-optimal and the authors concluded the paper by recommending the initiation of an adequately powered and properly designed Randomised Controlled Trial to compare the new adjustable SIMS with SMUS and this is exactly what is being done in the SIMS Trial.”
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