Animals cannot tell researchers about the pain from mesh experiments - report into implants used in NHS women’s operations is criticised
PUBLISHED: 14:00 07 July 2016 | UPDATED: 14:33 19 July 2016
Animals used in experiments to test mesh medical implants for women’s surgeries cannot talk about pain they are suffering, a campaigner has said.
The warning comes after a health watchdog boss cherry picked animal studies to ensure surgical mesh used in women’s operations was seen as safe, she said.
Ann Boni, of Sling the Mesh campaign said: “Instead of looking at the pros and cons of the medical implant material, the MHRA report looked at a handful of studies in animals to show mesh in a positive light.
“This was supposed to be a toxicology report and it is just a biocompatibility report looking at old, previously published, literature reviews in animals.
“Unfortunately animals cannot tell you when they are in pain, but humans can and we have, but the MHRA has failed to listen and have put the manufacturers profits above patient safety.”
She added there have never been any long term human trials to show the complications the implant can cause - despite it being implanted in women worldwide since 1996.
The report, by Dr Neil McGuire, director of medical devices at the MHRA, coincides with a separate study published by five UK medics which says polypropylene can cause “severe clinical complications in a significant minority of patients.”
Their study was carried out in search of a better pelvic floor surgery flexible fix using human stem cells spun with polyurethanes and co-polymer plastics to withstand the pressure of a woman sneezing or coughing.
Their study says such pressure can cause the plastic currently used in mesh slings to become “deformed” within seven days.
Canadian surgeon of 35 years experience, Dr Robert Bendavid, whose studies show surgical mesh can shrink, degrade and erode ,said of the MHRA toxicology report: “This is one of the worst, shallow, uninformative reviews I have ever read.”
“It reviewed the favourable literature without touching upon the problems which are being raised.
“Mr McGuire’s report is a simple-minded exercise in placating an unsophisticated audience.
“It was irrelevant in the discussion of infection and pore size - pore sizes in all polypropylene meshes have never been an issue in terms of infection.
“I note they didn’t use any of my studies with Blavais and Iakovlev which show mesh in a negative light.”
Dr Bendavid concluded that mesh plastics could cause leaching of toxins in patients as nobody truly knew what the materials were made of.
He said: “Most surgeons are derelict through their neglect in explaining the serious side effects and complications which happen not so rarely.
“Would they think differently if their daughters or wives were to be subjected to such harm? In 15-30 per cent of instances?”
• The MHRA said: “Biocompatility is an aspect of toxicology and the distinction between the terms toxicology and biocompatibility are addressed in the MHRA publication.
“As is highlighted there is common interchangeability and misinterpretation of the terminology and this does not equate to the scientific use of the terms. Independent toxicology expertise was called upon during the reviewing, writing and editing of the publication.
“The assertion of cherry picking is not accepted. The methods section of the MHRA publication clearly states the inclusion and exclusion criteria for articles reviewed.
“The MHRA publication considered all available literature and this was considered by a panel of reviewers as to its scientific value according to the evidence supporting any assertions made.
“Studies by Bendavid, Iakovlev a et al were conducted in humans and therefore did not meet the publication’s inclusion criteria.
“Animal studies were reviewed as they are useful for understanding adverse effects directly related to the material as they enable standardisation of experimental parameters.”
The added that Professor Ian Chapple’s report was “outside the scope of this publication however it does acknowledge that there are a small number of patients that have serious complications from the implantation of these devices.”
“The publication reports polypropylene is a suitable material for implantation and performs well in comparison with alternative synthetic and biological materials for the reasons given.
“The MHRA publication was thoroughly researched and is the most comprehensive study of available information on this subject.
“It has been extensively and independently peer reviewed prior to publication with attention to the appropriate scientific rigor required by the publishing internationally recognised journal.
ReadThe MHRA report