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Professor Heneghan has now launched a fresh attack on mesh, asking for them to be given temporary licences that restrict them solely to use in clinical trials - and not in humans.Professor Heneghan and colleagues argue evidence from large trials over the safety of mesh did not emerge until 20 years after the first products were introduced.The results show no evidence of any new clinical trial data at the time of device approval for all of these 61 devices, Professor Heneghan warned.They argue changes in design 'should have alerted regulators' to differences in the characteristics of the mesh that should have negated the use of equivalence.She wrote: 'From what I see each day, these patient experiences are not "transitory" at all.'However, Ethicon did not update them to remove the word 'transitory' at the time.The company’s latest IFUs, updated in 2015, say some effects may be permanent.A company owned by a multi-billion pound pharmaceutical failed to fully inform doctors of how dangerous vaginal mesh can be, a BBC Panorama investigation has found.The programme, airing tonight, will also reveal how an implant made by Ethicon was only tested on 31 women and in sheep before being used in patients.
And when longer term evidence did emerge, it identified serious concerns - which many officials have since ignored, implied Professor Heneghan and colleagues.The product, which Johnson & Johnson has since paid one sufferer who became reliant on a walking stick million, was withdrawn from the market in 2012.Ethicon told Panorama: 'While we empathise with those who have experienced complications, the vast majority of women with pelvic mesh see an improvement in their day to day lives.Christina Brajcic, 42, from Ontario, Canada, passed away last Thursday following a four-year battle with persistent infections - as a result of her mesh.Her death last week followed landmark moves by English and Australian health officials to recommend the controversial implants should no longer be used.
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'All surgical pelvic floor procedures – with and without mesh – come with the risk of developing complications.' The MHRA, the UK medical devices regulator, told Panorama it recognises some women develop serious complications.