Way back in July 2017, we blogged about how a leading professor from Oxford University was calling for a public inquiry into the practice of vaginal mesh surgery.
Now, six months later and according to recent reporting in The Guardian, at long last the Government plans to conduct a review into the use of vaginal mesh implants. It seems that despite the frequent calls from interested parties such as the Oxford professor, the audit was ultimately prompted by a parliamentary group on surgical mesh implants led by Owen Smith MP (Labour). Mr Smith described the controversy as one of the worst medical issues he had come across in his career. The Government report should be completed by April this year.
What Is A Vaginal Mesh Implant?
The vaginal mesh is a plastic device which has been implanted in thousands of woman across the UK. Its purported function is to strengthen weak pelvic floor muscles, in order to treat incontinence, hernia and prolapse.
However, more and more women are coming forward to describe the serious and dangerous side effects they have endured because of their implant. They report complications such as chronic pain, infection, perforation and difficulty walking. Other women have described how the complications impact more generally on their lives: losing jobs and partners as a result of pain, anxiety and depression. These complications are potentially life-threatening: a mesh implant caused septicaemia and organ damage in 42 year old Chrissy Brajcic, directly leading to her death last month.
Shockingly, the official rate of side effects and complications from the plastic implant is not yet credibly established and could be as high as 40%. The uncertainly is in part due to the fact that surgeons are not yet explicitly required to report mesh removals to the Government’s Medicines and Healthcare Products Regulatory Agency (MHRA). What is more, following a July 2017 review of the matter, the Director of Devices at MHRA said, ‘we are not aware of a robust body of evidence which would lead to the conclusion these devices [vaginal mesh implants]are unsafe if used as intended. We actively encourage patients and healthcare professionals to report complications associated with these implants’. So that’s okay then?!?
But NICE Guidelines Now Say No!
Perhaps the MHRA needs to update their research and recommendations, given the new advice from the National Institute for Health and Care Excellence (NICE). Guidelines published by the group in December 2017 recognised the serious safety concerns inherent to the mesh implant and emphasised that evidence of long-term efficacy of the procedure is ‘inadequate in quality and quantity’ : therefore the device should ‘only be used in the context of research’ (https://www.nice.org.uk). The problem is, the advice from NICE is just that – advice. The NHS is not legally compelled to act on its findings.
Medical Trials? What Medical Trials?
You might expect that any device destined for surgical or medical use would first be tested in clinical trials. It seems that this was not the case for many mesh devices, which were introduced without undergoing clinical testing: this meant that adequate data on potential complications and problems could never have been collated.
In 2006, Johnson and Johnson (J&J) launched a new vaginal mesh implant into the surgical world, without a clinical trial. Even more disturbingly, despite knowing that this particular device had a higher failure than their other devices, they continued to market the product ( The Guardian, 29 Sept 2017). It is also now known that senior J&J executives considered suppressing unfavourable data. Despite all this, the implant was only withdrawn from use in 2012.
See You In Court
Class actions against J&J are currently taking place in the USA and Australia. Recently a woman in the US successfully sued the company and was awarded damages of $57 million for the serious injuries she suffered from the implant. She endured severe, chronic pain and organ damage, and had to undergo a total of 3 separate surgeries to completely remove the plastic from her body. Her lawyer, was quoted in The Guardian as saying, ‘I am pleased the jury recognised the recklessness of J&J and I hope the company takes notice of the verdict and adjusts its practices accordingly’. J&J plan to appeal the verdict.
The Guardian also covered the court case in Australia, where 700 women also sued J&J. During the trial, it was argued the J&J had ‘aggressively marketed the devices to surgeons as a cheap, easy alternative to treating pelvic prolapse’.
And back here in the UK, a group of 800 women are also suing the NHS for failure to obtain adequate and informed consent, and the vaginal mesh manufacturers which includes J&J. We await the outcome with interest.
At Osbornes Law we care about how you are treated both by medical professionals at your GP surgery or at hospital and also under the care of private providers of health services. If you think that the care you or a loved one has received fell below the standards expected of a reasonably competent professional, then please do not hesitate to contact Partner and specialist medical negligence lawyer Stephanie Prior on 020 7681 8671.
Osbornes was also named ‘Law Firm of the Year’ at the Modern Law Awards in 2018.