Should vaginal mesh devices be banned?
Christian Beadell, a senior solicitor at Fletchers Solicitors, comments on the latest calls to ban mesh implants.
The use of vaginal mesh implants has once again become a hot topic within the House of Commons, with a number of MPs calling for an immediate ban on the use of the devices.
The subsequent debate led to an announcement by the health minister Jackie Doyle-Price that there would be no inquiry but instead the publication of new guidance by the National Institute for Health and Clinical Excellence (NICE) in relation to the use of mesh in gynaecological and urogynaecological procedures.
The fact that this announcement was responded to with gasps of astonishment in the House reflects the current polarisation of views in relation to the use of these medical devices.
If you look at the reports over the past decade, thousands of women have had mesh implants removed. A recent report claimed that one in 15 women, who have had the most common type of mesh device inserted, later required surgery to remove them due to complications. Some experts have questioned this study, but if the figures are correct, then this could suggest a far higher rate of complication for both TVT and TVM than previously believed.
In May this year, NICE did acknowledge the well recorded concerns around possible erosion of the device and the infections they can cause. Given the lack of clear data on safety and effectiveness, it was recommended vaginal meshes should be considered for use in the context of it being research. This would mean that there would be a greater degree of scrutiny and patient discussion when proposing the use of devices. But the last guidance on the use of mesh to treat incontinence was issued in October 2016 and concluded the overall benefits of mesh in stress urinary incontinence procedures justified their continued use.
This shows the ongoing problem for the staunch campaigners wanting a blanket ban on all mesh devices, as for many women they have provided significant relief from debilitating symptoms of incontinence.
However, that will provide no solace to those woman who have had complications from mesh devices and have been told that this is not a claim that relates to the product itself.
What is clear is that the device regulation system in the UK is in dire need of overhaul. It has been playing catchup because the devices were authorised for market use before full clinical trials had been completed regarding their safety. Whilst I would not be in favour of a blanket ban, as this removes patient choice, I would be in favour of a limited restriction on the use of mesh in the procedures with the highest incidence of complications.
The advancement of the NICE review is to be welcomed, but if we are to avoid this becoming a medical scandal as big as thalidomide, (which has been suggested) then swift action needs to be taken.