The recent flurry of media attention surrounding the problems experienced by hundreds of women who have been treated with polypropylene mesh serves to highlight the ongoing dilemma facing claimants and lawyers in how to progress these types of claims.
The history of mesh use in urogynae and gynaecological procedures is lengthy and I have commented on this in the past. Back in 2014 when Scotland suspended their use in all gynaecological procedures, there were hopes that NICE would provide and update of their guidance for use of these devices.
NICE, the body responsible for reviewing treatment within the NHS, issued updated guidance for treating Stress Incontinence in September 2013 and restated its view that the use of mesh for treating stress incontinence was merited.
It acknowledged the concerns in relation to the use of polypropylene mesh, but found in its review of published studies that whilst there were several recognised risks including tape erosion, infection and that in some cases these could be life threatening, the overall benefits of mesh in TVT/TOT procedures justified their continued use.
However, in relation to the use of mesh in TVM procedures there has been no recent update to the NICE guidance. The last update for Sacrocolpopexy use was in 2009 at which time the advice was that the continued use of mesh in such procedures was appropriate.
A quick internet search will highlight a flurry of firms seeking to bring defective device claims against the Manufacturers of the meshes used in the UK and yet the number of successful claims in the UK are minimal (if any). The problem for Claimant lawyers is that as yet the MHRA still lags behind the clear demand for a definitive review of these devices. The interim report produced by the Scottish regulator has not been updated and whilst internal reviews are continuing the silence is deafening.
As such, it is relatively easy at present for manufacturers to maintain and defend that position that their device is safe. For a claimant to prove otherwise, requires massive funding support and the ability to independently assess the data on a device across it’s entire use. For most firms and litigation funders this is simply unachievable. The has to be driven by the MHRA in their regulatory role. The ball has started rolling on mesh claims but seems to have become stuck.
Part of the reason for that, is that the reality of these devices is that there are good and bad outcomes. This provides a grey area for those who have been adversely affected. They fall into the smaller group who suffer devastating consequence of a device which is generally considered to be safe for use. The majority who have a positive outcome would say that the device has transformed their lives for the better. For the others, they have little redress unless the MHRA or the manufacturer prompt a recall or device notice.
This disparity in bringing claims for defective devices is arbitrary and unfair to large numbers of patients and it is time that the UK looked into alternative approaches. No fault schemes, which should be contributed to by manufacturers, to compensate those who suffer from the inevitable but rare complications need to be looked at again.
Perhaps with a more resolution based approach by the entire industry, a better outcome can be achieved.
Written by Christian Beadell, Senior Solicitor at Fletchers Solicitors.
Further information: www.bbc.co.uk/news/health-39567240