18 June 2014
Scotland Suspends Use of Vaginal Mesh Implants
The Scottish Health Secretary Alex Neil announced yesterday that he was requesting a suspension in the use of mesh implants by the NHS in Scotland, pending safety investigations.
This follows an impassioned plea to the Scottish Parliament by the Mesh Survivors Group as part of their “Hear our Voice” campaign which led to the lodging of a petition to suspend the use of meshes in Transvaginal Mesh (TVM) procedures in May 2014.
The announcement by Alex Neil, goes wider than the petition and is looking at the uses of all mesh in gynaecological procedures which includes their application in the treatment of urinary stress incontinence.
There has been much debate in recent years with regards to the use of mesh in gynaecological and urogynaecological procedures worldwide. In the USA a number of devices have been withdrawn following extensive lawsuits, but in the UK, the MHRA has continued to endorse its use and takes the view that problems associated with the use of mesh are often related to individual circumstances rather than problems with the mesh as a product.
The National Institute for Clinical Excellence (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. For example, mesh use in Sacrocolpopexy, was last updated in 2009 at which time the advice was that the continued use of mesh in such procedures was appropriate.
The 2013 guidance, acknowledges the reports of concerns with mesh in pelvic organ prolapse repair and the fact that the belief that mesh used in hernia repairs for many years could be applied for gynaecological treatment is now questionable. This is because the vaginal mucosa and surrounding area react differently to foreign bodies.
At present there is a danger that NICE will fall behind the current thinking / research in the use of mesh and this will expose patients to unnecessary risks.
In light of the stance taken in Scotland, this should now prompt a complete review of the appropriateness of using mesh in any urogynaecological procedure so that patients can reach decisions on the merits of accepting treatment with mesh on a fully informed basis.
At Slater and Gordon Lawyers we specialise in medical negligence claims and have particular experience of dealing with medical complications arising from urogynaecological treatment, including stress incontinence and pelvic organ prolapse.
If you have any concerns about medical treatment received by yourself or a loved one, please call us for a free consultation on freephone 0800 916 9049 or contact us online and we'll be happy to help.
Christian Beadell is a Senior Associate Solicitor specialising in Clinical Negligence Claims at Slater and Gordon Lawyers in Liverpool.
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