SCOTTISH HEALTH SECRETARY TO UNDERTAKE MESH IMPLANT INVESTIGATION
by Pharmacy Life - Published on 12 May 2014
Scottish Health Secretary Alex Neil is taking action to review the process of mesh treatments for women suffering from pelvic organ prolaspse following an American ruling which branded it ‘high risk’, including writing to the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Commission.
'I have personally met with some of the women adversely affected,' said Mr Neil, 'and I have listened carefully to the concerns they have about the use of transvaginal mesh implants. There is no doubt that these women have suffered considerably and they have my full sympathy.
'Although the regulation of medical devices, including implants, is a reserved matter dealt with by the UK Government, I remain concerned about the issues that have been raised and I am determined to take action.
'That is why we are seeking an urgent meeting with the Medicines and Healthcare products Regulatory Agency (MHRA), and I have written to the European Commission, who take the ultimate decision on the regulation of these types of products.
'In light of the proposals from the US Food and Drug Administration (FDA) to reclassify mesh as high risk, I have asked the MHRA and the European Commission to urgently consider whether this reclassification should be applied here.
'The Scottish Government has also set up an expert group to look at the issue of transvaginal mesh implants, which met for the first time in February.
'This group has been working in partnership with some of the women affected to develop an information leaflet and consent form for the use of synthetic vaginal tape procedures. This leaflet and form are being finalised at the moment, and I expect that they will be in use from June this year.
'The purpose of the information leaflet and consent form are to ensure that women who are offered treatment with a mesh implant are fully informed about any potential risks or side effects they may have.
'We are also working with the National Planning Forum to develop the best pathways of care for women presenting with pelvic organ prolapse and for those with complications from previous operations. This will involve looking at how best to set up services on a regional and national basis, so that we can offer the best possible care to women who require it. I hope that this work will lead to us being able to implement some changes to the way women are treated towards the end of this year.
'We have alerted all GPs and consultants to the potential side effects on mesh. Two letters from Scotland’s Chief Medical Officer have been sent out to GPs and consultants through the Medical Directors at each health board. Clinicians have also been reminded of the NICE guidance they should be following for mesh procedures.
'We are also committed to setting up a register of the use of mesh, and we are working closely with the other administrations within the UK on the establishment of a UK-wide database for reporting of adverse incidents and complications involving mesh.
'I am committed to finding a solution that will ensure all women across Scotland who require treatment for pelvic organ prolapse can receive the best possible treatment for their condition.'