Mesh Implants (National Health Service)
To ask the Scottish Government, in light of the recent reclassification of mesh implants as high risk in the United States, when mesh implants will be banned in the NHS in Scotland. (S4T-00695)
The Cabinet Secretary for Health and Wellbeing has written to both the Medicines and Healthcare products Regulatory Agency and the European Commission, asking that they urgently consider the United States Food and Drug Administration’s proposed reclassification of surgical mesh for the treatment of pelvic organ prolapse. The European Commission is seeking further research and expert opinion. The cabinet secretary has asked for assurance that it will act quickly, once the research is available, to reclassify these devices if the evidence points to that requirement.
The complications for many women after the implant of a mesh device are devastating, leaving them disabled, in chronic pain and facing a life of multiple operations and uncertainty. In the US and Australia, mass class actions are being taken against the manufacturers, which are pending.
The Scottish Government originally told me, in answer to a parliamentary question, that only six women in Scotland have suffered an adverse impact of a mesh implant. That figure then rose to 101 women, but a freedom of information request that I submitted to health boards revealed that more than 330 women have had to have mesh fully or partially removed. In addition, more than 10,000 women have had an implant despite a parliamentary answer that suggested that the number is 2,000.
Mr Findlay, can we have a question?
Does the minister now have definitive numbers for those who have had an implant and those who have suffered complications?
We have a range of figures for the number of procedures that were undertaken in which transvaginal mesh implants were used. Those figures go back to 2007-08 and up to 2012-13. I am more than happy to provide the member with the annual breakdown of those figures.
We do not have specific figures relating to problems with a particular product, because information relating to a specific product is not recorded in a patient’s medical notes. However, the Government is pursuing a programme of work on how the medical implant that is used in a procedure can be recorded in the patient’s electronic record so that we have a much clearer picture of the number of patients who may be affected should problems develop with a particular medical implant.
Despite the large numbers, the Scottish Government has been reluctant to suspend the use of mesh devices, apparently out of concern that the manufacturers will instigate legal action against the Scottish Government. Is the minister still concerned that the Scottish Government could face legal action from manufacturers, or has he changed his mind and is he now ready to put the women of Scotland first, before any legal concerns that he may have? Does he have the same concern about the legal action that is being pursued by those who have been horribly injured by these products?
The Government’s sympathy is with any woman who has suffered a complication as a result of treatment that has involved the use of these medical products. However, the member will understand that the products are regulated by the MHRA and the European Commission, and we must be led by their guidance on the matter. Unlike other regulatory bodies around the world, the MHRA in the United Kingdom is not recommending that the products should not be used at this time.
Nevertheless, we have asked for an urgent meeting with the MHRA to ask what action it intends to take as a result of the FDA’s actions in the US. Equally, we have asked the European Commission to be very clear about the two pieces of research that it is undertaking to ensure that, once we have the findings of those research projects, action is taken quickly. If a reclassification of the products is recommended, we will act on that. We have to work within the regulatory function that we have at present, but the member can be reassured that, if there is any change to the guidance or a recommendation is made by the MHRA or the European Commission, the Government will act swiftly on that.
Given the emerging worldwide concerns about mesh implants and the difficulties and costs associated with removing them, can the minister assure our Parliament and our constituents that the Scottish Government will issue fresh guidance to NHS boards on the use of mesh implants, will take a more open approach to dealing with legitimate concerns and will be prepared to play its part in a worldwide collaborative approach to resolving this emerging problem?
The cabinet secretary has established a working group to look at the issue, and one of its early actions will be to produce an information and consent form for women who undergo, or who are thinking of undergoing, this procedure. The working group intends to issue that form shortly, and we will roll it out across the NHS so that women are fully informed about the procedure and the issues associated with it.
The member also made reference to the impact on those women who suffer complications. Another piece of work that the expert group is doing is on the patient pathway for such women. The aim is to ensure that that pathway is robust and clear, and that they receive the early treatment that they require.
Of course, if there is a need for us to engage with authorities in the rest of the world, we will be more than happy to do so, but I hope that the member is reassured by the actions that the cabinet secretary has taken to ensure that, where a change is made to any of the recommendations to do with this procedure and this type of device, we will act quickly in NHS Scotland.
Have any risks been identified that relate to the use of other mesh devices, such as hernia mesh? Has the use of such devices been affected by the decision in the United States?
I am afraid that I can refer only to the proposal from the FDA, which I understand relates to the use of pelvic organ prolapse mesh; I cannot comment on mesh that is used for other procedures.
It is worth pointing out that, to date, the evidence does not point to a particular product produced by a particular manufacturer. It is important that we ensure that the public can have confidence in this procedure. The University of York is doing a piece of work to look at the use of mesh for the procedure and at the use of natural tissue, and to find out which has better outcomes for patients. Once we have the findings of that work from the MHRA, we will be in a position to consider how it can be rolled out to clinicians in NHS Scotland.
In February 2007, a constituent of mine was one of the first people to have a mesh implant. Within weeks, she knew that something was very far wrong. Consequently, she had some of it removed in 2008 and January 2014. What advice was given to those who took part in the pilot programme for the mesh implants? It is my constituent’s understanding that the Scottish Government made funding available for the removal of those implants in 2008 but, because of the number of cases involved, the Government had a change of heart when it realised the severity of the situation and the funding was removed. Was that the case?
In relation to the latter point, I have no recollection whatever of that happening. If there are patients who require a medical intervention on the basis that they are suffering from complications that relate to the use of a particular medical device in a previous procedure, we would expect clinicians to take that forward in the appropriate way. That is a matter for clinical rather than ministerial decision making.
As far as the member’s specific point about her constituent is concerned, if she writes to me with the details of that case, I will be more than happy to ensure that it is looked into and that she gets a full and detailed response.
North Sea Oil (Wealth Fund)
To ask the Scottish Government what its response is to the report in the Sunday Herald suggesting that the Labour Administrations in the 1970s ignored advice about setting up a North Sea oil wealth fund. (S4T-00691)
The two reports that were written by Professor Gavin McCrone, which were highlighted this weekend, provide further evidence of the mismanagement of Scotland’s oil and gas resources by successive United Kingdom Governments.
The costs of ignoring that advice are now clear. Norway, which discovered oil at the same time as Scotland did, now has an oil savings fund that is worth £500 billion, which is equivalent to £100,000 for every man, woman and child in Norway. There can be no clearer demonstration of the need for us to be able to make our own decisions on the issues that matter to Scotland than this weekend’s revelations, which show that, in spite of the evidence that was presented by the then Scottish Office and the arguments of distinguished individuals such as John Smith, the Treasury failed to put Scotland’s interests first.
However, given that up to 24 billion barrels of oil remain to be recovered from the North Sea, it is clear that the sector will be an important source of tax revenue for decades to come. With independence, we will have the tools to ensure that the wealth that is generated from those resources can be used for the long-term benefit of the people of Scotland.
I note the figures that the cabinet secretary mentioned in relation to Norway. Does he have any idea of how much money we might have had in our oil fund had the Callaghan Labour Government at the time heeded the advice of Government advisers?
Analysis of that point was undertaken by the fiscal commission working group, which concluded that, if Scotland had established an oil fund in 1980, it could have eliminated its share of UK public sector debt by 1982-83 and could have accumulated substantial financial assets of between £82 billion and £116 billion by 2011-12. The evidence that the fiscal commission working group has put into the debate is significant evidence of the strength of the economic opportunity that was missed for Scotland by not stewarding these resources in the most effective way in the long-term interests of the people of Scotland.
Sometimes we are told that bigger is better, but can the cabinet secretary explain why it is that a small country such as Norway has repeatedly made wise decisions and a larger country such as the UK has repeatedly made unwise decisions?
The information that became available at the weekend demonstrated that an active and deliberate choice was made in the 1970s to use the resources from North Sea oil and gas not to provide long-term economic security for the people of Scotland but to prop up the failing UK economy. The issues that Scotland faces today about determining our own political future are similar to the ones that were considered in the 1970s. The great advantage that we have is that in September we will have the opportunity to take a democratic decision to put the people of Scotland in the driving seat of determining their own future on this question.
The advice that Gavin McCrone gave to the UK Government last century is interesting, but perhaps more important and more topical is the advice that he gave to the Finance Committee last week, when he said:
“If Scotland’s public expenditure was similar to the UK average, North Sea oil would be a kind of bonus, which would be all right. However, Scotland’s public expenditure is about 10 per cent higher than the UK average.”—[Official Report, Finance Committee, 7 May 2014; c 4133.]
In other words, diverting oil revenues to an oil wealth fund in 2014 would require swingeing cuts in public expenditure. Is that the cabinet secretary’s plan?
No, it is not. What that question ignores—which Mr Gray always ignores—is the stronger financial position that Scotland is in. If Mr Gray happens to look at the “Government Expenditure and Revenue Scotland” information for the past five years, he will see that it shows Scotland to be in a stronger financial position, to the tune of £8.3 billion, than the rest of the UK. That opens up choices as to whether we reduce debt faster, invest more in public expenditure and public services, or invest in a long-term oil fund, but the crucial thing is that none of those choices is available to us, because the UK parties persistently squander the natural wealth and financial advantage of Scotland. The sooner we have the opportunity to take the decisions that are in the interests of the people of Scotland, the more we can take decisions about the long-term future of our country.
Based on the cabinet secretary’s oil figures, which he has yet to publish, how much does he think an independent Scotland could put into an oil fund in year 1, and how much could it put in in year 2?
The first thing to say in answering that point is to put on the record once again that, given the advice and given the opportunity to invest in a long-term oil fund over the past 40 years, the UK Government decided not to embark on that proposition. With the assistance of the fiscal commission working group, the Scottish Government has set out the arguments about how we could construct a long-term savings fund for Scotland, and I have just answered Iain Gray’s question, demonstrating that, based on the past five years, Scotland was in a stronger financial position than the rest of the UK, equipping us to invest in an oil fund if we choose to do so. The key point is whether we decide to take our future in our own hands or whether we leave it to the UK Governments that have made such a mess of the public finances of the UK and have wasted oil Scotland’s oil revenues in the process.
I apologise to Malcolm Chisholm and Chic Brodie. I simply do not have enough time to let you ask your questions, but I think that we have heard a wide range of views.
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