PIP Silicone Breast Implants
Agenda item 3 is consideration of correspondence from Independent Healthcare Advisory Services and the Cabinet Secretary for Health, Wellbeing and Cities Strategy in response to the questions raised by the committee following our meeting on 24 January. We have also received a letter from Rhoda Grant, asking the committee to revisit its decision to close petition PE1378, which raised wider issues about the safety of silicone breast implants.
It is important to set this morning’s discussion in the context of work that is continuing at a United Kingdom and European Union level. As the paper from the Scottish Parliament information centre explains, following recent concerns about PIP implants the UK Government has established two reviews. As regulation of medical devices, including breast implants, is a reserved matter, it is appropriate for those reviews to take place at a UK level. Separately, the European Commission is also taking action to investigate the potential health impact of faulty PIP implants.
In that context, our main interest should be to consider the Scottish Government’s approach to supporting women whose private provider is no longer in business or intends to charge for removal and replacement of PIP implants. The latest correspondence from the cabinet secretary includes guidance issued by the chief medical officer to national health service general practitioners and surgeons, but it remains unclear whether any woman in Scotland who has received PIP implants and cannot get redress from her private provider will be guaranteed support from the NHS. Given the circumstances, I feel that there needs to be absolute clarity about the support available to women from the NHS in Scotland.
I invite comments and questions from the committee.
I well remember our discussion about the petition. My comments can easily be accessed in the Official Report. We should have a one-off evidence session. I understand that there is a possibility of doing that on 20 March.
I note that the cabinet secretary said in her letter to the committee:
“NHS Boards have completed checking their patient records and I can confirm that no women have been supplied by NHSScotland with a PIP silicone breast implant.”
I know that we have a lot of other pressing business, but we should consider the situation. I note that it is a reserved matter, but the committee should look after the health of the women of Scotland.
I do not want to minimise in any way the seriousness of the issue or to appear hard-hearted, but I do not want the committee to find things to do. It seems to me that the two inquiries that are going on in Westminster and in Europe are fairly comprehensive in nature and scope, and I would much rather return to the issue in the light of the reports that those inquiries produce, in so far as they identify specific issues that we might want to pursue.
I heard what the cabinet secretary said in the Parliament and I thought that her commitment in relation to the NHS was fairly unequivocal, but I am not averse to our seeking to establish that further, if the committee thinks that it would be useful to do so. However, I did not think that I misunderstood what she said about provision.
Therefore, at this stage, I am not sure that rushing into further investigation on our own account would add value to the broad range of intelligence that we have. We have received a fairly comprehensive briefing. Perhaps we should wait until the reports are produced and then react and act in the light of them.
As Mr Carlaw said, comprehensive inquiries are being undertaken. The UK Government’s inquiry will report by March 2013. I acknowledge that much of the report will relate to reserved matters, but when reserved health regulation issues impact directly on the Scottish NHS there is a direct locus for this committee to get involved—it is important to put that on the record. However, this is not the time to do that, and we should perhaps return to the regulation of the industry when the UK Government has published its report. If the UK Government can provide interim information before March 2013, that would be welcome.
The matter in hand is the public concern in Scotland about PIP breast implants. Like Jackson Carlaw, I do not think that there has been any lack of clarity from Nicola Sturgeon and the Scottish Government on the issue. The Government has supplied precise information. A need for clarification would not be the reason for our deciding to have an evidence session. The driver for such a meeting would be the committee’s ability to offer a platform from which issues of public concern can be aired. It is important that our motivation for having an evidence session is the correct one.
Having said that, there is great public concern, and anything that the committee can do to give additional clarity and reassurance by engaging with topical health concerns in Scotland would be welcome. I support our having not an inquiry or investigation but a one-off evidence session, if a slot can be scheduled, at which some of the issues that have been raised with us in correspondence can be raised on the record.
The issue is serious and there are fairly wide ramifications for not just matters that are reserved to the UK but the whole process of European registration of devices. That is a much broader issue, and I agree with Bob Doris that it is a matter for the future. We will see what the reports indicate. It is a fact that PIP implants were approved by the German licensing authority on behalf of other countries in Europe and the German agency did not receive a report when the silicone was changed from medical grade to industrial grade. Whether that is important is a matter for the inquiries to which Jackson Carlaw referred and for the German inquiry that is going on.
I support what the convener said about getting an update from the cabinet secretary. Her initial comments were helpful, but it would be good to have a brief update from her, to clarify the position for women who received breast implants from the private sector and whose private provider is not responding appropriately, perhaps because it is bankrupt or for other reasons. We owe it to the public to check that the position is clear for such women, who are still very anxious about their situation.
I do not have much to add to what members said. I agree with Jackson Carlaw that we should reserve the right to revisit the situation when the reports from Europe and Westminster are in the public domain.
The issue is of concern to lots of women in Scotland and it would be beneficial to them and to the committee to hear from the cabinet secretary. The situation is changing—the drip feed of figures suggests an escalating number of women who are affected by PIP usage. For that reason, and to help the committee to understand where we are at, it would be worth while to have a one-off evidence session.
10:15
I endorse members’ comments and I am grateful to Richard Lyle for suggesting that we have a one-off evidence session on the issue. There is public concern about the health of women who are affected by PIP silicone breast implants. Notwithstanding Jackson Carlaw’s point about the cabinet secretary having stated her position unequivocally, and notwithstanding that the cabinet secretary has been more than willing to provide evidence to the committee, it would be helpful if she and the chief medical officer appeared before the committee on 20 March, if that is convenient, so that we can be reassured that the Scottish Government is doing all that it can do to protect the health of women who are affected.
I associate myself with Dr Simpson’s remarks about the wider issue to do with regulation of devices. The matter is reserved and there is a European issue that is outwith the scope of the committee, but we could revisit it when comprehensive inquiries have reported.
If there are no further comments, I thank members. I think that there is broad consensus that the committee does not want to launch a wider inquiry and that we would appreciate an update from the cabinet secretary, on the basis that was set out.
We did not talk about whether we want to hear from the private sector. Do members want to invite the Scottish Independent Hospitals Association to give evidence?
Members indicated agreement.
That is a yes, and we have a yes to hearing from the cabinet secretary. We have an opportunity to do that at our meeting next week, on 28 February, or on 20 March. Are members happy to take the evidence next week, if the cabinet secretary is available?
I would be more comfortable with having the one-off session on 20 March.
Everyone is concerned about the issue. I expressed concern when the committee considered PE1378, when I said that it is even worse than smoking in terms of what goes into your body.
By my reckoning, 20 March is clear of other business. If we could spend time on the issue then we would show people that we are very concerned, as members said.
We have an opportunity to take the evidence next week. I do not know why we would not do that.
We are talking about housekeeping, rather than the issue. If both slots are available, why not contact the cabinet secretary and see which one most suits her, given her busy schedule? That seems reasonable.
That is correct, but we do have a slot next week. We can ask whether she can make the first available slot. There is an alternative, of course.
Members indicated agreement.
Okay. It is important that the committee decides when to invite witnesses, although we always take account of ministers’ and cabinet secretaries’ diary commitments.
We agreed to take item 4 in private.
10:18 Meeting continued in private until 11:59.