Chamber
Meeting of the Parliament 14 June 2012
14 Jun 2012 · S4 · Meeting of the Parliament
Item of business
PIP Silicone Breast Implants
I welcome the opportunity to have the debate. I also welcome those from the Scottish campaign group who have joined us for the debate. They have been at the forefront in calling for a variety of actions to be taken following this incident.
The Scottish Government takes the issue very seriously. We fully recognise the concerns that have been expressed by people who have had PIP silicone breast implants. Members may be aware that the Deputy First Minister has met representatives of the PIP implant Scotland campaign on two separate occasions; the most recent meeting took place just last week.
At the outset, it should be stressed that the alleged fraudulent activity of a company that produced breast implants is at the very heart of the issue, and it is extremely difficult and challenging for any regulatory regime to deal with such fraudulent behaviour. Members will be aware that the regulation of medical devices is reserved to the Westminster Government, and the competent authority for that within the UK is the Medicines and Healthcare products Regulatory Agency, which has lead responsibility for considering products that are to be used as medical devices.
It may be helpful if I outline some of the actions that have been taken since the issue came to light. As a Government, we have worked closely with the MHRA, the Department of Health and the other devolved Administrations in addressing the concerns that have arisen, and three reviews have been established. The first of those—to which Jackie Baillie referred—reviewed the actions that the MHRA took, and the report was published on 14 May this year. That report found that the MHRA had acted appropriately based on information that was made available to it and that it had been proactive in seeking further information on PIP. The report, which was by Earl Howe, sets out a number of recommendations for the MHRA to take forward; that work is on-going.
A further review was commissioned to look specifically at data around rupture rates and toxicology issues relating to the particular implants. That expert review is currently taking place, and we expect its findings to be published later this month.
The third, longer-term review, also led by Sir Bruce Keogh, will look at the regulation of cosmetic surgery across the UK. In addition, it will review a number of the issues that were highlighted in the Howe report to see whether further action is required.
The intention of the three reviews is to ensure that a similar situation does not occur again. We should allow the review process to take place so that we can ensure that we have the right system in place to prevent such an incident from being repeated.
The Scottish Government takes the issue very seriously. We fully recognise the concerns that have been expressed by people who have had PIP silicone breast implants. Members may be aware that the Deputy First Minister has met representatives of the PIP implant Scotland campaign on two separate occasions; the most recent meeting took place just last week.
At the outset, it should be stressed that the alleged fraudulent activity of a company that produced breast implants is at the very heart of the issue, and it is extremely difficult and challenging for any regulatory regime to deal with such fraudulent behaviour. Members will be aware that the regulation of medical devices is reserved to the Westminster Government, and the competent authority for that within the UK is the Medicines and Healthcare products Regulatory Agency, which has lead responsibility for considering products that are to be used as medical devices.
It may be helpful if I outline some of the actions that have been taken since the issue came to light. As a Government, we have worked closely with the MHRA, the Department of Health and the other devolved Administrations in addressing the concerns that have arisen, and three reviews have been established. The first of those—to which Jackie Baillie referred—reviewed the actions that the MHRA took, and the report was published on 14 May this year. That report found that the MHRA had acted appropriately based on information that was made available to it and that it had been proactive in seeking further information on PIP. The report, which was by Earl Howe, sets out a number of recommendations for the MHRA to take forward; that work is on-going.
A further review was commissioned to look specifically at data around rupture rates and toxicology issues relating to the particular implants. That expert review is currently taking place, and we expect its findings to be published later this month.
The third, longer-term review, also led by Sir Bruce Keogh, will look at the regulation of cosmetic surgery across the UK. In addition, it will review a number of the issues that were highlighted in the Howe report to see whether further action is required.
The intention of the three reviews is to ensure that a similar situation does not occur again. We should allow the review process to take place so that we can ensure that we have the right system in place to prevent such an incident from being repeated.
In the same item of business
The Deputy Presiding Officer (John Scott)
Con
The next item of business is a debate on motion S4M-03294, in the name of Jackie Baillie, on women’s health.10:27
Jackie Baillie (Dumbarton) (Lab)
Lab
I welcome the opportunity to debate the PIP breast implant scandal.I welcome some of the women who have been caught up in the scandal, who are here today cam...
The Minister for Public Health (Michael Matheson)
SNP
I welcome the opportunity to have the debate. I also welcome those from the Scottish campaign group who have joined us for the debate. They have been at the ...
Dr Richard Simpson (Mid Scotland and Fife) (Lab)
Lab
One of our concerns is that the second Bruce Keogh review—not the toxicology review—is on cosmetic procedures only. There are many other procedures, such as ...
Michael Matheson
SNP
The review is dealing specifically with the issues that arise from the PIP implant matter, and we should give the review group the opportunity to consider th...
Nanette Milne (North East Scotland) (Con)
Con
I thank Jackie Baillie for bringing forward the debate, because although we do not agree with her conclusions on the issue we think that it is important that...
Jackie Baillie
Lab
In recognising the scale of the problem, does the member support a public inquiry being held at UK level?
Nanette Milne
Con
I will give the member my reasons for not doing so later.We must remember that silicone implants carry an inherent risk to an individual’s health. No such im...
Fiona McLeod (Strathkelvin and Bearsden) (SNP)
SNP
We are in a serious and worrying situation, so I am glad that we are having this debate. We should take the opportunity to reassure the many women out there ...
Jackie Baillie
Lab
I was quoting the cabinet secretary, who has consistently said that we would perhaps be safer using the upper limit, which is 4,000 women.
Fiona McLeod
SNP
Thank you, Ms Baillie. I confess that I was not at the Health and Sport Committee meeting that day—I was in hospital getting my gallbladder removed. However,...
The Deputy Presiding Officer (Elaine Smith)
Lab
Come to a conclusion, please.
Fiona McLeod
SNP
I contend that the EU and the UK have swung too far towards self-regulation and self-policing. Given that Scotland has no voice in Europe and only a small vo...
Mary Fee (West Scotland) (Lab)
Lab
When I first heard about the PIP silicone scandal, I was shocked. I still cannot comprehend the feelings of anguish and worry that must have been—and still a...
Margaret Burgess (Cunninghame South) (SNP)
SNP
I can only imagine the stress and anxiety that are felt by women who have PIP breast implants. For some time, they have lived with that worry day and daily. ...
Dennis Robertson (Aberdeenshire West) (SNP)
SNP
I, too, welcome members of the campaign to the chamber. However, although I have a great deal of sympathy for their situation, I am not sure that a public in...
Jackie Baillie
Lab
I did not invent the 4,000 figure; it actually came from the member’s own Cabinet Secretary for Health, Wellbeing and Cities Strategy. Nevertheless, the poin...
Dennis Robertson
SNP
As I said, the 4,000 figure came from the UK Government and relates to the purchase of implants. The cabinet secretary was quite right to highlight the upper...
Malcolm Chisholm (Edinburgh Northern and Leith) (Lab)
Lab
I first became very concerned about the issue a few weeks ago when a constituent came to one of my surgeries and showed me photographs of two breast implants...
Maureen Watt (Aberdeen South and North Kincardine) (SNP)
SNP
There has been much debate about exactly how many women in Scotland, the UK and across Europe might be affected. Those numbers remain unclear, but we can be ...
The Deputy Presiding Officer
Lab
We turn to the closing speeches. I call Nanette Milne. You have up to five minutes.11:17
Nanette Milne
Con
This has been a worthwhile, interesting and considered debate with good speeches from members in all parts of the chamber. As I said previously, it is import...
Jackie Baillie
Lab
This is not about apportioning blame, but about learning lessons of responsibility for the after-care of the women so that the same mistakes do not happen in...
Nanette Milne
Con
I appreciate that, but I still think that the on-going work and its conclusions will satisfy.It is certainly true that we can continue to improve regulation ...
The Deputy Presiding Officer
Lab
I call Michael Matheson. I can give you around seven minutes, minister.11:22
Michael Matheson
SNP
Thank you, Presiding Officer.It has been a useful debate. I think that, on reflection, most members would recognise that this is an issue that goes beyond pa...
Jackie Baillie
Lab
Will the minister take an intervention?
Michael Matheson
SNP
I am very short of time and I want to cover as many points as I can.A number of members mentioned the introduction of a register. Some members may be aware t...
Dr Richard Simpson (Mid Scotland and Fife) (Lab)
Lab
As all members have acknowledged, this has been a useful debate, but some questions remain unanswered.Why should there be an inquiry? Why should we not just ...