PIP Silicone Breast Implants
The next item of business is a debate on motion S4M-03294, in the name of Jackie Baillie, on women’s health.
10:27
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 campaigning for a public inquiry. The reason for a public inquiry is to ensure that something like this can never happen again. In the words of Trisha Devine, one of the leaders of the campaign:
“We’ve taken the battle to the floor of the Parliament and we look forward to giving our MSPs as much information and support as possible so we can make some real political progress in our quest for answers.
Our main goal is to ensure this awful situation can never happen again, and today’s public discussion gets the ball rolling.
We’ll build on this momentum and won’t stop until we have justice and a healthcare system we can trust in.”
Today’s debate in Parliament is the culmination of a tremendous effort on the campaigners’ part to have their voices heard by Parliament and Government. The debate is not about the rights or wrongs of plastic surgery. It is about how we act to improve care and support for patients, particularly when things go so spectacularly wrong.
These women have had their lives turned upside down by the scandal, but have rallied together to articulate a convincing case for a public inquiry to take place in Scotland. This is a serious public health issue, and the PIP implant victims deserve answers.
Today, Scottish Labour has published a seven-point action plan, which I hope that the Scottish Government will embrace. Covering everything from the need for a Scottish register of implants to the scope for a public inquiry, it forms the basis of ensuring that we avoid a scandal of this nature happening again.
Let me deal first with the need for a public inquiry. As the Scottish Government’s amendment suggests, a number of reviews are under way. All of them are internal reviews, conducted by the United Kingdom Government, and none of them is independent. One of those reviews, conducted by Earl Howe into the actions of the Medicines and Healthcare products Regulatory Agency, has now reported. There is a strong view from the campaigners that that fails to address some of their fundamental questions and concerns. Although the report concludes that the MHRA acted appropriately, it notes that it was trying to reach evidence-based conclusions without the necessary data to do so. It is the case that, for some years before their use was curtailed, a number of clinicians complained in the strongest possible terms to the MHRA about the efficacy of the implants, and that includes Scottish clinicians. I do not believe, therefore, that the Howe report can serve as a substitute for a full public inquiry; I think that it will helpfully inform any public inquiry that might be taken forward.
I look forward to the review that is being undertaken by Sir Bruce Keogh about the need for an implant register and whether better regulation of the cosmetic industry is required. However, given the scope of his review, there will still be questions to be answered at the conclusion of the process.
It is undoubtedly the case that the regulation of medical products is reserved to the UK Parliament, and I hope that it will consider much more robust action so that we can have better confidence in the efficacy of medical products and the means by which they are regulated and tested. Like most members, I am conscious that we have stringent levels of testing for drugs—it is right that we do—but the standard of testing for medical products appears to be substantially lower. That has to change.
However, in itself, that is not the whole story. There are questions that fall to the Scottish Parliament. I have always believed that the Scottish Government has an overarching responsibility for the nation’s health. The Scottish Government should instruct a public inquiry because we could include consideration of issues such as the extent of the use of PIP implants in Scotland and the rupture rate, because we are not clear that Sir Bruce Keogh’s review will deliver that information in a Scottish context. The inquiry could also consider establishing minimum standards for private clinics that operate in Scotland, which would include issues such as insurance coverage, disclosure to patients of the risks and safety of procedures, regulation of third-party providers—those companies that use hospitals and clinics in Scotland—and regulation of providers that consult in Scotland but perform the surgery elsewhere, usually in England.
Early notification is an issue. The issue was first highlighted as a problem by the MHRA in March 2010. However, I was surprised to see that it took until December 2011 before some women became aware of the problem through press reports. That is a 21-month difference. I know that Health Facilities Scotland, an agency of the Scottish Government, should have been told in March 2010. I am not sure whether it was told or, if it was, what action was taken by it or by the Scottish Government to ensure that people knew about the issue. It would be useful for a public inquiry to reflect on communication as one strand of critical work.
We could also use NHS National Procurement, which is a very efficient organisation that I had the privilege of visiting just a few weeks ago. It already purchases medical equipment and devices for the NHS, and uses clinicians as part of the team to inform that purchasing. Building on the expertise of an existing organisation would have provided quite an effective safety net. I have suggested that approach to the cabinet secretary, during a meeting with the campaigners. I hope that she will respond positively to the suggestion, as that is something that we can do now.
Of the 4,000 women who are thought to have received implants, the cabinet secretary told us that there was only one case of the NHS in Scotland using a PIP breast implant. That is great. For some reason, the NHS in Scotland used other products. Whatever the reason, the cabinet secretary was of the clear view that that was more a matter of chance than anything else. We really should not be leaving that to chance in the future.
Our action plan explores a range of other issues and I commend it to the chamber. Immediate issues can be tackled. For example, many victims told us about a postcode lottery of care when they approached the national health service. Some doctors turned women away and other women were not referred on to consultants. I want the Government to ensure that there is a consistent response.
Let me tell members about Emma, who lives in Scotland. Her implants were inserted in Birmingham by the Hospital Group. She went to Monklands hospital breast clinic in Lanarkshire and said that she had a problem on 21 September 2011. She was refused a scan. Her general practitioner sent an emergency referral letter on 19 January 2012, but it took until 16 April 2012 for that emergency letter to be acknowledged and for her to receive an appointment. The consultant whom Emma saw relied on incorrect information. He refused to offer a scan and refused to perform an extraction of the implant. Despite the Government’s best efforts, that is the kind of experience that women in Scotland are having. We want a consistent response to happen quickly.
Another initiative would be to call a summit of the private providers to ensure that they adopt a consistent approach to the aftercare of the women affected. Some providers have been very good, but others have been awful. Some providers asked women to pay £2,500 to have the implant removed and replaced, some initially charged for scans and the Hospital Group asked women to sign away their legal rights in return for treatment. That must stop and the Government must bring pressure to bear.
We need to regulate private healthcare better. Healthcare Improvement Scotland’s remit includes the regulation of private hospitals, private psychiatric hospitals, private clinics, private medical agencies and private ambulance services, but its regulations cover only private hospitals, psychiatric facilities and voluntary hospitals. The rest are not covered. We must close that loophole urgently and regulate private healthcare clinics and third-party providers in Scotland. In fairness to the Government, it has been consulting on the matter since July 2010, but I say to the minister, as gently as I can, that we cannot afford to wait much longer. In the spirit of consensus, let me offer to work with the minister to introduce regulations much more urgently.
The current regulatory regime does not include a minimum standard for what patients can expect if things go wrong. I urge the Government to consider setting out some of those standards in the national care standards. Our action plan calls on the Government to develop a better framework relationship with the MHRA to ensure that there is, on the one hand, proper retention and testing of implants and, on the other hand, a formal structure of regular communication. If such arrangements had been in place, the numerous and substantive concerns that clinicians expressed might have been picked up sooner and acted on more quickly.
I have two final points. Let us re-establish a Scottish implant register. I know that there were problems with the last one, but it is not beyond us to sort those out. On a practical level, let us allow the NHS to carry out both removal and replacement of PIP implants in the same operation, as it is safer for the women to go through one procedure rather than two. That should be done on the basis that the woman assigns her right to recovery of the cost to the NHS. In other words, the NHS reclaims the money from the private provider. That would be cost neutral to the NHS and clinically better for the women concerned.
What happened is a scandal. We must do our utmost to ensure that no one is placed in this position again. There needs to be confidence in the system of testing medical devices and implants. We need improved regulation, we need to improve care and support for patients when things go wrong and we need a public inquiry, which will help us to understand how we can prevent such a situation from happening again. I commend to the chamber Labour’s action plan and my motion.
I move,
That the Parliament notes that an estimated 4,000 women in Scotland are believed to have received breast implants manufactured by Poly Implant Prothèse (PiP); supports the ongoing criminal investigation in France into the former owner of PiP, Jean Claude Mas, for his role in the manufacture and distribution of the substandard implants containing industrial grade silicone; further notes with concern that PiP’s activities remained undetected by regulators for a considerable period of time and the lack of information provided to the victims of the scandal, a number of whom only became aware of the potential dangers through news reports in December 2011, over a year after the medical device alert was issued by the Medicines and Healthcare products Regulatory Agency in March 2010; regrets the lottery of aftercare offered by the private clinics that carried out breast augmentation operations with PiP implants for women in Scotland, particularly the charging for replacement operations and attaching conditions to treatment such as the waiving of legal rights; further notes the Cabinet Secretary for Health, Wellbeing and Cities Strategy’s assertion that it is only by chance that the NHS in Scotland did not use the potentially dangerous implants and that the true scale of the scandal in Scotland may never be known, and calls on the Scottish Government to do everything possible to address the suffering of the Scottish victims of the PiP implants scandal and ensure that lessons are learned for the future, including holding a public inquiry under the Inquiries Act 2005.
10:39
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.
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 laser eye treatment, that are real treatments and are not just cosmetic. The problems may be much broader than what the second Keogh review will cover.
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 that matter in detail. As a result of that review, other areas of cosmetic surgery and other aspects of healthcare may be identified that have to be addressed, but we must allow the review to take place so that we can see what its findings are and consider whether any further action is required.
I have set out the context of regulation in the UK, in which we operate. I also want to consider NHS Scotland’s response and address the request for a Scottish public inquiry. Although the initial indications were that NHS Scotland had not used PIP silicone implants, NHS Lothian subsequently identified one patient who had been given PIP implants. That patient was offered and received from the board an appropriate clinical care package to address her concerns.
As a Government, we have been very clear that we expect private healthcare providers to offer their patients clinically appropriate packages of care, and we believe that they have an ethical responsibility to do so. NHS Scotland is committed to supporting all women whose private healthcare provider is unable or unwilling to provide appropriate care or who places unreasonable conditions on women in providing care.
The approach that NHS Scotland has taken is appropriate and is in line with the longstanding mechanism in our NHS on the provision of cosmetic surgery. Members will be aware that NHS Scotland does not provide cosmetic surgery on a routine basis. That is well established in the NHS’s published criteria.
When the Deputy First Minister met the PIP implant Scotland campaign last week, she made clear her view that, on the basis of the information that was available to her at that point, she was not convinced that a case has been made for a Scottish public inquiry. She made clear that other options are open that would help to reassure women in Scotland. That includes continuing to work with the campaign group here in Scotland.
I hope that members are assured that the Scottish Government takes the matter seriously and is working with the appropriate bodies to ensure that provisions are in place to prevent this type of thing from happening again. We continue to be committed to working with the PIP implant Scotland campaign and to addressing concerns and issues that the group raises, which we will pursue with the Department of Health and the MHRA, as appropriate.
We are also committed to ensuring that we consider the recommendations that come from the two further reviews and their implications for the NHS here in Scotland. We will consider where it is appropriate to take action in Scotland to address the concerns that are raised.
I move amendment S4M-03294.1, to leave out from first “further notes” to end and insert:
“notes that the Scottish Government is working with the UK Government on the three UK-wide reviews; welcomes the findings of the report, Poly Implant Prothèse (PIP) silicone breast implants: Review of the actions of the Medicines and Healthcare products Regulatory Agency (MHRA) and Department of Health, which found that the Medicines and Healthcare products Regulatory Authority took appropriate action based on the information made available to it; looks forward to the outcome of the expert group looking at the rupture rate data and toxicology testing led by Sir Bruce Keogh, which is due to report later this month, and the review looking at the regulation of the cosmetic industry also being led by Sir Bruce Keogh, which will report by March 2013, and commends NHSScotland for the action taken by it to ensure that it responded appropriately by making information and advice available to women and ensuring that, where the private healthcare sector was unable or unwilling to provide a clinically appropriate package of care, NHSScotland provided appropriate care.”
10:46
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 the matter is discussed openly in the Parliament and that appropriate reassurance is given to the public.
I echo the sentiments of previous speakers in noting that the PIP implant fiasco undoubtedly caused grave concern among many women in Scotland, and I commend the cabinet secretary, NHS Scotland and the UK regulators for their good work in allaying some of the women’s fears. The amendment in the name of Michael Matheson recognises the full extent of that action, and I welcome that.
There has been a considerable and robust response from all levels of government, in Scotland, across the UK and within the European Union. We should remember that the 4,000 women who are potentially affected in Scotland are part of a much wider picture of 40,000 women in the UK and 400,000 women across 65 countries. The PIP incident was truly international and merited co-operative action, which I think is happening.
In recognising the scale of the problem, does the member support a public inquiry being held at UK level?
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 implants are completely safe and the use of medical-grade silicone is just one way of reducing the risk and the potential harm to women. As the UK expert group concluded, there is no clear evidence of a materially greater risk to health being presented by PIP implants. Both Governments have accepted that there is no justification for routine replacement of implants on the NHS, and that conclusion is backed up by scientific and medical evidence.
That is not to say that we have heard the last word on the issue—of course not. The matter is still being extensively reviewed by Sir Bruce Keogh. Meanwhile, Earl Howe’s review, which was conducted through the UK Department of Health, made a number of recommendations to ensure that our processes are as strong as they can be. No system of regulation can guarantee absolute safety of medical products, but there are lessons to be learned and we await Sir Bruce’s conclusions, which will add to the body of information that we have on how best to move forward.
I accept Earl Howe’s conclusion that the MHRA’s communication to the German regulatory body that certified the implants for use was entirely reasonable and that the agency’s actions were based on a proper examination of the data available to it—data that have continued to be analysed.
I am aware of and understand the strength of opinion of campaigners in Scotland on the issue, particularly those who have been personally affected and whose health has been placed at risk by the actions of PIP and, potentially, a number of individuals in that organisation. That is why Sir Bruce Keogh’s review will take a rounded view of the situation, including the reported experiences of patients.
I understand that the PIP implant Scotland campaign called its recent discussions with the cabinet secretary productive. I am confident that the cabinet secretary will do all that she can to work with NHS Scotland in bringing forward any modification of its internal practices, which may need to be examined in light of changes brought about by the UK reviews.
In all that, the role of the Scottish Government will be to ensure that there is a robust framework of reporting and of implementing guidance between clinicians and the regulatory bodies. Primarily, however, we must note that if blame is to be attributed, it lies entirely and unequivocally with the manufacturer, which failed to show any regard whatsoever for the victims of its actions. It was an appalling, but thankfully rare, act.
That is fundamentally why we on the Scottish Conservative benches believe that a public inquiry in Scotland is not the correct way forward. Although we should review our practices, the most important investigation to be carried out will properly be a criminal one. To operate effectively, a regulatory regime must at some stage rely on a degree of good faith, and will sometimes need to operate on the assumption that that exists. That is reinforced by the threat of criminal prosecution and the penalties that exist when fraudulent practices are evident.
In the meantime, we can do little better than to repeat the clear advice that has come from the NHS, the MHRA and the Government—people who received PIP implants and who have any clinical questions or problems should contact their implanting surgeon.
The clear statement from the First Minister that NHS Scotland will step in and provide appropriate care if private provision fails—either by refusing care or by no longer being in existence—is of course welcome. However, it should be remembered that healthcare providers—as with all businesses that are involved in the supply of goods—are obliged by law to replace unsatisfactory goods that they have provided.
I will leave it at that just now and deal a little more with the on-going reviews in my closing speech.
10:52
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 on just what the situation is in terms of the evidence. Rupture rates for the PIP implants are running at about 1 per cent with a possible maximum of 5 per cent. It is important that we put on the record that there is no evidence of genotoxicity should there be a rupture and that 1.7 per cent of the ruptures may lead to an inflammatory reaction. Those statistics are worrying, but it is important as a measure of reassurance that we have them on the record.
In the motion and in Ms Baillie’s speech there was mention of 4,000 women in Scotland possibly being affected by this—I am not sure about that, because it was made clear at the Health and Sport Committee meeting on 28 February that the maximum number was probably 1,300. Again, I think that reassurance is needed.
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.
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, on reading the evidence it looked as though the figure of 1,300 women was perhaps more robust.
How, under a regulatory regime that crosses Europe and the UK, could we come to the position that we have been in for the past year? There are three European directives that cover medical devices. Those directives have been implemented into UK legislation by the Medical Devices Regulations 2002. They are there to regulate safety and performance and to include provision for mandatory CE markings. Under that EU framework, we have REACH—the registration, evaluation, authorisation and restriction of chemicals. Under that architecture, we have the European Chemicals Agency, which is responsible for the CE marking. Parallel to that, we have the competent authorities in each member state; in the UK, the competent authority is hosted by the Health and Safety Executive. Under the competent authority are the notified bodies, which are appointed and accredited by the member states. In the UK, the notified body is the UK Accreditation Service—UKAS—whose role is to ensure that the design and manufacture of products make them safe and compliant.
Given that extensive regulatory framework, how was the fraud possible? I turn to the Howe report, which has already been quoted. Earl Howe said that the review found that the MHRA fulfilled its obligations regarding incidents that involved the implants, and that the MHRA’s work was hindered by a lack of complete or reliable evidence. Much of the information came from a manufacturer that has been found to have been working fraudulently.
Given all that, Howe concludes that there is nothing to suggest that the system for regulating medical devices is unsound and that the responsibility lies squarely with the fraudulent manufacturer. I must ask a further question: is the regulatory regime flawed? When I look to see what the REACH regulation was founded on, I find that it states that it
“places greater responsibility on industry to manage the risks from chemicals and to provide safety information on the substances.”
Come to a conclusion, please.
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 voice in the UK, I hope that an independent Scotland would ensure that it got health and safety right for workers, consumers and everyone involved.
10:56
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 are—going through the affected women’s minds. They would have been asking themselves whether they had received faulty PIP implants, and, if so, whether the implants would rupture, when they would rupture and whether they would cause lasting damage to their health; they would have been asking when their implants could safely be removed.
The conflicting views of the French and UK Governments, as well the inaction of the Scottish Government, have not helped those women. A public inquiry is long overdue. It is vital that any public inquiry is conducted by an independent member of the judiciary, as happened with the Penrose inquiry and the inquiry into C diff at the Vale of Leven hospital. So far, official investigations into the PIP scandal have been concerned only with maintaining public confidence in the Government.
Labour’s seven-point plan, which was introduced this morning by my colleague, Jackie Baillie, is the best and only way to help PIP victims and to avoid this happening again. The Scottish Government argues that the matter is reserved and therefore that it cannot hold a public inquiry. However, the Government has a duty of care to the Scottish people and it has a primary responsibility for the nation’s public health issues.
Earl Howe’s report does not adequately answer all the questions that are posed by campaigners. They deserve answers. Critical questions remain, such as the extent of the scandal in Scotland and what can be done to avoid something like this happening in the future. That is why Earl Howe’s report cannot be a substitute for a public inquiry. Statistical evidence needs to be gathered to discover the extent of the scandal in Scotland. A public inquiry would help to determine a minimum standard of care that private health clinics must provide to operate in Scotland. It would also determine whether more could and should have been done by the Scottish Government and Scottish health service in this matter, irrespective of the restrictions imposed on the Scottish Government. It would give clear and unequivocal regulations, going forward.
I agree with the view that a thorough public inquiry could determine the practicality of forming a Scottish procurement body for all medical products that are brought into Scotland. As many of my colleagues will highlight today, such a body would consider clinical issues specifically for Scotland.
As the amount of reconstructive and cosmetic surgery continues to rise in Scotland, with thousands of procedures conducted, it is imperative that we introduce uniform regulation of private health providers and that they are held to the highest of standards.
The Cabinet Secretary for Health, Wellbeing and Cities Strategy must put herself into the shoes of the 4,000 women in Scotland who received faulty implants, including Jenny Brown and Emma Hardie, who are in the public gallery today. Their health has been put at risk and they are still suffering today. That group of women are asking why this happened in the first place and what their Government is doing to ensure that it does not happen again.
The Scottish Government has a duty of care for the health and wellbeing of the people of Scotland. Currently it is letting down those 4,000 women. There is a dire need for an independent, transparent and comprehensive public inquiry so that the best justice is given to one and all.
11:00
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. Although the expert advice suggests that there is no evidence to support routine removal of PIP implants, I absolutely understand why some women who have them want them to be removed and replaced. Those women know that they have in their bodies implants that are made of a material that is not approved for medical purposes, and they fear that those implants might rupture at any time. In such circumstances, I would be angry and worried and possibly a bit frightened, so I understand the sentiments of the action group.
I am sure that all members support the on-going criminal investigation in France into Jean-Claude Mas, the former owner of PIP. We must not forget that that fraudulent manufacturer has the ultimate responsibility for the distress that has been caused to so many women throughout the world, including, as I understand it, about 1,300 in Scotland. As stated in Lord Howe’s review, the company covered up its deceit and showed complete disregard for the welfare of its customers, which is absolutely shocking. The people who are responsible must be brought to justice.
I welcome the Scottish Government’s actions in responding quickly and giving a commitment that the NHS will provide help and support—including removal of implants, if that is clinically appropriate—for women whose private surgery provider refuses to do so or has gone out of business. Private providers of the procedure throughout the sector have a duty of care to all their patients. Women should not be charged for replacement and removal of PIP implants. People who are affected by the scandal have enough on their plate without having to worry about how they will get the money to put things right.
I hope that any clinical assessment of whether to remove and replace implants will include an assessment of the mental health impact on the individual if the implants are not replaced. As many members have said, lessons need to be learned in order to prevent such an incident from happening again. I therefore welcome the Scottish Government’s involvement in the existing UK-wide inquiries, which are covering a range of issues, including health issues surrounding the implants; improving adverse incident reporting; better communication methods on issues that cause public concern; regulation of the cosmetic surgery industry; and a register of implants, for which there is a strong case.
There is also a European inquiry that is considering better information sharing between EU countries, increasing the scope for EU countries to work together, increased product traceability, and a European database to bring together information about medical devices, economic operations, market surveillance and clinical investigations. Those inquiries and the recommendations that will flow from them should ensure that a similar situation does not arise again.
I understand the sentiments of those who call for a Scottish public inquiry but, as we have heard, the regulation of medical devices is a reserved matter and the licensing of the products is an EU matter. Therefore, a Scottish public inquiry could not properly investigate all the issues. I have no doubt that the Scottish Government and the Parliament will continue to do all that we can to ensure that people in Scotland who are affected by the scandal get the answers that they deserve.
11:04
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 inquiry would be of benefit to them. This issue has certainly highlighted that women who seek breast implants need stronger guidance and information; indeed, it appears that many women have not been getting the information that they deserve prior to surgery.
My understanding is that breast implants require to be replaced anyway after 10 years or so, but I must point out that the 4,000 figure that Labour keeps highlighting appears to be based on figures from the UK Government about the purchase of implants. Evidence to the Health and Sport Committee suggested that the figure for Scotland is more in the region of 1,300.
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 point is that we do not know the exact figure, and a Scottish public inquiry would help us to address that lack of knowledge.
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 limit, while pointing out that it relates to the purchase of implants and not to procedures. As I have made clear, we need stringent guidance; after all, everyone who puts themselves forward for that kind of surgical procedure should know the risks involved.
The Health and Sport Committee considered a petition—PE1378, I believe—that called for a ban on all procedures involving silicone implants because of fears about rupture. I believe that there is a need for implants for cosmetic or other purposes and therefore do not think that a total ban on implants is absolutely necessary; however, the silicone that is used must be of the quality that is prescribed in EU regulations.
I noted Fiona McLeod’s speech, which was very precise and based very much on evidence. Indeed, I sometimes think that every speech that is made in this chamber is based on evidence from Fiona McLeod.
The Scottish Government has done, and will continue to do, everything that it can to provide information and support to people who have concerns, and the minister has said that dialogue will continue. He also made it clear at last week’s meeting that the petitioners and people in the campaign had indicated their satisfaction with the cabinet secretary’s response to date.
Sir Bruce Keogh’s report will make recommendations, so we should wait until that work has been completed. I hope that, as a result of that, a register will be established in Scotland, because I believe that such a move will reassure people in the future. We certainly need that, as well as robust guidance. After all, one of the problems that we face is that a lot of the information that we need is not available because of poor recording—mainly in the private sector, and not in the NHS.
11:09
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 that had been removed from her—one intact, the other ruptured. The contents of the ruptured implant had spread into her lymph nodes and she was experiencing great pain from lumps in that part of her body. I am pleased to report that she said that the NHS care that she received in the Western general hospital in Edinburgh was very good, but it is clear that there are inconsistencies in the NHS response throughout Scotland, to which Jackie Baillie referred.
My constituent also explained to me the shocking response that she got from the private clinic when she went to see it about the problems that had arisen. That shocking response has now become an absence of response, because the e-mail that she sent to the clinic three months ago, in which she summed up her concerns, has still received no reply, although I have recently followed up on that for her. I hope that we will hear something from the clinic soon.
My constituent also has many issues with the MHRA, the most urgent of which relates to testing of implants. I have written several letters to the MHRA and have asked for a meeting with it, because it is not willing to test the implants. Members will understand the anxiety of my constituent, given that the contents of one of those implants are still, to some extent, in her body and were in it to an even greater extent until recently. I ask the Scottish Government to continue to raise that issue with the MHRA. If the MHRA will not test the implants, I ask the Scottish Government to arrange testing.
There are two massive historical issues to do with the MHRA. First, why was it so slow to react when many clinicians pointed out problems, for which there was statistical evidence? Secondly, why did it not make more effort—indeed, it made no effort at all—to inform women once information about the use of industrial silicone became clear in March 2010? That question could also be put to the UK Government and the Scottish Government.
The Government’s amendment offers uncritical support for the UK Government’s Howe report, which I have read. I have never seen so many SNP members competing with each other to praise a UK Government report. I am sometimes more disposed to be more sympathetic to the UK Government—although not the present one—and I was highly critical of the Howe report. My views were shared by the Health Select Committee at Westminster and by its widely regarded chair, the Conservative Stephen Dorrell, who was the Secretary of State for Health when I was a Westminster MP in the 1990s. They are certainly not happy with what one might call an internal whitewash of the MHRA, and my constituent and the other women campaigners are not happy with it, either. I empathise with them and sympathise with their request for an independent look to be taken at the issue. I am sure that Michael Matheson must also have some empathy with them, as he took that view in relation to hepatitis C several years ago when I was the Minister for Health and Community Care. I am happy to admit that he was right about the need for an independent inquiry on hep C and that I was wrong.
An inquiry into breast implants would not just be about the past, as was the case with the hep C inquiry; it would also be about the future. An inquiry needs to look at regulation of private health care. The whole area, including private healthcare clinics, is a devolved responsibility of the Scottish Government. The way in which medical products are regulated and licensed also needs to be looked at. There is a procurement dimension to that, which is also a devolved responsibility. An inquiry could also consider the numbers issue that has come up.
The basic message is this: let us stand in the shoes of the women who have been affected, empathise with them and realise that they want the issue to be looked at independently.
11:13
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 sure that, for those who are affected, it is a very serious matter indeed; they are going through a time of great anxiety.
Although we can be somewhat relieved that no link has been established between the implants and an increased risk of cancer, it is a cause for concern that PIP implants appear to be more prone to rupturing and can be toxic. As my colleague Fiona McLeod pointed out, the rupture rates are estimated to be between 1 per cent and 5 per cent, but the women concerned do not know whether they will fall into that category.
It is welcome news that the NHS and the Cabinet Secretary for Health, Wellbeing and Cities Strategy have reassured the people of Scotland that there is only one known case of PIP implants being used by the NHS. However, I am a little puzzled by that. Does that mean that single purchases of implants are made, or does the patient bring the implants with them? Perhaps the minister could enlighten us.
The NHS is to be commended for offering to remove PIP implants from anyone who has been affected following either NHS or private surgery. We can only hope that the private clinics will choose to offer the same treatment. I echo the call from the Scottish Government and from various members during this morning’s debate that private practices provide the care that their patients expect, and offer surgery to rectify the problem.
Like Margaret Burgess, I agree that we should look again at resurrecting the register of implants. Clinics and hospitals must know the source of their implants and there must be batch numbers, so we should be able to do that. Some women might not even know whether they have PIP implants, and although NHS and private clinics are making efforts to contact those who do, the advice for anyone who is still concerned is to contact their GP or clinic in the first instance.
Reassuringly, it appears that the rigorous MHRA processes were not at fault. The manufacturers fraudulently, and with callous disregard for their customers, altered the make-up of their products. I reiterate my hope that the continuing UK-wide inquiries into the issue will provide both answers and peace of mind for those who have been affected.
It should be borne in mind, however, that no breast implant surgery or cosmetic procedure is entirely without risk. I know that there are often good medical reasons for having breast implants, but I am not alone in being concerned by the ever-increasing numbers of women who feel that they have to put their bodies through this ordeal for cosmetic reasons. The PIP case highlights the real dangers that are involved in cosmetic surgery. The unrealistic image of women that pervades much of our society, most worryingly among our young people, continues to drive women to measures such as cosmetic surgery at great expense and danger to themselves, all in the name of someone else’s idea of beauty.
Carol Craig of the Centre for Confidence and Well-Being is extremely concerned about the amount of money that is spent—by people who can ill afford it—on such treatments. The health impact of the practices is well documented and it is becoming increasingly apparent that the situation threatens to undermine the equality and emancipation of women in our society. We can all agree that the manufacturers and practitioners in question have a duty of care to their customers, but we should not forget the duty of care that we all owe each other in society, and to ourselves as women.
We turn to the closing speeches. I call Nanette Milne. You have up to five minutes.
11:17
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 important that the debate has been held. It has provided an opportunity at least to try to reassure the thousands of women in Scotland who are affected by the issue.
We heard a considerable amount about the response to date of the various bodies that are involved, whose conclusions have been supported by fully fledged expert reviews. Of course, the matter is by no means closed, and information will continue to accrue. The longer-term review into the regulation of cosmetic medical devices is predicted to run until March next year. I note what Richard Simpson said in his intervention, but I agree with the minister that we should look at the PIP issue first and perhaps go on to other matters after that. Considerable scientific data on PIP implants is also being gathered by the EU’s Scientific Committee on Emerging and Newly Identified Health Risks.
The various reviews have already identified some of the weaknesses of adverse incident reporting as a mechanism for analysing safety. It relies entirely on the people who provide care to appreciate the seriousness of the data that they can provide and their role in protecting patient safety. It does, however, form a genuine statistical link between reported patient experience and the regulators. The European investigation will go further and take evidence from across the member states in order to draw further conclusions on PIP implants and the possibilities for change in EU medical device legislation.
In calling for a public inquiry, Jackie Baillie has come to the conclusion that there are reasonable grounds to assume that there is a gap in our knowledge, or that there is some failure that has been caused by people other than the perpetrators of this fraud, and that that can be determined only by a public inquiry. However, I am afraid that I cannot come to the same conclusion.
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 the future.
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 of our healthcare system. Fiona McLeod raised some interesting points in that regard and I agree with Jackie Baillie and others that the suggestion that we re-open the implants register is worthy of consideration. I would welcome the minister’s opinion on that.
I am in no doubt that it is extremely important that we continue to review all regulation for its effectiveness. Areas for improvement have already been identified at UK level, and I continue to be confident that NHS Scotland is capable of co-operating effectively on the issue in the near future, and of considering what further changes may be required when the more general review concludes next year.
Many of the issues concern simple communication. For example, concerns were identified about the communication of medical alerts between the MHRA and private medical providers. Recommendations from Earl Howe have gone some way towards addressing those concerns, but Sir Bruce Keogh’s review, which is taking an holistic view of regulation in the sector, will be vital in tying together our actions and addressing weaknesses that may have arisen as the industry has changed over many years. As Earl Howe has observed, it is incumbent upon all those involved in delivering care to redouble their efforts in reporting incidents of concern, but it is even more pressing that communication as a whole be improved. We are also reminded of the importance of co-operation across national boundaries and regulatory sectors.
In view of all the work that has already been undertaken and that is on-going, Scottish Conservatives do not see the need for the public inquiry that Jackie Baillie seeks, and will therefore support the Scottish Government’s amendment at decision time this evening.
I call Michael Matheson. I can give you around seven minutes, minister.
11:22
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 party politics and is about trying to ensure that we do the right thing in addressing the concerns that have been raised. Unfortunately, Mary Fee’s suggestion that there has been inaction by the Scottish Government in that regard is not only not reflective of the facts, but is simply wrong. It is important that, in contributing to a debate on an issue of such importance around women’s health, members reflect on what action is being taken.
The experience of one of Malcolm Chisholm’s constituents demonstrates the type of response that we have asked NHS Scotland to make. I recognise that members may have different views on what that response should be, but it is simply wrong to suggest that no action has been taken.
It is right, when a matter such as this arises and when the regulatory regime that we have in place has not protected individuals from the alleged fraudulent activity of the company that produced the breast implants, that we look at whether there are ways in which we can ensure that the regulatory system is more effective in addressing the concerns. Nanette Milne is correct to say that it is not possible to get a 100 per cent fail-safe regulatory system, but we clearly have to ensure that we learn lessons in order to ensure that the system is sufficiently robust, which is what the Earl Howe review was intended to do. I acknowledge Malcolm Chisholm’s view about the content of that review, but it is important to recognise that the review will be supplemented by the wider review by Sir Bruce Keogh that is being undertaken at present and which will report next year on whether further measures need to be taken beyond the recommendations of the Earl Howe review.
I recognise that despite the review, people—including members of the PIP implants Scotland campaign—continue to have concerns about the regulatory regime. However, it is important that we ensure that the reviews that are taking place address those concerns and the concerns that the PIP implants Scotland campaign believes the MHRA, the Department of Health and others have to address. As a Government, we are open to considering the matters and to making the necessary representations where that is appropriate.
Concerns have been expressed about the content of PIP breast implants—Malcolm Chisholm made a specific point on that in relation to his constituent. I understand that the MHRA has carried out further tests on PIP implants and that, as part of Sir Bruce Keogh’s work, the data and the toxicology findings are being looked at. I am informed that there are difficulties in carrying out toxicology tests on breast implants that have ruptured, which leads to difficulties in offering certainty on what may be in those particular breast implants. That is the scientific expert advice that has been provided, but I understand that further tests have been taken as part of the Sir Bruce Keogh review.
Maureen Watt raised the issue of how breast implants are chosen by different clinicians. NHS Scotland does not routinely provide cosmetic surgery, and the number of breast implants is limited. The guidelines and criteria on their use are clear—they are largely for breast augmentation for women who have undergone a mastectomy. The choice of breast implant is largely decided by clinicians, who work with patients to establish what is most appropriate to that individual. That is why we allow boards to procure breast implants that their clinicians believe are best suited to their individual patients, rather than controlling procurement nationally. I am sure that Maureen Watt will recognise the benefit that is gained from that approach.
Will the minister take an intervention?
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 that we had a UK register that ceased because of the number of women who chose not go on it—only a small number were prepared to do it. That, too, is being looked at through regulation and the Sir Bruce Keogh review, which will report next year. If there is a clear recommendation about the need to consider establishing a register we will, as I have said, reflect on the reviews and the implications for Scotland and see what action we can take to address that.
Jackie Baillie expressed concern about a difficultly that has been experienced by an individual from the PIP Scotland group from whom she has received representation. That experience contrasts markedly with the experience of Malcolm Chisholm’s constituent. I assure all members that we will ensure that all cases of concern about how NHS Scotland has responded will be looked into. Members whose constituents have such experiences should feel free to make representations to the cabinet secretary or me to ensure that the matters are appropriately considered. The chief medical officer has written on two occasions in the past six months to GPs and surgeons to set out the Scottish Government’s position on assisting women with PIP implants through our NHS.
I acknowledge the concerns of members of the PIP campaign. As the cabinet secretary set out last week, she does not believe that—based on the present information—the case for a public inquiry has been made.
We need to continue to work with the PIP campaign in Scotland to address its concerns. When necessary, the Government will take appropriate action in areas in which we have responsibility, and will make representations to the UK bodies that are responsible for addressing the issue. We will continue to work with all those bodies in order to provide certainty and to address concerns as and when they arise. On that basis, the most appropriate course that we can take at present is to allow the review process to be completed. Once that is done, we will look at its implications for Scotland and address any issues that arise for us when appropriate.
11:30
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 rely on the Earl Howe report on the MHRA, and on the two reports by Sir Bruce Keogh? Why are they not sufficient? As the minister said, those reports are helpful, but they are not sufficient, although they will and should inform our approach.
In her thoughtful contribution, Nanette Milne reminded us of the fraud by the manufacturer, but the issue is not one of blame. We are talking about ensuring patient safety. That is what regulation is about, and the regulatory system failed those patients, some of whom are in the gallery today.
The Earl Howe report says that the MHRA did all that it could, but it fails to examine whether the system of reporting was adequate, as reports were made directly to the company and might have been used as a substitute for an effective UK reporting system. Systems for reporting on adverse effects generally are an area of concern and, as Malcolm Chisholm said, there was a refusal to test at least some of the extracted implants.
The House of Commons committee has been justifiably critical of the Earl Howe report, although it is a pity that there has not been a greater analysis of it. The Government simply appears to have accepted it as being wholly valid.
I was somewhat disappointed in Maureen Watt’s contribution. Many of the women that we are talking about have had reconstructive surgery, but others who sought private implants did so for quite genuine and reasonable psychological reasons. Although I understand what she is talking about when she talks about the emphasis on body image, it is not particularly relevant.
The stories of the affected women are striking for a number of reasons. It is those women who are asking the Parliament to act to ensure that what happened does not happen again in either this or other contexts, and I will come to that point in a minute. It is those women who are asking for an inquiry in Scotland—because there is a Scottish dimension to the issue. It is they who want the situation not to arise here again.
A number of members have talked about the difficulties that the women encountered as the scandal unfolded. The French Government took strong and decisive action, which contrasted with the rather slower and more confused action that was taken at the UK level. Margaret Burgess’s description of the women’s distress resonated, and that was quite helpful.
When we are told that some women had to pay for removal of the device even once it was established that the producing company had switched from medical grade silicone to industrial grade silicone without telling us and had not passed on information about the level of ruptures, we have to question what private companies were doing.
Those affected tell us that there has been some suggestion of a postcode lottery, so I welcome the minister’s agreement to listen to and take up the issue for any woman who has not had a satisfactory response from the NHS. I hope that the campaign group will spread that information around so that some of the cases that we have already heard about can be raised.
When we hear about the woman who was not only charged for the removal procedure but was charged £100 for disposal of the removed device, we must question the ethics of the private company involved. Some women were also charged when the provider did not think that the removal of the device was necessary, but if a woman faced with the situation wishes to have the device removed because her anxiety levels have increased, she should be entitled to have it removed, especially given the level of fraud that has allegedly occurred. We have particular problems in Scotland, because class actions cannot be taken here, unlike in England, but that is a separate issue that I do not fully understand.
The Howe inquiry has gone so far and the Keogh inquiry will go further, so why do we want to establish our own public inquiry? It is not that we do not welcome both of those inquiries, but if we are serious about a potential move to independence, we will need to consider having not just a Scottish Medicines Consortium to authorise medicines, but a similar body—the 81st regional body—to authorise devices. With 27,000 devices approved, that would be no mean undertaking.
The EU may revise the rules on devices, but it is clear from the scandal and from the scandal that is going to unfold regarding metal-on-metal hip replacements that the regulation of medical devices—particularly those involving implantation—is inadequate. Moreover, we cannot look to the United States for better regulation, as they, too, have problems with what constitutes a threshold for notification by companies of changes in devices. They, too, have their own unfolding scandals.
Scotland and this Government have a duty of care to Scottish residents, as Jackie Baillie and Mary Fee made clear, which falls within the scope of an inquiry. What efforts did the Scottish Government make when the first medical alert came out in March 2010? We are not accusing the Government of inaction once the scandal began to evolve, but there was a medical alert in 2010. Did we, at that point, inform all the providers in Scotland whose regulation we have responsibility for that they must pay heed to that medical alert? Did we, at that point, talk to women who had had implants that were subject to the alert? No, we did not. There was delay, and that must be considered by the inquiry because the issue may also arise in relation to the metal-on-metal scandal that we will shortly face. We need much greater clarity and effort to ensure patients’ safety.
Some issues are reserved, and the MHRA deals with those. The Health Professions Council deals with the regulation of practitioners, but we have responsibility for determining the minimum standards of care, which can include things such as insurance cover and the medical qualifications that we believe are required. For example, should only dentists be able to perform tooth whitening? That is another issue that is coming up. There have been legal cases on the subject, but the fact remains that unqualified people are still performing tooth whitening. Eye laser surgery is not cosmetic, but the level of qualification required of those who undertake it in Scotland is not fully regulated beyond HPC level. Regulations in respect of companies that do marketing in Scotland or undertake surgery in Scotland should be introduced quickly. We passed legislation in 2010, we held a consultation in 2010 and the consultation was completed in July 2011, but we still have not had a report. We have not acted with speed on the issue of more effective regulation of high-street surgery and the private sector; it requires greater speed.
Those are all issues on which we believe a public inquiry is needed to ensure that Scottish patients are adequately protected going forward. I therefore support Jackie Baillie’s motion calling for a public inquiry.