With permission, Mr Speaker, I would like to make a statement about PIP breast implants. The House will be aware that approximately 40,000 women in this country have had implants manufactured by the French company Poly Implant Prothese, and that these implants could have been made of a non-medical grade silicone gel. My concern throughout has been for the safety and well-being of all these women. I wish now to update the House on what happened; how we are looking after the women concerned; and the further actions required.
In 1997, PIP received a European CE mark for its silicone breast implants. The CE mark was overseen by the German notified body, TUV Rheinland. The Medicines and Healthcare products Regulatory Agency adverse incident centre received a number of reports annually about PIP implants. Based on such reports, in 2008, the MHRA raised its concerns with the German regulatory authorities and the manufacturer. The MHRA was reassured by the notified body that the number of adverse reports was adequately explained by changes in the company’s reporting practices and by the increasing number of implants sold.
However, in March 2010, the French regulator discovered that rather than using medical grade silicone gel in the implants, PIP had in fact been using unauthorised silicone gel. This is in clear violation of the CE mark. The mark was promptly withdrawn and all EU member states immediately alerted. The MHRA immediately issued advice to stop using PIP breast implants in the UK. The French authorities are currently investigating this as a criminal matter, and the UK Government will help in any way we can with their investigation.
Initial toxicology tests in both France and the UK found no significant health risk to women with the implants. Also the MHRA could find no evidence of an increased risk of cancer. However, on 23 December 2011, following an increase in the number of reported ruptures, the French Ministry of Health announced that it was advising women, as a non-urgent precautionary measure, to consider having their PIP implants removed. The MHRA’s advice was that there was no scientific basis for recommending routine removal of implants in the absence of symptoms.
The available data, however, were incomplete. For this reason, I asked Sir Bruce Keogh, the NHS medical director, to form an expert group and to review the available data, including information from the French authorities, and to offer more definitive advice. I received the group’s interim report on Friday 6 January and a copy has been placed in the Library. I would like to thank the experts and members of the profession for their hard work and commitment in producing this rapid report.
The main findings of the expert group were, first, that there is no causal link between these implants and breast cancer. Secondly, the evidence on the rate of ruptures for PIP implants compared with other implants is incomplete and so this risk cannot be assessed definitively. Thirdly, although the rupture of implants or leakage of material can result in inflammation, there is no clear evidence that these problems are more serious in relation to PIP implants than other implants, or that they result in increased long-term health risks. Therefore, they have not recommended routine removal of the implants. Fourthly, there are risks inherent in the removal of breast implants, just as with any surgery, and these risks should be taken into account when taking any clinical decisions. However, for this particular group of women the risk is very low. Fifthly, the expert group recognises, as we have throughout, that women with PIP implants will be understandably concerned that they did not have the character of implant that they thought they did. The expert group advises, as we have, that we should give every woman an opportunity to secure advice, investigation and remedy.
The women who received the implants did so on the understanding that the implants met the requirements of the CE mark and were safe. That was not the case, and every provider has a responsibility to put things right. Although the majority of women will have received their implants privately, some—such as those who have had reconstructive surgery following mastectomy—will have received PIP implants through the NHS. All those patients will receive the highest possible standard of care. First, they will be contacted to inform them and give them all the relevant information and advice. Women who wish to will be able to speak to their GP or the surgical team that carried out the original implant to get advice on the best way forward for them. If the woman chooses, that could include an examination by imaging. If, when informed by an assessment of clinical need of the risks involved and the impact of any unresolved concerns, a woman decides with her doctor that it is right to do so, the NHS will remove and replace the implants, if the original operation was done by the NHS. Last week the NHS chief executive wrote to the service, and Dame Sally Davies, the chief medical officer, wrote to GPs and relevant health professionals. Copies of those letters are available in the Library.
It is right that those who received their care privately should also receive a similar level of service and reassurance from their care provider. However, I do not think it fair to the taxpayer for the NHS to foot the bill for patients who had their operation privately. Eight private health care companies, including Nuffield Health, Spire Healthcare and BMI, have confirmed that they will follow the same guidelines as those that I have set out for NHS patients. However, I want to be absolutely clear that the NHS will continue to be there to support any woman. If a clinic that implanted PIP implants no longer exists or refuses to remove the breast implants, where that patient is entitled to NHS services, the NHS will, in consultation with their doctor, support the removal of PIP implants in line with the guidance that I have just outlined. Any NHS service in that instance would cover only the removal of the implant, which would not include the replacement of private cosmetic implants. In such cases the Government would pursue private clinics to seek recovery of our costs.
These events highlight the need to ensure the safety of people having cosmetic interventions. It is clear from the information that we have received from the industry that the safety information that it collects and provides to the regulator is of variable quality. Without good data, we have no way of knowing when problems arise. I believe that there are a number of things that we now need to do. First, lessons need to be learned from this case and incorporated into the ongoing review of the EU medical devices directive. I spoke to Commissioner Dalli yesterday, and can confirm that this European work is under way. We also need to understand what happened in this instance in the United Kingdom. A review for that purpose will be led by the Minister for Quality, Earl Howe, with expert advice, and will shortly put its terms of reference in the Library. That review will investigate and report rapidly. The blame for what happened lies with PIP, but the review will enable us to learn lessons to improve future regulatory effectiveness and will feed into the Commission’s review.
In addition, the Care Quality Commission will conduct a swift review of private clinics. That review will look at evidence of compliance, patient safety and clinical quality, and the information and support given to their patients. Where a provider does not meet those requirements, the CQC has a wide range of enforcement powers that it can use to protect the safety of patients. The findings of that review will be published before the end of March.
Looking to wider issues of clinical safety and regulation, I have also asked Sir Bruce Keogh to reconstitute his expert group to look at how the safety of patients considering cosmetic interventions can be better ensured in the future. That will include treatments such as cosmetic surgery and dermal fillers. I expect his review to consider whether cosmetic products and interventions are appropriately regulated and have strong clinical governance; whether patients and consumers can be confident that the people who carry out procedures have the skills to do so; and whether the settings in which such procedures take place are able to ensure the care and welfare of people who use their services. That review will consider issues of governance, data quality, record keeping and surveillance, as well as ensuring that proper information is provided to secure patients’ informed consent.
I expect the review also to include consideration of an outcomes-based register of frequently implanted devices, covering everything from breast implants to heart valves and replacement joints, in order to provide the United Kingdom with a valuable asset for further innovation and safety improvement. There is already considerable clinical support for such a comprehensive register. The Government’s commitment is to provide effective reassurance and remedy for women with these implants, and also to learn the lessons to deliver safety and quality for the future. I commend this statement to the House.
I thank the Health Secretary for his statement, and for the steps that he is taking to help the thousands of women who have found themselves in this worrying situation. We welcome much of what he has just announced, including the further reviews that he has commissioned. I assure him that we will support him in his efforts to reach a resolution as quickly as possible for all those people who are affected, but I have to tell him that he has a lot of work to do, and a lot of ground to recover, as his response to date has not helped to build those people’s confidence.
Over the Christmas break, the mixed messages coming from the Government did not go unnoticed. They only added uncertainty in what has been an anxious time for many people. The Health Secretary has gone from downplaying the dangers on 23 December to announcing an urgent review on new year’s eve, then giving an inconclusive statement late last Friday evening. This has left the people affected struggling to make sense of what it means. For the vast majority whose implants were fitted privately, there was precious little practical advice or help from the Department of Health as they began approaching their private providers. Many women were unable to access their records or told that long delays would be involved. Others have been asked to pay large fees to access their records. Many have simply hit a brick wall when they have sought medical advice or removal, even where there is evidence of rupture.
What people needed at the earliest stages was a strong statement from the Government of what was expected of all private providers—namely, that records should be provided without delay and without charge; that consultations should be arranged when people were worried; and that removal should be arranged urgently when there was evidence of rupture. The reality is that the Government’s failure to provide that leadership from the outset has left people fending for themselves in the face of a self-serving and unaccountable industry.
The Health Secretary was right, however, to establish an urgent review of the evidence by the NHS medical director, Professor Sir Bruce Keogh. We welcome the speed with which that review was conducted, and we echo the Health Secretary’s thanks to the members of the review panel. We accept the Government’s judgment on the advice to women regarding the removal of implants on the basis of the data that they have seen, but what confidence can we have in the evidence and data on which those decisions were reached?
We note the Secretary of State’s public comments about the industry’s failure to provide quality information in a timely fashion, and the interim report’s finding that the evidence is subject to “considerable uncertainty”. The review concludes that it should reconvene in “about four weeks time” to examine any new evidence, and to consider whether to update its recommendation on removal. I have to tell the Health Secretary, however, that that feels way too vague and ad hoc. May I press him to give a clearer timetable for this further process of review on whether to change the recommendation on removal? People need absolute clarity on when further statements will be made, so that they can make informed decisions. This is of course a separate matter from the long-term reviews that he has announced today.
This is particularly important in the light of the different decisions that other Governments are beginning to make in response to the situation. Yesterday, the Welsh Government announced that all women who received PIP implants, including those treated privately, will be offered replacement implants on the NHS. That is of course different from what the Health Secretary has announced today. What discussions did he have with his counterpart Minister in the Welsh Assembly Government before their announcement was made? Will he assure the House today that all the data that were available to Welsh Ministers and officials were also available to, and considered by, the Keogh review? Governments around Europe have responded sooner, more decisively and with greater clarity than the coalition has done. By contrast, people here have found the Government’s statements in response to be both inconclusive and ambiguous.
We support the decision to help NHS patients to have PIP implants removed and replaced, but does the Secretary of State appreciate how that decision has added to the confusion that many people feel and was interpreted as contradictory to the review’s overall finding? The clear implication of the Keogh review is that the best course of action is, in fact, to have the implants removed, but again no practical help was offered beyond the statements of expectation for private providers to match the support on offer from the NHS and the reference made to “moral duty”.
I, too, commend the private providers, such as Nuffield, Spire and BMI, that have done the right thing by their patients, but in recent days we have heard how some of the leading cosmetic surgery clinics have simply ignored the Health Secretary’s appeal. Transform, which used PIP implants on over 4,000 patients, has said that all women affected will have to pay £2,800 for removal, while the Harley Medical Group, which has 13,900 patients with PIP implants, has offered to pay for the cost of the new implant, but only if the NHS pays the far greater bill for the surgery. I am sure the whole House will agree that this is an appalling response to this situation, and that the failure of these companies to face up to their duty of care for their patients leaves everybody, including the Government, in a difficult position. It is simply unacceptable for any woman in England to be left in a position where she is worrying about her health and thus has no peace of mind, but is unable to afford to do anything about it.
I appreciate what the Health Secretary has said today about helping people out of this predicament. I agree with his decision where private clinics no longer exist, but in accepting that the NHS will provide private treatment where private providers refuse to, is he not in danger of letting those providers off the hook? May I remind him that most people will not accept that the NHS should subsidise the failures of private companies, and will look to him to pursue them to the nth degree to get any costs back? For instance, has he fully explored the insurance position of these private providers as a means of recovering costs? He says he will pursue them, but what assumptions has the Department of Health made about the likelihood of his success, and how much money is expected to be recovered? Has he fully explored the position of the French Government and considered whether there is any residual liability on the device manufacturer in that company?
Let me turn briefly to questions of regulation. Can we support what the Secretary of State said today about the wider review of regulation of the cosmetic surgery industry? If there are any loopholes, we will support him in closing them down.
Finally, the right hon. Gentleman’s Health and Social Care Bill envisages a much expanded role for the private sector in the delivery of health care. I make no comment about that, but has he reflected on the Bill and revisited the assumptions behind it? Will he assure us that issues of quality and safety will be safeguarded in the NHS that he seeks to create? We want to be assured that he is giving careful consideration to all these issues, as he considers his response to this worrying situation.
I am grateful to the shadow Health Secretary for his welcome of my statement and the principles behind what we are setting out to do to look after the women affected by these implants.
I do not share the right hon. Gentleman’s view that there were any mixed messages. I am sure he would have been the first to complain if I had not identified the lack of available and consistent data and not asked an expert group to look into this. As we look at countries across the world, we can be confident that we have set an exemplary standard in looking after women through the NHS and in bringing together an expert panel fully to understand what would be the best advice for women. The advice that no identified specific safety concern justified the “routine removal” of these implants was true on 23 December and it remains true today. As we have recognised from the outset and as I said on 23 December, if women are worried or concerned about the possibility of not having the implant they thought they had, that provides a perfectly reasonable basis on which to seek advice and investigation. It would be right for some women to ask for removal, but we should not assume that women are choosing to have these implants removed on the basis of clinical advice—even in France.
The chief medical officer spoke to a clinical counterpart in the Welsh Assembly Government before the publication of the expert group’s work. I have made sure that they are informed, but I have to say that the Welsh Government made an announcement yesterday without previously informing us.
It may be called devolution. I respect the devolved Administrations and always inform them of what I am doing, where it is relevant to them. We do not recognise the advice that Wales received. Sir Bruce Keogh’s expert group, which included some of the foremost experts in plastic surgery, made clear recommendations last week for patients in England and concluded that there was no significant increased clinical risk in cases where implants are not replaced.
If the shadow Secretary of State commends what the Welsh Government have done—[Interruption.] Perhaps he did not, but if he or anyone were to commend it, they would need to recognise that it runs the risk of letting the private providers off the hook. I am very clear that they should provide an equivalent standard of care. As the right hon. Gentleman made clear, there are limitations on what can be done. I do not have powers and I did not inherit powers to control what the private providers do in the private sector. I have to tell the right hon. Gentleman, however, that I have reflected on the Health and Social Care Bill, which is a positive legislative step forward. Just as it allows Monitor as a health and social care sector regulator, on which we are consulting, to look at the prudential regulation of private providers in social care, so it would allow us to consider the role of Monitor as a health sector regulator in licensing private providers of private health care. It is thus a positive not a negative step forward. There is no comparison, as the right hon. Gentleman will recognise, between the role of the private sector providing private care and the private sector in the NHS, which is subject to the same duties and obligations as an NHS provider. The Bill does not lead to an increase in private sector provision, but in so far as there are private sector providers, they will be properly regulated in the NHS.
On the role of private providers, they may be insured and there may be warranties relating to these implants. We do not have data on this aspect, but I am clear that these providers have legal and, indeed, moral obligations. I particularly commend a letter issued this morning by the leaders of the profession—the two principal professional associations—to their surgical colleagues. Having talked about the standard of care in the NHS, the letter went on to say:
“Those working in the private sector are urged to support in similar fashion. We would hope that implanting surgeons would honour requests for replacement surgery free of surgical charge”.
The private providers that have not made this offer to the women for whom they are responsible can see that their surgical associates are willing to carry this out free of surgical charge, so I see no reason why they should not now step up and deliver the standard of care that women have a right to expect.
May I welcome my right hon. Friend’s statement and the prompt action he has taken over the last few weeks to address this issue? Does he agree that the first priority when these concerns came to light was to ensure that the women who have had these implants had clear, authoritative advice based on the evidence of the right way to treat them, and that the process he established under Sir Bruce Keogh has provided and will continue to provide exactly that authoritative evidence-based advice? Does he further agree that there are some longer-term policy issues around the regulation of this industry that need to be addressed, but in a more considered way and not tied up in the emotions of this immediate concern?
I am grateful to my right hon. Friend and agree with all his points. I would add that when the French Government informed us of their prospective announcement—I spoke to the French Health Minister the day before it—we gave the best advice to date, based on the MHRA’s knowledge of the toxicology tests and its discussions with the French regulator. What we have to do is to establish the extent to which surveillance of these implants over a number of years should have led to any different conclusion. It remains true, however, that there is no evidence of long-term health effects that would give rise—and would have given rise at that time—to a different recommendation from the one that we made.
This is not a new issue, as the Secretary of State must know. Twenty years ago I raised the case of a constituent who had to have a double mastectomy because silicon implants had leaked in her body. As a result, we set up an organisation called SOS—Survivors of Silicon. We worked with Which? magazine and the Department of Health, and we helped to set up the register of implants, which was unfortunately not made compulsory. That is why the data are missing.
This is part of a wider issue, of the proper regulation of the cosmetic surgery industry, 70% of which is virtually unregulated. I hope that the Secretary of State will insert an amendment into the Health and Social Care Bill to ensure that there is proper regulation of the whole industry.
I completely understand the right hon. Lady’s point, but this activity is not unregulated. For example, the Care Quality Commission is responsible for the registration of providers, and for ensuring that they meet essential standards of safety and quality. However, for precisely the reasons cited by the right hon. Lady, I am asking Sir Bruce Keogh’s group to consider wider issues relating to the regulation of cosmetic surgery and cosmetic interventions.
The registry to which the right hon. Lady referred was discontinued in 2004 because a substantial number of women were not consenting to the addition of their names to the register. I believe that, given the positive experience that has followed the establishment of the National Joint Registry, we can reassure women that their data can be entered without prejudicing their patient confidentiality.
I should make it clear that as yet we have no evidence demonstrating any significant difference between the rupture and leakage rates of PIP breast implants and those of other implants. Last June the American Food and Drug Administration published the findings of a study of normal implants, two of which had a 10% to 13% rupture rate over a 10-year period. It is important to appreciate that implants in themselves pose a distinct risk of rupture and leakage.
I welcome the clear commitment to putting women’s health needs first in this context, but is not the heart of the problem the obvious conflict of interests for private clinics when it comes to the provision of long-term safety statistics? Will my right hon. Friend ensure that any future system allows women to self-report to the registry—albeit with a follow-up from specialists for confirmation purposes—so that we can have a complete picture of the long-term complications caused by devices of this kind?
My hon. Friend is right. When Sir Bruce and his colleagues are considering the establishment of a wider registry, they will consider not only the possibility of self-registration but the possibility of making clinical professionals responsible for the publication of such data. The responsibility should not rest solely on providers or manufacturers.
I understand that a number of private clinics will not even scan a patient with PIP implants without charging. However, these goods were counterfeit. They were not of a medical standard, and they could be injurious to health. Should not the NHS be prepared to help women who must be worried sick, and perhaps cannot even afford to have a scan to reassure them? I cannot believe that the NHS would turn its back on a patient who was suffering after drinking counterfeit vodka, so why should it turn its back on these patients?
I am sorry that the hon. Lady framed her question in that way, because I thought I had made it clear that the NHS would always be there to support women. We will seek to recover the cost to the NHS if the original provider was a private provider: that approach has been adopted for years, and I am sure that it would have been adopted by my predecessors. No woman should have to feel that she will not be looked after, but I am making a different point—namely that, in the first instance, women should be looked after by the original providers, who have a continuing duty of care. They also have legal obligations—as well as the moral obligations to which I have referred—but it is not for me to advise on those.
If the Government are paying for something that is needed, it is logical to assume that some private firms must be dodging their responsibilities. If those firms are not indemnified against the risks of surgery or willing to accept responsibility for its consequences, why on earth do we allow them to practise? Does the remedy not lie in our hands?
I entirely understand my hon. Friend’s point. The position we have inherited is that I have no powers in relation to the provision of private health care by private companies. As I said to the right hon. Member for Leigh (Andy Burnham), the Health and Social Care Bill provides for the establishment of Monitor as a health sector regulator that will license such providers. I am not making any judgment at this point on whether it would be appropriate for conditions to be attached to such licences in relation to the continuity of service to patients, but it is one option that we can consider.
May I suggest to the Secretary of State that the problems in the cosmetic intervention industry may be far more extensive than we have known thus far? A few years ago, I had my eyes lasered. I visited five clinics, four of which seemed to be trying to sell me an intervention rather than trying to do anything that would be in my general health interest. Will the Secretary of State add laser surgery clinics to his list, and also private dentists, many of which are encouraging patients to undergo operations that they certainly do not need?
I will reserve my position on dentistry, because there is a very wide range and cosmetic intervention constitutes a substantial proportion of overall dentistry activity, but I will happily consider whether there is an issue to be dealt with. As for laser eye surgery, I will ask Sir Bruce’s group to consider not only the establishment of a registry in relation to implants and devices, but cosmetic interventions more generally. I hope that we shall be able to reassure the hon. Gentleman when we publish the terms of reference.
I commend the Black Country Partnership NHS Foundation Trust on conducting 517 breast implant operations in the decade before 2008 without the use of a single PIP implant.
What this furore has revealed to me is the existence of a growing private sector offering a vast array of cosmetic surgery that extends well beyond breast implants. I fear that the need for tighter regulation of the industry will prove widespread, and I therefore welcome the Government’s commitment to a review. Does my right hon. Friend expect to be able to charge the private sector for the costs of any additional regulation that the review group may deem necessary?
I am grateful to my hon. Friend for what she said about the NHS. I think that before considering whether there is a cost associated with regulation and how it might appropriately be met, we should consider what is necessary to assure patients of safety and quality.
I welcome the statement, but may I caution the Secretary of State against placing additional burdens on the Care Quality Commission without providing it with additional resources? May I also urge him to heed the advice of my right hon. Friend the Member for Leigh (Andy Burnham), and pause to listen and reflect on what lessons can be learned and what safeguards can be provided for the future? I am thinking both of the protection of patients’ safety and of future NHS liabilities when surgical procedures or treatments are carried out by the private sector, which is likely to become more frequent as the privatisation provisions of the Health and Social Care Bill are implemented.
For reasons that I have already explained, the hon. Gentleman is simply wrong about that. It is nonsensical to attempt—as the editor of The Lancet did this morning—to compare the regulation of private providers of private care with that of private providers of NHS care. There is no comparison at all.
The CQC will inspect a sample of providers of cosmetic surgery to check that they are meeting registration requirements, and will undertake a number of unannounced inspections as part of that. We expect the inspections to be completed by the end of the month, and expect the CQC to have published its report by the end of March. It has confirmed that it has enough resources to undertake the inspections within its existing budget.
I add my support and thanks to the Secretary of State for what he is doing on this very important issue which has caused so much distress to so many women. Does he agree that this episode flags up a wider issue in the cosmetic surgery industry, in that some practitioners performing medical procedures do not have any medical qualifications or knowledge of anatomy? Does he also agree that it is a problem that there is no psychological counselling and that a holistic look at patients is not taken, as this is an on-demand industry? Finally, does he agree that there must be a proper paper trail and record system in the industry, so that we can consider what is in the best interests of patients and so that there is proper accountability for all providers?
My hon. Friend makes a number of important and perceptive points. It is, and will continue to be, one aspect of NHS advice that psychological assessment can form an important part in the management of patients referred for low-priority procedures, including cosmetic surgery. However, although we will look at cosmetic interventions and their regulation more widely, we must recognise that the issue in this instance related to what was a criminal act—seeking to adulterate the material in the implants. Many private providers were using what they regarded as properly certified implants for a perfectly proper procedure. To that extent, they were not engaging in any improper behaviour. However, they have legal and moral obligations to their patients, and I am asking them to discharge those obligations.
It saddens me that, despite previous reports recommending more effective regulation of the cosmetic surgery industry, it has taken this crisis, causing so much distress to so many women, for the issue to be taken seriously. I am nevertheless glad that it is being taken seriously. Will the Secretary of State consider ensuring that people seeking cosmetic procedures must have independent counselling and advice from a body that will not make a profit from that procedure, and whose whole concern is the health of the patient?
I welcome the statement. What has the Secretary of State learned from this episode about the quality and take-up of routine insurance products offered by private companies to protect both patients and providers when cosmetic surgery goes wrong?
I am grateful to my hon. Friend for her welcome for the statement. Those seeking cosmetic interventions must ask serious questions about not only the nature of the procedure but the quality and reputation of the provider organisation, and ask it how it would protect their interests if things went wrong.
The Secretary of State referred in his statement to the possibility that an organisation that had carried out operations had gone out of business. As there are long-term implications from such surgical interventions, has the Secretary of State considered instituting some form of levy or fund that would have to be paid into—nor do I want to let the private sector off the hook—so that if organisations go out business there would be a sum of money from which people could claim?
As I hope the hon. Lady will appreciate from what I said to the right hon. Member for Leigh (Andy Burnham), the Health and Social Care Bill introduces for the first time a comprehensive continuity of service regime for the NHS, and it also creates, through the health sector regulator, the potential for us to consider whether such continuity of service needs to be extended beyond the NHS.
If the NHS stands behind private providers in such cases, it is effectively providing free indemnity insurance. Will the Secretary of State look at the insurance position of providers of such services and ensure that the taxpayer does not face open-ended liabilities?
As my hon. Friend points out, to that extent the NHS has always stood behind the private sector provision of health care. If things go wrong, people have the right to access NHS treatment as they must be looked after on the basis of clinical need. Referring back to points I made earlier, the Health and Social Care Bill gives us an opportunity to look more systematically at continuity of care for patients both in the NHS and the private sector and at the responsibilities of providers under their licence.
I thank the Secretary of State for coming to the House and making this statement. How many clinics will the CQC be reviewing, and what will happens in respect of any clinics that are no longer practising? Presumably the CQC will not have access to their records.
I cannot tell the hon. Lady how many clinics the CQC will visit, but it will be a sample of providers, not all of them. As she may know from the material we published last Friday, there were 93 private providers. The operations were heavily concentrated in that a lot of them were carried out by a small proportion of providers, but about 87 other small providers, or even single-handed providers, are involved and accessing data from all of them will be difficult. I also recognise that, as the hon. Member for Edinburgh East (Sheila Gilmore) said, some may not be in business any longer, or there may be surgeons who have retired.
I also thank the Secretary of State for making the statement. Following on from a vein of questioning that has already been explored, will he elaborate on the point about the Government pursuing firms to recover costs and explain what mechanisms are available to the Secretary of State to recover costs?
I will do so to an extent. It depends on the nature of the legal contract between a woman and her private provider. I hope that in many cases the legal obligations derived under that contract or under sale of goods and services legislation will clearly mean that the woman will get redress from her private providers or her insurers. If the NHS becomes involved, there may be compensation through the injury costs recovery scheme, so if the NHS incurs costs, we can go on to seek to recover them.
Given the nature of the work I am asking Sir Bruce Keogh and his group to undertake, it will take them some time to look at the range of cosmetic interventions and make any recommendations. They are coming together as rapidly as they can. Many of them have given up a great deal of time over the past two weeks to help us in this work. We must recognise that there are things we need to do rapidly to ensure that there is support and reassurance for any woman affected by PIP implants, and we are acting rapidly. There are lessons and wider implications to be learned. This particular area of cosmetic surgery was not without regulation. The question is to what extent things were properly regulated with surveillance and enforcement over a number of years.
I welcome the Secretary of State’s statement. As he knows, I co-chair the all-party group on breast cancer and we will want to monitor how women are treated by the NHS and private providers, and we will certainly feed that into the Department. For women who have fought breast cancer and been through the trauma of reconstructive surgery, this will bring it all back and be tremendously upsetting. Does the Secretary of State therefore agree that speed is of the essence in respect of replacement surgery where it is wanted, so that those women can again put this nightmare behind them?
I am grateful to my hon. Friend and I completely recognise the points he makes. As he will know, the overwhelming majority of the approximately 3,000 women who had PIP implants through the NHS will have had them as breast reconstruction surgery following mastectomy. From day one, we were clear that we wanted all those women to be able to get advice, investigation and remedy, and removal and replacement, should they wish. If the NHS was responsible for the original operation, we will be responsible for the replacement with new implants, if that is what is wanted.
The NHS is very clear about this issue in the advice that was presented. I welcome the fact that my professional colleagues in the associations are making it clear that, through the NHS, replacement procedures for these women should be possible rapidly, but it should not prejudice the availability of urgent referral for cancer, which will continue to be an operational requirement in the NHS.
The question arises of access to records in both the private and NHS sectors. Is it not time to look again at who is the keeper of medical records? Should it not be the patient—therefore bringing together the NHS and private provision, where applicable—rather than the institutions?
Of course, as the hon. Lady knows, we have been thinking hard about precisely this issue. The NHS Future Forum made further recommendations to us only yesterday about achieving access for patients to their own records by 2015 across the NHS. The NHS should keep records, but the patients themselves should have access to them. We will pursue that issue in the NHS, although frankly, I am not in a position to mandate that in the private sector. However, any patient would be well advised to say, “Why can’t I hold my own record from a private provider?”
I welcome the Secretary of State’s statement, but PIP is not the sole supplier of breast implants across the industry. What assurances has he received from the industry that no other company has embarked on the practice of using non-medical grade silicon in its breast implants, so that women who have had such implants can feel safe?
I have no evidence of such behaviour on the part of other companies. My hon. Friend is right: PIP is only one of a number of suppliers, and in this country probably only one in seven breast implants were PIP implants. Other countries have looked at this, and across Europe the regulatory process should ensure the scrutiny of these implants, including proper testing. The European review must look at whether that surveillance, including unannounced inspections and appropriate testing, gives us the assurance we are looking for.
Yesterday, I was contacted by a constituent who had PIP implants inserted by the Harley Medical Group in 2006. She said:
“There is so much conflicting information at the moment, I feel as though I’m being pushed from pillar to post. To add absolute insult to injury nobody is keen on helping us, they are saying the NHS should help…or they say they will perform the procedures on us for an extra fee.”
Can the Secretary of State tell me precisely what further representations he will be making to private providers to ensure that all women get access to the advice and treatment they need?
We have been very clear about the advice we have given to women, and I hope that, through the NHS, any woman in those circumstances would go and see their general practitioner, who will have full access, from the chief medical officer, to the expert advice we have disseminated. I know that the Harley Medical Group has not shared with others the view that it can match the NHS’s standard of care; but given that, the professions are suggesting to surgeons that they should honour requests for replacement surgery free of surgical charge. I hope that gives a basis on which more of the private providers will now meet their full obligation of a duty of care.
I am sorry to disappoint my hon. Friend but I cannot offer him such an estimate. We know that some 37,000 women had PIP breast implants. Clearly, not all those will necessarily want removal, and on advice, it might be any proportion of those; I cannot tell him what that figure would be. As we see in France, recommending the removal of implants does not mean that all women will have them removed.
I acknowledge the Secretary of State’s commitment to engaging proactively with the devolved Administrations on this issue. However, in his statement he used somewhat clumsy language regarding the third main finding of the expert group, saying that “there is no clear evidence that these problems are more serious in relation to PIP implants than other implants, or that they result in increased long-term health risks.” Is he not concerned that, put so clumsily, that will not only fail to reassure those with PIP implants but extend concern and alarm to those who have received other implants?
I am afraid that absence of evidence does not mean evidence of absence. We can be very clear, on expert advice, that there are no specific safety concerns that routinely require the removal of these implants, nor identification of any increased long-term health risks, in precisely the way I have described. I cannot go further and provide, on advice, absolute assurance, and the expert group was clear about that. That is why the French Health Minister, whom I was talking to last week, and I were clear that we should undertake additional toxicology tests on implants when they are explanted, in cases where they were implanted over a period of time, to begin to understand the extent to which they had adulterated filler material and what was in it.
I commend my right hon. Friend’s initiative. However, he said the following, which may have been sloppy wording: “those who have had reconstructive surgery following a mastectomy, will have received PIP implants through the NHS.” Of course, the majority will not have done so, and I have confirmed with surgeons in Cornwall that PIP implants have never been used in the NHS in Cornwall. Given that the Medicines and Healthcare products Regulatory Agency issued advice to stop using PIP implants in the UK in March 2010, can the Secretary of State confirm that this advice was acted on, no doubt within the NHS but across private clinics as well?
I hope I did not say what the hon. Gentleman ascribes to me. Some 3,000 women, we think, had PIP implants, and of course, that is only a fraction of the number having breast reconstruction surgery. I think I can offer him reassurance. The MHRA withdrew authorisation in March 2010, and given that there was only one distributor of these implants in this country—Cloverleaf—they will not have been distributed for use after that date.
A constituent in Chesterfield contacted me who is at her wits’ end. She has been in considerable pain since having a PIP implant fitted, and has been told by the private provider that she will have to pay £3,600 to have it replaced. What more can the Secretary of State do to ensure that her private provider follows the example of the other eight providers that are doing this free of charge? Let us put some pressure on these companies to make sure that all of them do the same as the NHS and replace the products they have fitted.
I think I have made it clear that not only the Government but, helpfully, the professional associations are looking to give no reason why private providers should not match that standard of care, especially if the implanting surgeons are willing to offer replacement surgery free of surgical charge themselves. It would be very helpful if the hon. Gentleman and other Members gave us details of such cases on behalf of their constituents. Clearly, his constituent will have had that implant before March 2010. The adverse incident centre has had 478 reports of ruptures over the whole period, which extends back many years. One of the things we want to understand as part of our review is why, if there were ruptures and, more to the point, adverse health effects associated with these implants, they were not disclosed to the adverse incident centre. As yet, we have not seen a range of health effects over a period of time that, in themselves, distinguish these implants from other, normal implants.
I contacted the Harley Medical Group on behalf of a concerned constituent this morning and was told that it would be making a decision on its response to this issue by Friday, although that is somewhat contradicted by the comments made by the shadow Secretary of State. Regardless of that, does my right hon. Friend not agree that the Harley Medical Group, or any other company, should step up to the plate, take full responsibility and work to make sure that it gives the people involved complete satisfaction, without any cost to the individual concerned?
My hon. Friend will understand that I cannot speak about the precise details of the situation with the Harley Medical Group. All I can say is that the group has told the media that it does not feel it can offer that standard of care completely, but that will have been before the professional associations wrote to their members asking them to support replacement surgery free of surgical charge. I know that the group has told members of the media that it is willing to offer to the Government that if we are responsible for the removal of implants, it will pay for implants to be available for replacement purposes. Frankly, if surgeons are willing to waive the surgical charge and the group is willing to pay for the implants, it is not too much to ask for it to be responsible for removal and replacement, where it is in the woman’s best interests to do that.
Does the Secretary of State not regret failing to react to the call made last May for British patients to have the same protection against failures of all medical devices as that enjoyed in the United States? Is not the real scandal here, again, the chronic under-reporting by the industry and the MHRA of failures of devices and drugs? Is not the answer for this probe to look into the possibility of having a genuinely independent regulatory authority, instead of one that is entirely funded by the industry, because self-regulation is often no regulation?
The hon. Gentleman says that this body is entirely funded by the industry. It is true that in relation to pharmaceuticals the MHRA is funded by levies on the pharmaceutical industry, but much of the cost of the regulation of medical devices is actually met by the taxpayer. I regard the MHRA as operating in an independent fashion and its expert and scientific advice as independent from Ministers. None the less, as he says, the review that Earl Howe will lead will examine the lessons to be learned, including those about the effectiveness of regulatory surveillance and enforcement in this country, albeit that the regulatory failure occurred, in essence, in Germany, in the first instance, and in France.
The uncertainty that many women face relates to not only the level of risk associated with PIP implants, but whether the implants they had fitted were PIP implants. I accept what other hon. Members have said about problems with record keeping in the private sector, and that needs to be taken up. The Secretary of State said that the estimated 3,000 NHS patients will be written to. If they are to receive such a letter, will he reassure them about when that will be?
Will the Secretary of State send officials to investigate the Birkdale clinic in Rotherham and its executive, Mr Promod Bhatnagar? Scores of women have had PIP implants at the clinic and are now being told that they have to pay £2,900, in cash, to be screened and looked at again. Mr Bhatnagar has threatened groups in south Yorkshire with “unimaginable consequences” if they raise this issue. After his very unclear statement, will the Secretary of State finish by saying that as in every other European country, and standing with the women of Britain, taxpayers do not mind paying for a few hundred women to be properly investigated? My constituents have contacted me saying that the women of south Yorkshire should be able to go to their general practitioner, go straight into hospital and be seen to, and we should clear up all the fuss about bills afterwards.
I think I have been absolutely clear about what I expect to happen, in relation both to women treated through the NHS and what I expect of private providers. I have also made it clear that if private providers will not or are unable to meet that standard of care, the NHS is available to support women. It is absolutely wrong to say that we are somehow responding to women differently from other European countries, because across Europe countries affected by this are taking exactly the same view that we take.
I thank the Secretary of State for his statement and I again highlight the concerns that a great many ladies have. Just today, I have been made aware that constituents of mine, as well as those from other regions of the United Kingdom, have had PIP breast implants carried out privately in the Republic of Ireland. When they contacted the firm, they found that it had gone bust, so what help can he give ladies, both financially and physically, who were NHS patients in the United Kingdom but had operations carried out outside the United Kingdom, specifically in the Republic of Ireland?
The Secretary of State has demonstrated his obvious concern for the women affected by this situation. Does he accept that they are gravely concerned about the difference of opinion that is emerging between Governments in the countries where these implants have been used, in particular, the difference between our Government’s advice and that of the country where the implants were manufactured, France? Will he also reflect on whether companies in the private sector that are giving either cosmetic or other treatments of this nature to women are properly insured, so that even if they go out of business the insurer will cover women for future treatments should something go wrong?
On the hon. Gentleman’s final point, I refer him to what I said earlier about how we might deal with that in the future. On the point about other countries, I have spoken to Commissioner Dalli and I have spoken to my French counterpart twice. What I want to be clear about is that the French authorities did recommend routine removal of implants, but from any individual woman’s point of view we are, in effect, recommending that the same thing should happen: any individual woman should see the clinician responsible, should be examined—by imaging, if necessary—and should consider, in the light of that and in a clinical decision with her adviser, what is right for her. That will be true in France and in Britain. I wish to emphasise that we have not seen, on advice, scientific evidence that justifies the recommendation of the routine removal of these implants. We are not saying to women that we think they should have them removed; we are saying that women should have access to imaging. Clearly, women with symptoms, or women for whom evidence of rupture or leakage has been provided through imaging, may well choose to have the implants removed, and we would support that.