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Andrew Rosindell (in the Chair)
I call the Minister. Sorry, I call Mr Dorrell.
Mr Stephen Dorrell (Charnwood) (Con)
I think my hon. Friend the Minister might need some time; she will respond to views expressed by members of the Select Committee on Health, and other hon. Members who have forsaken attractions elsewhere and turned up to this debate.
The Health Committee is grateful to the Backbench Business Committee for nominating this subject for debate this afternoon. Our report on PIP breast implants aroused considerable interest among those directly affected. That is hardly surprising, because it addresses an issue of major concern for more than 40,000 women who have received breast implants that were later found to be non-compliant with standards that everyone believed they met on the day the implantation took place. That has led to considerable concern among a large number of women about the health implications of that failure of an implantation into their body, and it also raises important policy issues that the Committee has sought to address in its two reports on the subject, to which the Government have sought to respond. We now think that the issue merits wider debate.
I will begin by stating relatively briefly how we arrived at this set of circumstances. The breast implants supplied were subject to European law and a European licence that was issued by the French regulatory authorities. I will not amuse the House by offering a French accent because, happily, the words in question are similar to their English equivalents: Poly Implant Prothèse, or PIP, is, or rather was, a French company that had a licence to deliver those products. In plain English, it was not merely a question of the company not complying with the terms of the licence. French regulatory authorities have acknowledged that fraud took place, and that falsified returns were made to the French regulators. However, not only did the breast implants supplied by PIP not comply with the regulations, but the company knew that at the time they were supplied.
The licence was issued and maintained by the French authorities, but in March 2010—the date is significant—the French regulator reported the existence of fraud within PIP, and stated that the implants that the company had supplied contained non-compliant silicon. As a result, the product was deliberately not the one that had been licensed for supply and use in human surgery.
There was then a long period—I intend to return to this issue—between March 2010 and December 2011 during which it was unclear to the Committee, as we undertook our inquiries, whether anything like a proper reaction was expressed by the French regulators or, it must be said, the regulatory system in this country. I will later return to, and dwell on some of the lessons to be learned from what happened in that time lapse between March 2010 and December 2011.
Before I consider the substance of those issues of concern to the House, I would like to complete the timeline. One might think that the announcement that there had been a fraud, and that non-compliant breast implants were being supplied, would have raised concerns and prompted somebody to do something about the matter in March 2010. As I said, however, nothing much happened until December 2011, when more or less out of the blue—at least as far as we could make out—the French regulator announced that it had decided that even though 21 months had elapsed, its concerns about the implants were now such that it recommended “precautionary removal”, as it is phrased. By Christmas 2011, the recommendation from the French regulator was that the implants should be removed forthwith—no, not forthwith; on a non-urgent basis.
Over 21 months, therefore, the regulator had gone from frankly not doing much about the issue to announcing, just before Christmas, that its concerns were such that there should be a precautionary removal of the implants. On the basis that nothing ever happens at a convenient time, that took place just as everybody was going away for Christmas, and my hon. Friend the Minister and my right hon. Friend the Secretary of State therefore had to deal with the issue during the Christmas holidays. During that period, the Government set up two inquiries. One was led by the medical director of the NHS and focused, rightly, on the priority subject, which was the risk to patients and the proper response in terms of patient care. The other inquiry was led by the Health Minister in the House of Lords, Lord Howe, who looked at the policy lessons from the point of view of the regulators.
The Committee heard evidence in February and issued its report in March. The Government responded, and we now have the question of the lessons to be learned, and the Committee’s response to the Government’s position. The Government have accepted the Committee’s recommendations in the report, with two important exceptions. I wish to talk about those exceptions, and then deal with one or two other issues raised by the Committee on which it would be useful to hear the Government’s current thinking.
The first issue concerns what happened between March 2010 and December 2011 and the lessons to be learned. In the Committee’s view, one of the most important lessons was that we were surprised, to put it extremely mildly, that implants can be put into the human body and no record kept of the fact. That seems to have implications that go way beyond the issue of breast augmentation. An implantation into the human body can take place and there is apparently no regulatory requirement on any of the professionals, service providers or providers of the devices to keep a record of that.
During the various inquiries held immediately after the Christmas recess, the Secretary of State said that the Government were minded to move back to the previous rather weak requirement for a register, but I hope that when the Government consider the subject, they will look not just at the context of breast implantation, but at a much wider question. It seems to me that if a medical device is being implanted into a patient, the burden of proof is on anyone who wants to argue that a record should not be kept. The PIP implant saga perfectly illustrates why there should be a record of which patient received which product on which day. It is so that a proper response can be organised if the product is later found not to have complied with the regulations on the day on which it was implanted, as in this case, or if the product is later found not to be desirable for any number of reasons that may not be known about on the date of implantation.
Ms Diane Abbott (Hackney North and Stoke Newington) (Lab)
Does the right hon. Gentleman agree that the idea of a register of implants—not just breast implants, but implants in general—has been raised before, but was rejected, sadly, by Minsters in a Labour Government because officials for some reason resisted the idea, and that it is important that we push forward with that common-sense idea?
Mr Dorrell
I agree. In fairness to officials, it was not so much the officials who were resistant in the days of the previous Government, as I understand it; the issue was that the requirement was relatively weak, and many patients were resistant. However, for reasons that I have given, it seems to me that it should be part of the regulatory structure within which medicine is practised that implantations into the human body are the subject of very secure records.
Mr Denis MacShane (Rotherham) (Lab)
I agree with everything that the right hon. Gentleman is saying. Does he agree with me that there is a cultural problem, in that “regulation” has become a dirty word in modern politics—not recently, but over a number of years—and that the words “European regulations” are not so much dirty words as a total obscenity that people only whisper in dark corners of this place? The European regulations were inadequate, and we did not have the guts to insist to the professions and the people making money out of this that they needed a bit more regulation.
Mr Dorrell
I have some sympathy with what the right hon. Gentleman says. I do not think that we should be frightened, when the burden of proof is discharged, and when it is necessary, of ensuring that there is an adequate regulatory structure that is proportionate, not over-burdensome, and effective at delivering proper safeguards for, in this case, patients. I have been here long enough, Mr Rosindell, to know that if I want to get any political audience to be opposed to something, I have merely to describe it as European and the job is done. In this case, as it happens, I do think that there is a strong case for an effective European regulatory structure, so that the suppliers of proper medical devices, of which this country is a major supplier, do not have to go through 25 different regulatory structures to supply those products in a unified market.
Mr Dorrell
The Chairman, of course, is neutral in all matters when he is in the Chair, but I propose confining myself to the substance of the argument, Mr Rosindell, which is that there is a strong interest in this country, from a commercial point of view and, more importantly, the point of view of patients, in ensuring that there is a proper regulatory structure that provides for an audit trail of where products have been implanted. I would be grateful if the Minister could respond on the Government’s current thinking on that subject.
The Committee was concerned about the regulatory response during the 21-month period. With great respect to the Government response, I am sure that, seen from the helicopter, people were doing their best, but if 40,000 women are told in March 2010 that, in effect, an implant in their body is the subject of a fraudulent regulatory failure, and no response is made to them as patients for 21 months after that, that is not, in my view, an adequate regulatory response. An important part of the reason why that happened was that there was not an adequate information base to allow people to follow up, and to take the necessary action vis-à-vis those patients.
That is the first set of issues that arise from this saga. The second set of issues is more precisely about the decision-making position of the Government, and the NHS offer to patients who received the faulty, substandard implants. The Committee said, and the Government agree, that there is a clear moral and legal duty on the clinics that provided the implants to remove them and replace them at their own cost. Everyone, including the Government, agrees on that.
We also said as a Committee that we welcomed the fact that by the time we held our hearings, the Government had made it clear that the NHS was the back-up provider. If there was a faulty implant and no one else was going to remove it, the NHS, as a public health authority, needed to be able to be that back-up provider of a proper public health response, with, of course, the important proviso that if the NHS removes a faulty implant in those circumstances, it has a perfect right to recover the cost from the people who put it in. Again, there is no argument there.
The argument arises when a patient who has received a substandard implant has it removed in those circumstances by the NHS, but wants a replacement implant. Currently, the patient will need to have surgery to have the faulty implant removed, be discharged, and go to a different hospital on a different day and again take the risks—they are relatively small risks, but they are risks none the less—associated with any clinical procedure in order to have a replacement implant put in place. The reason given for that—I am very familiar with these arguments because of my background in the Department—is that the NHS cannot do a single operation where part of it is at public expense and part of it is at the individual’s expense. In the jargon of the NHS, there cannot be top-up charges for a single procedure.
I understand the NHS theology that lies behind that, but I recoil from the consequence, because what it says to the women—it is a relatively small number of cases—is that they have to go through surgery twice. There is a cost implication to that, but much more importantly, there is a clinical implication that I would have thought any doctor would recoil from. I urge the Minister to think again, and to think more imaginatively about the application of the familiar doctrine, which no one in the House would disagree with, that we should not have top-up charges in the NHS. I urge her just to think about the practical implication for the woman in those circumstances. I hope that the Government will find it possible to think again on that issue.
I would like to talk about a number of other issues that have arisen following our report. They mainly arise from the final report of Sir Bruce Keogh on the clinical consequences of this product failure. First, we welcome—I certainly welcome—the fact that Sir Bruce has finally confirmed what the women themselves told us: these products have a significantly higher rupture rate than other products supplied for the same purpose. I make the point to emphasise that if we had had a proper register, that would not have been a secret. That would have been clear in the evidence, and it should have led to a challenge to the terms of the licence as soon as that evidence became available. However, the evidence was initially debated and has only now been confirmed, two and a half years after the licence for the product was removed. Evidence is there when we look for it; we need to make certain that it is there in a proper way.
The second issue is Sir Bruce’s finding that there is no evidence of long-term clinical harm being caused by ruptures. I have not mentioned this yet, but the Select Committee organised a web forum. We are very grateful to the dozens of women who contributed to that forum to make it clear that the views that we had been expressing were supported by those most directly involved. Many contributors to the forum simply do not accept that there is no clinical consequence from a rupture of the implants. Sir Bruce recognises the short-term clinical consequence, in terms of soreness, but argues that there is no evidence of long-term clinical consequence. The women most directly affected are not convinced that that is true, and we can all understand why. That is the finding of Sir Bruce’s group now, but what process will we set up to ensure that it is not a once-and-for-all finding? It is one thing for it to be a judgment at a point in time, but if evidence that changes our understanding comes to light today, tomorrow or the day after, we must be clear that the finding is subject to ongoing review.
My third question concerns the clinic licensing system. I want to read some of the contributions to the web forum. They pose a question about the clinic licensing system, which continues to allow clinics to provide this service—subject, as probably should be the case, to the clinic having a licence. One woman said:
“it took weeks for them to respond to any emails, even though I knew I had PIPs and had 4 of the symptoms which they stated on their website.”
That organisation continues to provide this service. Another respondent said:
“The clinic were very slow to respond. At first they answered the phone and dismissed my concerns saying there is no proof PIP’s are unsafe/no link with cancer. They then stopped answering calls at the clinic and calls diverted to a call centre”.
A third respondent said:
“I contacted the provider who told me as I had had the implants for over 10 years…there was nothing he could do”,
because
“they should be changed after 10 years. This was news to me as when I had them originally done I was told they would last…15–20 years”.
Those organisations still have a licence. I put it to the Minister that that is not compatible with the delivery of good standards. Every one of those accusations—and no doubt there will be many more—should be followed up by the regulator, and the performance of the individual clinic should be tested.
I apologise, Mr Rosindell, for going on slightly longer than I had intended. Finally, there is an issue that came to light in the Committee hearings that I would like to question the Minister on: the challenge for the medical professions, and the individuals responsible for and engaged in the delivery of this service. The service was delivered in clinics, but the operations were performed not by the clinics, the system, or the venture capitalist, but by a doctor in a surgery with a patient in front of them. Like all medicine, it was one to one, and, like all medicine, it is subject to regulation by the professional regulator—another form of regulation of which I am strongly in favour.
The challenge to the professions that deliver such services, whether in the public or private sector, is to show that the duty of care that the professional owes to the patient was properly discharged and enforced. I will quote again from the web forum to illustrate why I am not convinced that that happened, particularly in regard to the obligation that a clinician has to advise a patient on the consequences and implications of a procedure that they are about to undertake. A woman said that a nurse at the clinic that she went to
“told me that she could see no reason why I wouldn’t take these implants to my grave as they were so good.”
As not many women have such operations in their 80s, and as women these days live into their 80s, it seems unlikely that that was clinically appropriate advice to give. Another woman said that she
“was assured that implants never need to be replaced”.
Whoever gave that assurance was quite clearly in violation of their professional obligation to give good advice to their patients. Another said:
“My surgeon told me that PIPs were the best and most expensive available and that they should last a lifetime.”
The evidence available is that even if they were the best and most expensive available, which they were not, they had a lifespan of between five and 10 years. They certainly were not designed to last a lifetime, and no clinician should have given that advice to their patient.
In conclusion, this saga throws a very unflattering light on the professions and the regulatory structure in this part of medicine. It also raises questions that have application well beyond the world of breast augmentation surgery. I look forward to the Minister’s response to the questions that I have raised, because I suspect that the issue will not go away any time soon.
Mr Denis MacShane (Rotherham) (Lab)
I concur with nearly everything that the right hon. Member for Charnwood (Mr Dorrell), the Chairman of the Health Committee, said and I congratulate the Committee on its thorough work. I was dragged into this matter simply because the Birkdale group had a clinic in Rotherham, not far from where I live. People phoned me directly, and I got more and more calls as I took an interest, so I tried to inform myself about the subject.
I am glad that the Chairman of the Committee made reference to what I thought was a distinct shortfall in compassion on the part of the Government and the Secretary of State in responding, “Nothing to do with us, guv, unless you had them put in inside an NHS hospital,” in other words, the 5% of the roughly 47,000 women who had the implants inserted as part of an NHS operation. The Secretary of State for Health is not the Secretary of State just for the NHS, but for the health of the country, so I thought a little more compassion and reaching out might have been needed, because the behaviour of some of the private clinics, including Birkdale, which had an operating base in my constituency, was, frankly, indifferent to the point of cruelty: demanding that money was paid up front, even for an examination, and then another huge fee for any kind of extraction, let alone a replacement operation.
This is about greed and lack of regulation. We are in parallel with a debate about banking in the main Chamber, and that, too, has some connection to greed and regulation. I understand that the Birkdale clinic performed some 150,000 operations over its lifetime at about £4,000 or £5,000 a go. We can work out just how profitable it was. Surgeons were flown in from eastern Europe to do 20 operations on the trot in a single day. That was happening not a mile from where I live. I did not know about it. The local NHS did not know about it, much. The council did not know about it. Local doctors did not know about it. I heard about it only when the crisis broke, so I am not in any way trying to be holier than thou.
We now know that in Britain about 47,000 women and their families are affected by the PIP scandal. It is not only about individuals, but the people around them, who have to live with a worried daughter, a worried mother or a worried grandmother. In their various reports, the British Government said that there is no significant risk to health for British women with PIP implants, yet other Governments take a different view. We should spend a little more time on comparative politics both in Select Committee reports and in our debates, and look at the approach of other Governments.
We might learn from the Food and Drug Administration in the United States, which took one look at the original PIP factory 11 or 12 years ago and simply banned the implants in the US. That is a worry for Europe; it is not a British point, particularly. The FDA said that under no circumstances should the implants be used in operations on US women, but we continued to allow them—when I say “we” I mean the whole EU. The reason is that they were the cheapest, at £150 in a £4,000 operation—QED, in terms of the profit to be made. Another country that banned them was Venezuela. I do not often have much good to say about President Chávez, but in this case perhaps he rendered the women of Venezuela some service.
What do we know about these PIP implants? They are six times more prone to rupture than other implants, and they contain industrial silicones that were never intended for human use and have never been tested on humans. Reports suggest that as many as 68 toxic chemicals and unidentified chemical compounds are in the mattress filler that is used in PIP implants.
We know why women have breast implants: it could be sagging breasts after babies, uneven breasts after mastectomies, and all sorts of psychological conditions. One of the most offensive things about this matter were comments in the press and from some hon. Members—on both sides; this is not a party political affair—suggesting that it is about vanity and cosmetic surgery, “It serves them right”. It is a woman’s decision, perhaps not always a wise one—as the right hon. Gentleman said—to have her breast opened up and something foreign inserted, and we should respect it. I am not sure whether we have not been just a bit scornful, especially in a profession still overwhelmingly dominated by men, despite the welcome presence of the Under-Secretary of State for Health, the hon. Member for Guildford (Anne Milton).
Other countries have set up crisis funds to allow women to have substandard PIPs removed. Ministers in other countries say, “We are in charge of the nation’s health. Women’s health is important. Therefore, we will find the money to look after these people.”
As for the argument that it is somehow a woman’s fault, I have to say that when someone is drunk and gets into a car crash it is their fault, and when someone smokes too many cigarettes and gets lung cancer it is their fault, but the NHS does not shut the door to them because the injury or disease was somehow self-generated. We are a compassionate nation, but compassion was lacking in this case.
In France, the alarm was raised when 48 cases of breast cancer were found in women with PIP implants and two women died. I am sure that the distinguished medical experts among us today will point out that because women have breast cancer, because they die and because they have PIP implants those things are not all interconnected. None the less, there is cause for the concerns that were raised.
I am not sure that the British Government’s final conclusion in these reports is right. I repeat the right hon. Gentleman’s admonition that we should not say that this is the end of the day; the matter must be kept permanently under review. Because a judgment is made at one point in time, that is not the end of it. Let us listen to the women who have formed the PIP committees and taken up the issue, and keep collecting evidence from other countries in case we have to revise the current medical advice.
Some clinics, such as Birkdale, have closed. They have made their fortune, shut their doors and left the matter for someone else to sort out. Other clinics have opened under a different name to avoid liability. Others have made women sign disclaimers before offering them diagnostic tests or treatment. Some breast cancer patients with PIP implants have been on waiting lists for five months or more at NHS hospitals as the waiting lists get longer. Will the Health Committee look at the follow-up from the Government’s initial statements about getting money back from the clinics? I have no evidence that that has actually happened. It is important that Ministers do not announce that something is going to happen, and then not deliver it.
Women themselves should be at the heart of the debate. They have the great trauma of unexpectedly having to remove the implants at very short notice. They face physical, emotional and financial upheavals. Women are not sure who they can turn to. They need to trust the Government, but when the Government’s official line is that there is no evidence of harm, they just do not believe them. I wonder whether officials and Ministers have understood just how concerned women are.
GPs see their patients, but very few of them are experts on the impact that some of these devices can have on health. There is no official recognition of the symptoms that arise when a woman finds these things leaking into her body. She feels uncomfortable in her body. Some of the most distressing aspects of my short personal involvement were the e-mails and telephone calls from women saying, “What is happening inside my body? Nobody will tell me.” I certainly was in no position to tell them.
The Secretary of State made statements in December and January, but I am not sure that the clinics are abiding by their “legal and moral duty” to remove and replace the defective devices they have fitted into women’s bodies. Furthermore, the Medicines and Healthcare products Regulatory Agency is reluctant to release all the precise details of the toxicology testing that has been performed. It is important that there is full transparency.
In conclusion, there is a case for a public inquiry. I really do not want to get into a debate on parliamentary and judge-led inquiries; that is not for this afternoon. I am possibly going a bit beyond the good first work of the Select Committee. We need an investigation of the commonly reported symptoms through patient reports and assessment of medical records, which underlines the right hon. Gentleman’s point that we do not adequately record such operations. The MHRA should release details of the toxicology testing on implants.
Will the Minister tell us what governmental or legal power the Department of Health has to oblige clinics who have fitted PIP implants to offer free removal and replacement or face losing their licence to practise? We need the Department to give us full statistics on exact rupture rates, and all breast clinics should be sent details about PIP breast implants. We need much clearer directives to the NHS and the private sector. Of course the MHRA should be obliged to have a register of every medical device fitted into a human body, detailing the serial numbers and the manufacturers, and we need public disclosure of the 68 chemical compounds found in PIP implants so far.
There are other technical points that the campaigners want answered, but I do not want to take up other colleagues’ speaking time. Women feel alone. It is a small number, but who do they turn to for help? Why did it take two years for an unannounced inspection of the PIP factory? Why has the MHRA not fully published all the details of the 68 chemical compounds said to be found in PIP implants?
Such requests for information are reasonable. As I said, this is not a party political issue; it could easily have happened under the previous Government. As the shadow Minister, my hon. Friend the Member for Hackney North and Stoke Newington (Ms Abbott), said, in 1994 my right hon. Friend the Member for Cynon Valley (Ann Clwyd) proposed more regulation of breast implants. Her Bill was rejected by the previous Government, and not much was done; if anything, the deregulation mania continued. We should learn lessons from that and try to find ways of sending messages of increased solidarity to the women, many of whom are still very worried about what was done to their bodies when they went in for these PIP implants.
Dr Sarah Wollaston (Totnes) (Con)
It is a pleasure to serve under your chairmanship, Mr Rosindell. I thank the Chairman of the Health Committee for this excellent report.
Let me touch on just four areas: putting patients first; the ethics of the industry; how we reduce the burden for the future because this is not the first time that we have had scares about breast implants; and the need for a register of all implants and an update on how that might progress.
Of course it is a tremendous relief that the expert group concluded in its final report that there is no evidence that PIP implants represent a materially greater risk to health than other types of silicone implant. However, the point is that PIP implants rupture much more frequently—six times more often—and when they do they cause severe local reactions in many cases. For that reason, many women will opt to have them removed. If their private clinic has gone out of business and the procedure is offered under the NHS, there is an issue about whether the NHS should then allow them to pay separately to have a private implant fitted.
The reality is that having an implant removed does not just result in a minor cosmetic difference to a woman’s appearance. There is a very significant difference in the appearance of the breast once an implant has been removed. For women who cannot afford a separate operation, there will be a devastating impact on their body image and the way that they feel about themselves.
Of course, we already have a precedent for top-ups and I take issue with the point in the report that top-ups cannot occur. Although I completely agree that as far as possible, we should separate private and NHS treatment, we recognise that in dentistry, for example, a patient can already pay to have a different type of filling and have a top-up in that way. The precedent is already there.
At the core of the issue must be putting the patient first. It cannot be ethically right to force women to go through a separate surgical procedure, with all the risks that go with having a second general anaesthetic; these are not simple procedures carried out under local anaesthetic. I hope that the Minister will reassure us that the NHS will uphold the overriding principle, which is that we put the needs of those women first, over and above the other principle, which we all accept is important; nevertheless, it must take second place in this instance.
Secondly, there is the question of who should fund this type of treatment in the future. As I have already said, this is not the first time that we have had implant scandals. Would it be reasonable to expect those who have cosmetic procedures to take out some form of insurance, because of the risk of clinics going out of business and to cover the long-term liability? Can the Minister say whether that is being considered for the long term, so that we do not find ourselves in this position again 10 years down the line, perhaps with other types of implants? There is sometimes a great temptation for clinics to declare themselves bankrupt, only for the same surgeons to set up down the road and for the NHS to pick up significant costs in the future.
Thirdly, let me turn to the ethics of the industry. I wrote an article for The Guardian on 2 January. I actually wrote:
“Perhaps women damaged by complications from oversized breast implants should take their cases to the General Medical Council and ask them to consider how those surgeons mutilating them…could in any way have put their safety first.”
What happened was that The Guardian, as a result of advice from its legal department, removed the word “oversized” without my permission. There is a distinction to be made. For example, a teenage girl may wish to go into the glamour industry; she goes to see a surgeon and has the size of implant that cannot put her safety first in the long term. There are ethical considerations, and we should not allow surgeons off the hook, because they are complicit in promoting what cannot be other than a damaging stereotype for women. They should reconsider the ethics because, as we have heard, these implants are not long-term implants. They have a shelf life and women will inevitably need to have them replaced on numerous occasions if they have them fitted as teenagers, or else they will need significant reconstructive surgery at a later date if they choose not to continue with the same size of implant.
The British Association of Plastic, Reconstructive and Aesthetic Surgeons and the British Association of Aesthetic Plastic Surgeons both claim that they always put patient safety first, but I do not feel that that is the case when we see repeated examples of the type of practice that we have heard about on our forum; I will not repeat the quotes that we have already heard from my right hon. Friend the Member for Charnwood (Mr Dorrell). In practice, there is a consistent failure to tell women about the long-term implications of having breast implants, and I want to see the General Medical Council investigate the entire ethical basis of the industry and issue some very firm guidance.
I close by raising the issue of a register. I hope that the Minister can update us on plans for the future, so that we do not again see women left at home—sometimes for weeks—suffering from extreme stress because they do not know whether the implant that they have had fitted is one of the implants that we are concerned about. A register would allow proper long-term monitoring of side-effects.
David Tredinnick (Bosworth) (Con)
Thank you, Mr Rosindell, for giving me the opportunity to speak in this debate.
It is a pleasure to follow my hon. Friend the Member for Totnes (Dr Wollaston) and my right hon. Friend the Member for Charnwood (Mr Dorrell), who is not only the Chair of the Health Committee but who was, of course, Secretary of State for Health in the Major Government. I think I can say modestly that I have been in Parliament long enough to remember him as an Under-Secretary in the Department of Health—at that time, of course, he was the MP for Loughborough—although I have not been in Parliament as long as he has.
I do not wish to repeat the remarks that were made earlier by my right hon. Friend and my hon. Friend, other than to say that we are basically dealing with a French company—Poly Implant Prothèse, or PIP— that produced a defective product. It then used false documentation—my recollection is that it did so by registering in Germany; I think that came up in the Health Committee. The company was also using non-compliant silicone. My right hon. Friend also said that there was a period—between March 2010 and July 2011—when there was a lack of action. The Health Committee was certainly concerned about why my hon. Friend the Minister and our right hon. Friend the Secretary of State for Health did not look at the issue earlier.
My right hon. Friend the Member for Charnwood has already given us the background, so I do not want to go into it further, but there are two types of issue to consider: first, the PIP implants, which are the defective products; and secondly, the wider issues.
Both my right hon. Friend the Member for Charnwood and my hon. Friend the Member for Totnes have mentioned the lack of a register, which is a fundamental problem. Without a register, we do not know the size of the problem. I have no doubt that my hon. Friend the Minister will refer to that issue in her response.
The second issue that really exercised me when the Select Committee was considering this topic was what I noted down as “the double jeopardy rule”—it is not quite a double jeopardy rule, but a woman will potentially need two operations if they have this problem. The NHS is looking to offer more patient choice and greater flexibility, and dealing with this issue is a good opportunity to provide greater flexibility. It makes absolutely no sense to have a surgeon remove an implant and then to have another surgeon at another time replace it with something else. First, I think it is clinically unwise; I do not know if my hon. Friend the Member for Totnes wants to comment on that. Secondly, it is certainly bad value. Thirdly, it means that the patient will have a much higher level of stress. I would have thought that statistically the probability of complications must be greater if a patient has two operations rather than one.
The third issue that I want to raise is advertising. The advertising for these products appears to be misleading, to say the least. We have heard that there is a failure to mention the inevitable requirement for removal of the implants. It is not only the surgeons or the promoters of the operation who should make patients aware of that requirement, but the advertising, which should carry a warning at the bottom.
The next point about advertising of these products is that I think a lot of it is targeted at less well-off people—a market in which people might not necessarily apply their minds as extensively as people in some other socio-economic groups might do to the consequences of these implants. A culture, or belief, has grown up around implants that they will enhance careers and make a person more attractive, which may not necessarily be the case.
Taking things a stage further, when teenagers are encouraged to have implants there is an absolute duty of care on those who promote them to explain to those concerned that although they may not be very full in the front at that age, if they have children they will naturally expand and have no need for implants. Furthermore, if they reach that point of having children, they may not want the implants that they received earlier. We need to think particularly about the market involving younger people.
My right hon. Friend the Member for Charnwood and the Committee agreed to the web forum on patient experiences, which was a very good exercise. Select Committees should consider using such an approach regularly in the future. We had responses from 194 women, and there were 279 posts. That widened the base of the pyramid of knowledge that the Committee had to reflect on, provided a greater degree of certainty about where things are going, and gave us understanding.
My hon. Friend the Member for Totnes touched on the long-term consequences of ruptures and the fact that that issue has not been fully recognised in the responses so far. Last week we had a presentation in private by distinguished academics from the university of Leeds. One point that came up was that if the silicone leaks, it can find its way into glands and lymph nodes. I cannot believe that that is a desirable impact for any patient. It defies logic to suggest that if there is a foreign body in a part of someone’s body there will be no complications or implications; and if there are none now, where will we be 30 or 40 years down the road? As a Member who has represented a constituency with a declining coal mining industry, I deal even now—30, 40 or 50 years down the road—with cases of emphysema and other mining-related diseases. What will happen after that length of time with the issue we are discussing now? We simply do not know. We cannot tell.
Dr Hardy and Professor Holliday at Leeds made two recommendations, which I am not going to claim as my own, and which merit serious consideration. The first is that all advertising should carry the risk rate. I am thinking both of advertisements and the agents’ recommendations to the client. There should be an absolute requirement to explain complications, and the fact that implants will have to be replaced at some time. The failure to tell patients that implants must, whether faulty or not, be replaced at some point, came through on many occasions in evidence.
The second point was also an excellent one: the contract that the patient forms should be not with the agency, which could fold, but with the surgeon, who is covered by a form of insurance, and tightly regulated. Any issue in the future would be with the surgeon himself. That would give us a much greater degree of accountability and make the regulation much more simple.
Dr Daniel Poulter (Central Suffolk and North Ipswich) (Con)
It is a pleasure to follow my hon. Friend the Member for Bosworth (David Tredinnick), and, indeed, all the hon. Members who have spoken. I pay tribute to my right hon. Friend the Member for Charnwood (Mr Dorrell), who has worked very hard on putting together a good Select Committee report, championed the cause diligently over the past few months in Parliament, and helped to bring about this debate.
One thing that came across from the remarks of all right hon. and hon. Members, but which was highlighted particularly by the right hon. Member for Rotherham (Mr MacShane), is the concern, which unites the House, for the women who have been exploited and, in many cases, treated badly by some private sector cosmetic providers.
The expert group appointed by the Department of Health published its report on 6 January and concluded that there was no causal link between PIP implants and cancer, and on 1 February the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks published its report on the matter, which reached similar conclusions. Although there may not be a risk of cancer, we know that PIP implants are not of good quality, and their rate of rupture is six times greater than that of other implants. It is because of that inferiority, and the concern and worry that it has caused many women, and because of wider issues about the cosmetic surgery industry, that we are having this debate; and those are the issues that I want to talk about.
To me, the primary issue is duty of care. NHS providers, whether traditional ones or private providers commissioned by the NHS, have a duty-of-care relationship with their patients, whether women or men. Clearly, in the cases that we are considering, the cosmetic industry has not shown that duty of care because of the contractual relationships that women were in.
My right hon. Friend the Member for Charnwood highlighted the problem of the Medicines and Healthcare products Regulatory Agency failing to keep a sufficiently vigilant eye on PIP or other implants, and I do not want to dwell on that. However, the cosmetic industry’s wider role, and the governance and culture of not only plastic surgery and cosmetic clinics, but the surgeons and others in the industry, are key to how we improve—how we take matters forward and make things better for women in the future.
On the duty of care, all the women whom we are talking about are patients. If an invasive procedure is performed on someone’s body, they must be considered a patient—someone to whom a duty of care is owed. It does not matter if the procedure is done by the NHS or a private provider outside the NHS, as in the cases we are considering. That duty of care should exist. Yet with the cosmetic industry, because there is a contractual relationship, it is clear that that duty of care does not exist and that many of the women have been exploited, potentially, and misinformed by the cosmetic industry. The relationship has not protected women or acted in their best interest.
Mr Dorrell
I hope that my hon. Friend would agree that the mere existence of a contract between the provider and the patient does not in any way undermine the duty of care that the one owes the other. As I said, a surgeon who provided the service without giving proper advice to the patient would be in violation of their professional duty of care to the patient, and the provider would not be providing the service required by the contract, either.
Dr Poulter
I fully agree. Unfortunately, although a contractual duty should inherently also be a duty of care, in this case there has been poor medical practice and poor medical accountability on the part of some surgeons in a number of clinics—a point highlighted by my right hon. Friend, and by the right hon. Member for Rotherham. Some providers have not behaved with the kind of responsibility and care for their patients that we would expect of anyone offering a service, particularly one involving invasive bodily procedures.
My right hon. Friend the Member for Charnwood was right to highlight the doctrine of top-up charges, because women have, in some cases, been forced to have two operations in order to have their implants replaced with better ones. That is not only unacceptable medically, but also on the basis of the duty of care. Given that many cosmetic surgery clinics that work under a contractual arrangement cannot claim back money under their insurance when the data do not necessarily show a risk from PIP implants, they are not in a position to offer the replacement procedures without going bankrupt. Although they have a moral duty to offer those procedures, they are not always in a financial position to do so, and that goes to the heart of the matter.
When people take up private procedures outside the NHS, and a contractual duty is in place, there needs perhaps to be a levy on the private providers to ensure that when things go wrong, other providers—either in the private sector or the NHS—can ensure that things are put right. I would be grateful if the Minister could reply on that suggestion of a course of action that the Government could look into. We want our primary concern to be the care of the women affected, and there are providers that, as my right hon. Friend the Member for Charnwood says, consider themselves to have a duty of care, but are, because of the financial consequences, perhaps unable to put things right. We might, therefore, need a levy or some kind of insurance to safeguard against such a situation occurring again.
I want to touch on the governance of the plastic surgery industry. The professional responsibility of plastic surgeons and everyone involved in the industry should be no different from that in other parts of medicine, but we have seen some very bad practice by some cosmetic surgeons. Earl Howe’s report states that under General Medical Council guidance and rules for good governance, there is a duty on doctors and other medical professionals to have good auditing and record keeping, but far too often, data on the care of the women affected have not been properly kept. Good medical records do not exist, and there has been a neglect of duty by some medical professionals. As my hon. Friend the Member for Totnes (Dr Wollaston) pointed out, that is something for the GMC to look into, and I am sure that the Royal College of Surgeons will look into that in further reviews.
We need to ensure that regardless of whether a procedure is carried out in the NHS or the private sector outside the NHS, good medical practice as regards audit and record keeping is always maintained. When things go wrong with the cosmetic industry and private operators outside the NHS, it is always the NHS that picks up the pieces, and NHS doctors therefore need to be put in the best position from which to look after the patients.
Finally, the exploitation of women in many of these situations has been talked about widely. The Committee has heard of many cases of women having gone in good faith to cosmetic providers and having received at best inducement, and at worst poor information, at the moment of consenting to an operation. The basis of all medical treatment is informed consent. A patient should understand the consequences of any operation, be fully availed of the facts, and together with a medical professional, make an informed decision about the right way forward and about how they should be treated. Far too often, the evidence has shown that women do not give informed consent and are not fully availed of the facts. That is bad medical practice and, as my right hon. Friend the Member for Charnwood pointed out, it is an issue for the cosmetic industry. The Royal College of Surgeons and the General Medical Council should investigate surgeons who have not done things in accordance with good medical practice, as set out by the GMC.
We need to consider the wider consequences, and to move the cosmetic industry from a purely contractual arrangement towards one involving a duty of care. We need to consider ways of properly looking after women when things go wrong and, given the doctrine of top-up charges, we must ensure that money is available to look after women. Perhaps there is a role for a levy on private operations. We must also ensure much greater accountability of medical professionals and better record taking, so that we can have proper patient care, which is what we all want. I am pleased to have taken part in the debate, and I look forward to the responses of the Minister and the shadow Minister.
Ms Diane Abbott (Hackney North and Stoke Newington) (Lab)
I congratulate the Health Committee on a thorough piece of work. There has been some debate in recent days about the effectiveness of Select Committees in interrogating the facts, but the report shows how effective they can be. I also congratulate the Backbench Business Committee. I have noticed that in this Parliament we have been a lot better at addressing, in a timely fashion, issues that are of concern to our constituents, and we must thank the Committee for that.
For the more than 40,000 women concerned, this has been a period of fear, anxiety, uncertainty and distress. I have observed a tendency to address health matters in a dry, managerial manner, but there are thousands of frightened women out there who feel isolated and do not know what to believe. The Opposition accept the advice that the Government have been giving on the basis of the evidence that they have, but we are disappointed that they are not providing more help to the women affected. In addition to the general confusion, unnecessary anxiety was caused to thousands of women over Christmas and the new year. It is simply not enough for the Government to say that private providers have a moral duty to their patients; there must be, as has been said, practical action on that duty of care.
Christmas was a troubling time. On 23 December, the Secretary of State said:
“we have no evidence of a link to cancer. We have no evidence of toxicity, we have no evidence of substantial difference in terms of ruptures of these implants compared to others”—
a statement that was proved wrong—
“So we don’t have a safety concern that would be the basis for the routine removal of these implants.”
By 31 December, he had announced that the NHS medical director, Professor Bruce Keogh, would carry out an urgent review of the situation.
The problem is that months later, the websites of some of the private providers still had the Health Secretary’s original, somewhat consoling, statement. The shift of emphasis during that period caused uncertainty and allowed private clinics to rest on the earlier statement, rather than acknowledge the fact that an urgent review had been called for. We found that many women were unable to access their records, and that some had to pay up to £50 to access them. In the case of what was intrusive surgery, it is unacceptable that women could not access their records as a matter of routine. The uncertainty was unnecessary and women are still unhappy about it.
Women who have PIP implants are still concerned about the Government response. As the Minister will be aware, many of them are calling for a public inquiry, and I must do them the justice of putting that demand to her. Among their concerns is that the Government have received advice that there is no problem with the implants and that they are not a threat to health. Among the things that women want is an investigation of common reported symptoms in patient reports, and an assessment of medical records, which has already been referred to. They want the Medicines and Healthcare products Regulatory Agency to release details of the toxicology testing done on the implants. Everyone present will be aware that they also want clinics that have fitted PIP implants either to offer free removal and replacement, or to face sanctions, such as losing their licence.
The women’s biggest concern, however, remains the health aspect, after the trauma of unexpectedly having to remove the implants. Let us bear in mind that this is not like chiropody; this is invasive surgery. Women’s breasts and reproductive organs are a particularly sensitive matter of concern for them. Ministers have spoken about the issue as if women who purchase cosmetic surgery were purchasing cans of beans off the shelf and should, therefore, observe the rule of caveat emptor—let the buyer beware. The fact is that any sort of invasive surgery is not like purchasing beans off a shelf. The issue of duty of care by individual practitioners and by clinics—and even by Government Ministers when they talk about the issue—should be at the forefront of our debate.
These women have faced this trauma, and many of them still feel that they have nowhere to turn with the symptoms that they continue to experience, even after the implants have been removed. The official Government line remains that there is no evidence of harm, but women are anxious that that should not be a once-and-for-all conclusion on the physical and medical consequences of the implants, and that the ongoing research and information should be kept under review. In such situations, we all know that it can take many years to find out what the real health issues are.
The women are calling for the publication of exact rupture rates, and for the cosmetic clinics to have sufficient information about PIP breast implants. Above all, they are calling—this has been echoed by both Government and Opposition Members—for a register of medical implants, an issue that was first raised by Labour MPs in the 1990s. Members of all parties have raised the issue, and the time to address it came long ago. We cannot possibly help to rectify problems if we do not even know who all the women, men and children who had the implants are. That is a basic requirement, and I hope that the Minister will say that the Government intend to move speedily towards addressing that.
Apparently, 68 chemical compounds have been found in implants so far. The women are concerned about the evidence showing that the substance has the capacity to migrate across organs. They are concerned that, if it can migrate across membranes, there could even be implications for chemicals crossing to the placenta. It is not good enough for Ministers to say, in the summer of 2012, that there is no evidence of harm while not keeping what is happening under review.
Women want to know why the UK is one of the only countries not recommending routine removal. They want to know, as my right hon. Friend the Member for Rotherham (Mr MacShane) has said, why it took 25 months for an unannounced inspection of a PIP factory. Why did the MHRA not test the products for sale in the UK? The women want to know about the 68 chemical compounds. They have noted the Health Committee’s view that Sir Kent Woods’s statement that there was “no evidence of harm” was misleading, and they want to know why Ministers have not retracted it.
On the role of private clinics, we know that some of the leading cosmetic surgery clinics are ignoring the Government’s appeal. We know that one such clinic, Transform, which used PIP implants on more than 4,000 patients, has said that women will have to pay £2,800 for their removal. We know that the chairman of the Harley Medical Group, which has 13,900 patients with PIP implants, has said that he will pay for the cost of the new implants, but only if the NHS pays the bigger bill for surgery. This is not a satisfactory state of affairs. It reduces the purchase of invasive surgery—even if it is invasive cosmetic surgery—to the status of a mere purchase of some grocery product from a supermarket. The women think that the Government have not been empathetic to their situation or fulfilled their duty of care, let alone ensured that the private clinics fulfil theirs.
There is a strong feeling among our constituents that the clients of those private clinics have been let down. If I may say so, that shows the importance of regulation in relation to large-scale private sector involvement in health care. It should not be the case that women get a better duty of care from health service providers than from private sector providers, but that is their experience, whether it applies to getting their records or to being charged for the removal of the implants.
In view of the reluctance of some private health-care providers to foot the bill to replace the implants, what action will the Secretary of State take to help women who are unable or cannot afford to access their records? Has the Secretary of State considered regulation, or some kind of levy, so that private companies, now and in the future, can cover the cost of removing defective devices? Will the Government’s recommendations be kept under review?
The issue has caused a great deal of personal concern, fear and anxiety to tens of thousands of women. The uncertainty in the run-up to Christmas was unnecessary and we are anxious that the Government do not just take a once-and-for-all view of the health consequences of the implants. We are also concerned that broader issues exist in relation to the regulation of not just cosmetic surgery, but cosmetic procedures such as botox. Ministers need to consider those issues.
We live in an extraordinarily body-conscious era. Recent figures show that unprecedented numbers of girls under 16 are having breast reduction surgery, and that unprecedented numbers of teenage girls are having breast enlargement surgery. That is not because there is suddenly a whole new range of associated medical problems, but because of the pressure on women of all ages with regard to their body and their appearance, and, frankly, because of the exploitative and predatory activities of some people in the cosmetic surgery industry. I hope to return to those broader issues on the Floor of the House.
In closing, I say to the Minister that there are tens of thousands of women, some of whom are in the Public Gallery today, who do not feel that they had the clear advice they should have had in the run-up to Christmas; who do not feel that they have had the support they should have had; and who do not feel that the Government are taking their position sufficiently seriously. I hope that she will have answers to some of the questions asked by my hon. Friend and me this afternoon.
The Parliamentary Under-Secretary of State for Health (Anne Milton)
Sadly, as I only have about five minutes left, I will not be able to answer all the issues that the shadow Minister, the hon. Member for Hackney North and Stoke Newington (Ms Abbott), raised.
David Tredinnick
On a point of order, Mr Rosindell. My understanding is that the debate can continue at the discretion of the Chair.
Andrew Rosindell (in the Chair)
Yes, indeed that is so. I intend to let the debate run on a bit longer to allow the Minister to respond and Mr Dorrell to have his two minutes towards the end.
Anne Milton
Thank you very much, Mr Rosindell. I am also grateful to my hon. Friend the Member for Bosworth (David Tredinnick). I was not aware that we were allowed to run on.
I am grateful to the Liaison Committee for choosing the topic for debate and to my right hon. Friend the Member for Charnwood (Mr Dorrell) for the thoughtful way in which he introduced it. I concur with the statement made by the shadow Minister about the usefulness of the Backbench Business Committee. It has allowed us all to raise issues of interest to our constituents in a much more timely fashion.
I welcome the opportunity to set out the Government’s position. My right hon. Friend described much more eloquently than I could the events that led up to what has happened. The stress that the women concerned have gone through has been immense. I am disappointed that the shadow Minister was slightly party political in her response. The right hon. Member for Rotherham (Mr MacShane) said that the issue is not very party political. I gather from the debate that the matter has been on the stocks since 1994. It is time for us to shine a light—possibly this issue has done so—on cosmetic surgery and, indeed, on interventions. We need to make sure that we get our house in order.
The women concerned believed that they had received breast implants containing silicone that was safe and of medical quality. They certainly did not expect to discover that they had been, in some cases, cruelly and cynically deceived and that their interests had been ignored through the fraudulent activity of the manufacturer. Over the past few months, I have met a number of women with PIP implants. They all feel, as do I, that the right lessons should come from what has happened. In fact, although the women concerned certainly do not want to be in the position they are in, they are keen to know that the Government will learn some lessons.
We should start with the science. I assure the shadow Minister that, of course, as with anything, research and review of practice is ongoing. One does not just carry out a review of research and end it there, because research continues. It is extremely important, and not only in this country, that we continue to learn lessons from ongoing research on a number of issues and that we remain open-minded.
Within weeks of the discovery of the fraud, the MHRA commissioned tests to find whether the material in PIP implants was dangerous. Because of legal difficulties over similar tests in France, the MHRA was the first agency in a position to publish the results of that testing, in September 2010. For obvious reasons, the tests were based on a limited number of samples, but the conclusions at that time were relatively reassuring. More tests were then carried out in France and Australia during 2010 and 2011. The results were broadly similar to ours, apart from some inconsistencies over a test for skin irritation.
Towards the end of 2011, the French regulator began to notice that more people were reporting that their PIP implants had ruptured. There was a report of a rare form of cancer in one woman with a PIP implant. The French cancer institute looked at the data and decided that there was no excess cancer risk associated with PIP implants. Nevertheless, as a precaution, the French Government decided to advise all women with PIP implants to have them removed. A number of European countries followed suit.
We, in the UK, decided that an expert group chaired by the NHS medical director should look at the evidence and advise on appropriate policy for the NHS in England. The expert group delivered an interim report within a matter of days; it advised that the evidence at that time did not justify removing all PIP implants as a matter of course. Instead, the group advised that women should speak to their specialist and come to a decision individually. However, it also noted that the evidence base was not perfect, and said that it would collect more information and advise further in due course. I understand that the Health Committee supported that decision.
I am sorry if the shadow Minister feels that anybody from the Government has not appeared sympathetic. It is certainly not a view I have heard expressed. It would be hard not to sound sympathetic when people have been the victims of what, as I said at the beginning, were the cruel and cynical actions of a fraudulent company. I have met a number of the women concerned since then. I hope not only that lessons will be learned, but that any Government procedures will ensure that responses are more timely.
Mr Dorrell
On the evidence of toxicological damage, one of the things that the women most directly affected are seeking is more precise detail about the evidence that has been used by the MHRA to reach its conclusions. Will the Minister clarify whether that is to be published or whether there is a constraint that prevents its publication?
Anne Milton
My only hesitation is that there might be constraints that I know nothing about. However, I can see no reason why not if the evidence has been assessed. The evidence will, almost by definition, be in the public domain because it will be in papers that have been peer-reviewed and probably published. There should therefore be no reason why it should not be available to all women.
My right hon. Friend raises an important point: it is not just about what one does, but about what one is seen to do. Any restriction on access to information raises suspicions in people’s minds. All those women have already had a bad experience—they had their surgery and were reassured by surgeons and staff at the organisations they went to—and already feel that they have been deceived. Therefore, it is more important than ever to make sure that they have access to the information that we have access to.
As I said, Sir Bruce’s group has published its final report, which was informed by detailed tests on the silicone used in PIP implants and by large-scale data on the rupture rate of the implants. It draws on what doctors found when they removed some implants. It was painstaking work, and three main conclusions stand out. It is important to reiterate that research—data—should always be under constant review.
First, the evidence supports the fact that impurities in silicone gel do not pose a threat to health. That fits with the conclusions of tests on the gel carried out in the UK and other countries. Secondly, there is clear evidence that the rupture rate for PIP implants is significantly greater than for other silicone gel implants on the UK market. Thirdly, although some ruptures are associated with local clinical reactions, in the great majority of cases, that was already apparent before removal of the implant. So-called silent ruptures detected by scanning, but with no outward signs or symptoms of a possible rupture, are not in general associated with significant clinical reactions when the implants are taken out. The group therefore concluded that PIP implants are clearly substandard—there is no doubt about that—but that if the implants are still whole inside the body, there is no evidence of an increased risk of clinical problems.
I stress that that is not what the Government say; it is what an expert group says. I am happy to send anybody who wants it the list of who made up that expert group. It is important and it is about confidence in what we are doing. Ministers are not scientists. It is important that we rely on and get the best possible scientific advice, and that we remain vigilant in scrutinising that advice.
[Mr Joe Benton in the Chair]
David Tredinnick
My hon. Friend might be about to move on to this, but did the expert group consider the points made about two operations for people having problems with implants? She will probably deal with that in a moment, but she will forgive me for nudging her.
Anne Milton
I need no nudging, but I take my hon. Friend’s intervention in the friendly manner in which it was intended. I will move on to that.
The group reiterated the earlier advice that women with evidence of ruptured implants should be offered removal, and women with no sign of rupture should talk to their specialists, discuss the pros and cons of removal and decide with their doctor the best way forward.
In January 2012, in line with the interim advice, we published the NHS offer: women who originally received implants from the NHS are entitled to a consultation and a scan if appropriate. Then if the woman and her doctor so decide, the NHS will offer to remove and replace the implants. From the start, we made it clear that we expected private providers to match that offer. Many have done so. In fairness and for balance, I point out that some have been very responsible. I hesitate to mention some, as the list will not be conclusive, but BMI Healthcare, Linea Cosmetic Surgery, Nuffield Health, Ramsay Health Care, Spire Healthcare, The Hospital Group and Transform have been responsible and stepped up to the plate. It would be a shame if this debate cast negative views on all those involved in the plastic surgery industry, but I will come to some of the other points raised before I finish.
Where a private provider has gone out of business or fails to meet its moral and legal obligations, the NHS will provide a consultation, a scan if appropriate and removal, but not normally replacement, of the implants. That policy remains in place today. My hon. Friend the Member for Bosworth (David Tredinnick) wanted me to go on to the question whether the policy should be varied. As has been reiterated today, the Select Committee on Health suggested that women should be able to pay a fee for new implants to be put in place by the NHS during the same operation in which the old ones are taken out. I completely understand why, and I have discussed the issue at length.
There are several points. Allowing a mixture of NHS and privately funded care within a single operation risks undermining a founding principle of the NHS that care is free. I take the point made by my hon. Friend the Member for Totnes (Dr Wollaston) about co-payments in the NHS for dentistry, glasses and so on—I could go on. I believe that Bevan resigned within two or three years of the formation of the NHS, on that very point. The issue of co-payments goes back a long time. However, I feel that this situation, although complicated, is different. If the NHS were to carry out replacement breast augmentation, it would become responsible for all the aftercare, including possible future replacements. As my hon. Friend the Member for Totnes and my right hon. Friend the Member for Charnwood mentioned, the rupture rate is significant anyway. Breast implants do not last a lifetime; it is unlikely that they will.
Dr Wollaston
Does the Minister accept that if someone has a gold filling, for example, for which they paid a top-up on the NHS, if that gold filling fails, the NHS will still treat them, rather than expecting them to take responsibility for having the gold filling replaced in the private sector? There is a precedent. Again, I make the point that we must put women first in this situation and not subject them to two operations.
Anne Milton
The NHS is free at the point of delivery on the basis of clinical need. The point is that the NHS might not put in a gold filling. I would hate to stray from the issue of co-payments. When I was on the Health Committee, we considered co-payments, and there are numerous areas of inconsistency. My hon. Friend’s point is well made, but—
Mr Dorrell
I am sorry, but I am going to have a go at my hon. Friend the Minister, and not on the subject of gold fillings. Her point is that if a provider removes the faulty implant on the NHS and then goes on to provide a paid-for replacement of the implant, the NHS somehow becomes responsible for the ongoing maintenance of the replacement implant. However, that assumes that we consider the provider hospital as the NHS for that purpose. We all know that NHS hospitals provide private care. The NHS does not accept responsibility for that private care. If the patient pays in an NHS hospital for care, it is private care, and the NHS is not responsible for paying for follow-on care. If a patient who happens to be in a private NHS hospital pays for a new implant and that half of the procedure is private, I genuinely do not understand why the NHS would suddenly become responsible for it on an ongoing basis.
Anne Milton
That may be a subject for a Backbench Business Committee debate on co-payments and what the NHS is and is not responsible for. The difficulty is—
Ms Abbott
Because the Minister mentioned Nye Bevan, I feel obliged to intervene to say that there is no more vigilant defender of an NHS true to Nye Bevan’s principles than me. However, when women will be faced with two separate invasive operations, we ought to make an exception to the rule.
Anne Milton
I thank the shadow Minister for her intervention. I accept the strength of feeling on the issue in this debate. The clinching argument is that if the NHS were to offer what is in effect subsidised breast augmentation for non-clinical purposes—I stress the use of the word “clinical”; it is not that cosmetic surgery is unavailable on the NHS, but that it is available if there is a clinical need for it—
Mr MacShane
He is very generous. Can I inform the Minister and the House that today is the 64th birthday of the NHS? Why not give a birthday present to those lovely ladies and say that the NHS will look after them before its 65th birthday? Come on, Minister, take a decision. They will not kill you on the box. We will talk to the Secretary of State for Health and sort it out.
Mr Joe Benton (in the Chair)
Order. Before the Minister replies to that intervention, I point out that there is another debate to follow this one. Try to keep interventions to a minimum. The debate has gone well past 4 o’clock.
Anne Milton
We have tried Mr Benton’s patience. I thank the right hon. Member for Rotherham for his suggestion. I am sure that the Secretary of State will listen closely to what I say next. Changing Government policy on the hoof during a debate—
Anne Milton
It might indeed. It might also be a career-limiting move.
The surgery must be based on clinical need. I cannot see any way out of the dilemma. It is difficult, and as I said, the strength of feeling in this debate will have been noted.
Moving on, I know that the Health Committee has criticised the MHRA for not finding a way to communicate to women with PIP implants, preferring instead to use its central alerting system, the national media and specialist associations as its main channels of communication. We should recognise that that approach clearly did not work well, although it was possibly understandable at the time. Since then, active social networking sites have developed. It is right that both the Department of Health and the MHRA need to find better ways of communicating.
I finish by talking about some of the wider issues that have been raised, specifically Sir Bruce Keogh’s ongoing review. It is a wide-ranging review of all aspects of the regulation of cosmetic interventions: the devices and substances used, the practitioners involved and the way the organisations work. It will pay particular attention to the marketing and promotion of cosmetic interventions, and the need for fully informed consent. The review is expected to report by March 2013.
My hon. Friend the Member for Central Suffolk and North Ipswich (Dr Poulter) raised the issue of informed consent. Nothing could be closer to my heart. I have heard some dreadful stories from women who went in for breast augmentation and, literally two or three minutes before they were about to go under anaesthetic, somebody rushed in with a form saying, “We’ll lift your eyelids or give you a facelift at half the price if you sign here now.” Absolutely outrageous. A lot of women, even if they were informed, did not feel informed, and that is what matters. It is not good enough just to tell people. It is important that the surgeon, and all those undertaking the procedure, are satisfied that the woman, or indeed anybody else having any sort of surgery, is fully informed.
There is information about lists of medical devices. It is worth putting on the record that the EU is currently revising the regulations on them, and looking at medical devices.
On the number of substances that were found in PIP implants, we have to be very careful and stick to science. All sorts of chemicals are found in hip replacements, knee replacements and all the other things that can be implanted for medical reasons. The important point is whether they have any impact on health.
Insurance was mentioned. It will be looked at. Professional standards are two words that are rarely heard. In reviews after bad things happen, we rarely talk about professional standards. It is extremely important that we do talk about them.
Issues were raised about loss of licences and the need to keep records so that we can make timely, prompt contact with people who are affected when things go wrong, as they inevitably will from time to time. It is important that we do everything beforehand to ensure that they do not go wrong, but that if they do we have access to the women. That is why we need Sir Bruce Keogh to look at that work, and clinical licensing systems and compulsory insurance too. I am very grateful to the Committee for its many helpful suggestions, all of which will be taken forward by Sir Bruce’s team.
I end with a note about some of the women who have taken the time to talk to me. It is very hard to understand the distress caused when terrible things happen, particularly when people have previously trusted the organisation, and maybe the surgeon, that they were dealing with. Betrayal of trust is a dreadful thing. It can be awful if they go back and there is nobody to help them. In some instances, women have gone to their GPs, and even their own GPs have cast inappropriate value judgments on them and not been as helpful as they should. For many women, we cannot turn the clock back, but we can make sure that this does not happen again.
Mr Joe Benton (in the Chair)
There are two minutes for a winding-up speech, if the right hon. Member for Charnwood (Mr Dorrell)wants to speak.
Mr Dorrell
I propose to be extremely brief, Mr Benton. We have already trespassed on the time of the following debate.
I am very grateful to my hon. Friend the Minister for the way she responded to the debate. I hope that she will continue to think about the challenge of what my hon. Friend the Member for Bosworth (David Tredinnick) called “double jeopardy”. I hope that she will take forward work on a proper register, because that is the best way of making certain that things are handled better in future.
backbench business