Cosmetic Surgery

Stephen Dorrell Excerpts

Thursday 5th July 2012 Westminster Hall

[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 MacShane]

The Chairman is getting twitchy.

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[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.

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[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.

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[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?

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[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—

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[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