Cosmetic Surgery

Anne Milton Excerpts

Thursday 5th July 2012 Westminster Hall

[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?

--- Later in debate ---

[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]

Will the Minister give way?

[Anne Milton]

If we can bear on Mr Benton.

[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—

[Mr MacShane]

—gets you into the Cabinet.

[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.