Cosmetic Surgery

Diane Abbott 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.

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[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.

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[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—