Cosmetic Surgery

Debate between Stephen Dorrell and Diane Abbott

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.