Breast Implants

Paul Flynn Excerpts

Wednesday 11th January 2012 Commons Chamber

[Mr Lansley]

I am grateful to the shadow Health Secretary for his welcome of my statement and the principles behind what we are setting out to do to look after the women affected by these implants.

I do not share the right hon. Gentleman’s view that there were any mixed messages. I am sure he would have been the first to complain if I had not identified the lack of available and consistent data and not asked an expert group to look into this. As we look at countries across the world, we can be confident that we have set an exemplary standard in looking after women through the NHS and in bringing together an expert panel fully to understand what would be the best advice for women. The advice that no identified specific safety concern justified the “routine removal” of these implants was true on 23 December and it remains true today. As we have recognised from the outset and as I said on 23 December, if women are worried or concerned about the possibility of not having the implant they thought they had, that provides a perfectly reasonable basis on which to seek advice and investigation. It would be right for some women to ask for removal, but we should not assume that women are choosing to have these implants removed on the basis of clinical advice—even in France.

The chief medical officer spoke to a clinical counterpart in the Welsh Assembly Government before the publication of the expert group’s work. I have made sure that they are informed, but I have to say that the Welsh Government made an announcement yesterday without previously informing us.

[Paul Flynn (Newport West) (Lab)]

It’s called devolution.

[Mr Lansley]

It may be called devolution. I respect the devolved Administrations and always inform them of what I am doing, where it is relevant to them. We do not recognise the advice that Wales received. Sir Bruce Keogh’s expert group, which included some of the foremost experts in plastic surgery, made clear recommendations last week for patients in England and concluded that there was no significant increased clinical risk in cases where implants are not replaced.

If the shadow Secretary of State commends what the Welsh Government have done—[Interruption.] Perhaps he did not, but if he or anyone were to commend it, they would need to recognise that it runs the risk of letting the private providers off the hook. I am very clear that they should provide an equivalent standard of care. As the right hon. Gentleman made clear, there are limitations on what can be done. I do not have powers and I did not inherit powers to control what the private providers do in the private sector. I have to tell the right hon. Gentleman, however, that I have reflected on the Health and Social Care Bill, which is a positive legislative step forward. Just as it allows Monitor as a health and social care sector regulator, on which we are consulting, to look at the prudential regulation of private providers in social care, so it would allow us to consider the role of Monitor as a health sector regulator in licensing private providers of private health care. It is thus a positive not a negative step forward. There is no comparison, as the right hon. Gentleman will recognise, between the role of the private sector providing private care and the private sector in the NHS, which is subject to the same duties and obligations as an NHS provider. The Bill does not lead to an increase in private sector provision, but in so far as there are private sector providers, they will be properly regulated in the NHS.

On the role of private providers, they may be insured and there may be warranties relating to these implants. We do not have data on this aspect, but I am clear that these providers have legal and, indeed, moral obligations. I particularly commend a letter issued this morning by the leaders of the profession—the two principal professional associations—to their surgical colleagues. Having talked about the standard of care in the NHS, the letter went on to say:

“Those working in the private sector are urged to support in similar fashion. We would hope that implanting surgeons would honour requests for replacement surgery free of surgical charge”.

The private providers that have not made this offer to the women for whom they are responsible can see that their surgical associates are willing to carry this out free of surgical charge, so I see no reason why they should not now step up and deliver the standard of care that women have a right to expect.

--- Later in debate ---

[Mr Lansley]

My hon. Friend will understand that I cannot speak about the precise details of the situation with the Harley Medical Group. All I can say is that the group has told the media that it does not feel it can offer that standard of care completely, but that will have been before the professional associations wrote to their members asking them to support replacement surgery free of surgical charge. I know that the group has told members of the media that it is willing to offer to the Government that if we are responsible for the removal of implants, it will pay for implants to be available for replacement purposes. Frankly, if surgeons are willing to waive the surgical charge and the group is willing to pay for the implants, it is not too much to ask for it to be responsible for removal and replacement, where it is in the woman’s best interests to do that.

[Paul Flynn (Newport West) (Lab)]

Does the Secretary of State not regret failing to react to the call made last May for British patients to have the same protection against failures of all medical devices as that enjoyed in the United States? Is not the real scandal here, again, the chronic under-reporting by the industry and the MHRA of failures of devices and drugs? Is not the answer for this probe to look into the possibility of having a genuinely independent regulatory authority, instead of one that is entirely funded by the industry, because self-regulation is often no regulation?

[Mr Lansley]

The hon. Gentleman says that this body is entirely funded by the industry. It is true that in relation to pharmaceuticals the MHRA is funded by levies on the pharmaceutical industry, but much of the cost of the regulation of medical devices is actually met by the taxpayer. I regard the MHRA as operating in an independent fashion and its expert and scientific advice as independent from Ministers. None the less, as he says, the review that Earl Howe will lead will examine the lessons to be learned, including those about the effectiveness of regulatory surveillance and enforcement in this country, albeit that the regulatory failure occurred, in essence, in Germany, in the first instance, and in France.