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Meeting of the Parliament 14 June 2012

14 Jun 2012 · S4 · Meeting of the Parliament

Item of business

PIP Silicone Breast Implants

Milne, Nanette Con North East Scotland Watch on SPTV

I will give the member my reasons for not doing so later.

We must remember that silicone implants carry an inherent risk to an individual’s health. No such implants are completely safe and the use of medical-grade silicone is just one way of reducing the risk and the potential harm to women. As the UK expert group concluded, there is no clear evidence of a materially greater risk to health being presented by PIP implants. Both Governments have accepted that there is no justification for routine replacement of implants on the NHS, and that conclusion is backed up by scientific and medical evidence.

That is not to say that we have heard the last word on the issue—of course not. The matter is still being extensively reviewed by Sir Bruce Keogh. Meanwhile, Earl Howe’s review, which was conducted through the UK Department of Health, made a number of recommendations to ensure that our processes are as strong as they can be. No system of regulation can guarantee absolute safety of medical products, but there are lessons to be learned and we await Sir Bruce’s conclusions, which will add to the body of information that we have on how best to move forward.

I accept Earl Howe’s conclusion that the MHRA’s communication to the German regulatory body that certified the implants for use was entirely reasonable and that the agency’s actions were based on a proper examination of the data available to it—data that have continued to be analysed.

I am aware of and understand the strength of opinion of campaigners in Scotland on the issue, particularly those who have been personally affected and whose health has been placed at risk by the actions of PIP and, potentially, a number of individuals in that organisation. That is why Sir Bruce Keogh’s review will take a rounded view of the situation, including the reported experiences of patients.

I understand that the PIP implant Scotland campaign called its recent discussions with the cabinet secretary productive. I am confident that the cabinet secretary will do all that she can to work with NHS Scotland in bringing forward any modification of its internal practices, which may need to be examined in light of changes brought about by the UK reviews.

In all that, the role of the Scottish Government will be to ensure that there is a robust framework of reporting and of implementing guidance between clinicians and the regulatory bodies. Primarily, however, we must note that if blame is to be attributed, it lies entirely and unequivocally with the manufacturer, which failed to show any regard whatsoever for the victims of its actions. It was an appalling, but thankfully rare, act.

That is fundamentally why we on the Scottish Conservative benches believe that a public inquiry in Scotland is not the correct way forward. Although we should review our practices, the most important investigation to be carried out will properly be a criminal one. To operate effectively, a regulatory regime must at some stage rely on a degree of good faith, and will sometimes need to operate on the assumption that that exists. That is reinforced by the threat of criminal prosecution and the penalties that exist when fraudulent practices are evident.

In the meantime, we can do little better than to repeat the clear advice that has come from the NHS, the MHRA and the Government—people who received PIP implants and who have any clinical questions or problems should contact their implanting surgeon.

The clear statement from the First Minister that NHS Scotland will step in and provide appropriate care if private provision fails—either by refusing care or by no longer being in existence—is of course welcome. However, it should be remembered that healthcare providers—as with all businesses that are involved in the supply of goods—are obliged by law to replace unsatisfactory goods that they have provided.

I will leave it at that just now and deal a little more with the on-going reviews in my closing speech.

10:52

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Meeting of the Parliament 14 June 2012

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