Hansard

I welcome the opportunity to debate the PIP breast implant scandal.

I welcome some of the women who have been caught up in the scandal, who are here today campaigning for a public inquiry. The reason for a public inquiry is to ensure that something like this can never happen again. In the words of Trisha Devine, one of the leaders of the campaign:

“We’ve taken the battle to the floor of the Parliament and we look forward to giving our MSPs as much information and support as possible so we can make some real political progress in our quest for answers.

Our main goal is to ensure this awful situation can never happen again, and today’s public discussion gets the ball rolling.

We’ll build on this momentum and won’t stop until we have justice and a healthcare system we can trust in.”

Today’s debate in Parliament is the culmination of a tremendous effort on the campaigners’ part to have their voices heard by Parliament and Government. The debate is not about the rights or wrongs of plastic surgery. It is about how we act to improve care and support for patients, particularly when things go so spectacularly wrong.

These women have had their lives turned upside down by the scandal, but have rallied together to articulate a convincing case for a public inquiry to take place in Scotland. This is a serious public health issue, and the PIP implant victims deserve answers.

Today, Scottish Labour has published a seven-point action plan, which I hope that the Scottish Government will embrace. Covering everything from the need for a Scottish register of implants to the scope for a public inquiry, it forms the basis of ensuring that we avoid a scandal of this nature happening again.

Let me deal first with the need for a public inquiry. As the Scottish Government’s amendment suggests, a number of reviews are under way. All of them are internal reviews, conducted by the United Kingdom Government, and none of them is independent. One of those reviews, conducted by Earl Howe into the actions of the Medicines and Healthcare products Regulatory Agency, has now reported. There is a strong view from the campaigners that that fails to address some of their fundamental questions and concerns. Although the report concludes that the MHRA acted appropriately, it notes that it was trying to reach evidence-based conclusions without the necessary data to do so. It is the case that, for some years before their use was curtailed, a number of clinicians complained in the strongest possible terms to the MHRA about the efficacy of the implants, and that includes Scottish clinicians. I do not believe, therefore, that the Howe report can serve as a substitute for a full public inquiry; I think that it will helpfully inform any public inquiry that might be taken forward.

I look forward to the review that is being undertaken by Sir Bruce Keogh about the need for an implant register and whether better regulation of the cosmetic industry is required. However, given the scope of his review, there will still be questions to be answered at the conclusion of the process.

It is undoubtedly the case that the regulation of medical products is reserved to the UK Parliament, and I hope that it will consider much more robust action so that we can have better confidence in the efficacy of medical products and the means by which they are regulated and tested. Like most members, I am conscious that we have stringent levels of testing for drugs—it is right that we do—but the standard of testing for medical products appears to be substantially lower. That has to change.

However, in itself, that is not the whole story. There are questions that fall to the Scottish Parliament. I have always believed that the Scottish Government has an overarching responsibility for the nation’s health. The Scottish Government should instruct a public inquiry because we could include consideration of issues such as the extent of the use of PIP implants in Scotland and the rupture rate, because we are not clear that Sir Bruce Keogh’s review will deliver that information in a Scottish context. The inquiry could also consider establishing minimum standards for private clinics that operate in Scotland, which would include issues such as insurance coverage, disclosure to patients of the risks and safety of procedures, regulation of third-party providers—those companies that use hospitals and clinics in Scotland—and regulation of providers that consult in Scotland but perform the surgery elsewhere, usually in England.

Early notification is an issue. The issue was first highlighted as a problem by the MHRA in March 2010. However, I was surprised to see that it took until December 2011 before some women became aware of the problem through press reports. That is a 21-month difference. I know that Health Facilities Scotland, an agency of the Scottish Government, should have been told in March 2010. I am not sure whether it was told or, if it was, what action was taken by it or by the Scottish Government to ensure that people knew about the issue. It would be useful for a public inquiry to reflect on communication as one strand of critical work.

We could also use NHS National Procurement, which is a very efficient organisation that I had the privilege of visiting just a few weeks ago. It already purchases medical equipment and devices for the NHS, and uses clinicians as part of the team to inform that purchasing. Building on the expertise of an existing organisation would have provided quite an effective safety net. I have suggested that approach to the cabinet secretary, during a meeting with the campaigners. I hope that she will respond positively to the suggestion, as that is something that we can do now.

Of the 4,000 women who are thought to have received implants, the cabinet secretary told us that there was only one case of the NHS in Scotland using a PIP breast implant. That is great. For some reason, the NHS in Scotland used other products. Whatever the reason, the cabinet secretary was of the clear view that that was more a matter of chance than anything else. We really should not be leaving that to chance in the future.

Our action plan explores a range of other issues and I commend it to the chamber. Immediate issues can be tackled. For example, many victims told us about a postcode lottery of care when they approached the national health service. Some doctors turned women away and other women were not referred on to consultants. I want the Government to ensure that there is a consistent response.

Let me tell members about Emma, who lives in Scotland. Her implants were inserted in Birmingham by the Hospital Group. She went to Monklands hospital breast clinic in Lanarkshire and said that she had a problem on 21 September 2011. She was refused a scan. Her general practitioner sent an emergency referral letter on 19 January 2012, but it took until 16 April 2012 for that emergency letter to be acknowledged and for her to receive an appointment. The consultant whom Emma saw relied on incorrect information. He refused to offer a scan and refused to perform an extraction of the implant. Despite the Government’s best efforts, that is the kind of experience that women in Scotland are having. We want a consistent response to happen quickly.

Another initiative would be to call a summit of the private providers to ensure that they adopt a consistent approach to the aftercare of the women affected. Some providers have been very good, but others have been awful. Some providers asked women to pay £2,500 to have the implant removed and replaced, some initially charged for scans and the Hospital Group asked women to sign away their legal rights in return for treatment. That must stop and the Government must bring pressure to bear.

We need to regulate private healthcare better. Healthcare Improvement Scotland’s remit includes the regulation of private hospitals, private psychiatric hospitals, private clinics, private medical agencies and private ambulance services, but its regulations cover only private hospitals, psychiatric facilities and voluntary hospitals. The rest are not covered. We must close that loophole urgently and regulate private healthcare clinics and third-party providers in Scotland. In fairness to the Government, it has been consulting on the matter since July 2010, but I say to the minister, as gently as I can, that we cannot afford to wait much longer. In the spirit of consensus, let me offer to work with the minister to introduce regulations much more urgently.

The current regulatory regime does not include a minimum standard for what patients can expect if things go wrong. I urge the Government to consider setting out some of those standards in the national care standards. Our action plan calls on the Government to develop a better framework relationship with the MHRA to ensure that there is, on the one hand, proper retention and testing of implants and, on the other hand, a formal structure of regular communication. If such arrangements had been in place, the numerous and substantive concerns that clinicians expressed might have been picked up sooner and acted on more quickly.

I have two final points. Let us re-establish a Scottish implant register. I know that there were problems with the last one, but it is not beyond us to sort those out. On a practical level, let us allow the NHS to carry out both removal and replacement of PIP implants in the same operation, as it is safer for the women to go through one procedure rather than two. That should be done on the basis that the woman assigns her right to recovery of the cost to the NHS. In other words, the NHS reclaims the money from the private provider. That would be cost neutral to the NHS and clinically better for the women concerned.

What happened is a scandal. We must do our utmost to ensure that no one is placed in this position again. There needs to be confidence in the system of testing medical devices and implants. We need improved regulation, we need to improve care and support for patients when things go wrong and we need a public inquiry, which will help us to understand how we can prevent such a situation from happening again. I commend to the chamber Labour’s action plan and my motion.

I move,

That the Parliament notes that an estimated 4,000 women in Scotland are believed to have received breast implants manufactured by Poly Implant Prothèse (PiP); supports the ongoing criminal investigation in France into the former owner of PiP, Jean Claude Mas, for his role in the manufacture and distribution of the substandard implants containing industrial grade silicone; further notes with concern that PiP’s activities remained undetected by regulators for a considerable period of time and the lack of information provided to the victims of the scandal, a number of whom only became aware of the potential dangers through news reports in December 2011, over a year after the medical device alert was issued by the Medicines and Healthcare products Regulatory Agency in March 2010; regrets the lottery of aftercare offered by the private clinics that carried out breast augmentation operations with PiP implants for women in Scotland, particularly the charging for replacement operations and attaching conditions to treatment such as the waiving of legal rights; further notes the Cabinet Secretary for Health, Wellbeing and Cities Strategy’s assertion that it is only by chance that the NHS in Scotland did not use the potentially dangerous implants and that the true scale of the scandal in Scotland may never be known, and calls on the Scottish Government to do everything possible to address the suffering of the Scottish victims of the PiP implants scandal and ensure that lessons are learned for the future, including holding a public inquiry under the Inquiries Act 2005.

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