Breast Implants

Andy Burnham Excerpts

Wednesday 11th January 2012 Commons Chamber

[The Secretary of State for Health (Mr Andrew Lansley)]

With permission, Mr Speaker, I would like to make a statement about PIP breast implants. The House will be aware that approximately 40,000 women in this country have had implants manufactured by the French company Poly Implant Prothese, and that these implants could have been made of a non-medical grade silicone gel. My concern throughout has been for the safety and well-being of all these women. I wish now to update the House on what happened; how we are looking after the women concerned; and the further actions required.

In 1997, PIP received a European CE mark for its silicone breast implants. The CE mark was overseen by the German notified body, TUV Rheinland. The Medicines and Healthcare products Regulatory Agency adverse incident centre received a number of reports annually about PIP implants. Based on such reports, in 2008, the MHRA raised its concerns with the German regulatory authorities and the manufacturer. The MHRA was reassured by the notified body that the number of adverse reports was adequately explained by changes in the company’s reporting practices and by the increasing number of implants sold.

However, in March 2010, the French regulator discovered that rather than using medical grade silicone gel in the implants, PIP had in fact been using unauthorised silicone gel. This is in clear violation of the CE mark. The mark was promptly withdrawn and all EU member states immediately alerted. The MHRA immediately issued advice to stop using PIP breast implants in the UK. The French authorities are currently investigating this as a criminal matter, and the UK Government will help in any way we can with their investigation.

Initial toxicology tests in both France and the UK found no significant health risk to women with the implants. Also the MHRA could find no evidence of an increased risk of cancer. However, on 23 December 2011, following an increase in the number of reported ruptures, the French Ministry of Health announced that it was advising women, as a non-urgent precautionary measure, to consider having their PIP implants removed. The MHRA’s advice was that there was no scientific basis for recommending routine removal of implants in the absence of symptoms.

The available data, however, were incomplete. For this reason, I asked Sir Bruce Keogh, the NHS medical director, to form an expert group and to review the available data, including information from the French authorities, and to offer more definitive advice. I received the group’s interim report on Friday 6 January and a copy has been placed in the Library. I would like to thank the experts and members of the profession for their hard work and commitment in producing this rapid report.

The main findings of the expert group were, first, that there is no causal link between these implants and breast cancer. Secondly, the evidence on the rate of ruptures for PIP implants compared with other implants is incomplete and so this risk cannot be assessed definitively. Thirdly, although the rupture of implants or leakage of material can result in inflammation, there is no clear evidence that these problems are more serious in relation to PIP implants than other implants, or that they result in increased long-term health risks. Therefore, they have not recommended routine removal of the implants. Fourthly, there are risks inherent in the removal of breast implants, just as with any surgery, and these risks should be taken into account when taking any clinical decisions. However, for this particular group of women the risk is very low. Fifthly, the expert group recognises, as we have throughout, that women with PIP implants will be understandably concerned that they did not have the character of implant that they thought they did. The expert group advises, as we have, that we should give every woman an opportunity to secure advice, investigation and remedy.

The women who received the implants did so on the understanding that the implants met the requirements of the CE mark and were safe. That was not the case, and every provider has a responsibility to put things right. Although the majority of women will have received their implants privately, some—such as those who have had reconstructive surgery following mastectomy—will have received PIP implants through the NHS. All those patients will receive the highest possible standard of care. First, they will be contacted to inform them and give them all the relevant information and advice. Women who wish to will be able to speak to their GP or the surgical team that carried out the original implant to get advice on the best way forward for them. If the woman chooses, that could include an examination by imaging. If, when informed by an assessment of clinical need of the risks involved and the impact of any unresolved concerns, a woman decides with her doctor that it is right to do so, the NHS will remove and replace the implants, if the original operation was done by the NHS. Last week the NHS chief executive wrote to the service, and Dame Sally Davies, the chief medical officer, wrote to GPs and relevant health professionals. Copies of those letters are available in the Library.

It is right that those who received their care privately should also receive a similar level of service and reassurance from their care provider. However, I do not think it fair to the taxpayer for the NHS to foot the bill for patients who had their operation privately. Eight private health care companies, including Nuffield Health, Spire Healthcare and BMI, have confirmed that they will follow the same guidelines as those that I have set out for NHS patients. However, I want to be absolutely clear that the NHS will continue to be there to support any woman. If a clinic that implanted PIP implants no longer exists or refuses to remove the breast implants, where that patient is entitled to NHS services, the NHS will, in consultation with their doctor, support the removal of PIP implants in line with the guidance that I have just outlined. Any NHS service in that instance would cover only the removal of the implant, which would not include the replacement of private cosmetic implants. In such cases the Government would pursue private clinics to seek recovery of our costs.

These events highlight the need to ensure the safety of people having cosmetic interventions. It is clear from the information that we have received from the industry that the safety information that it collects and provides to the regulator is of variable quality. Without good data, we have no way of knowing when problems arise. I believe that there are a number of things that we now need to do. First, lessons need to be learned from this case and incorporated into the ongoing review of the EU medical devices directive. I spoke to Commissioner Dalli yesterday, and can confirm that this European work is under way. We also need to understand what happened in this instance in the United Kingdom. A review for that purpose will be led by the Minister for Quality, Earl Howe, with expert advice, and will shortly put its terms of reference in the Library. That review will investigate and report rapidly. The blame for what happened lies with PIP, but the review will enable us to learn lessons to improve future regulatory effectiveness and will feed into the Commission’s review.

In addition, the Care Quality Commission will conduct a swift review of private clinics. That review will look at evidence of compliance, patient safety and clinical quality, and the information and support given to their patients. Where a provider does not meet those requirements, the CQC has a wide range of enforcement powers that it can use to protect the safety of patients. The findings of that review will be published before the end of March.

Looking to wider issues of clinical safety and regulation, I have also asked Sir Bruce Keogh to reconstitute his expert group to look at how the safety of patients considering cosmetic interventions can be better ensured in the future. That will include treatments such as cosmetic surgery and dermal fillers. I expect his review to consider whether cosmetic products and interventions are appropriately regulated and have strong clinical governance; whether patients and consumers can be confident that the people who carry out procedures have the skills to do so; and whether the settings in which such procedures take place are able to ensure the care and welfare of people who use their services. That review will consider issues of governance, data quality, record keeping and surveillance, as well as ensuring that proper information is provided to secure patients’ informed consent.

I expect the review also to include consideration of an outcomes-based register of frequently implanted devices, covering everything from breast implants to heart valves and replacement joints, in order to provide the United Kingdom with a valuable asset for further innovation and safety improvement. There is already considerable clinical support for such a comprehensive register. The Government’s commitment is to provide effective reassurance and remedy for women with these implants, and also to learn the lessons to deliver safety and quality for the future. I commend this statement to the House.

[Andy Burnham (Leigh) (Lab)]

I thank the Health Secretary for his statement, and for the steps that he is taking to help the thousands of women who have found themselves in this worrying situation. We welcome much of what he has just announced, including the further reviews that he has commissioned. I assure him that we will support him in his efforts to reach a resolution as quickly as possible for all those people who are affected, but I have to tell him that he has a lot of work to do, and a lot of ground to recover, as his response to date has not helped to build those people’s confidence.

Over the Christmas break, the mixed messages coming from the Government did not go unnoticed. They only added uncertainty in what has been an anxious time for many people. The Health Secretary has gone from downplaying the dangers on 23 December to announcing an urgent review on new year’s eve, then giving an inconclusive statement late last Friday evening. This has left the people affected struggling to make sense of what it means. For the vast majority whose implants were fitted privately, there was precious little practical advice or help from the Department of Health as they began approaching their private providers. Many women were unable to access their records or told that long delays would be involved. Others have been asked to pay large fees to access their records. Many have simply hit a brick wall when they have sought medical advice or removal, even where there is evidence of rupture.

What people needed at the earliest stages was a strong statement from the Government of what was expected of all private providers—namely, that records should be provided without delay and without charge; that consultations should be arranged when people were worried; and that removal should be arranged urgently when there was evidence of rupture. The reality is that the Government’s failure to provide that leadership from the outset has left people fending for themselves in the face of a self-serving and unaccountable industry.

The Health Secretary was right, however, to establish an urgent review of the evidence by the NHS medical director, Professor Sir Bruce Keogh. We welcome the speed with which that review was conducted, and we echo the Health Secretary’s thanks to the members of the review panel. We accept the Government’s judgment on the advice to women regarding the removal of implants on the basis of the data that they have seen, but what confidence can we have in the evidence and data on which those decisions were reached?

We note the Secretary of State’s public comments about the industry’s failure to provide quality information in a timely fashion, and the interim report’s finding that the evidence is subject to “considerable uncertainty”. The review concludes that it should reconvene in “about four weeks time” to examine any new evidence, and to consider whether to update its recommendation on removal. I have to tell the Health Secretary, however, that that feels way too vague and ad hoc. May I press him to give a clearer timetable for this further process of review on whether to change the recommendation on removal? People need absolute clarity on when further statements will be made, so that they can make informed decisions. This is of course a separate matter from the long-term reviews that he has announced today.

This is particularly important in the light of the different decisions that other Governments are beginning to make in response to the situation. Yesterday, the Welsh Government announced that all women who received PIP implants, including those treated privately, will be offered replacement implants on the NHS. That is of course different from what the Health Secretary has announced today. What discussions did he have with his counterpart Minister in the Welsh Assembly Government before their announcement was made? Will he assure the House today that all the data that were available to Welsh Ministers and officials were also available to, and considered by, the Keogh review? Governments around Europe have responded sooner, more decisively and with greater clarity than the coalition has done. By contrast, people here have found the Government’s statements in response to be both inconclusive and ambiguous.

We support the decision to help NHS patients to have PIP implants removed and replaced, but does the Secretary of State appreciate how that decision has added to the confusion that many people feel and was interpreted as contradictory to the review’s overall finding? The clear implication of the Keogh review is that the best course of action is, in fact, to have the implants removed, but again no practical help was offered beyond the statements of expectation for private providers to match the support on offer from the NHS and the reference made to “moral duty”.

I, too, commend the private providers, such as Nuffield, Spire and BMI, that have done the right thing by their patients, but in recent days we have heard how some of the leading cosmetic surgery clinics have simply ignored the Health Secretary’s appeal. Transform, which used PIP implants on over 4,000 patients, has said that all women affected will have to pay £2,800 for removal, while the Harley Medical Group, which has 13,900 patients with PIP implants, has offered to pay for the cost of the new implant, but only if the NHS pays the far greater bill for the surgery. I am sure the whole House will agree that this is an appalling response to this situation, and that the failure of these companies to face up to their duty of care for their patients leaves everybody, including the Government, in a difficult position. It is simply unacceptable for any woman in England to be left in a position where she is worrying about her health and thus has no peace of mind, but is unable to afford to do anything about it.

I appreciate what the Health Secretary has said today about helping people out of this predicament. I agree with his decision where private clinics no longer exist, but in accepting that the NHS will provide private treatment where private providers refuse to, is he not in danger of letting those providers off the hook? May I remind him that most people will not accept that the NHS should subsidise the failures of private companies, and will look to him to pursue them to the nth degree to get any costs back? For instance, has he fully explored the insurance position of these private providers as a means of recovering costs? He says he will pursue them, but what assumptions has the Department of Health made about the likelihood of his success, and how much money is expected to be recovered? Has he fully explored the position of the French Government and considered whether there is any residual liability on the device manufacturer in that company?

Let me turn briefly to questions of regulation. Can we support what the Secretary of State said today about the wider review of regulation of the cosmetic surgery industry? If there are any loopholes, we will support him in closing them down.

Finally, the right hon. Gentleman’s Health and Social Care Bill envisages a much expanded role for the private sector in the delivery of health care. I make no comment about that, but has he reflected on the Bill and revisited the assumptions behind it? Will he assure us that issues of quality and safety will be safeguarded in the NHS that he seeks to create? We want to be assured that he is giving careful consideration to all these issues, as he considers his response to this worrying situation.