Cosmetic Surgery

Denis MacShane Excerpts

Thursday 5th July 2012 Westminster Hall

[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.

[Mr Denis MacShane (Rotherham) (Lab)]

I agree with everything that the right hon. Gentleman is saying. Does he agree with me that there is a cultural problem, in that “regulation” has become a dirty word in modern politics—not recently, but over a number of years—and that the words “European regulations” are not so much dirty words as a total obscenity that people only whisper in dark corners of this place? The European regulations were inadequate, and we did not have the guts to insist to the professions and the people making money out of this that they needed a bit more regulation.

[Mr Dorrell]

I have some sympathy with what the right hon. Gentleman says. I do not think that we should be frightened, when the burden of proof is discharged, and when it is necessary, of ensuring that there is an adequate regulatory structure that is proportionate, not over-burdensome, and effective at delivering proper safeguards for, in this case, patients. I have been here long enough, Mr Rosindell, to know that if I want to get any political audience to be opposed to something, I have merely to describe it as European and the job is done. In this case, as it happens, I do think that there is a strong case for an effective European regulatory structure, so that the suppliers of proper medical devices, of which this country is a major supplier, do not have to go through 25 different regulatory structures to supply those products in a unified market.

[Mr MacShane]

The Chairman is getting twitchy.

--- Later in debate ---

[Mr Denis MacShane (Rotherham) (Lab)]

I concur with nearly everything that the right hon. Member for Charnwood (Mr Dorrell), the Chairman of the Health Committee, said and I congratulate the Committee on its thorough work. I was dragged into this matter simply because the Birkdale group had a clinic in Rotherham, not far from where I live. People phoned me directly, and I got more and more calls as I took an interest, so I tried to inform myself about the subject.

I am glad that the Chairman of the Committee made reference to what I thought was a distinct shortfall in compassion on the part of the Government and the Secretary of State in responding, “Nothing to do with us, guv, unless you had them put in inside an NHS hospital,” in other words, the 5% of the roughly 47,000 women who had the implants inserted as part of an NHS operation. The Secretary of State for Health is not the Secretary of State just for the NHS, but for the health of the country, so I thought a little more compassion and reaching out might have been needed, because the behaviour of some of the private clinics, including Birkdale, which had an operating base in my constituency, was, frankly, indifferent to the point of cruelty: demanding that money was paid up front, even for an examination, and then another huge fee for any kind of extraction, let alone a replacement operation.

This is about greed and lack of regulation. We are in parallel with a debate about banking in the main Chamber, and that, too, has some connection to greed and regulation. I understand that the Birkdale clinic performed some 150,000 operations over its lifetime at about £4,000 or £5,000 a go. We can work out just how profitable it was. Surgeons were flown in from eastern Europe to do 20 operations on the trot in a single day. That was happening not a mile from where I live. I did not know about it. The local NHS did not know about it, much. The council did not know about it. Local doctors did not know about it. I heard about it only when the crisis broke, so I am not in any way trying to be holier than thou.

We now know that in Britain about 47,000 women and their families are affected by the PIP scandal. It is not only about individuals, but the people around them, who have to live with a worried daughter, a worried mother or a worried grandmother. In their various reports, the British Government said that there is no significant risk to health for British women with PIP implants, yet other Governments take a different view. We should spend a little more time on comparative politics both in Select Committee reports and in our debates, and look at the approach of other Governments.

We might learn from the Food and Drug Administration in the United States, which took one look at the original PIP factory 11 or 12 years ago and simply banned the implants in the US. That is a worry for Europe; it is not a British point, particularly. The FDA said that under no circumstances should the implants be used in operations on US women, but we continued to allow them—when I say “we” I mean the whole EU. The reason is that they were the cheapest, at £150 in a £4,000 operation—QED, in terms of the profit to be made. Another country that banned them was Venezuela. I do not often have much good to say about President Chávez, but in this case perhaps he rendered the women of Venezuela some service.

What do we know about these PIP implants? They are six times more prone to rupture than other implants, and they contain industrial silicones that were never intended for human use and have never been tested on humans. Reports suggest that as many as 68 toxic chemicals and unidentified chemical compounds are in the mattress filler that is used in PIP implants.

We know why women have breast implants: it could be sagging breasts after babies, uneven breasts after mastectomies, and all sorts of psychological conditions. One of the most offensive things about this matter were comments in the press and from some hon. Members—on both sides; this is not a party political affair—suggesting that it is about vanity and cosmetic surgery, “It serves them right”. It is a woman’s decision, perhaps not always a wise one—as the right hon. Gentleman said—to have her breast opened up and something foreign inserted, and we should respect it. I am not sure whether we have not been just a bit scornful, especially in a profession still overwhelmingly dominated by men, despite the welcome presence of the Under-Secretary of State for Health, the hon. Member for Guildford (Anne Milton).

Other countries have set up crisis funds to allow women to have substandard PIPs removed. Ministers in other countries say, “We are in charge of the nation’s health. Women’s health is important. Therefore, we will find the money to look after these people.”

As for the argument that it is somehow a woman’s fault, I have to say that when someone is drunk and gets into a car crash it is their fault, and when someone smokes too many cigarettes and gets lung cancer it is their fault, but the NHS does not shut the door to them because the injury or disease was somehow self-generated. We are a compassionate nation, but compassion was lacking in this case.

In France, the alarm was raised when 48 cases of breast cancer were found in women with PIP implants and two women died. I am sure that the distinguished medical experts among us today will point out that because women have breast cancer, because they die and because they have PIP implants those things are not all interconnected. None the less, there is cause for the concerns that were raised.

I am not sure that the British Government’s final conclusion in these reports is right. I repeat the right hon. Gentleman’s admonition that we should not say that this is the end of the day; the matter must be kept permanently under review. Because a judgment is made at one point in time, that is not the end of it. Let us listen to the women who have formed the PIP committees and taken up the issue, and keep collecting evidence from other countries in case we have to revise the current medical advice.

Some clinics, such as Birkdale, have closed. They have made their fortune, shut their doors and left the matter for someone else to sort out. Other clinics have opened under a different name to avoid liability. Others have made women sign disclaimers before offering them diagnostic tests or treatment. Some breast cancer patients with PIP implants have been on waiting lists for five months or more at NHS hospitals as the waiting lists get longer. Will the Health Committee look at the follow-up from the Government’s initial statements about getting money back from the clinics? I have no evidence that that has actually happened. It is important that Ministers do not announce that something is going to happen, and then not deliver it.

Women themselves should be at the heart of the debate. They have the great trauma of unexpectedly having to remove the implants at very short notice. They face physical, emotional and financial upheavals. Women are not sure who they can turn to. They need to trust the Government, but when the Government’s official line is that there is no evidence of harm, they just do not believe them. I wonder whether officials and Ministers have understood just how concerned women are.

GPs see their patients, but very few of them are experts on the impact that some of these devices can have on health. There is no official recognition of the symptoms that arise when a woman finds these things leaking into her body. She feels uncomfortable in her body. Some of the most distressing aspects of my short personal involvement were the e-mails and telephone calls from women saying, “What is happening inside my body? Nobody will tell me.” I certainly was in no position to tell them.

The Secretary of State made statements in December and January, but I am not sure that the clinics are abiding by their “legal and moral duty” to remove and replace the defective devices they have fitted into women’s bodies. Furthermore, the Medicines and Healthcare products Regulatory Agency is reluctant to release all the precise details of the toxicology testing that has been performed. It is important that there is full transparency.

In conclusion, there is a case for a public inquiry. I really do not want to get into a debate on parliamentary and judge-led inquiries; that is not for this afternoon. I am possibly going a bit beyond the good first work of the Select Committee. We need an investigation of the commonly reported symptoms through patient reports and assessment of medical records, which underlines the right hon. Gentleman’s point that we do not adequately record such operations. The MHRA should release details of the toxicology testing on implants.

Will the Minister tell us what governmental or legal power the Department of Health has to oblige clinics who have fitted PIP implants to offer free removal and replacement or face losing their licence to practise? We need the Department to give us full statistics on exact rupture rates, and all breast clinics should be sent details about PIP breast implants. We need much clearer directives to the NHS and the private sector. Of course the MHRA should be obliged to have a register of every medical device fitted into a human body, detailing the serial numbers and the manufacturers, and we need public disclosure of the 68 chemical compounds found in PIP implants so far.

There are other technical points that the campaigners want answered, but I do not want to take up other colleagues’ speaking time. Women feel alone. It is a small number, but who do they turn to for help? Why did it take two years for an unannounced inspection of the PIP factory? Why has the MHRA not fully published all the details of the 68 chemical compounds said to be found in PIP implants?

Such requests for information are reasonable. As I said, this is not a party political issue; it could easily have happened under the previous Government. As the shadow Minister, my hon. Friend the Member for Hackney North and Stoke Newington (Ms Abbott), said, in 1994 my right hon. Friend the Member for Cynon Valley (Ann Clwyd) proposed more regulation of breast implants. Her Bill was rejected by the previous Government, and not much was done; if anything, the deregulation mania continued. We should learn lessons from that and try to find ways of sending messages of increased solidarity to the women, many of whom are still very worried about what was done to their bodies when they went in for these PIP implants.

--- Later in debate ---

[Anne Milton]

I thank the shadow Minister for her intervention. I accept the strength of feeling on the issue in this debate. The clinching argument is that if the NHS were to offer what is in effect subsidised breast augmentation for non-clinical purposes—I stress the use of the word “clinical”; it is not that cosmetic surgery is unavailable on the NHS, but that it is available if there is a clinical need for it—

[Mr MacShane]

Will the Minister give way?

[Anne Milton]

If we can bear on Mr Benton.

[Mr MacShane]

He is very generous. Can I inform the Minister and the House that today is the 64th birthday of the NHS? Why not give a birthday present to those lovely ladies and say that the NHS will look after them before its 65th birthday? Come on, Minister, take a decision. They will not kill you on the box. We will talk to the Secretary of State for Health and sort it out.

[Mr Joe Benton (in the Chair)]

Order. Before the Minister replies to that intervention, I point out that there is another debate to follow this one. Try to keep interventions to a minimum. The debate has gone well past 4 o’clock.

[Anne Milton]

We have tried Mr Benton’s patience. I thank the right hon. Member for Rotherham for his suggestion. I am sure that the Secretary of State will listen closely to what I say next. Changing Government policy on the hoof during a debate—

[Mr MacShane]

—gets you into the Cabinet.

[Anne Milton]

It might indeed. It might also be a career-limiting move.

The surgery must be based on clinical need. I cannot see any way out of the dilemma. It is difficult, and as I said, the strength of feeling in this debate will have been noted.

Moving on, I know that the Health Committee has criticised the MHRA for not finding a way to communicate to women with PIP implants, preferring instead to use its central alerting system, the national media and specialist associations as its main channels of communication. We should recognise that that approach clearly did not work well, although it was possibly understandable at the time. Since then, active social networking sites have developed. It is right that both the Department of Health and the MHRA need to find better ways of communicating.

I finish by talking about some of the wider issues that have been raised, specifically Sir Bruce Keogh’s ongoing review. It is a wide-ranging review of all aspects of the regulation of cosmetic interventions: the devices and substances used, the practitioners involved and the way the organisations work. It will pay particular attention to the marketing and promotion of cosmetic interventions, and the need for fully informed consent. The review is expected to report by March 2013.

My hon. Friend the Member for Central Suffolk and North Ipswich (Dr Poulter) raised the issue of informed consent. Nothing could be closer to my heart. I have heard some dreadful stories from women who went in for breast augmentation and, literally two or three minutes before they were about to go under anaesthetic, somebody rushed in with a form saying, “We’ll lift your eyelids or give you a facelift at half the price if you sign here now.” Absolutely outrageous. A lot of women, even if they were informed, did not feel informed, and that is what matters. It is not good enough just to tell people. It is important that the surgeon, and all those undertaking the procedure, are satisfied that the woman, or indeed anybody else having any sort of surgery, is fully informed.

There is information about lists of medical devices. It is worth putting on the record that the EU is currently revising the regulations on them, and looking at medical devices.

On the number of substances that were found in PIP implants, we have to be very careful and stick to science. All sorts of chemicals are found in hip replacements, knee replacements and all the other things that can be implanted for medical reasons. The important point is whether they have any impact on health.

Insurance was mentioned. It will be looked at. Professional standards are two words that are rarely heard. In reviews after bad things happen, we rarely talk about professional standards. It is extremely important that we do talk about them.

Issues were raised about loss of licences and the need to keep records so that we can make timely, prompt contact with people who are affected when things go wrong, as they inevitably will from time to time. It is important that we do everything beforehand to ensure that they do not go wrong, but that if they do we have access to the women. That is why we need Sir Bruce Keogh to look at that work, and clinical licensing systems and compulsory insurance too. I am very grateful to the Committee for its many helpful suggestions, all of which will be taken forward by Sir Bruce’s team.

I end with a note about some of the women who have taken the time to talk to me. It is very hard to understand the distress caused when terrible things happen, particularly when people have previously trusted the organisation, and maybe the surgeon, that they were dealing with. Betrayal of trust is a dreadful thing. It can be awful if they go back and there is nobody to help them. In some instances, women have gone to their GPs, and even their own GPs have cast inappropriate value judgments on them and not been as helpful as they should. For many women, we cannot turn the clock back, but we can make sure that this does not happen again.