HOUSE OF COMMONS HANSARD REPORTJune 11th 2002
Tom Brake (Carshalton and Wallington): I welcome the opportunity to follow up a debate that I introduced a couple of years ago on silicone implants. Implants were introduced almost 40 years ago, and breast enlargement is now the most common cosmetic surgery procedure to be performed on women in the United Kingdom. It is estimated that 10,000 operations are performed each year, and 80 per cent of those who receive implants opt for silicone gel implants. Significantly, 80 per cent of operations are cosmetic, rather than for reconstruction purposes.
According to those who campaign on the issue, 60,000 women in the UK suffer from the effects of silicone implants and the number of websites that provide information on the issue makes the point. Despite the debate held a couple of years ago, and the report by the Select Committee on Health in March last year, no decisive action has been taken. The Government have been slow to act, and I have no evidence that they have struck the right balance between the benefits and risks of breast implants.
It is worth going over some of the ministerial responses to the March 2000 debate. At the time, the independent review group recommended that all patients who underwent surgery should be able to obtain free, independent and comprehensive information from a designated body or from the Government. That information is now available and there is a Department of Health booklet entitled “Breast Implants Information for women considering breast implants”. As others have said, however, the information in that document is not as challenging as it should be. Furthermore, the Department’s website address is incorrect, so women who want to visit the website to obtain a copy of the leaflet would be unable to do so. The information in the leaflet is quite bland, and does not put across the real impact of a breast implant that goes wrong.
It is worth returning to the case history of a constituent to show that the problems associated with breast implants are not merely tenderness or the shape not being quite correct. The medical implications can be very severe, but that does not come across in the leaflet. Implants may have to be removed, and some women are left with prominent scars or holes in the tissue. Infections can also arise. Furthermore, concern about the failure of a breast implant may lead to conditions related to stress, such as peptic ulcers. There is also concern that women who have had silicone implants that have leaked or ruptured could develop other conditions further down the line, such as myalgic encephalomyelitis or rheumatoid arthritis. The Minister may say that there is no medical evidence to support that, but there is certainly anecdotal evidence. There is concern among a significant number of women that implants have such side effects, and severity of their concerns should be reflected in the document, but it is not. The Health Committee believes that the document does not provide sufficient information about the risks of these products. Since its report, the document may have been reviewed and additional information provided, but the Consumers Association also said that it was disappointed with the leaflet and was concerned about its usefulness.
Informed consent for an operation is another issue. Will the Minister tell us how thorough and useful is the new consent form? Will she provide an update on progress made on implementation of the Health Committee’s recommendation N0. 8, which will make it mandatory to give women an identification card containing the make and model of their breast implant? That will give women a physical record to which they could refer if anything went wrong in the future.
Registration was another issue referred to two years ago, and I want to press the Minister on it now. The Government say that the registration process by which women place their details on a national breast implant register should be voluntary. Does not the Minister agree that it would be preferable to have a compulsory registration scheme in which the details of individuals were not available, but the details of the implants were? That would provide a mechanism for tracking and linking details to individual people if problems subsequently developed.
Surely we should keep proper information. When we use our cards in Tescos and Safeways, we give the supermarket chains a whole host of information about what we purchase and why, and few people bat an eyelid about that. As clear health concerns are involved with implants, compulsory registration with the data anonymised – and no means of identifying particular individuals – should not cause women any problems. If it were compulsory, we would have consistent and complete data on all the implants in the UK. Will the Minister respond to that point?
I checked with Liberty, and was told that it has no concerns from a human rights standpoint. As long as the data is anonymised, it is not worried about data protection issues. If the Minister believes that an important issue is at stake with compulsory registrations, will she explain why Liberty – the organisation most likely to clamour against it does not?
The register was established in 1993 but what research has the information been used for subsequently? The Minister will correct me if I am wrong, but it seems to me that no work has been done whatever. Nine years on, the Department of Health is commissioning a contract to establish whether the register can be used to assess the outcome of breast implants. When the register was set up, surely its main purpose was precisely that. I am alarmed that nine years after the register was established research is being carried out to see whether it can be used for the purpose for which it was originally intended. Many women consider that, because the register has not been used to conduct detailed research into the outcomes of breast implants, women in the UK may have been used as guinea pigs in clinical trials, which would be unacceptable in countries where a moratorium on the use of implants for cosmetic reasons are in force.
Another area of concern is the apparent inconsistency in the approaches to the different types of implant. As there is insufficient evidence to show that trilucent implants are safe, the view is that they should be banned, but as there is insufficient evidence to show that silicone implants are unsafe the view is that we should allow them. Perhaps the Minister can explain that position, and why one implant is banned and another is not.
The Minister will, I am sure, be aware that a draft European Union directive will be adopted in September that will reclassify implants as class 3 highest risk medical devices. Does she think that will help? Is she worried that the Government are not concerned about silicone implants, whereas the EU is reclassifying them as class 3 devices, which will mean that more pre-market clinical testing of the products will be needed.
Associated with that at an EU level is the concept of CE marking. Everyone will have seen those two letters on products on sale on our shops and supermarkets. It is a badge of certification to show that they pass certain standards. The trilucent implants have received that badge. Is the Minister satisfied with that form of classification? Is she satisfied that the fact that a CE mark has been allocated ensures that a particular implant is safe?
Does the Minister have any concerns about the moratorium that other countries have imposed on implants and does she feel that we should introduce one here under the precautionary principle? It is widely recognized by all quarters that silicone gel can be released into the tissue. Implants can rupture, and silicone oils can bleed through the shell into a woman’s body. Silicone was found in my constituent’s armpits. There is clearly concern about leakage. The associated risks, such as infection, are not spelled out clearly in the Department of Health leaflet. Perhaps some photographs of the affected women are needed. That might draw it to people’s attention more than the rather bland text.
The implications for women’s health need to be taken into account to a much greater extent. It is not good enough to explain the relative lack of action by saying that it takes a long time for illnesses that affect the whole of a women’s body to show up, and to argue that we need to wait for further evidence before we can conduct research into the health implications of implants. There is no conclusive evidence that they are 100 per cent safe, and other countries have taken a harder line than the UK. It is therefore time that the UK Government erred on the side of caution and immediately banned the use of silicone implants for cosmetic purposes.
The Parliamentary Under-Secretary of State for Health (Ms Hazel Blears):
I congratulate the hon. Member for Carshalton and Wallington (Tom Brake) on securing a debate on an important issue that is of great concern to many women who have had, or are contemplating having breast implants. Since the hon. Gentleman first raised the issue, there have been many developments in the safety of breast implants, whether they are filled with silicone gel or other materials. I welcome the opportunity to respond to the points that he made, and to put into the public domain further details about these developments.
The Government have always taken seriously the health of women who have had silicone gel breast implants. In the past 10 years, there have been several definitive expert reviews of the safety of those implants, and recent developments must be considered in the light of the fact that each review has firmly established the suitability of silicone for use as implant material.
In 1991, it was suggested that silicone gel breast implants might cause connective tissue disease. The Department of Health immediately initiated a detailed review of the relevant evidence, and convened an independent expert advisory group. In 1992 and 1994, the group concluded that there was no evidence of an increased incidence of connective tissue disease associated with silicone gel breast implants, and there was therefore no scientific case for changing practice or policy on breast implantation in the UK.
Despite those reassurances some women remained convinced that silicone gel breast implants may have caused debilitating illnesses. As a result of those concerns, one of the Government’s first actions in May 1997 was to ask the chief medical officer to take a fresh look at the safety of silicone gel breast implants. The chief medical officer set up an independent review group to examine pre-operative patient information and the possible health effects associated with the implants. The hon. Gentleman referred to the Department of Health leaflet, to which I will refer in detail in a moment.
In July 1998, the independent review group published its report, in which it concluded that silicone gel breast implants are not associated with any health risk greater than that associated with other surgical implants. The hon. Gentleman said that we should take steps to ban implants if we cannot be satisfied that they are 100 per cent safe. I am sure that he will accept that no procedure will be 100 per cent safe with any implant surgery. There will always be risks in any surgery, and therefore balancing those risks is an important consideration.
I entirely agree with the Minister. However, there is a slight difference in that a medical implant is being used for cosmetic purposes.
The Government and the independent review group must take into account the medical and scientific evidence not the purpose for which the procedure is carried out. We are committed to developing a rigorous evidence base for everything that the Department of Health does. We must concentrate on that evidence base when we consider the risks to ensure that we get the balance right for people who are contemplating any implant surgery.
The hon. Gentleman referred to other countries and their views. Conclusions similar to those of the review group were reached by the American Medical Association, a Canadian independent advisory committee, the Institute of Medicine of the United States National Academy of Science, a national science panel appointed by the US Federal Court, and a scientific technological options assessment carried out on behalf of the European Parliament.
The UK is not alone in taking the advice of the independent review group, which concluded that silicone gel implants are as safe as any other surgical implant. The Government consider it important that the group continue to meet, and that this is not a one-off review. The group should consider any new evidence as it appears. It continues to meet about twice a year, and so far nothing has emerged that has caused it to alter its original conclusions.
However, although the review group was satisfied on the safety of silicone gel breast implants, it was concerned about a number of issues associated with their use. It felt that information provided to women undergoing breast implantation was often inadequate, and that problem needed to be addressed. It made several important recommendations about information provided to women and clinicians, and about possible consequences.
Since the publication of that report, we have implemented various actions to try to ensure that clinicians and women have appropriate information. We have formed an advisory group to prepare an information booklet for women, which included representatives of women’s support groups. It is crucial that patient advocates are involved in preparing the information. From October 2000, 80,000 copies of the booklet were circulated. It has recently been revised, taking into account the recommendations made by the Health Select Committee in March 2001, and a further 100,000 copies have been printed and are being distributed.
The leaflet includes a full section on the potential consequences and risks: the possibility of hardness, discomfort and changes in breast sensation. It talks about capsular contracture, whereby scar tissue is formed within the breast cavity, and about what happens when the scar tissue hardens and the effect of that on the implant. It refers to rupture rates and life expectancy of implants. A section makes clear that breast implants are a long-term commitment. It states:
“Remember that breast implants do not come with a lifetime guarantee. They are likely to need replacing with consequent further surgery and expense. A young woman who has implants may expect to have further operations in her lifetime”.
That is very clear. The section on risk is graphic.
“Occasionally, the silicone can spread outside the capsule and create a series of lumps known as siliconomas. These may give rise to local symptoms such as tenderness… Breast tissue may be lost when the implants are removed”.
On scarring, it says that
“In a small number of women (up to 1 in 20) as with any surgical procedure, scars will be red, or highly coloured, thick, painful and will take several years before they improve.”
On creasing and folds in the breasts, it states:
“The nature of the implant capsule may enhance less desirable characteristics such as creasing, kinking, vertical ripple folds and rippling in the breast.”
The leaflet does not underplay the likely effects of the surgery. It tries to set out for women what the decision involves. It refers to the silicone controversy, to the independent review group and to some of the symptoms that have become apparent. It says that some people believe that symptoms include muscle spasm, swollen and painful joints, rashes, changed eye and saliva fluid and hair loss. It contains some photographs, and if any woman contemplating breast implantation read it, it would give her a pretty good tour around the issues.
I am in favour of informed consent and of anyone undertaking operations having full knowledge. The hon. Gentleman asked about the consent form and about the data registry. We want to ensure that when people are entered on the registry they get a copy of the entry, with all the details about the batch and the manufacturer of the implants so that the women is in possession of those important details.
The Minister has correctly pointed out that there are photographs in the leaflet, but they would not do anything to dissuade women from having implants- I suspect that they would have the opposite effect. The Minister pointed out the uncertainty of the life expectancy of implants, and said that women would know that they would have something inside them with an unknown life expectancy. She has also set out some of the many problems associated with implants. Does not she consider that the problems outlined in the leaflet are sufficient to introduce a moratorium on the cosmetic use of implants?
No. It is for patients to decide, on the basis of information and knowledge about the likely implications, whether they want to proceed. We are in the business of assessing and balancing risk and ensuring that people are empowered to make those decisions themselves, not making those decisions for them. That is a fundamental principle, and the information in that leaflet is accurate and graphic enough to outline the risks. The hon. Gentleman’s point was that the information was bland and did not really draw out the details, but I disagree.
The hon. Gentleman also raised the specific issue of reclassification of devices under the European directive from class IIb to class III. The UK has been at the forefront of the push for devices to be in class III, which will require a more detailed assessment of individual dossiers of each device. Indeed, many of the EU’s recommendations have been made on the basis of actions that we have already implemented in the UK, and I can reassure him that we are at the forefront in clinical practice. He will also know that with the introduction of the National Care Standards Commission, we now have the opportunity to regulate, inspect and monitor standards in the private health care sector. That will be in the best interests of women undertaking such surgery.
The hon. Gentleman asked about research and the length of time that it has taken to use the registry to support research. The National Breast Implant Registry was set up in 1993, and it takes about five or six years to gain the necessary information. Our studies will be five years on from implantation and will consider the epidemiological implications for women. It takes time to gather the data and then to conduct the studies. Almost two years ago, a particular company proposed a study that met the quality issues for research, but it proved impossible in the negotiations to reach an agreed contract on the terms and conditions. The company raised concerns about indemnities and liability.
However, I am pleased to say that we have been able to agree a research project that will use information from the breast registry to examine epidemiological implications. The contracts are just about to be agreed, so we should be able to get on with it soon. The hon. Gentleman is right, as there has been a delay because of the difficult contract negotiations with the original research body, but that has now been resolved. I want to ensure that we press on and get research on this important topic.
The hon. Gentleman raised the point about trilucent breast implants, which have soya bean oil fillings. They were withdrawn in March 1999 as a precautionary measure, and since then we have learned more about the risks that they pose. In June 2001, the Medical Devices Agency issued a hazard notice that advised women with the implants to have them removed, because of concerns about the toxicity of the filling. When the soya bean oil starts to break down it can have toxic effects. There is no such evidence with silicone gel or saline, which are other currently approved implants. In the trilucent case, the manufacturer organised an implant removal programme, and I understand that 95 per cent of woman who received the implants have had them removed and there are only about 200 women in the country who still have them.
There have been a number of developments in breast implants. The hon. Gentleman is right to raise the concerns of his constituent, but the UK is at the forefront of ensuring that the issues are considered in this country and throughout the European Union. When devices are approved for use in any European country, they can be used here. We are trying to get as much information and scientific evidence as possible so that women’s health is protected. It is fundamental that women should be able to make the decision themselves in the light of the best available scientific knowledge. That is our current position on this extremely important issue.