§ Motion made, and Question proposed, That this House do now adjourn.—[Mr. Sutcliffe.]
2.30 pm§ Mr. Tom Brake (Carshalton and Wallington)I am pleased to have the opportunity to bring the House's attention to an issue that affects more and more women in the United Kingdom as well as abroad, on which I believe the Government have so far failed to take decisive action. I first became aware of the health risks associated with silicone implants when I was approached by a constituent whose case will, I believe, interest the House. It raises concerns about the safety of the operation as well as the product itself, but it is the latter that I shall consider in detail.
Dawn contacted me in September last year, having already suffered from the adverse effects of breast implants for more than a year. In June 1998, she found that the implant in her left breast had ruptured and needed to be replaced. In July, the implants were removed and replaced with others; however, Dawn found that the implants had made one of her breasts larger than the other. Moreover, it appeared that the scar tissue was infected.
A course of antibiotics was prescribed in an attempt to resolve the problem, requiring Dawn to return to hospital every week for 10 weeks. However, her condition deteriorated further: holes developed in her breast, requiring her to return to hospital for a further course of antibiotics. It culminated in her being rushed to hospital, where a doctor found that the implant was beginning to fall out. I apologise for going into such detail, but the detail highlights the concern felt by many about the safety not just of the operation, but—as I shall demonstrate—of the product itself.
Further intervention was required: an implant was removed. Subsequently, the wound had to be left to heal, with no stitches, so that the infection could be cleared. That obviously had a detrimental effect on both the physical and the mental well-being of my constituent, who, after what should have been a straightforward operation, was experiencing pain and—because she could not work for a long period—loss of income. She described herself as having been depressed and even suicidal. Moreover, she developed a peptic ulcer, which I think her doctors would suggest was a result of the stress that she experienced.
A further operation was performed to replace the implant, which left my constituent feeling numb on her left side down to the waist. Apparently, she was told that that was perfectly normal. For a further two months she had to visit the doctor every couple of weeks, and was taking painkillers and other medication.
By April, my constituent's doctor was still concerned about one of the implants, which he thought might have encapsulated. There was concern that her lymph glands were swollen. That evening, she was in such pain that she had to be admitted to hospital. After that series of operations, both implants were removed. The doctor informed her that, during removal, staff had had to remove a benign lump from her breast and—this is key—had found silicone around the lymph glands in her armpit.
My constituent continues to suffer the pain and anguish associated with the operation and with what happened subsequently. She continues to see various specialists to 739 try to get the matter resolved. It seems that hers is not a lone case. She has been in regular contact by e-mail with concerned women throughout the world who are experiencing similar problems. Apparently, she is receiving up to 50 e-mails a day from different parts of the world. People are passing on information about the impact that Dow implants may have had on their health.
Silicone Support UK, which runs a helpline for women with similar problems, has told me that it has been in contact with no fewer than 2,000 women who are suffering from similar symptoms, so it is by no means a unique case. It appears that many thousands of women are affected in the UK and in other countries. I am sure that each hon. Member will have constituents who have health problems that would appear to be associated with either the operation to put the implants in, or the implants themselves, which I learned today contain no fewer than 37 constituent parts; they contain different chemicals or metals. It is not just inert silicone that is contained in implants, but many other materials which Members would find less acceptable and would say were in no way inert.
The problems associated with silicone implants that have been reported by different women range from partial paralysis to arthritis, severe allergies, chronic fatigue syndrome and memory problems. As hon. Members may know, a moratorium on silicone implants exists—except for clinical trials, in the United States and Canada—and they are banned in Australia, Japan and France, so what are the UK Government doing? I would not want to accuse the Government of doing absolutely nothing. Historically, action was taken when public awareness was perhaps at its height. In 1992, the Department of Health set up an independent expert advisory group to investigate the association between silicone gel breast implants and connective tissue disease. Apparently, it found no evidence of a link and no reason to alter existing policy.
In 1993, public anxiety was such that a breast implant registry was established at Salisbury district hospital. Apparently, the registry was to form the basis for future research projects. In 1994, the Medical Devices Agency of the Department of Health, which has continued to keep the issue under review, published a further analysis of the health risks of silicone implants and reached the same conclusions that had been reached in 1992. It is worth noting that medical health professionals are under no obligation to report incidents to the agency: there is a voluntary arrangement, which is a source of concern.
In 1997, the Government set up an independent review group to review all the evidence of possible health risks. The history is that, as concern has mounted, the Government have naturally wanted to reassure the public and be seen to be doing something, but being seen to do something is about all that it amounts to.
Let us examine a specific example. The breast implant registry at Salisbury district hospital was set up in 1993, nearly eight years ago. A parliamentary question that I tabled recently has identified that, since the registry was established, no research has yet been published.
The purpose of the registry is to collate information on breast implants, to enable research to be undertaken on the basis of that information and identify potential problems. However, although the registry has been up and running for seven years, no research has been published. I have been told that only one research project is under way. If one research project is all that the registry has been able 740 to achieve in the past seven years—perhaps the Minister will correct me if it has accomplished more than that—it is not a terribly great achievement.
The registry contains details on 40,000 implant recipients, the ages of whom range from 12 to 80. The registry's scientific co-ordinator states:
Current uses of the registry are concerned with improving and extending this process, raising awareness of the process, increasing the proportion of total procedures that are registered, internal audit with collaborating centres and assisting with some vigilance and safety concerns.Perhaps the Minister will say precisely how the registry has been able to raise "awareness of the process" and how the proportion of total registered procedures has increased since the registry was established in 1993.The fact that no research has been completed might explain why no findings have been published. Surely the Minister will agree that, so far, it seems to be a case of activity for its own sake, rather than to serve a specific purpose. I wonder how the registry is informing the Government's policy. I should also like to know how much money has been invested in the registry. Perhaps the Minister will clarify that issue—if not now, then later, in writing. The registry does not so far seem to have been terribly good value for money.
The independent review group was established in 1997, to review all the evidence on possible health risks, and it reported in 1998. It identified various problems and made various important recommendations. The key issue is information and advertising. Hon. Members may have seen advertisements in various women's magazines, such as the one I am holding, which mention the "Natural look", "Natural feel" and "Natural push-up" of implants. There is nothing in the advertisements about the possible health and safety implications of implants. As a doctor told me, the results that are demonstrated in photographs in such advertisements are always perfect, whereas, as doctors accept, in many cases, the results can be anything but perfect.
What response has there been to the independent review group's recommendation that better information on implants should be provided? The Advertising Standards Authority and the Government are considering how best to deal with the matter, and they will seek to ensure that information on the risks of implant surgery is made readily available. However, it is another case of action in progress, but nothing delivered. The absence of advice for women on breast implants is a major stumbling block.
The independent review group also recommended that all patients undergoing surgery should be able to obtain free of charge comprehensive information from a designated body. I was told in the answer to my parliamentary question that such information would be available by the end of 1999, but that information has still not materialised. Will the Minister clarify when that freely and readily available information on the operation—to inform women of the risks, and perhaps of the financial costs—will be available to the general public? I have been told that information from the European Union on implants could be made available, but has been refused as inappropriate or not good enough for the United Kingdom. If that is not good enough, could we have something very quickly that is?
741 The Government banned soya bean breast implants one year ago, after reports of 74 adverse incidents among the 5,000 women who had received such implants since they were introduced in 1995. Apparently, they were banned in accordance with the precautionary principle. Perhaps the Government were concerned about genetically modified organisms in soya when they banned those implants on the basis of the precautionary principle, which is now being advanced as a reason for scaling down the use of genetically modified organisms.
The deputy chief medical officer commented last year:
The Medical Devices Agency has received reports of local complications in a small number of women who have trilucent implants. There has been no evidence of permanent injury or harm to health…However on the precautionary principle we consider that no more of these devices should be implanted.If those particular implants have been banned on the basis of the precautionary principle, there is at the very least a persuasive argument for the Government to ban silicone implants, as has been done in many other countries. I know that the Minister will not concede that today, but I hope that she will give me the modest assurance that the Government will agree to look at the matter again, perhaps with a greater degree of urgency than has been demonstrated so far. For my constituent, Dawn, and thousands of women like her, that is the very least that we can demand.
§ The Parliamentary Under-Secretary of State for Health (Ms Gisela Stuart)I thank the hon. Member for Carshalton and Wallington (Mr. Brake) for raising this issue, which is of great concern to many women who have, or are thinking of having, breast implants. I should also like to take the opportunity to express my sympathy for his constituent. No one underestimates or doubts the considerable distress that she has suffered.
Currently, there is much confusion about silicone breast implants and we are determined to get straight, evidence-based information, validated by Department of Health experts, to women and general practitioners, so that they can take appropriate decisions about their own health care—including women who have had implants and those who are thinking of having them.
The hon. Gentleman will know that a systematic review of the evidence is the way to get a rational debate on the issue. I am grateful for the opportunity to reassure him that the Department of Health does not just wish to be seen to be doing something about it, but is doing something and to share that information with the hon. Gentleman and the House.
Regulations are in place throughout Europe and they include essential requirements for safety and performance which apply to all medical devices, including breast implants. It is important to acknowledge that there are risks inherent is all medical procedures, but the regulations require that any risks associated with medical devices are considered acceptable when balanced against the benefits arising from the use of a device.
The Department of Health's Medical Devices Agency identified the breast implant device to which the hon. Gentleman referred—the one filled with soya bean oil rather than silicone gel—as possibly unsafe and it was 742 withdrawn from clinical use last year. In the same way, the MDA identified potential safety concerns several years ago in relation to polyurethane-coated breast implants and took steps to ensure that these implants were no longer used. When we first became aware of concerns in these cases, and in the case of silicone breast implants, we started by reviewing the available data and took action.
In the case of silicone gel breast implants, the data reviewed provided consistent reassurance that risks to patients were no greater than for other implants.
The possibility that silicone gel breast implants might cause connective tissue disease was first suggested in 1991. I shall not repeat the review process that the hon. Gentleman accurately identified. He also drew attention to the setting up in 1993 of the National Breast Implant Registry at Odstock hospital in Salisbury.
In spite of the reassurances, many women remained convinced that their breast implants may have been the cause of the debilitating illnesses they were suffering. Precisely because of those continuing concerns, one of the first actions the Government took when they came to power in May 1997 was to ask the chief medical officer to take a fresh look into the issues surrounding silicone gel breast implants.
The CMO set up an independent review group with the task of reviewing the possible health effects associated with silicone gel breast implants and the issues relating to pre-operative patient information examining.
The IRG is chaired by Professor Roger Sturrock, an internationally acknowledged expert in rheumatology. The findings of the IRG were published in July 1998, and I shall outline some of the actions that were taken as a result of those recommendations. I shall briefly summarise its conclusions. First, silicone gel breast implants were not seen to be associated with any greater health risk than other surgical implants. Secondly, the IRG found no evidence for an abnormal immune response to silicones or for any link between silicone gel breast implants and any established connective tissue disease.
Those conclusions are corroborated by the earlier assessments by the Department of Health, the American Medical Association, the Canadian Independent Advisory Committee, the National Science Panel appointed by the US federal court, and the Institute of Medicine of the US National Academy of Science. Importantly, the IRG also pointed out that the information provided to women undergoing breast implantation was of poor quality, and that that needed to be addressed.
The hon. Gentleman mentioned the recommendations made by the IRG and I shall take them step by step. In relation to information for patients and the consent required, the IRG recommended that information should be provided to patients about benefits and risks and the likely financial implications. It also recommended that a specific consent form should be developed, incorporating all the relevant issues. In response, we set up a small group led by Baroness Emerton of Tunbridge Wells to produce independent advice for women considering breast implants. A team comprising health care professionals, women who have had breast implants and representatives of other interested organisations—including the independent sector—has produced an information booklet. The booklet was issued widely for consultation—because it is important that we get it right—between July and September last year, and 100,000 copies will be 743 published at the end of the month. The booklet will be available through the NHS health literature line on 0800 555 777, the Health Information Service, NHS Direct and on the Department of Health website.
The IRG also expressed concerns about the control of advertisements. The Department of Health has discussed those concerns with the Advertising Standards Authority, and we are working with the ASA on the standards that we think advertisers should observe, with a view to involving the ASA in action against those producing materials for the public that could be misleading and dangerous to health.
The hon. Gentleman also mentioned adverse incidents and the Medical Devices Agency published guidance on the reporting of breast implant-related adverse incidents in 1999. That was circulated to plastic surgeons, to hospitals and clinics in both the public and private sectors and to manufacturers. It includes advice to manufacturers on which incidents they have, by law, to notify to the MDA. The guidance is also useful to plastic surgeons and other health service staff, who can report adverse incidents directly to the MDA's adverse incident centre. Over the past two years, we have spent some £50,000 investigating adverse incidents with breast implants.
In relation to standards of care, a Royal College of Surgeons committee, under the chairmanship of a leading plastic surgeon, Mr. Michael Brough, is now developing clinical guidelines for breast implant surgery. Those will also address the issue of consent.
The hon. Gentleman will also be aware that the Care Standards Bill, currently awaiting Report stage in the other place, will introduce a new framework and recommendations for control of the independent health care sector that will benefit women who use that sector by imposing clinical standards, complaints procedures and monitoring.
The IRG also recommended that registration of implants with the National Breast Implant Registry should be compulsory. In the UK, reporting by clinicians is an aspect of good professional practice rather than a legal requirement. The entry of data onto a registry also requires consent by the patient. Therefore, registration cannot be made compulsory.
The intent behind the IRG's recommendation can, however, be met by increasing compliance. Since 1994, more than 40,000 implants have been registered. It is important to note that the number registered in 1998 was almost four times the number registered when the register was established.
The cost of the national breast implant registry to date is £200,000. This year, the MDA has increased this level of funding by £20,000, to allow an increase in compliance monitoring.
The hon. Member for Carshalton and Wallington asked what had been done with that register. It is intended to be used as a research tool. There is no consistent picture from international research to date on local complications associated with breast implantation, such as rupture and contracture. That is why the Department of Health is planning a study to look at this, based upon patients registered in the first years of the breast implant registry. It is only now that we can use registry data as a basis for such research, as reliable answers on the incidence of local complications cannot be obtained until at least five years of data have been acquired.
744 We must wait even longer for any registry-based research into systemic diseases, such as connective tissue disease, since those diseases would not manifest themselves until about 10 years after implantation. However, between 2 million and 3 million women around the world are estimated to have received breast implants, and the IRG agreed that the question of the incidence of systemic disease has already been addressed by studies from North America and Europe.
Finally, the IRG recommended that a steering group be set up to organise research, and that new information should be kept under review. In March 1999, the Department of Health's research and development division established a steering group to monitor current research and to consider areas and approaches for new research of high scientific quality. The group includes a consultant plastic surgeon, an emeritus professor of immunology, a representative from industry and Professor Kent Woods, the chairman of the NHS health technology assessment programme.
In January, it considered the results of research on antibody tests carried out on Dutch women with silicone gel breast implants. The Dutch work is thorough, but so far it has failed to show any association between antibody test results and the degree of disability in the women examined. However, the IRG continues to meet about twice a year to review any new evidence related to its remit, and we are committed to continuing to respond to its recommendations.
§ Mr. BrakeI thank the Minister for giving way and, given the time, she may have to respond in writing to the questions that I want to ask. First, will she clarify whether the voluntary arrangement about reporting incidents requires patients' consent? Will personal details be stripped out of the information, so that an accurate picture can be built up about the problems associated with certain products?
Secondly, when will the Department complete the study using the register, and what will be its terms of reference?
§ Ms StuartI can tell the hon. Gentleman that the Royal College of Surgeons is reviewing the data consent form to ensure increased compliance. The terms of reference for the research based on that data have been framed to accommodate the fact that immunological data must be acquired over a period of 10 years.
I turn now to information available on the Department's website. The internet is a powerful tool, but it carries much unreliable information. The Department's website ensures that women have access to reliable information.
Finally, I can assure the hon. Gentleman that the Government's financial commitment to this matter is not inconsiderable. Since April 1997, we have spent in excess of £800,000 on the monitoring programme. That covers £450,000 for MDA staff time, £250,000 for the IRG, and £100,000 for the national breast implant registry.
The Government are determined that women should have access to reliable information, and to continue to research and monitor an issue that causes a lot of concern to women. Some of that concern may be unnecessary.
§ Question put and agreed to.
§ Adjourned accordingly at one minute past Three o'clock.