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2.46 pm

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

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withdrawn from clinical use last year.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

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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.

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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.

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