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 U.K.
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 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 the silicone gel breast implants are not associated with any health risk greater than that associated with other surgical implants. The hon Gentlemen said that we should take steps to ban implants if we cannot satisfy that they are 100 percent safe. I am sure that he will accept that no procedure will be 100 percent safe with any implant surgery. There will always be risks in any surgery, and therefore balancing those risks is an important consideration.
I agree entirely 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 the evidence base when we consider the risks to ensure that we get the balance right for the people who are contemplating any implant surgery.
The hon Gentlemen 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 U.K. 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 there 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 the 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. Its 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 breast, 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 Gentlemen asked about the consent form and about the data registry they get a copy of the entry, with all details about the batch and 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 affect. The Minister pointed out that the uncertainty of the life expectancy of implants, and said women would know that they have something inside of 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 if 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. Gentlemen also raised the specific issue of reclassification of devices under the European directive from class IIb 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 U.K. 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 sector. That will be in the best interests of women undertaking such surgery.
The hon Gentlemen 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 neccesary 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 the 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 Gentlemen 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 the 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 curretly approved implants. In the trilucent case, the manufacturer organised an implant removal programme, and I understand that 95 percent of women who received the implants have had them removed and there are only two hundred women in the country who still have them.
There have been a number of developments in breast implants. The hon Gentlemen 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.
this document is copied straight from the Hansard report
Lots of the views and opinions in it are not the same views and knowledge of silicone survivors!
If I had my way all breast implants would be banned there are 4 million women worldwide suffering from the effects of breast implants .the evidence is there for the UK Government they just don't want to see it