Select Committee on Health Appendices to the Minutes of Evidence


Memorandum by Christine Williamson (B 6)

  I write this submission as one who has severely suffered as a casualty of the confusions which surround the breast implant issue. My evidence is based on the experience I have gained during my voluntary task over the past four years of running a help line for the many, many casualties who are confronted with the greatest of difficulties when things go wrong. This task has become increasingly demanding, to the extent that I have neglected my own legal pursuit and aspects of my personal life. I am unable, therefore, to write a lengthy account here; but I will make the following comments:

  Ideally, I would hope to see a moratorium on silicone gel devices in line with the situation in the USA. If this cannot be achieved, and in the case of all breast implants, I would like there to be a compulsory (rather than voluntary) register from which research could be realistically drawn. I gather that this, for reasons of confidentiality, cannot be done at present. But surely some kind of system using numbers, rather than names and thus protecting the patient's confidentiality could be devised? Such a system would enable government to obtain precise figures on implantations, explantations, ruptures and other complications regarding these dangerous and unreliable medical devices, which have such a relatively short life span. Anything less than a compulsory register is useless. As things stand, it is all the more necessary for there to be something firmer than mere guidelines to require that people wishing to undertake breast implantation be presented with a full body of information including the risks and the numbers of patients reporting disease symptoms and other complications. In terms of communication/information, a reform in the attitude of doctors who encounter patients with problems would be helpful, as well as an improved willingness for doctors to report and confer on these problems.

  Last year, I was included in the NHS working party which devised a Breast Implant Patient Information booklet in line with recommendations by the IRG. Those of us in the group who, as casualties and campaigners, were very concerned about the risks involved were, naturally, in the minority, but we fought our corner to get something of the risks included in the booklet. However, some of the people who read draft copies did not seem to have really absorbed the comments on risks involved. It seems to me, then, that this aspect should have been far more greatly stressed in the booklet. Some of the people who ring me are those contemplating breast implantation. People who desperately want to have this operation are only too ready to ignore any but the boldest of warnings about risks. It is worth mentioning that although the booklet was published at the beginning of October 2000, nobody I have spoken with on the help line has so far been presented with it by a surgeon or by anybody.

  I recently accessed the minutes of the Independent Review Group Meeting. I was surprised to read (item 8 see attached extract) [1]that the MDA were claiming a lower number of reports of adverse incidents than previously submitted to them. This makes me think that there must be some great gap between the number of reported adverse incidents and the number of actual adverse incidents. Over the past year, I have spoken with some 2,000 callers on my help line. A portion of these are women who are contemplating implants for the first time and want to hear the pros and cons. But by far the greatest number are those who are having problems, some of them severe, including leaked silicone into glands under the arms, inflammation and serious debility. This involves the need for removal of ruptured implants. A number of women, even though they are in pain and unwell will want to have their ruptured implants exchanged for new implants. I have sometimes advised people to report to the MDA and the registry if they know they have a ruptured implant. I am not sure whether or not this suggestion is taken up. In any case, so many of us have had frustrating experiences with the MDA, that it is difficult to recommend it with any conviction. It must be the case that plastic surgeons are not reporting adverse incidents to the MDA. I believe, too, that the MDA has not sufficiently gone out to invite reports. Our impression has been that the MDA does not want there to be a problem and this affects their inadequate PR. One official will contradict another sometimes when we make queries.

  I believe most strongly that the information offered by patients themselves on the problems with breast implants has not been sufficiently taken on board by either the IRG or the MDA. Casualties are a source of information which needs to be genuinely heard and circulated amongst medical professionals. One of the examples of the way in which this clearly was not happening was at a meeting of plastic surgeons into which I and some other casualties managed to gain access in November 1998 at the Institute of Medicine. The form of "information" at this meeting at which a lecture was given by a lawyer paid by the manufacturers, was little more than a sales promotion exercise, this at the expense of patients who were represented as silly or hysterical. So long as methods such as this are acceptable as a form of the circulation of information amongst medical practitioners, it seems that there is a long, long way to go before any balance of information can be redressed.

1   Not printed. Back

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