Select Committee on Health Appendices to the Minutes of Evidence

Annex 1

Statement of Russell Levy to the National Academy of Sciences' Institute of Medicine, review of the safety of silicone breast implants

  I am a solicitor and partner with Leigh Day & Co. We are specialist medical, environmental, product liability, occupational health and industrial disease lawyers. I have acted on behalf of women concerned about the safety of silicone breast implants since 1992 and represent 450 women from all over the United Kingdom (a few of our clients live in other European countries or the United States) who have suffered illnesses or injuries that they believe were caused by their silicone gel breast implants. In this statement I will confine myself entirely to important issues that I believe the panel needs to consider when evaluating the contribution made to the debate by the recently published report of the Independent Review Group (IRG) to the United Kingdom Government's Chief Medical Officer.

  Like other people interested in the field I warmly welcomed the incoming Government's decision to set up a group to review the possible health risks associated with silicone gel breast implants. However, it became apparent from a very early stage that the IRG's focus was to be largely upon consent issues and that it was structured in such a way as to make an in-depth review most unlikely. In the end, I regret to have to say that the report is essentially nothing more than a glorified literature review. The IRG took oral evidence from only 18 people of whom I was one. The only specialist doctors or scientists who have been concerned about the health risks associated with silicone on behalf of patients who gave evidence were Professor Garry and Professor Shanklin. Offers made by me and others to arrange for other eminent experts from the United States to give evidence to the IRG were not taken up. I am not aware of any steps taken by the IRG or the Medical Devices Agency of the Department of Health (the MDA) to seek out scientists or doctors from whom they believed evidence should be obtained; the process, I believe, was essentially a passive one, with the IRG only considering taking evidence, on the whole, from those who offered.

  What the panel should know is that contrary to media reports and the way in which their conclusions have been represented by the manufacturers of silicone implants and plastic surgeons, the IRG did not conclude that silicone implants are safe. It concluded that there is at present insufficient evidence of a link and recommended further research.

  Although the IRG states it considered written evidence, again, so far as I am aware, no public appeal was made for people to submit evidence to it. I provided the IRG with an anonymised list setting out the symptoms each of our clients complains of with an offer for the IRG to select for themselves those women whose medical charts they wished to review or whom they might wish to have examined and speak to. The offer was declined; instead the IRG took evidence from only three representatives of silicone support groups. The IRG did not solicit plaintiff and defence submissions to the rule 706 panel appointed by Federal Judge Pointer—I gave these to them.

  The IRG comprised six doctors and one lawyer. My understanding is that for all of the members this was a part-time appointment carried out in conjunction with their other usual appointments and duties. The report lists nine advisers who "were asked to consider specific information". The IRG was also assisted by a secretariat provided by the MDA. The extent to which the members of the IRG themselves considered the evidence rather than relying upon the interpretation of others is unclear. What is clear, however, is that this was not an exhaustive investigation carried out by the members of the IRG.

  Limited literature reviews in relation to the possible association between silicone gel implants and connective tissue disease were carried out by the Medical Devices Directorate which subsequently became the MDA. [12]The 1993 report was authored by Tinkler, Campbell, Senior and Ludgate and the 1994 article by Tinkler, Gott and Ludgate based on a study by Tinkler and Gott. They came to the conclusion that there was insufficient evidence of an association between implants and connective tissue disease which, crucially, became the basis for the United Kingdom Government's decision not to take any steps to regulate the use of silicone gel-implants.

  Three of the four members of the secretariat provided by the MDA to the IRG were Dr Gott, Dr Ludgate and Mr Tinkler. There is no doubt that their minds were made up before the IRG started its work—attached is a copy letter from Mr Tinkler to one of my clients dated 5 August 1997. [13]In particular I would draw your attention to the first paragraph where Mr Tinkler states:

    "Thank you for your letter.. enquiring about the position of the Medical Devices Agency on silicone gel breast implants. I enclose a copy of a summary of the Agency's views... Unfortunately we have not had time to update this since April, since when the Minister of Health has asked for a further review of the subject. This will concentrate particularly on the issue of the provision of appropriate advice to women contemplating surgery, since conclusions about the health risks relating to silicone are now fairly well established." (My emphasis)

  When I was called to give evidence, the IRG wanted to focus exclusively on consent issues. They were surprised when I insisted that whilst consent issues were important, the real issue that needed to be addressed was whether there is sufficient evidence as to the safety of silicone implants. The evidence given by the other plaintiff's lawyer who appeared before the IRG, Mr Paul Balen, focused almost entirely on consent issues. If the panel wishes copies of the transcripts of the evidence can be submitted.

  The IRG recognised the paucity of good evidence. They failed to consider why that should be so given that the products have been marketed for over 30 years and manufacturers have had more than ample opportunity to obtain good evidence. Regrettably, the IRG was only prepared to recommend limited research into the true incidence of rupture and the aetiology of symptoms in particular in relation to sub-clinical infection. It decided, effectively on a cost benefit analysis, that it could not justify recommending further epidemiological studies to investigate any link between silicone implants and connective tissue diseases even though it recognised that the majority of reported cohort studies were based on a diagnosis reported by a doctor and referred only to specific diagnostic groups. Although the IRG were not prepared to recommend further research, on the checklist of issues they suggest plastic surgeons must discuss with patients considering cosmetic breast augmentation surgery the "possible association between silicone and generalised illness such as connective tissue disease or autoimmune effects or a new connective tissue disease like syndrome" is included.

  It is also regrettable that the IRG includes only one specialist plastic surgeon who has himself continued to use silicone breast implants throughout the period of the review and only one epidemiologist who had himself previously published summaries of epidemiological studies concluding that there was insufficient evidence that silicone implants were unsafe. When I gave evidence to the IRG the epidemiologist, Professor Silman, stated "... one is always left with the anxiety is one dealing with the complication of an implant or the complication of being the kind of woman who subject herself to an implant."

  My own major criticism is of the approach that has characterised the United Kingdom Department of Health's view in relation to silicone gel implants throughout this decade: there is insufficient evidence that silicone implants are unsafe rather than seeking sufficient evidence of safety. I was not successful in persuading the IRG that if the manufacturers could not show that their products were safe after more than 30 years, the public interest demands a very cautious approach to the use of those products. The IRG felt that..." is not a simple concept..." Essentially their report concluded no more than the previous Medical Devices Directorate reports that there is insufficient evidence of an association between silicone gel implants and abnormal auto-immune responses and connective tissue diseases. Media in the United Kingdom, including those who should know better[14]almost universally reported the IRG conclusion as demonstrating that silicone implants are safe. Most regrettably, the IRG took not steps whatsoever to caution members of the public that this is by no means necessarily so.

  If there is any information that the panel would like I would, of course, be more than happy to assist further.

27 August 1998

12   see for example MDD report/92/42 February 1993 and Health Trends Volume 26 No.1 1994 p25. Back

13   Not printed. Back

14   "UK review group gives silicone implants all clear" The Lancet Volume 352 July 18 1998. Back

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