Select Committee on Health Appendices to the Minutes of Evidence


Memorandum by Russell Levy, and Olive Lewin and Nicholas Johnson on behalf of Leigh Day & Co, Solicitors (B 17)

  Leigh, Day & Co. was formed as a specialist personal injury law practice in 1987. The firm is committed to representing those who have been injured. The firm has a team of over 100 people, including 60 lawyers, based in London and Manchester. Several of the lawyers are members of the Law Society Specialist Personal Injury and Clinical Negligence panels. A number are also members of the AVMA (Action for Victims of Medical Accidents) Clinical Negligence panel.

  The firm, which is committed to carrying out high quality work for its clients, also campaigns for improvements in the law. Leigh Day & Co. tries to ensure that the rights of those who have been injured are debated in society. The firm has represented women involved in the US Breast Implant litigation since 1992 with over 400 clients since 1994. As a matter of policy, since 1992, the firm has only taken on as clients women who believe they have actually suffered documented injuries caused by their breast implants. Over 3,000 women who simply wished to register in the litigation were referred to other firms of solicitors. The women represented by Leigh, Day & Co have a very broad spectrum of illness ranging from general fatigue, lethargy and joint pain to crippling injuries and SLE. A high percentage had reconstructive rather than augmentative breast surgery.

Russell Levy

  Russell qualified as a solicitor in 1984, and joined Leigh, Day and Co. as a partner in 1991. His principle areas of practice since 1985 have been claimant clinical negligence and medical devices (product liability) litigation. He has been closely involved in many of the changes in clinical negligence cases and procedure over the past 15 years. He has written for various specialist publications and is a regular speaker on clinical negligence and other legal topics. He is the lead solicitor dealing with the Breast Implant cases at Leigh, Day & Co.

Olive Lewin

  Olive is a partner within the clinical negligence department. She has experience of working on complex medical claims and multi-party actions. Prior to qualifying as solicitor she was a registered general nurse, having trained at University College Hospital, London. Olive joined Leigh, Day & Co. in 1991, becoming a partner in 1998. She is responsible for the individual clients in the US Breast Implant Litigation team at Leigh Day & Co.

Nicholas Johnson

  Nicholas qualified as a doctor in 1983 at Charing Cross Hospital Medical School, London. He worked in general practice in Australia, becoming a Fellow of the Royal Australian College of General Practitioners. In 1995 he returned to the UK to retrain as a lawyer and was called to the Bar in 1998. Nicholas joined the clinical negligence team in January 2001. He has day to day responsibility for the management of the Breast Implant Litigation cases. Prior to joining Leigh, Day & Co. he was the medical support worker in the Lawyers Service at AVMA (Action for Victims of Medical Accidents).


  1.  "The primary task of the Medical Devices Agency (MDA) is to help safeguard public health by working with users, manufacturers and legislators to ensure that medical devices meet appropriate standards of safety, quality and performance and that they comply with relevant Directives of the European Union." [10]

  It is our view that in the context of silicone breast implants the Medical Devices Agency has not satisfactorily discharged its duties as defined in the mission statement.

  2.  The Independent Review Group (IRG) concluded in 1998 that there was insufficient epidemiological evidence for any link between silicone gel breast implants and any established connective tissue disease. The group did recognise that there were a number of complications such as capsular contracture and gel bleed associated with breast implantation. Unfortunately the IRG did not address the issue of whether or not the various manufacturers of breast implants had provided safety data of a standard acceptable to the MDA to enable continued marketing of their products within the United Kingdom.

  3.  Attached is a statement by Russell Levy to the United States' National Academy of Sciences' Institute of Medicine in August 1998. Regrettably, the concerns expressed in that statement in relation to the constraints placed by the IRG on its role and its consequent findings remains.

  4.  The MDA appears to be using the findings of the IRG as the basis of its continuing permission for these products to be marketed. This decision is in direct contrast to the position adopted by equivalent agencies in other jurisdictions.

  5.  In 1991 the Food and Drug Administration (FDA) in the United States requested the manufacturers of silicone gel implants to submit evidence in a pre-market approval (PMA) application that silicon gel-filled breast implants were safe and effective. This evidence has never been provided and in the absence of enough data on safety and effectiveness the FDA determined that silicone gel-filled breast implants could not be approved. The current position in the United States is that these products are only available to women through FDA approved studies:

    —  an adjunct study;

    —  an investigational device exemptions (IDE) study.

  These provisions allow women who are seeking either breast reconstruction or revision of an existing implant to use these products. Silicone gel-filled implants are not available to women who are undergoing breast augmentation for cosmetic reasons.

  6.  The position in New Zealand is that although silicone gel-filled implants are still available, the government has issued an unequivocal statement to the effect that the use of breast implants is not endorsed, and that the safety of such implants cannot be confirmed or refuted.

  7.  In Canada the only implants available are saline filled implants. In 1992 following concern about the safety of silicone gel-filled implants a voluntary moratorium was imposed on their use. To date the manufacturers have not filed any applications demonstrating the safety, quality and effectiveness of their products. As a consequence none of these products can be sold legally as they have not obtained a Notice of Compliance from Health Canada.

  8.  In Australia breast implants are regarded as therapeutic goods under the terms of the Therapeutic Goods Act (1989) which came into force in 1991. When this Act was implemented silicone gel-filled breast implants were entered onto the Australian Register of Therapeutic Goods (ARTG) as "grandfather status" low risk devices. In 1991 following concerns about these products the manufacturers were advised that the status of these products would be changed from low risk (Listed) to high risk (Registrable) devices. The manufacturers and suppliers were informed that adequate data supporting the safety of silicone gel-filled implants would need to be supplied to the Therapeutic Goods Administration (TGA) by 31 January 1992 if they wished to continue marketing these devices. At the time, no manufacturer or supplier had such information and there are still no silicone gel-filled breast implants on the ARTG. Silicone gel-filled breast implants cannot be legally supplied in Australia, except on an individual patient use (IPU) basis under certain circumstances.

  9.  It is our understanding that the MDA has not sought adequate safety data from the manufacturers for these products, nor attempted to impose any restrictions on their use until this safety data has been provided. We would remind that Committee that in the US, Australia and Canada manufacturers have not made any significant attempt to re-enter the market and would respectfully suggest that the Committee draws the inference that it is possible that the manufacturers themselves have doubts about the safety of their products. It is in any event clear that the manufacturers are unable to demonstrate the safety of these products.

  10.  The MDA has taken an inconsistent approach to the licensing of breast implants. Trilucent implants were approved for use in the United Kingdom by the MDA. Following concerns about the lack of long-term safety data for this product, particularly in relation to the breakdown of the lipid filler, the MDA required the manufacturer to carry out further toxicological testing and provide further safety data. It is not clear why the MDA has been unable to adopt a similar approach in relation to silicone gel-filled breast implants. The MDA say that they have taken action to prevent the use of Trilucent breast implants because there is insufficient evidence as to their safety. The MDA continue to say that they see no need to take action to prevent the use of silicone breast implants because there is insufficient evidence that they are unsafe. We do not understand the difference.

  11.  Tracking adverse incidents is an important function of the MDA. In contrast to comparable organisations overseas the MDA does not appear to welcome reporting of adverse incidents from lay people. This view is supported by the experiences of a number of our clients when attempting to report problems with their implants to the MDA.

  12.  The information booklet provided by the FDA provides full details on how to contact the FDA and report adverse events. The booklet provided by the TGA in Australia positively encourages lay reporting, emphasising the importance of being able to track the types of problems experienced with individual implant types.

  13.  The booklet produced by the Department of Health mentions the MDA but does not provide contact details.


  14.  The MDA is charged with collecting and analysing information relating to adverse events. On this basis it is our view that the MDA is the most appropriate organ for disseminating information relating to risks associated with medical devices. The MDA has demonstrated with Trilucent that it is able to provide appropriate information, both to the medical profession and patients, concerning the risks of a medical device. This activity is to be applauded, but at the same time we are of the view that the MDA can take steps to improve its interface with the general public. The experience of a number of our clients in attempting to report adverse events is worrying. The FDA in the United States and TGA in Australia both actively encourage patient reporting of adverse events. It is our view that much could be achieved if the MDA were to follow the lead of these organisations.


  15.  The IRG recommends that all patients undergoing cosmetic breast augmentation surgery should be able to obtain, free of charge, from a designated body, comprehensive information about the benefits and risks of such surgery. This information should be accompanied by a checklist of topics, which should be covered when the possibility of an operation is discussed. [11]

  16.  It is our view that this recommendation has only been partially addressed. A common complaint of our 438 clients concerns the lack of Information provided to surgery. The IRG recognised that the information provided to women to assist them in making informed decisions about whether to proceed with breast implant surgery was frequently inadequate, in terms both of quality and quantity.

  17.  The IRG held an Open Day on 5 October 2000 when the progress on its recommendations was reviewed. With regard to the recommendation concerning provision of information, the IRG noted that an advisory group had produced a booklet for women considering breast implant surgery. This can be obtained from the Department of Health website. We have reviewed the information provided in other jurisdictions and would consider that the Department of Health booklet is less informative than similar publications available in other jurisdictions. The Department of Health booklet consists of thirteen pages of notes and tables. In contrast the information provided in the United States is considerably more detailed, but at the same time user friendly. The approach is fair and balanced, and a bibliography of the sources of information used is provided. Sample questions women contemplating breast surgery may wish to ask are provided in contrast to the checklist provided by the Department of Health. Adequate advice is given on how to contact the FDA and how to report adverse events.

  18.  The TGA in Australia has also produced a comprehensive booklet for persons considering the use of silicone gel-filled breast implants. This booklet is far more detailed than that available from the Department of Health.

  19.  Although the Department of Health booklet does discuss the risks of breast implant surgery it is our view that these risks are somewhat understated. It would be preferable for information of the type available in Australia and the United States to be available. The IRG has recommended that comprehensive information about the benefits and risks of breast augmentation surgery should be available. It is our view that although the current information is an improvement on what was previously available, it does not comply with the IRG recommendation.


  20.  Current guidance to health care professionals focuses on the findings and recommendations of the IRG. Our view is that undue emphasis has been placed on the lack of any demonstrable link between silicone gel-filled implants and connective tissue disease. Insufficient attention has been paid to the lack of safety data provided for these products. Despite the fact that silicone gel-filled breast implants have been marketed for over 30 years, manufacturers have organised no long term research or trials. We suggest that the IRG and the MDA have failed to attach to this failure the significance it warrants.

  21.  We would welcome a statement outlining the position of the MDA in relation to the lack of safety data, research and testing being included in guidance provided to health care professionals in relation to silicone gel-filled breast implants.

  22.  If as we believe, the position regarding the provision of safety data in the United Kingdom is no different compared to Australia, New Zealand, Canada and the United States then the MDA should state whether or not it intends to request that the manufacturers provide this information. If the MDA does not intend to request this information then any guidance issued should explain why the MDA has decided that this information is not required.

  23.  The MDA should also be encouraged to give guidance on the relative and absolute contraindications of all types of breast implants, and if silicone gel-filled implants are to continue to be marketed in the United Kingdom guidance should be issued as to the circumstances in which they may be used. We refer again here to the guidance issued by the FDA and TGA.


  24.  In 1994 when we first raised concerns about the then Medical Devices Directorate's approach to the safety of silicone breast implants our correspondence was immediately passed to the Department of Health's solicitor. His answer was that he had advised Dr Ludgate "...that it is not appropriate for either her or I to become involved in a lengthy dialogue with you about this, that or the other piece of scientific evidence..." Regrettably, this refusal to delve into issues put forward by women who believe they have suffered injuries from their silicone breast implants and those representing them has continued. Since the first position paper published by the Medical Devices Directorate in 1993 the view taken by the MDA has been that there is insufficient evidence for an association between the implantation of silicones and connective tissue (and other) diseases. Accordingly, no action restricting the use of silicone implants has ever been taken. The conclusion we believe the Committee has to draw is that, as unpalatable as it may seem, the main objective of the MDA since 1993 has been to stand by their initial view, thereby justifying their inaction, rather than to protect and inform women contemplating undergoing silicone breast implant surgery.

15 March 2001

10   Medical Devices Agency mission statement. Back

11   Silicone Breast Implants: Report of the IRG, 1998 (Recommendation1). Back

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