Select Committee on Health Fourth Report


The Health Committee has agreed to the following Report:—



1. Debate about the safety of breast implants - and in particular of silicone gel breast implants - has raged for decades. Most of the peer-reviewed scientific papers assessing the risks of breast implants have failed to find associations with particular diseases.[8] On the other hand, there is a very substantial (and growing) body of anecdotal evidence from women who maintain that they are suffering illnesses - often extremely debilitating illnesses - which they ascribe to breast implants.[9] And some doctors also back these claims.

2. We did not feel qualified to enter the debate about the safety of breast implants. Moreover, we fully accept that many women will be pleased with their decision to have breast augmentation surgery and will feel it has boosted their self-image. We were, however, concerned that women undergoing surgery for breast augmentation should make an informed choice about the consequences of the procedure, and should not undergo unnecessary surgery. With this in mind, on 6 February we announced our intention to hold a single oral evidence session on "The Provision of Information by the Government Relating to the Safety of Breast Implants". Our terms of reference were as follows:

The Committee will consider

  • The role of the Medical Devices Agency
  • The process whereby information relating to risk is disseminated
  • The information provided by the Department of Health directly to the public and action taken in response to concerns raised
  • Guidance to health care professionals

Please note: The Committee will not be in a position itself to assess evidence as to the safety or otherwise of particular types of breast implant.

3. We took oral evidence on 22 March from: Professor Roger Sturrock, Chairman, Silicone Gel Breast Implants Independent Review Group; Mr Paul Balen, head of medico-legal and product liability unit, Freethcartwright Solicitors, Ms Rose Irwin and Ms Brenda Livsey, Action Against Silicone Gel-UK (AASGUK), Maxine Heasman, Founder, The Breast Implant Information Society; and Gisela Stuart MP, Parliamentary Under-Secretary of State, Dr Pat Troop CBE, Deputy Chief Medical Officer, Department of Health (DoH) and Dr Susanne Ludgate, Medical Director, Medical Devices Agency.

4. We also received around 20 written memoranda which were invaluable in our discussions. We are grateful to all those who have submitted written or oral evidence.

5. In our inquiry we were ably assisted by Professor Carol Black, Royal Free and Medical University College Medical School and Mrs Sandra White, Royal College of Nursing, Breast Awareness Unit. We are extremely grateful to them for sparing time to assist us in a complex inquiry. Their advice has been most helpful.

History of breast implants

6. The first attempts to alter and enhance the shape of women's breasts occurred in the early years of the Twentieth Century when doctors attempted to transplant fat from other parts of women's bodies to their breasts. These operations failed, since the body simply reabsorbed the relocated fat.[10]

7. In the 1930s, scientists developed silicone,[11] a long thin flexible polymer and in 1943 two American corporations, Dow Chemical Company and Corning Glass Works, joined forces to find uses for silicone as a substitute for rubber. The new company, Dow Corning, developed silicone gel.

8. In the 1950s scientists first envisaged the potential for silicone to be used as a means of breast augmentation. Originally the substance was injected directly into women "with disastrous results".[12] Serious medical complications ensued. Eventually, a silicone envelope was created which contained the gel and today all types of breast implants, whatever their filling, rely on an outer silicone envelope.

9. Widespread marketing of breast implants began in the 1960s. No figures are collated centrally, and most operations take place in the private sector making reliable data difficult to obtain, but it is estimated that in the UK about 10,000 women undergo breast enlargement annually,[13] making this "the most common cosmetic procedure performed on women in the United Kingdom".[14] Worldwide, over 1.8 million women have had silicone breast implants since 1962, in most cases for cosmetic reasons,[15] but sometimes as a consequence of reconstructive surgery following mastectomy.

The Operation

10. Breast implants are always performed under general anaesthetic. The surgeon makes an incision either in the armpit, around the lower half of the areola, or on the underside of the breast. An implant is inserted either just in front or just behind the muscle of the chest wall. A tube may be left in the breast for a day to drain blood and fluid.[16]

Types of breast implants and the history of their use in the UK

(a) Silicone Gel

11. These comprise 80%[17] of the implants currently chosen. There have been three generations of silicone gel breast implants. These are described in a memorandum from Professor David Sharpe, Consultant Plastic Surgeon, writing on behalf of the British Association of Aesthetic Plastic Surgeons (BAAPS):

"The first manufactured from 1963 to 1975 had a thick wall and contained silicone gel, few of these ruptured and many are still in place today without problems. The second-generation implant from 1975-86 was fundamentally flawed, had a thin wall and 50% of these ruptured within 15 years. I have personally dealt with a large number of them and recently published a paper in the American Journal of Plastic and Reconstructive Surgery of 482 the largest personal series in the world. The consequences of rupture were in every case insignificant and easily dealt with although one or two of these cases required some resection of breast tissue. The third generation implants from 1986 onwards have much thicker shells and have very much lower rupture rates. I have used 1500 in the last ten years of which I have operated on 150 for reasons of capsular contracture,[18] concern regarding the silicone controversy and for change of size. In only two of these were there any rupture, none of which entered the breast tissue."[19]

12. One might in passing note the use of that word "insignificant" as regards the consequences of rupture in respect of the second generation implants. Professor Sharpe is speaking in purely medical terms, but several of the memoranda from women affected point to the distressing nature of both rupture and techniques for dealing with hardening of the implant.

(b) Saline

13. The only other type of implant currently licensed for use in the UK, and the only type licensed for normal use in the USA and Canada. The silicone envelope is filled with a salt water solution and can be supplied ready filled or filled after insertion via a valve.[20] According to the Which? Guide to Women's Health, "saline implants have a tendency to wrinkle and the wrinkles may show through the skin. Some 10% of saline implants rupture and then need to be removed".[21]

(c) Soya

14. Marketed as the natural safer alternative to silicone, soya bean oil filled implants were also held to have the advantage of letting X-rays through, making mammograms easier to perform. They were manufactured by a Swiss company Lipomatrix Inc and marketed in the UK by Collagen Aesthetics UK Ltd., a subsidiary of an American company, under the trade name Trilucent, since about 1993. When licensed for use, these implants were chosen by about 15% of women. Although invented in the US these implants were never licensed for use there but were licensed for use in the UK via the EU (see below for licensing procedure). Following safety concerns, these implants are now banned in the UK (see below paragraph 55).

(d) Hydrogel

15. Hydrogel implants are the least common of all, made up of water, sugar and salt. These implants were intended to create a more natural effect than ordinary saline implants. It was also held that the body would naturally excrete any filling that leaked. Until their withdrawal in December 2000 on safety grounds (see below paragraph 62) two companies, PIP of France and NovaGold of Germany, supplied products in the UK. Approximately 4000 women received the PIP implants and 250 those from NovaGold.[22]

Health Risks and their Reviews

16. Although it is not part of our remit to assess the safety of particular breast implants, issues relating to the extent of patients' awareness of risk can only be understood in the context of the wider debate. Concerns have been voiced by both clinicians and patients for many years as to the potential health risks of breast implants. Between 1988-90 the Medical Devices Agency (MDA) reviewed carcinogenicity data on silicone gel and referred this to the DoH Committee on Carcinogenicity who concluded that the risk to humans was "remote".[23] In 1991 the MDA reviewed the potential carcinogenicity of the polyurethane coating applied to some breast implants and concluded that the risk was "theoretical but low" and issued advisory notices to this effect. Meanwhile, in the USA the Food and Drug Administration (FDA) imposed a moratorium in 1992 on silicone gel breast implants pending further research on the issue, restricting their use to clinical trials and for patients undergoing reconstructive surgery following mastectomy. This moratorium remains in place, and similar restrictions apply in Canada and Australia. It was in the context of these concerns that a flood of lawsuits was initiated against the manufacturers of silicone breast implants, leading to Dow Corning filing for bankruptcy in 1996.

17. From 1992 onwards the MDA started to review a hypothesised link between silicone gel breast implants and other diseases. It referred its report to a "specially convened Independent Expert Advisory Group" (IEAG) which concluded "there is no evidence of an increased risk of connective tissue disease in patients who have undergone silicone breast implants and therefore no scientific basis for changing practice or policy in the UK".[24] This assessment was based on meta-analysis of published data, not original research on patients. The IEAG continued to advise the DoH until 1997. The National Breast Implant Registry (NBIR) was set up in 1993 in response to a recommendation from the IEAG. The aim of the NBIR is to provide a comprehensive record of breast implant operations carried out in both the private and the NHS sectors in the UK. MDA funds the NBIR and acts as secretariat of the NBIR Steering Group, which was set up in 1999 to advise MDA on the management of the Registry and the use of the data. A pilot study using NBIR data, designed in the light of the IRG's recommendations, has been commissioned. The NBIR was criticized in several of the memoranda in that data is only supplied to it on a voluntary basis, though the DoH/MDA assured us that this was for legal reasons, owing to restrictions imposed by human rights legislation.[25]

18. In 1997, following the General Election, the then Minister of State in the Lords, DoH, the Baroness Jay of Paddington, responded to repeated concerns about silicone-gel breast implant safety by setting up the Silicone Breast Implants Independent Review Group (IRG). The IRG's remit was to:

"Review the evidence relating to the possible health risks associated with silicone gel breast implants, to examine the issues relating to pre-operative patient information, and to report to the Chief Medical Officer."[26]

Under the chairmanship of Roger Sturrock, Professor of Rheumatology at Glasgow University, the Review Group took both oral and written evidence. The IRG published its report in July 1998. Its overall conclusions were:

  • There is no histopathological or conclusive immunological evidence for an abnormal immune response to silicone from breast implants in tissue.

  • There is no epidemiological evidence for any link between silicone gel breast implants and any established connective tissue disease. If there is a risk of connective tissue disease, it is too small to be quantified. The IRG cannot justify recommending further epidemiological studies to investigate this hypothesis.

  • Good evidence for the existence of atypical connective tissue disease or undefined conditions such as 'silicone poisoning' is lacking. It is possible that other conditions such as low grade chronic infection may account for some of the non-specific illnesses noted in some women with silicone gel breast implants.

  • The overall biological response to silicone is consistent with conventional forms of response to foreign materials, rather than an unusual toxic reaction.
  • There is no evidence that children of women with breast implants are at an increased risk of connective tissue disease.

  • The IRG recognised that there were issues such as the precise incidence of rupture where the scientific data were incomplete so that rigorous conclusions could not be drawn.[27]

19. In contrast to these findings is the substantial body of anecdotal evidence from women that breast implants have caused them debilitating illness. Dr Sarah Myhill, a GP with a particular interest in chronic fatigue syndrome, offered evidence largely at odds with the findings of the IRG. She estimated that 100 of the 1500 chronic fatigue syndrome sufferers she had dealt with suffered as a result of breast implants:

"The problems from which patients suffer in order of importance are:

  • Chronic fatigue syndrome characterised by severe physical fatigue, wide-spread muscle pain and symptoms of early dementia caused by systemic leakage of silicone.
  • Implant hardening - this is often treated by surgeons who crush the breast with its implant between their hands thereby rupturing the implant and accelerating other problems
  • Autoimmune disorders causing severe arthritis
  • Nerve damage such as peripheral neuropathy and multiple sclerosis
  • Spontaneous implant rupture resulting in local migration of contents. 50% of implants are ruptured at 12 years, 95% at 25 years."[28]

20. Representatives of Action Against Silicone Gel-UK (AASGUK) who gave oral evidence to us, claimed that they were in no doubt that silicone breast implants had ruined their health, that they were aware of thousands of cases of women who had had similar experiences, and that a growing number of doctors were breaking ranks from the received line that silicone was safe. Ms Rose Irwin, a founder Member of AASGUK described the problems she had faced:

"After a time, the implants grew old, some 12 years in my case, and I felt what I thought was a sensation of rupture or leakage or something that I had not felt before ... I developed symptoms some months later which became, to cut a long story short, classified as ME: tingling in the fingers, joint pains and so on."[29]

Ms Irwin visited a plastic surgeon who performed a closed capsulotomy, manually pressing the hardened implants to soften them. She then reported bruising, swollen lymph nodes, lumps and illness. Following an X-ray, she discovered both implants had ruptured. Following explantation of the implants, her health gradually improved. Ms Irwin assured us that her case mirrored those of many other women worldwide. She told us that Christine Williamson who ran a support helpline for "silicone survivors" had over a thousand women on her books.[30]

21. We put it to Professor Sturrock that there appeared to be a contradiction here between his scientific assessment that there was no association between breast implants and negative disorders and the accounts of women convinced their illnesses were due to implants. He replied that some women might be suffering as a result of pre-existing psychological conditions, whilst many of the symptoms mentioned "would fit with the presence of low grade infection", an area that his Committee had recommended required further research.[31]

22. Turning from the fundamental health debate over silicone gel implants, the IRG made a number of other recommendations and called for better provision of information to women. They wanted tighter regulation of private clinics where most operations took place; they sought compulsory registration of implants and explantations at the National Breast Implant Registry; they urged that all breast implant related adverse incidents should be reported to the MDA who should issue guidelines to clinicians on which incidents should be reported; and they called for further research on the incidence of rupture and the aetiology of symptoms exhibited by women who had received implants, in particular to elucidate the role of sub-clinical infections.

23. The IRG said it would continue to meet to consider any new evidence on issues relating to breast implants or associated health concerns. In October 2000 they held an Open Day to give members of the public and other interested parties an opportunity to submit new evidence and put questions to the Group. Action Against Silicone Gel UK, in oral evidence, was critical of this meeting, claiming that Professor Sturrock had reneged on a commitment to provide follow up answers to questions not covered at the meeting.[32]

Why women choose to have breast implants

24. According to the IRG, four groups of women seek breast enlargement:

25. The Breast Implant Information Society has conducted market research by sending out detailed questionnaires to women who have had breast implants. These women gave the following reasons for undergoing surgery:[34]

Reason cited


To feel more confident

To feel feminine

To have a proportionate figure

To feel normal

To regain bust size and shape after pregnancy

To attract attention from men

To have a large bust

To stop partner noticing other women

To make partner jealous










26. The fact that a lack of confidence is the single most persuasive factor ties in with our more general findings in our recent inquiry into The Regulation of Private and other Independent Healthcare. In that inquiry, we were impressed by evidence put forward by the charity Changing Faces which suggested that the main reason people sought appearance-enhancing treatments was that they perceived their current appearance to be the cause of their low esteem.[35]

27. The DoH information booklet Breast Implants: Information for Women Considering Breast Implants (2000) deals with this crucial issue only in the most glancing way:

"Breast implants can bring psychological benefits for women who may feel that their breasts are unwomanly and inadequate. They can help restore lost self-esteem and improve the quality of life. However, you should think carefully about your reasons for having implants and be sure that breast implants are the best solution. Your surgeon will wish to explore with you the psychological aspects of having breast implants."

28. This analysis begs as many questions as it answers. It is indeed the case that many surgeons will discuss with women undertaking surgery their motivations but many more will not. The Breast Implant Information Society found that 11% of women surveyed did not even meet their surgeon until the day of surgery, a fact we find appalling. The Department's booklet, in its list of contact addresses at the end, offers no psychological counselling services.

29. Undoubtedly, one of the pressures on women to undergo breast augmentation lies in societal pressures to conform to a particular 'type' of appearance. Substantial advertising of breast augmentation is targeted at young women in style and fashion magazines. Brenda Livsey of AASGUK told us that in her view breast implants were now regarded as merely a "fashion accessory".[36] We sent a batch of advertisements for breast enlargement all taken from a single recent issue of a young woman's style magazine, Marie Claire, to the Centre for Social Marketing at the University of Strathclyde, and asked the team there for their views on what the advertisements were targeting. We provide their analysis in the box below:

The ads combine the imagery of BUPA with that of Estee Lauder. The former emphasises medical respectability, scientific provenance and health rather than salesmanship. The aim is to reassure that procedures are safe, effective and have the backing of the medical establishment. Note, however, that they avoid actually using words like safe or effective, which might raise anxieties, or constitute claims that could be challenged - nor do they mention any negative issues, like side effects. Instead, establishment names, such as 'Grosvenor' 'Harley' and 'Clinic', are used, as are descriptors like 'advanced' and 'latest' coupled with technical terms like 'liposculpture'. Official looking logos complete the image.

The danger is that this creates a spurious reassurance about procedures that are actually quite questionable, in a way that is extremely difficult to pin down, let alone validate.

Turning to Estee Lauder, the founder of this company famously maintained that he didn't sell cosmetics, he sold hope. These ads sell the hope of a natural, young and beautiful body. They use both words and pictures to do this. The pictures are discreet but still very clearly depict young and beautiful figures. The language includes terms like 'natural' and 'youthful', linking these with the deeply held needs of their target audience - 'the bust you've always wanted'; 'the shape and size you've always dreamt of'. The ultimate implication is that breast 'enhancement' will not just improve your bust, but make your whole body more


The danger here is that the ads may exploit women who are anxious about their body shape, by confirming that they are right to have their concerns, and offering a ready and easy solution. This raises two problems. First, whilst there may be women who have such deeply ingrained anxieties about their bodies that surgery is the only answer, advertising is not the way to find them. Most women - and men for that matter - have some insecurities about their bodies, but surgery is the last thing they need. Second, the solution is not ready or easy. In short, cosmetics and cosmetic surgery are very different products, which require very different marketing approaches.

A final thought: the context of these ads is also important. They are often placed at the back of magazines that are full of slim, attractive young models, which themselves raise insecurities in women readers. These ads then capitalise on this by offering an apparently easy way to look the same.

Centre for Social Marketing, University of Strathclyde

30. The IRG suggested "advertisements in all media promoting breast implant surgery should include a statement indicating that anyone contemplating this type of surgery can obtain information about the operation and its risks from a designated body".[37] This partly chimes with a recommendation we made in our report into The Regulation of Private and Other Independent Healthcare, where we said:

"We recommend that those providing cosmetic surgery should be obliged as a minimum to print a conspicuous health warning on all their advertisements to the effect that all surgery carries an element of risk."[38]

The Government did not accept our recommendation[39] nor have they chosen to act on the recommendation of the Independent Review Group. Professor Sturrock felt that such warnings "might make some people think seriously"[40] before submitting themselves to surgery.

31. We regret that the Government refuses to insist that advertising for cosmetic surgery should carry health warnings. We are not suggesting that such warnings would necessarily substantially impact on the numbers of women choosing to have such operations. Nonetheless, we do think that appropriate warnings might at least disrupt some of the "spurious reassurance" pointed to in the note from the Centre for Social Marketing at Strathclyde University. We have on a number of occasions in recent years found the Advertising Standards Authority to be impotent in regulating the content of advertising in health related areas. We believe the Government should introduce measures to bring into effect the IRG's recommendations forthwith.

32. On a related area, it seems to us that too much of the Government's - and the IRG's - focus has been on the medical aspects of cosmetic surgery. Too little effort has been made to analyse the psychological motivations of women having such surgery. Since we believe many of the procedures being undertaken are perhaps unnecessary, and since, as Mr Paul Balen of Freethcartwright Solicitors pointed out, even operations in the independent sector risk incurring costs to public funds in terms of potential lost income, benefits and the cost of corrective surgery, we think the Government should do more to investigate the social marketing of cosmetic surgery, and the influences which determine why women want this surgery. We recommend that the Government commissions the Centre for Social Marketing at Strathclyde University to undertake research into the impact of advertising in this area. We also believe that the Government should commission or evaluate other research to obtain a fuller profile of the motivation of the women undergoing cosmetic surgery to feed into the educational process. This might inform the PSE element of the school curriculum.[41]

8   See for example Nyren et al, BMJ, 316 (7129): 417 (7 February, 1998): A recent major retrospective cohort study in Sweden assessed the additional risk of connective tissue disorders amongst women with silicone breast implants and concluded there was "no excess of connective tissue disease among over 7000 Swedish women with breast implants followed for an average of eight years." Back

9   See eg Appendices 1-6 of this volume. Back

10   Ev., p.8. Back

11   Silicon is the second most abundant element, making up 28% of the earth's crust; silicones are man-made polymers used in a wide variety of products such as fluids, gels and rubbers. They have a high degree of chemical inertness, thermal stability and resistance to oxidation (Report of the Independent Review Group on Silicone Gel Breast Implants 1998, p.11 [hereafter IRG Report]). Back

12   Ev., p.9. Back

13   Ev., p.44. Back

14   IRG Report, p.11. Back

15   British Medical Journal, 1999, 319:8 (3 July). Back

16   The Which? Guide to Women's Health, Dr A Robinson, London, 1996, p.391. Back

17   Ev., p.44. Back

18   Capsular contracture refers to the pressure created by the fibrous capsule the body forms around an implant. Contraction of this capsule as the body attempts to expel a foreign object can lead to hardening and inflamation of the breast.  Back

19   Ev., p.67. Back

20   Ev., p.13. Back

21   p.393. Back

22 Back

23   Ev., p.44. Back

24   Ev., p.10; Ev., p.44. Back

25   Q142. Back

26   IRG Report, p.5. Back

27   IRG Report, p.26. Back

28   Ev., p.61. Back

29   Q40. Back

30   Q105. Back

31   Q27. Back

32   Q62. Back

33   IRG Report, p.11. Back

34   Ev., pp.26-27. Back

35   Fifth Report of the Health Committee, Session 1998-99, The Regulation of Private and Other Independent Healthcare, (HC281), p. xxviii. Back

36   Q88. Back

37   IRG Report, p.27. Back

38   HC 281, para 52. See also Q4. Back

39   Cm 4540, p.3. Back

40   Q10. Back

41   Q94. Professor Sturrock also supported this principle (Q36). Back

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