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:
- women who are dissatisfied with the size or appearance
of their breasts (the basis for at least 80% of all implants)
- women with congenital absence of one or two breasts
- women who have had normal breast development
but the breast size has decreased following pregnancy or with
increasing age
- women who have undergone mastectomy for treatment
of breast cancer or because of a strong family history of breast
cancer[33]
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
|
87
80
72
68
27
14
12
6
1
|
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
attractive.
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 www.medical-devices.gov.uk. 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
