Fw: THE PROVISION OF INFORMATION BY THE GOVERNMENT RELATING TO THE SAFETY OF BREAST IMPLANTS ~ UK

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From: " Ilena Rose " <ilena@...>

Sent: Wednesday, August 15, 2001 2:26 PM

Subject: THE PROVISION OF INFORMATION BY THE GOVERNMENT RELATING TO THE

SAFETY OF BREAST IMPLANTS ~ UK

~~~ Bravo to all of the activists who got this investigated! ~~~

http://www.parliament.the-stationery-office.co.uk/pa/cm200001/cmselect/cmhea

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308/30803.htm

Select Committee on Health Fourth Report

------------------------------------------------------------------------

FOURTH REPORT

The Health Committee has agreed to the following Report:ã

THE PROVISION OF INFORMATION BY THE GOVERNMENT RELATING TO THE SAFETY OF

BREAST IMPLANTS

Introduction

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 Sturrock,

Chairman, Silicone Gel Breast Implants Independent Review Group; Mr

Balen, head of medico-legal and product liability unit, Freethcartwright

Solicitors, Ms Rose Irwin and Ms 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 ne 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 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 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.

( 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]

© 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 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 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

on 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. 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 , 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 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]

------------------------------------------------------------------------

8ÝÝ 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. " ÝBack

9ÝÝ See eg Appendices 1-6 of this volume.ÝBack

10ÝÝ Ev., p.8.ÝBack

11ÝÝ 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]).ÝBack

12ÝÝ Ev., p.9.ÝBack

13ÝÝ Ev., p.44.ÝBack

14ÝÝ IRG Report, p.11.ÝBack

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

16ÝÝ The Which? Guide to Women's Health, Dr A , London, 1996,

p.391.ÝBack

17ÝÝ Ev., p.44.ÝBack

18ÝÝ 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. ÝBack

19ÝÝ Ev., p.67.ÝBack

20ÝÝ Ev., p.13.ÝBack

21ÝÝ p.393.ÝBack

22ÝÝ www.medical-devices.gov.uk.ÝBack

23ÝÝ Ev., p.44.ÝBack

24ÝÝ Ev., p.10; Ev., p.44.ÝBack

25ÝÝ Q142.ÝBack

26ÝÝ IRG Report, p.5.ÝBack

27ÝÝ IRG Report, p.26.ÝBack

28ÝÝ Ev., p.61.ÝBack

29ÝÝ Q40.ÝBack

30ÝÝ Q105.ÝBack

31ÝÝ Q27.ÝBack

32ÝÝ Q62.ÝBack

33ÝÝ IRG Report, p.11.ÝBack

34ÝÝ Ev., pp.26-27.ÝBack

35ÝÝ Fifth Report of the Health Committee, Session 1998-99, The Regulation

of Private and Other Independent Healthcare, (HC281), p. xxviii.ÝBack

36ÝÝ Q88.ÝBack

37ÝÝ IRG Report, p.27.ÝBack

38ÝÝ HC 281, para 52. See also Q4.ÝBack

39ÝÝ Cm 4540, p.3.ÝBack

40ÝÝ Q10.ÝBack

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

Ý