Memorandum by Paul Balen Freethcartwright
Solicitors (B 15)
EXECUTIVE SUMMARY
1. Breast implant suppliers in the UK have
not been asked to produce long-term safety data to the Medical
Devices Agency prior to licensing.
2. In the case of silicone implants women
are being asked to demonstrate lack of safety instead of manufacturers
demonstrating long term safety.
3. In spite of three Government sponsored
reviews of silicone implants research has only involved a meta-analysis
of existing literature. No steps have been taken to sponsor research
on UK women patients.
4. Only saline implants are licensed for
use in USA and only since May 2000.
5. Trilucent and Hydrogel implants have
both been banned by MDA after receiving CE marking from European
Notified Bodies and being supplied for years in the UK.
6. Failure of the licensing system to require
production by manufacturers of adequate safety data prior to licensing
and supply has led to the female population being treated virtually
as guinea pigs for the testing of breast implants.
7. The Consumer Protection Act fails to
protect consumers and as currently applied serves to protect suppliers.
8. There is a lack of informed consent by
women seeking breast augmentation.
9. There is a lack of Governmental control
over the cosmetic surgery industry generally and cosmetic surgeons
in particular.
10. Breast augmentation operations have
a high incidence of complications. 80 per cent of implants rupture
within 15 years of insertion. Product failures create human tragedies
and increased costs to the state.
11. There is a need for tighter regulation,
licensing, and monitoring of implants and their manufacturers
and suppliers by MDA and a review of the CE licensing system and
the public accountability of Notified Bodies.
12. There are substantial deficiencies in
the steps taken by the MDA following hazard and warning notices
relating to Trilucent and Hydrogel implants. The Government may
have misled Trilucent victims and failed to anticipate and deal
with problems arising from the recommendation that woman have
their breast implants removed.
13. The MDA and/or Department of Health
has failed to obtain the co-operation of the suppliers of Hydrogel
implants when suspending the supply of these products in the UK
to ensure women may obtain free medical attention.
14. Failures by the MDA or Department of
Health have unnecessarily increased the distress of women who
received Trilucent and/or Hydrogel implants.
RECOMMENDATIONS
1. We recommend that the standard consent
form used should contain an interactive element in which the patient
is encouraged to display her understanding of the issues/risks
involved. We recommend that such interactive consent form should
be prescribed by the D of H and/or all relevant professional bodies.
2. We recommend that the MDA clearly explain
to women why the use of silicone implants has not been suspended
for cosmetic purposes when the suppliers of such implants in this
country have not been asked to satisfy the MDA that they have
acceptable long-term safety data.
3. We recommend that only plastic surgeons
duly accredited by the relevant Royal College should by law be
able to describe themselves as cosmetic surgeons.
4. We recommend that there should be a legal
duty on clinics to inform patients in writing of the identity
and professional standing of the surgeons operating at their premises
and a professional duty on such surgeons to do likewise.
5. We recommend that the Government insists
that Notified Bodies provide public access to conformity assessment
documentation.
6. We recommend that trial data be sought
before licensing and supply to avoid withdrawal of implants after
they have already been inserted in large numbers of women.
7. We recommend that the MDA should carry
out regular rigorous inspections of implant suppliers based in
their country and publish its inspection reports.
8. We recommend:
— Use of the Breast implant registry
should be compulsory.
— Notification of failed implants should
be compulsory.
— Notification of possible side effects/complications
should be compulsory.
— The breast implant register keeper
should publish annual league tables showing numbers of implants
used; failure rates and complications reported.
9. We recommend that the onus of proof should
be reversed in product liability cases and that the Government
be invited to propose an amendment to the Consumer Protection
Act 1987.
10. We recommend for the future that when
a product is withdrawn, the D of H and/or the Medical Devices
Agency ensures that a system is set up which guarantees treatment
free to the patients and provides for resolution of disputes without
patient involvement.
11. We recommend that in future cases, and
in the Trilucent case, the Department of Health insists on the
formation of a panel of wise men representing manufacturers and
plastic surgeons who could decide in any individual case the responsibility
for covering the costs of future treatment.
12. We recommend that the MDA/D of H produce
evidence that the companies supplying Trilucent implants had agreed
to pay all medical expenses. If it transpires that the assurance
to women that "you will not have to pay for this" was
an assertion without foundation, we recommend that the D of H
provide funds to affected women to meet the shortfall in medical
expenses and associated legal costs.
13. We recommend that in cases in which
an immediate decision as to the liability of costs for future
treatment cannot be reached, the MDA/D of H should insist that
AEI or the equivalent company should bear initial responsibility
so that the patient is absolutely protected and has the treatment
she is recommended to have and requires, whilst the eventual liability
is resolved between AEI and the companies or surgeons involved.
The principle to be adopted in these cases should be that the
patient's health and well being comes first and that the patient
should not be concerned with payment for operations necessitated
as a result of shortcomings in the manufacturing and licensing
processes.
14. We recommend that our proposed system
of compulsory registration should apply to both private and NHS
sectors and that there should be an obligation to record the identity
of the implants used both in the register and in the patient's
medical records.
THE PROVISION OF INFORMATION BY THE GOVERNMENT
RELATING TO THE SAFETY OF BREAST IMPLANTS
1. WHO WE
ARE
1.1 Freethcartwright is a 45 partner firm
of solicitors based in the East Midlands. It has a national reputation
for its medico-legal practice, which includes a specialist product
liability unit. The firm currently acts for over 4,000 women who
have had breast implants and liaises with over 250 other firms
of solicitors acting for many more women.
1.2 Paul Balen who is the author of this
paper heads the firm's specialist medico-legal and product liability
units. Paul is one of only three solicitors in the country to
be awarded a Senior Fellowship of the College of Personal Injury
Law; is a past Secretary of the Association of Personal Injury
lawyers and co-author of Multi-party Actions published by the
Legal Action group in 1995. He is an assessor for the Law Society's
Specialist Clinical Negligence Panel and a member of the Personal
Injury Specialist Panel.
1.3 Freethcartwright have acted for breast
implant women for around eight years. Paul negotiated the protocol
for settlement of the claims by recipients of the 3M Capital Hip
Prosthesis which was the subject of a Medical Devices Agency (MDA)
Hazard Notice in 1997; negotiated the settlement protocol for
the women who received the Trilucent soya breast implants and
acted for two of the six lead case Hepatitis C claimants in the
contaminated blood claims against the National Blood Authority,
the trial of which took place at the end of last year and in which
judgement is awaited.
2. BREAST IMPLANTS—THE
HISTORICAL BACKGROUND
(a) America
2.1 In the early 20 century doctors seeking
to enhance women's breasts attempted to use fat taken from the
patient's own bodies. Although these operations initially appeared
successful after a while it became apparent that the fat was being
absorbed back into the body leaving the breasts back in their
previous state.
2.2 The search was on for an alternative
solution. At one stage in the 1930's surgeons even used glass
balls to increase breast size.
2.3 In that same decade scientists developed
silicone, a long thin flexible polymer made up of repeating molecules
of oxygen and silicone. They found that silicone could be linked
in relatively short chains to make a rather runny liquid or into
longer chains, which were more rigid. There was no immediate use
found for silicone and it remained a laboratory curiosity for
the next 10 years. Then in 1943 two large American corporations
Dow Chemical Company and Corning Glass works joined forces in
a joint venture to develop uses for silicone as a substitute for
rubber. Dow Chemical developed silicone gel, which the new company
Dow Corning marketed for use as an insulator, a coolant, for lubrication
and for sealing transformers. Silicone was also subsequently marketed
to children as silly putty (play dough).
2.4 In the 1950's surgeons saw a use for
silicone as a means of breast enhancement. Originally it was injected
directly into the body with disastrous results. Serious medical
complications and deaths ensued and the technique was banned.
2.5 The solution surgeons came to was to
create a silicone envelope using the longer polymers which contained
the silicone gel. This had the advantage of retaining a more natural
look without the silicone running free inside the body, which
had led to the disasters with the direct injection technique.
2.6 The silicone material was supplied to
the breast implant industry by companies such as General Electric.
They made it clear that the silicone it supplied had never been
tested or approved for human use.[1]
2.7 The early implants had a thick outer
shell which women complained gave them an unnatural rigid look.
In the mid-1970's the manufacturers responded by producing thinner
shells.
2.8 Although manufacturers had begun widespread
marketing of silicone implants in the early 1960's, it was only
when complaints reached a crescendo in America in early 1991 that
the Food and Drugs Administration (FDA), which had not previously
regulated breast implants, called for manufacturers to supply
information demonstrating their safety. Because there had been
no human safety trials, they were not able to do so by the deadline
of July 1991. Data from the American Society of Plastic Surgeons
at this time showed that of two million women with breast implants,
123,000 had breasts, which had hardened, and another 155,000 had
suffered rupture or infection.
2.9 In 1992, after two hearings before independent
advisory committees the FDA banned the use of silicone breast
implants except in limited research.[2]
Most breast implant manufacturers then withdrew from the market
in the USA. Japan, Australia and Canada followed the American
example and banned the use of silicone breast implants.
2.10 In America therefore since 1992 silicone
gel implants have been banned except where authorised for a study
approved by the FDA under an investigational device exemption.
A typical approved study would require follow up for at least
10 years post implantation and overview by an institutional review
board. The only exceptions to this are where the implants are
required for reconstruction purposes after a mastectomy, or to
replace a previously failed silicone gel implant. Even these women
are followed by a study for a minimum of five years. Women requiring
breast implants for cosmetic purposes cannot be enrolled in these
studies.
2.11 Litigation began in America in the
early 1980's. Women alleged that the manufacturers had claimed
that the implants would last a lifetime unless exposed to external
trauma, even though there was increasing evidence that implants
ruptured and leaked for no apparent reason. As a result many women
were faced with having to have replacements. It was also alleged
that implants were responsible for a wide range of auto-immune
type disorders. Documents recovered from Dow Corning showed that
it had conducted no long-term safety studies even though product
literature implied that it had been done.
2.12 Thousands of women worldwide joined
the American cases. In one individual instance an American woman
was awarded £17m after she claimed that silicone had leaked
from two sets of implants. Manufacturers and their insurers facing
these claims felt that their value and the companies' legal costs
might exceed their assets and insurance cover available.
2.13 The solution proposed was a global
"no fault" settlement involving women from all over
the world and most manufacturers. This settlement was supervised
by a Judge in Birmingham Alabama but the proposals foundered when
it became clear that there were more women eligible to claim than
assets available. The settlement collapsed. One of the biggest
players Dow Corning sought shelter in the American Chapter 11
Bankruptcy rule days after declaring record profits on a record
turnover. Other smaller companies surrendered their assets to
women claimants so each woman received a small payment. The remaining
companies such as 3M, Baxter and Bristol Myers put together a
replacement settlement while Dow Corning submitted settlement
proposals within its bankruptcy.
2.14 British women received small payments
from various US bankruptcy settlements and larger payments from
the revised global settlement. The Dow Corning bankruptcy settlement
proposals should lead to further payments to UK women subject
to the appeals which are currently pending through the US Court
system. None of the payments require proof of fault or admission
of liability. Most do not require proof of causation. Higher payments
are available for women who demonstrate on medical evidence that
they are suffering from one or more of a series of listed diseases.
Causation evidence is not required. We have so far distributed
around £2 million to our clients who have registered under
the various American settlement schemes.
2.15 In May 2000 the FDA for the first time
licensed the use of saline implants. Silicone implants remain
banned. The health issues related to silicone implants remain
highly controversial. For every paper published exonerating silicone
another appears condemning it. One proposed explanation has been
that silicone caused a unique species of disease process, which
cannot be defined by existing criteria. It was in other words
an a-typical disease process.
2.16 As an article by two American doctors
in the British Medical Journal in 1994 pointed out:
"The question of risks to health . . . is
difficult to study. No precise data exist on how many women have
received silicone implants; no systematic follow up data has been
collected. Virtually nothing is known about how many women have
had repeat procedures or how many with silicone breast implants
have died."[3]
What is not in dispute is that these implants were
originally marketed without long-term human safety data being
available.
2.17 As recently as 14 December 2000 one
of the American suppliers announced:
"Mentor, a leading medical device company
that makes breast implants, has recently started a clinical trial
for silicone gel-filled mammary implants."
(b) The UK
2.18 Breast enlargement is the most common
cosmetic surgical operation performed on women in the UK.[4]
The use of breast implants in the United Kingdom followed the
pattern experienced in the USA with most implants originating
from American suppliers. Americans also set up companies in this
country while the Government became indirectly involved as backers
of Remploy, the company for the disabled, which assembled implants
for Nagor, a cosmetic appliance company based in the Isle of Man.
2.19 The first governmental involvement
appears to have been a referral by the Department of Health to
a committee considering possible carcinogenic effects of silicone
implants between 1989 and 1990. The FDA's action in banning silicone
implants in the USA prompted a health circular from the Chief
Medical Officer in January 1992[5].
No ban was imposed in the UK but the position was to be reviewed,
as more information became available.
2.20 The Department of Health convened a
meeting of independent experts whose conclusions, reached it appears
in April 1992, were circulated with a further Dear Doctor letter
nearly a year later on 25 March 1993.[6]
The Review[7]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".
2.21 As will be commented upon later such
a conclusion was simply based on a review of available literature.
Not for the last time in the saga of breast implants no review
of actual British patients' experiences was conducted whilst the
usual burden was reversed—patients being expected to prove
that the product was unsafe rather than manufacturers being asked
to prove safety and regulators being asked to satisfy themselves
that the product was safe.
2.22 One interesting and concerning effect
of the report was the fact that it was then repeatedly used by
American manufacturers in their own country as evidence that their
implants were safe. The theme being that if the British Government
says they are safe they must be, or that at least the British
Government supports our position.
2.23 As a result of a recommendation in
the report a voluntary breast implant patient registry was set
up to facilitate surveillance of women with breast implants. This
was based at the Wessex Centre in Salisbury and came into existence
in July 1993. The report also recommended that women should be
informed of difficulties in assessing breast disease in women
with implants, but emphasised that the responsibility for doing
so rested with the surgeons.
2.24 As the silicone controversy in America
deepened at the end of 1993, the Department of Health asked the
independent review group to review all literature on the subject
that had been published since 1991. The review[8]
concluded that there was no proven link between implants and disease.
However, closely read, the report clearly indicated that the evidence
was inconclusive. It again recommended no change in UK policy.
Again the onus was placed on patients to prove defect rather than
suppliers to prove safety. Again the report was a meta-analysis
of published literature and involved no new patient orientated
research. Again the report concentrated solely on the alleged
link between implants and autoimmune disorders or connective tissue
disease.
2.25 Some idea of the attitude of the time
is conveyed by the response of the Senior Consultant Plastic Surgeon
delegated by the Government to run the implant registry:
"I am afraid the information on the registry
is not available to anyone, except the Department of Health and
those people who participate in the providing of information in
the first place. Even those people are not privy to the entire
contents of the registry. I am sure you are well aware that the
only pay out that is likely to take place is the covering of fees
for the removal of prostheses if people so wish.[9]
There is no evidence anywhere in the world to implicate an association
between breast implants and any other form of known human disease.
There have been papers that claim this but the statistical base
from which they have worked is extremely thin and the manner of
gaining information and material highly suspect.[10]
And as he wrote to a patient:
"I think that it is important that you realise
that if you register with the American court, you give up all
rights for subsequent claims against any manufacturer or any other
person. The whole point of registration is simply for the Americans
to count up the size of the litigation problem and I have to tell
you they have very firm views about who will and will not get
any form of compensation and their considered view at the moment
is that practically no-one will get any. The reason for this is
that when the proof comes out that there is absolutely no association
between silicone and any other form of human disease, then the
need to compensate will be removed.[11]
2.26 Communicating with patients, particularly
when the bulk of them have been dealt with through the private
sector, is far from easy, and obtaining information from such
patients is similarly difficult. Even though most patients with
implants qualified for payments from American settlements simply
by registering, the reticence and often obstructive attitude of
the medical profession was exemplified by the direction given
to surgeons by the Medical Protection Society and Medical Defence
Union that:
"it was inappropriate for surgeons to contact
patients directly unless they have knowledge of the patient having
suffered because of the implantation of breast implants.[12]
2.27 In the private sector driven by financial
considerations there was no incentive to contact patients and
it appears neither was there any professional obligation.
2.28 The Government did step in to help
by issuing a press release[13]
prompting women to consider registering with the American settlement.
There appeared to be no discussion with the legal profession dealing
with such claims in this country, which presumably accounted for
the incorrect opening sentence[14]
and the generally lukewarm message conveyed. The D of H was clearly
caught between opposing considerations—encouraging women
to claim what was rightfully theirs to claim, but reassuring them
and others at the same time.
2.29 General concern at the problems reported
by patients and their representatives led the Government to commission
a third review which was announced on 4 June 1997. This time the
terms of reference were somewhat wider than before:
"To review the evidence relating to possible
health risks associated with silicone gel implants, examine the
issues relating to the adequacy of pre-operative patient information
and report to the Chief Medical Officer on its conclusions".[15]
2.30 The writer was invited to give oral
evidence to the committee (the IRG). We revealed that of 1,750
women instructing freethcartwright, 288 had informed us that their
implants had ruptured and 294 claimed they had a breast implant
related illness. In 1995 we had carried out a survey of other
solicitors representing a total of 2,109 breast implant clients,
796 of whom claimed they were suffering from a breast implant
related disease and 226 of whom had suffered a rupture.
2.31 We believed that these figures were
significant bearing in mind that women were required to register
with American settlements even though they were suffering from
no problems at all. We felt that the high incidence of ruptures
and claims of disease in our sample ought to be of sifgnificance
and ought to be researched. We offered to assist such review by
encouraging clients to make their medical histories available
to the IRG. Our offer was not taken up.
2.32 We also recommended that the medical
profession should be required to inform women considering implants
as a minimum that:
(a) There is a scientific debate on the effect
of silicone implants on the human body.
(b) Silicone implants have never been the
subject of human safety trails on a long term basis.
(c) There is a high statistical probability
that the implants will fail to last for the remainder of the woman's
life.
2.33 The report from the IRG[16]
was once again not based on any of its own scientific research.
This time its detailed review of published literature and its
evaluation of the witnesses it had interviewed led for the first
time to a call for more research. It concluded that there was
no good evidence for the existence of a silicone related disease
noting that problems could be caused by the body's natural response
to foreign materials, and accepted that there were issues such
as the precise incidence of rupture where scientific data was
incomplete. Apart from recommending better counselling of women
before they consented to implantation, the UK Government policy
on silicone implants remained unchanged.
2.34 We have seen little evidence that the
recommendations relating to patient information and follow up
have been adopted as compulsory by the medical profession. The
fact that most operations are advertised and carried out in the
profit making/private sector that remains largely unregulated
currently militates against enforcement of these desirable practices.
2.35 We, like the IRG, have concerns at
the lack of informed consent and external pressure brought to
bear on women considering breast implants. The recent publicity
given to a 16 year old girl's desire for implants is an illustration
of this. Issues of informed consent are not unique in breast augmentation
surgery. However, as the commonest cosmetic operation and one
with a track record of complications, we recommend that the standard
consent form used should contain an interactive element in which
the patient is encouraged to display her understanding of the
issues/risks involved. We recommend that such interactive consent
form should be prescribed by the D of H and/or all relevant professional
bodies.
2.36 It is also alarming to note that years
after the breast implant issue first raised its head, the IRG
acknowledged that scientific data was incomplete. Yet again there
was little evidence of an obligation, assumed to exist in relation
to other products, that it must be for the suppliers to demonstrate
safety, not for patients/consumers to demonstrate defect/lack
of safety. This is particularly striking for a product for which
there is no urgent therapeutic benefit
2.37 One practical and praiseworthy consequence
of the report was the publication by the D of H in October 2000
of a booklet "Breast Implants—Information for women
considering breast implants."[17]
The fact that the D of H took this step illustrates the importance
of the issue. At the same time the Government's role in all this
remained unclear[18].
2.38 The booklet clearly spells out that
having breast implants is a long-term commitment for a woman.
For the Government the commitment is that it:
"will continue to evaluate carefully any
new scientific evidence. Should the conclusions previously reached
about breast implants change in the light of this ongoing evaluation,
then further advice will be communicated to the public.[19]
2.39 There is no explanation in the booklet
of the Government's licensing role or of the fact that when listing
Hydrogel implants as an alternative type of implant it must already
have had concerns about their safety. There has still been no
approach to review the medical experience of UK women who have
received silicone implants. Presumably, the absence of any Government
sponsorship, whether research takes place is at the whim of interested
surgeons and the availability of sponsorship monies. Plastic surgeons
operating mainly in the private sector appear to have little incentive
to pursue such research. Oddly in view of the pre-emptive steps
taken by the Government in respect of Trilucent soya implants
and Hydrogel implants in banning products because of lack of safety
data, so far as silicone implants are concerned the current position
remains that the onus is placed on women to prove defect and not
on suppliers to establish safety.
2.40 It is noteworthy, however, that this
move to provide information came no less than eight years after
the FDA in America had decided that such information should be
given to American women.[20]
As we explain below, many women chose alternative breast implants
because of concern about the safety of silicone breast implants.
Many of our clients now have had to have those implants replaced
with silicone implants following MDA advice. There is widespread
concern as to whether the long-term safety of those implants has
been demonstrated.
2.41 We recommend that the MDA clearly explain
to women why the use of silicone implants has not been suspended
for cosmetic purposes when the suppliers of such implants in this
country have not been asked to satisfy the MDA that they have
acceptable long-term safety data.
2.42 We are also concerned at the side of
the medical profession operating on women in cosmetic clinics.
There appears to be no control over who can describe themselves
as Cosmetic Surgeons. In one recent medical negligence claim arising
from cosmetic surgery which we conducted, not involving breast
implants, we discovered that the surgeon operating was not an
accredited plastic surgeon but a moonlighting general practitioner
with a criminal record for assault and prescription offences.
It is also interesting to observe that following the recommendation
that Trilucent implants should be removed, at least one well known
cosmetic clinic wrote to patients explaining that because removal
of Trilucent implants was complicated, the operation would have
to be conducted by a plastic surgeon rather than the original
surgeon used at the clinic.[21]
2.43 We recommend that only plastic surgeons
duly accredited by the relevant Royal College should by law be
able to describe themselves as Cosmetic Surgeons.
2.44 We recommend that there should be a
legal duty on clinics to inform patients in writing of the identity
and professional standing of the surgeons operating at their premises
and a professional duty on such surgeons to do likewise.
3. TYPES OF
IMPLANTS
Silicone
3.1 All implants have silicone envelopes—it
is their contents which differ. However, the original implants
contained silicone gel and these are by far the most common. There
are three main types:
(a) Single lumen—a silicone shell containing
silicone gel.
(b) Double lumen—a silicone inner shell
filled with silicone gel within an outer silicone envelope.
(c) Polyurethane foam coated outer silicone
envelope with a gel filled inner silicone shell.
3.2 Silicone implants are not licensed for
use for cosmetic surgery in the USA.
Saline
3.3 The silicone envelope of these implants
is filled with a salt-water solution and can be supplied either
ready filled or to be filled after insertion through a valve at
the time of surgery.
3.4 Saline implants were finally approved
for marketing by the FDA in the USA on 11 May 2000.
Soya
3.5 Soya implants were marketed under the
trade name Trilucent. They consist of a silicone envelope filled
with soya bean oil. The were manufactured by a Swiss company Lipomatrix
Inc and supplied in the UK by Collagen Aesthetics UK Ltd, a subsidiary
of an American corporation. These implants were never licensed
in the USA where they were invented, but were licensed in the
UK via the EC. Over 9,000 implants have been implanted into around
5,000 UK women. Many women specifically opted for or even switched
to soya implants because they were marketed as the natural, safer
alternative to silicone and were also amenable to scanning.
3.6 In March 1999 the Medical Devices Agency
effectively banned the further use of these implants in the UK
because of concerns about potential adverse health effects of
the breakdown of the soya filler in the human body. Members of
the D of H Committee on Toxicity recommended that further data
be obtained. The manufacturer's voluntarily suspended supply and
the MDA issued an Advice Notice.[22]
The Advice Notice stated that there was no evidence to suggest
that the implants should be removed but that women should seek
immediate medical advice if they experienced swelling or inflammation.
3.7 On 6 June 2000 a Hazard Notice[23]
was issued by the MDA recommending the removal of Trilucent breast
implants because of potential genotoxic components from the breakdown
of the soya filling.
Hydrogel
3.8 The envelope of these implants is filled
with a gel made up of water, sugar and salt which if they leak
or rupture should have the advantage that the body will easily
excrete the solution. Hydrogels are polymeric materials that have
the ability to swell in water without dissolving and retain water
within their structures.
3.9 Until December 2000, there were two
models of Hydrogel filled breast implants on the UK market. PIP
Hydrogel breast implants were made in France and supplied in the
UK by Clover Leaf Products Ltd. Approximately 4,000 women in the
UK received these implants since they were first introduced in
1994. NovaGold breast implants were made in Germany and supplied
in the UK by Somatech Medical Ltd. Approximately 250 women in
the UK received these implants since they were first introduced
in 1996. It is estimated that around 80 per cent of these implants
were implanted by the private sector for cosmetic reasons.
3.10 In December 2000 the MDA issued Device
Alerts [24]
as a result of which both PIP Hydrogel and NovaGold products were
withdrawn from the market. The MDA revealed that although few
adverse incidents have been reported as part of its ongoing review
of breast implant products it had identified:
"that the manufacturer's safety assessment
was inadequate, due to lack of long term toxicity data or clinical
follow-up, together with methodological flaws in some of the pre-clinical
tests."
4. COMPLICATIONS
OF BREAST
IMPLANT SURGERY
4.1 When in 2000 the FDA licensed saline
implants for the first time it became evident that the true rate
of complication was almost certainly underestimated by manufacturers
and doctors alike. Using data collected by one manufacturer Mentor
Corpn, 43 per cent of women who had augmentation for cosmetic
reasons suffered complications within three years—for mastectomy
patients the figure was 73 per cent and 27 per cent had to have
their implants removed as a result. The FDA has a page on its
web site devoted to photographs or illustrations of breast implant
complications.[25]
We list below some of the more common complications.
Capsular contracture
4.2 Whenever a foreign object is placed
in the human body, a fibrous capsule is formed around it as the
body seeks to isolate and expel it. The capsule contracts apparently
trying to squeeze out the foreign object. The breast can become
hard, painful and inflamed and the implant can become displaced.
Originally surgeons treated this by manually massaging the breast
until the capsule fractures and the tension was released. This
practice ceased to be acceptable in the mid-1990's when it was
realised that this often caused the rupture of the implants contained
by the capsule. Standard practice now is to open the chest, cut
or remove the capsule and replace the implant.
4.3 Capsular contracture was first reported
in the UK in 1980 when around one third of women followed up had
experienced this. Even then the surgeon was highlighting deficiencies
in follow up in the private health sector.[26]
4.4 The D of H advises that one in every
10 women with breast implants will experience painful hardened
and/or deformed breasts as a result of capsular contracture.[27]
Rupture
4.5 This is the fracture of the implant
causing leakage of the implants contents into the capsule and
the chest cavity. There is clear evidence of a high incidence
of spontaneous rupture as the implants apparently fail to cope
with the expulsive forces placed on them by the body. Research
shows that most implants will rupture over time. Some will rupture
because of external trauma or damage during insertion. Because
the implant is held in place by the fibrous capsule, a woman and
her doctor may be unaware that the implant has ruptured. MRI or
ultra sound scans may be required to demonstrate this. Research
carried out by the FDA has also shown that after 10-15 years 80
per cent of women will experience a ruptured implant. Research
carried out as long ago as 1991 showed all implants older than
ten years were leaking or ruptured.[28]
Leakage
4.6 All implants leak as their contents
can in appropriate circumstances pass through the permeable silicone
envelope even though the envelope remains intact.
Infection
4.7 As with any operation there is a risk
of infection, which may required the chest cavity to be reopened,
and the implant removed or replaced.
Migration of contents
4.8 The body does not naturally excrete
silicone. It appears that silicone can migrate through the lymphatic
and circulatory system.[29]
Silicone gel has been reported in the wrist and fallopian tubes
in the groin.
4.9 Soya is excreted but has to escape from
the chest cavity first. There is no safety data on soya retained
within the body and not excreted.
Interference with Scanning
4.10 The presence of an implant can reduce
visual clarity in the scanning process because it may produce
a shadow; impede the transmissions of the x-rays etc involved
or compress tissue making architectural distortions difficult
to visualise. This may cause delay in detecting cancerous growths.
The ill-fated Trilucent soya implants were marketed as having
no impact on scanning and many women were attracted to this feature,
some switching from silicone implants to take advantage of this.
Scarring
4.11 Implants are typically inserted through
an incision in the fold underneath the breast but alternative
routes are through the nipple or via the armpit. As with all operation
sites some are slow to heal. Repeat surgery is usually undertaken
through the same incision site to reduce scarring but scar tissue
and keloid scarring may be unwanted side effects. Around one in
every 20 women with breast implants may expect problems with their
scars.[30]
Creasing
4.12 Some women will experience the creasing
or folding of their implants often described as rippling. This
may lead to rupture if the wall of the implant is weakened and
in any event surgical intervention may be required to resolve
the unwanted appearance.
Nipple sensation
4.13 One in seven women may experience permanent
loss of nipple sensation.[31]
For others sensation may increase so the effect becomes unbearably
painful.
Breast feeding problems
4.14 According to a reputable American study,[32]
breast implant surgery makes it less likely that a woman will
breast-feed either because of inadequate milk supply or of concern
at the unknown effects on the child.
5. WARNINGS
5.1 There has to be concern at the promotion
of life-style enhancing breast enlargement by the use of prosthesis
as opposed to those required medically for reconstructive purposes.
However, the question may be how far the Government should involve
itself in individual freedom of choice.
5.2 A healthy woman agreeing to have breast
implants needs to be informed that:
(a) The implant is highly likely to create a
capsule, which may harden and require surgery.
(b) The implant is highly likely to rupture and
require surgery.
(c) Most young women will require several
operations over time[33].
(d) Each operation would involve the removal
of breast tissue and scarring.
(e) Her breast will never look the same so
removal without replacement may not be an option.
(f) No implants have been subjected to long-term
human safety trials.
5.3 All of this takes place within an industry
geared to making a profit in which the consultant may be a salesman
and not a doctor; as stated above any doctor can apparently describe
himself as a cosmetic surgeon; most patients (still!) trust their
doctor and complications lead to more bills for the patient and
therefore act as a deterrent to seeking prompt medical attention.
5.4 In our experience a surprising number
of women incur debt to finance the original operation and do not
even tell their nearest and dearest that they have had the operation.
When things go wrong both factors add to the distress involved.
As well as a human tragedy when things go wrong there is usually
a price paid by the state, whether through benefit payments, use
of NHS or otherwise.
1 Exhibit 1 Back
2
Kessler DA. The Basis of the FDA's decision on Breast Implants.
New England Journal of Medicine 1994; 330:1748-9. Back
3
Sancez-Guerro, Lang BMJ Vol 309 1 October 1994-Exhibit 1 (a). Back
4
D of H Booklet 21218 1P 80m Sept 00 (CWP) Breast Implants-Information
for women considering breast implants p3. Back
5
PL/CMO(92)1. Back
6
PL/CMO(93)2-Exhibit 2. Back
7
Evidence for an Association between Implantation of Silicones
and Connective Tissue Disease MDD Report 92/42 D of H Feb 1993. Back
8
Evaluation of Evidence for an Association between the Implantation
of Silicones and Connective Tissue Disease Medical Devices Agency
Dec 1994. Back
9
This statement was plainly wrong. Back
10
Personal communication from Mr DC McNeil 18 November 1994-Exhibit
3 Back
11
Letter from McNeil to patient 7 November 1994-Exhibit 4. Back
12
Quoted in letter from Plastic surgeon PMO'Hare-Exhibit 5. Back
13
D of H 94/255 25 May 1994-Exhibit 6. Back
14
All women could register not simply those "who believe their
health has been affected". Back
15
D of H Press release 97/125 Thursday 4 June 1997; 97/131 12 June
1997-Exhibit 7. Back
16
Silicone Gel Breast Implants July 1998. Back
17
21218 1P 80m Sept 00(CWP). Back
18
D of H press release 2000/0556 4 October 2000-Exhibit 8. Back
19
D of H Booklet 21218 1P 80m Sept 2000 (CWP) Breast Implants-Information
for women considering breast implants p9. Back
20
FDA letter 28 February 1992-Exhibit 9. Back
21
Letter Harley Medical Group (undated-June 2000)-Exhibit 8a. Back
22
AN1999(01)-Exhibit 10. Back
23
MDA HN2000(05)-Exhibit 11. Back
24
MDA 2000 (07) and (08)-Exhibit 12. Back
25
www.fda.gov/cdrh/breastimplants/breast-implants-photos.html-Exhibit
13. Back
26
Wallace; British Journal of Plastic Surgery (1982) 35,374-5-Exhibit
14. Back
27
D of H Booklet 21218 1P 80m Sept 00 (CWP) Breast Implants-Information
for women considering breast implants p7 Back
28
de Camara DL.Rec.Surg.91:5 1993 828-34-Exhibit 15. Back
29
Kossovsky et al; Analysis of the surface Morichology of recovered
silicone mammary prosthesis; Plastic Reconstructive Surgery 1984
71(6): 795-804. Back
30
D of H Booklet 21218 1P 80m Sept 00 (CWP) Breast Implants-Information
for women considering breast implants p8. Back
31
D of H Booklet 21218 1P 80m Sept 00 (CWP) Breast Implants-Information
for women considering breast implants p8. Back
32
National Academy of Sciences Institute of Medicine: Safety of
Silicone Breast Implants, National Academy Press, Washington DC
1999 p197. Back
33
See D of H Booklet 21218 1P 80m Sept 00 (CWP) Breast Implants-Information
for women considering breast implants p10. Back
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