Memorandum by Paul Balen Freethcartwright
Solicitors (B 15) (continued)
6.1 It may be thought that the object of
Government licensing is to certify officially that a product has
been thoroughly tested and is safe. If not one may ask what is
the purpose of a licensing procedure and the Government's involvement
6.2 Most consumers would think the CE European
quality mark denotes Government approved safety. It appears that
it does not. In fact in Europe, medical devices are not licensed
by a regulatory authority. Instead they carry the CE marking purely
to draw attention to the manufacturers' claim that the
device is safe and fit for its intended purpose and meets all
the requirements of the Medical Devices Regulations.
6.3 We believe that the introduction and
use of the CE Mark as an aid to harmonisation of standards in
the EC may have had the effect of reducing the standards in this
country and therefore reducing the safety of products supplied
6.4 The CE mark does not in any way represent
a guarantee of safety. We believe that consumers believe and require
that such marking should represent such a guarantee. The MDA acts
on behalf of the Secretary of State for Health. We believe that
the MDA as the UK national authority should exert responsibility
for checking claims of safety before authorising use and
not after, particularly when that product is to be implanted
into the human body.
6.5 Breast implants are in a medium risk
category where that claim is assessed and endorsed by independent
companies who offer commercial certification facilities. These
companies are known as Notified Bodies. The granting of a CE marking
means that the product can be freely marketed anywhere in the
European Community without further control.
6.6 The MDA appears to have responsibility
for supervising Notified Bodies in the UK. We do not believe it
has any responsibility in the rest of Europe. This means that
the UK is bound to accept products with CE marks granted by notified
bodies anywhere in Europe over which it has no control.
6.7 The commercially driven system has transparently
failed to deliver a substantiated guarantee of safety which consumers
are entitled to expect, as the frequent banning of CE marked products,
particularly in the breast implant field illustrates. Consumers
are entitled to believe that too often they are being treated
as human guinea pigs, and that later banning of products and criticism
of manufacturers' safety information smacks then of shutting the
stable door after the horse has bolted.
6.8 Notified Bodies can be selected anywhere
in Europe by manufacturers seeking approval for their product.
Commercial sensitivity means that information is hard to come
by, but the risk to consumers is that manufacturers seeking a
foothold in Europe could be tempted to select the commercial organisation
it concludes is the "weakest link" is certify its product.
6.9 Notified bodies as profit centres are
also likely to be under pressure not to fail products thereby
risking a reduction in their income. The responsibility of those
companies who are accepted as Notified Bodies is yet to be tested.
It is odd that they can be in a position of overruling national
device regulatory processes. This is recognised by the MDA which
has apparently secured a review of the operation of the European
Directive for Medical Devices.
6.10 It is understood that measures under
active discussion include the establishment of a European Notified
Body Oversight Group and the reclassification of most medical
implants, including breast implants, into the highest risk group.
This would afford them the most vigorous controls allowed under
the Regulations and, for example, require the Notified Bodies
to assess the manufacturer's design dossier for each device. It
is astonishing that implants which are used for major operations
for large numbers of women and which have a long track record
of safety concerns are not already subject to that kind of rigorous
review. We would ask why that state of affairs was allowed to
6.11 In addition, at the request of the
European Parliament, the European Commission is preparing a document
that outlines specific measures to ensure the reliability of breast
implants. We believe that these are likely to follow the recommendations
of the 1998 UK's Independent Review Group.
6.12 We are also concerned at the lack of
public accessibility to Notified Bodies. A simple request for
a copy of the declaration of conformity submitted to the Notified
Body responsible for the licensing of the Trilucent implants was
met by the response:
"as the declaration of conformity is a document
which is issued by the manufacture of a medical device himself,
you have to ask the manufacturer for this document. Furthermore
we are not entitled to release any document from a conformity
assessment procedure to any person except the manufacturer and
the competent authorities.
6.13 We believe that public accountability
requires free access to this information parallel to the Freedom
of Information provisions in the USA. Commercial sensitivity must
take second place to safety considerations. In any event the single
biggest users of freedom of information applications to the FDA
in America are allegedly the main pharmaceutical companies.
6.14 We recommend that the Government insists
that Notified Bodies provide public access to conformity assessment
6.15 In America the FDA now requires all
manufacturers to submit a Pre-Market Approval application in order
to determine whether implants are safe for continued sale. As
a result, for example, the FDA ordered that manufacturers of PIP
saline implants cease selling these implants in the USA by May
2000 because it did not have sufficient trial data of patients
two years post surgery.
6.16 In this country 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. Trials should be conducted under the usual ethical and
professional standards so that women know they are part of a trial.
At present it appears that the general population of women has
been treated as unknowing guinea pigs in the use of breast implants.
6.17 In Australia, for example, a clinical
trial of Hydrogel implants was announced in 2000 and 2001 to allow
for a full commercial launch. The purpose of the trial is to evaluate
the prosthesis, to ensure it is safe and conforms to Australian
regulatory authority. This evaluation has to be carried out before
wider use is licensed.
6.18 The laxity of the UK/European position
is demonstrated by this description taken from a reputable US
website before Trilucent implants were banned in the UK:
"An American company offers the soy oil
breast implants done in England. The package offer involves travel
to England. However this does not guarantee its safety by American
7.1 It would also appear that the FDA has
an aggressive monitoring process which includes the inspection
of manufacturing plants of companies supplying the US market wherever
in the world they are located. An example, which should cause
concern in the UK, is what happened to Biosil Ltd.
7.2 Although Biosil has manufacturing plants
in Cumbernauld in Scotland and Ashy de la Zouch in Leicestershire
it, like its distributor Nagor, is an Isle of Man company owned
by Americans which supplies silicone and saline implants to both
UK and US markets.
7.3 On two occasions in 1996 and again in
the FDA has banned its products from the USA on the grounds that
inspection of its premises in Cumbernauld in Scotland has shown
substantial deficiencies potentially leading to the supply of
adulterated products. The warning letters have been available,
posted on the FDA website. Biosil has maintained its supply to
the UK market throughout with no apparent intervention by any
Government agency. Indeed it is somewhat unclear whether the MDA
have any remit equivalent to the action taken by the FDA. The
suspicion is that the MDA was taken by surprise by the FDA inspection
7.4 In the course of our enquiries we have
seen uncorroborated information obtained anonymously from a Biosil
employee describing how the company in its manufacturing plant
allegedly used out of date materials; patched up holes in implant
shells and changed manufacturing specifications to allow failed
implants through quality control.
7.5 We recommend that the MDA should carry
out regular rigorous inspections of implant suppliers based in
this country and publish its inspection reports.
7.6 Implants do fail and some fail very
early after insertion. Almost inevitably this leads to further
major surgery. Whilst some companies are amenable at least to
supplying replacement implants, compensation for the pain, suffering
and medical expenses suffered by these women is often refused.
As we review below, the law may create difficulties for women
seeking to have put right what has gone wrong. Often the supplying
companies will blame the surgeon or simply point to such episodes
as being an inevitable consequence of breast implant surgery challenging
the women concerned to prove what has gone wrong with their implants.
Little or no information is available on the processes inside
the manufacturing companies. Defects in those processes and in
quality control may account for the high number of early failures
of breast implants.
7.7 Statistics as to failure rates and their
cases are hard to come by. The breast implant registry is voluntary.
Notification of defects is voluntary.
Use of the Breast Implant Registry
should be compulsory.
Notification of failed implants should
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.
7.8 All this would enable better monitoring
of implants, enable regulators to pick up concerns earlier, and
patients and doctors to make a more informed choice as free as
possible from marketing, advertising and commercial considerations.
This would parallel the introduction of hospital league tables
and the monitoring of doctors' performance, which are now beginning
in the NHS.
8. THE LAW
8.1 The Consumer Protection Act 1987 was
designed to implement the European Product Liability Directive
The Directive predicates that to balance the influence of multinational
corporations supplying goods across international boundaries,
the consumer needs to be protected by the creation of a strict
liability regime whereby compensation is paid for injuries suffered
as a result of a defective product regardless of proof of fault.
Manufacturers can protect themselves through insurance and claims
against other parties they believe may have been responsible.
The test for defective product is that:
"the safety of the product is not such as
persons generally are entitled to expect.
8.2 The Act has been poorly used and severely
A detailed analysis is probably outside the scope of this paper
but a breast implant case of ours, Foster v Biosil
illustrates the difficulties experienced by consumers.
8.3 In this case a woman's two implants
ruptured or leaked only a few months after insertion necessitating
further surgery to replace each implant one after the other. The
supplying company denied liability. It blamed the surgeon alleging
that he must have torn or cut the implants when inserting them.
The surgeon gave evidence denying this and this part of the defence
was dismissed. However, the trial judge, Cherie Booth QC, held
that while persons generally would not have expected implants
to rupture or leak in this way the consumer claimant still had
to prove what the defect was. In this case there was no way of
proving why the implants had failed or what the manufacturing
defect had been. Consumers will rarely be able to do this. Breast
implant recipients will most likely be unable to do so, particularly
if the implant has been ruptured, destroyed or disposed of.
8.4 To give protection to consumers it should
be sufficient to demonstrate that a product was not as safe as
expected (as per the wording of the Act and Directive) without
identifying the cause of the defect. Under the Directive the supplying
company still has the ability to seek indemnity from another person
in the supply chain
but the concept is and should be that the manufacturer is directly
liable to the consumer. If there is a battle it should be between
the manufacturer and other partyin this case the surgeon.
Alternatively it should be for the supplying company to demonstrate
that there was no defect. In other words, the onus of proof of
causation should be reversed. Only then will consumers be protected
in cases where products fail and cause injury but the consumer
does not know the mechanism of failure.
8.5 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
8.6 After all, the act is the Consumer Protection
Act not the suppliers' protection act. It should therefore protect
consumers not suppliers.
9.1 Immediately the Hazard Notice was published
recommending removal the supplying companies, which had up until
then resolutely denied legal liability whilst paying some medical
expenses and some compensation in individual cases, entered into
negotiations with us on behalf of claimants in order to devise
a settlement scheme. The aim was to avoid a lengthy and costly
court battle. For our part we were seeking reasonable compensation
to be paid to affected women as quickly as possible. After 5 months
of negotiations a settlement scheme was
announced and the first payments under that scheme have now been
9.2 The payment of medical expenses promised
by the Hazard Notice and compensation promised under the settlement
protocol should not disguise the real distress and difficulties
experienced by many women.
9.3 When the MDA announced its recommendation
that women with Trilucent implants should have them removed, it
announced that it had agreed with the responsible company AEI
Inc that AEI would bear responsibility for medical expenses. Women
were told that the company would cover all medical expenses. 
The Hazard Notice was accompanied by a Statement and an Information
sheet to be given to affected women. Women were told that:
"The company that is responsible for these
implants, AEI Inc, has agreed to pay for treatment that is needed.
If you do have Trilucent breast implants and decide to have them
removed or replaced, you will not have to pay for this".
9.4 The company set up the Trilucent Care
Centre managed by BUPA, which supervised the consultation, implant
removal, replacement and follow up care costs by requiring surgeons
to contact them for authority. It also devised, without consultation,
a scale of charges, which the company would find acceptable.
9.5 The weakness of this procedure is that
the MDA and the responsible company are dealing with a commercial
fragmented private sector. Furthermore as we illustrate the Company's
policy did not meet the commitment announced by the MDA.
9.6 As could have been anticipated, a minority
of surgeons and hospitals saw no reason to alter their standards
commercial procedures. For them the patient was a customer who
would be responsible for the hospital and the surgeon's charges
at whatever level the hospital or surgeon decided to charge. In
a few , but far too many cases, surgeons and hospitals refused
to accept the fees set as standard by the Trilucent Care Centre
as a result of which women, who were already naturally distressed
by the whole experience found themselves pawns in a pay dispute.
Some women received solicitors and bailiffs' letters; some women
were forced to sign agreements under threat that their operations
would not proceed that day unless they guaranteed payment; some
surgeons threatened the women directly.
9.7 This demonstrated an alarming failure
by the Government through the MDA and the D of H to understand
the nature of the profession with which it was dealing and to
ensure that the patients had the protection that both the D of
H and the MDA made it clear they expected them to receive. No
system was built into the scheme arranged by the MDA for disputes
to be resolved. Some plastic surgeons displayed little, if any,
caring attitude towards their patients. One in particular insisted
on speaking to the writer about his fees and when learning he
was engaged, demanded that the phone call or meeting be interrupted
on the grounds that "he was a plastic surgeon". Even
BUPA hospitals disputed some levels of fees allowed by the BUPA
run Trilucent Care Centre, the internal BUPA dispute being explained
away on the grounds that BUPA was in fact a series of totally
None of this was any comfort to the vulnerable patients. Some
patients found their surgeons refusing to provide the confirmation
of their medical position which was required to enable them to
claim compensation, on the grounds that the company had not paid
9.8 We recommend for the future that when
a product is withdrawn, the Department of Health 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.
9.9 We further recommend that the MDA/D
of H produce evidence that the supplying companies 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.
9.10 As can be seen from the list of complications
arising from breast augmentation surgery, the D of H and the MDA
must have anticipated that the mass removal of implants would
lead to a large number of women suffering further complications
for which medical treatment was required. It is clear that the
D of H or MDA agreed no facilities with the company for the payment
of these expenses.
9.11 Women therefore who experienced capsular
contraction and other problems with their replacement implantscomplications
which they would not have experienced but for the necessity to
have their Trilucent implants replaced following the MDA notice
of 6 June 2000, found themselves having to pay for treatment or
going without treatment because the Trilucent Care Centre refused
to pay for further treatment. TCC claimed that the women should
first look to the suppliers of the replacement implants, even
though there was no evidence and would probably never be any evidence,
of a defect in the replacement implants.
9.12 Again, no system of dealing with these
problems was set up. Instead, the women's only recourse was to
argue long and hard with the company through its solicitors, leading
to greater distress and concern for already worried women. Legal
action may not provide payment up front, so women are faced with
paying for further operations themselves or not having medical
treatment that they are advised to have. If they do have that
treatment and pay for it, they then have to claim the cost back
first, from AEI Inc as responsible company for Trilucent implants,
and if it denies responsibility, joining into any claim against
the suppliers of the new implants (quite conceivably AEI's holding
company which also supplies McGhan silicone implants) or if the
company alleges that the surgeon was negligent, the surgeon himself.
9.13 We recommend that in future cases,
and in this case, the D of H 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.
9.14 As none of this would have arisen without
the removal operation caused as a result of the defective Trilucent
implants in the first place, we recommend that in cases in which
an immediate decision as to the liability for costs of 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 or licensing
10.1 This problem was further exemplified
by the later suspension of supply of Hydrogel implants. In December
2000 when the announcement was made,
the MDA made it clear that there was no evidence of a health hazard,
simply concern at deficiencies in the manufacturers' safety data.
This distinction was of little comfort to women who had those
implants, some of whom had received Hydrogel implants as replacement
for their silicone and/or Trilucent implants which had been the
subject of previous health scares or bans. Women were clearly
going to be concerned that their implants had been banned for
use for future patients and that the health position was currently
10.2 The MDA announcement stated:
"Women who think they may have Hydrogel
implants and are concerned should contact the surgeon who carried
out the operation, or their GP . . ."
10.3 Women were told that there is no evidence
at present to recommend explantation; that if they were worried
they should seek a consultation with their surgeons and that:
"The Department of Health is currently discussing
reimbursement for clinical consultations with the manufacturer."
10.4 In fact, when we made enquiry of the
manufacturers on behalf of worried women, PIP/Cloverleaf denied
any responsibility while Novaguard offered to pay £100 towards
the cost of a consultation, but only if this was accepted in full
and final settlement of all claims both now and in the futurea
condition which was clearly oppressive and incapable of acceptance.
10.5 It was obviously unsatisfactory that
all that was done, as the announcement indicated was that contact
was being established with the manufacturers to sort out payment
for the consultation fees that many affected women would incur.
Presumably it was the wish of the Department of Health and the
Medical Devices Agency that no women would be charged for having
their implants checked in the light of the warning notice, but
neither manufacturer was prepared to provide this and oneNovagoldas
we have seen, did offer a small financial payment but only on
the most onerous terms which it had to have known that no woman
would be advised to have accepted. Presumably the MDA knew this
when the announcement was made but does not appear to have resolved
10.6 Furthermore we have discovered that
Novagold expressly did not accept the MDA announcement. It stated
"our company . . . do not understand the
need for the device Alert (MDA 2000(08)), indeed our company believes
that the action the medical devices agency took was both inappropriate
and unjustified and therefore in breach of article 8 of Council
. . . We do not advise that patients seek medical
advice and clearly there is no question of explantation being
10.7 This demonstrates a total lack of understanding
of the effect of the MDA announcement on women who had their company's
products; a total lack of sympathy for their position and appears
to place innocent women as pawns in a dispute between the MDA
and the company about which both the D of H and MDA have been
totally silent. It should not be left to us as the women's lawyers
to try and resolve this. In any event the law is often a blunt
weapon in such circumstances. What the women need is medical advice
without cost, not the possibility of including those medical costs
in a claim at a later date.
10.8 The MDA announcement suggested that
it was made with the agreement and co-operation of the suppliers.
This does not seem to have been the case. The consumers appear
to have been left exposed.
10.9 PIP of France, the other manufacturers
of Hydrogel implants simply stated:
"at this day, it is not proved that our
products are defective or dangerous. Then, our liability is not
11.1 Even though the Trilucent implant system
was one of the more advanced registration procedures used in implant
supply, one of the other problems, which has emerged with all
devices, is the lack of a failsafe method of product identification.
Here the problem appears to be worse in the NHS. Whereas private
clinic doctors tended to ensure that patents registered their
Trilucent implants with the manufacturers, the NHS did not appear
to be geared to arrange this. Hence the supplying company appeared
unaware of the patients who received their implants in the NHS
where they were occasionally supplied to victims of breast cancer
who had undergone mastectomies.
11.2 Some women are uncertain as to which
implants they received or, where there is more than one supplier
of the same type, the identity of the supplier of their particular
implants. When faced with the notices issued by MDA it is essential
that women can readily identify their implants and their source.
11.3 We have often been handicapped by not
being able to find out the identify of implants inserted in a
client. Some clients in the American settlements have been unable
to claim compensation because the identity of their implants cannot
11.4 We even have an example of a woman
having paid for Trilucent implants, and therefore having to have
them removed, discovering on awaking from the anaesthetic after
the removal operation that she had had silicone and not Trilucent
implants. She had therefore undergone an unnecessary operation
and had possibly been tricked by the implanting clinic/doctor,
as Trilucent implants were generally more expensive than other
11.5 Other women complain that they were
unaware of the MDA announcement. Some clinics efficiently followed
up women; others did not and in any event with an increasingly
mobile population contact with some recipients were always going
to be difficult
11.6 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 patients
11.7 Such systems would aid identification;
monitoring of complaints/defects and notification of warnings/withdrawal
12.1 Failure of the licensing process as
exemplified by the Trilucent saga leads to human tragedies. The
following random comments from some of our clients ought to drive
the point home. Some face the same traumas again following the
ban on Hydrogel implants:
1. "I am heartbroken. There is not a
day that goes by that I am not in pain and that only reinforces
the unhappiness that I now have due to the removal and replacement
of what I was more than happy with."
2. "As you can imagine with just 2 days
to go before surgery I am very nervous and tearful"
3. "I decided after many hours of discussion
(and tears) with my husband to terminate my pregnancy. I really
could not bear the thought of having a baby that may be handicapped
in some way due to the Trilucent implants. My replacement operation
is booked for Tuesday. Wish me luck."
4. "I was separated from my husband
and had to endure all the travelling and emotional upset on my
own. I also had a small child to look after I have just completed
university and have a job. I have paid for university with loans,
and now have approximately £10,000 worth of debt. I am a
single parent of an already traumatised child who has watched
me through operation after operation this is surely a further
punishment to us both who have not consciously chosen this path."
5. "I had a court hearing . . . I had
to pay rent and arrears and I've missed a few weeks partly because
I took time off work to have my breast done and the money I lost
would have covered three weeks rent. I have been served with an
eviction notice. Rosie (one of our secretaries) doesn't know me
at all and she was concerned and she listened to me blubbering
on, even if you cannot help I would just like to thank her."
6. "I am in the same position I was
in 1992 having to contemplate life without a bust. My husband
has never seen me without implants despite reassurances he will
love me no matter what I don't particularly love myself at this
moment in time. I am writing this two days after my operation
feeling very low, let down, my body in ruins. If I had had any
other implants I would be sitting on a beach, potentially pregnant
enjoying the sum . . .Unfortunately we have taken two weeks off
work, my husband, a GP, and myself, a health visitor, to try and
put our lives back together baby less and boobless. Please help."
7. "It was an inconvenience in the first
place not to mention having to wait a month to have the operation
and the stress and worry of what the implant has done to my body.
I am self-employed and do not have an income as I am a hairdresser
and clients are waiting for me to return to work. My partner has
left me and my two children with all the stress and upset this
has caused. Everything has suffered due to this horrendous experience
. . . I do hope you can help me."
8. "I am a widow with two young sons"
. . .
9. "I have gone from feeling confident
and happy to the complete opposite."
13.1 We append some random examples of the
chaos caused by the failure of the Government's assurance that
women will not have to pay the medical expenses arising from treatment
following the MDA Hazard Notice of 6 June 2000. The examples are
typical and are extracts from relevant letters or e-mails. The
party sending the letter e-mail is identified in brackets at the
end of the extract.
St Anthony's pricing for each Trilucent patient
differs immensely as their invoicing includes items right down
to the last suture! Some patients therefore incur more than the
fee schedule set out by the TCC.
I have recently been advised by Steve Holland, account
manager, St Anthony's, Hospital, about four patients who have
incurred more costs than the TCC fee schedule. None of the extra
payments concern post op complications, as far as I am aware.
Steve Holland is well aware of the limit to
which TCC are prepared to go in terms of fee schedules. Therefore
in every case he insists that the patients sign to say that they
will personally settle costs above the ceiling amount. Unfortunately,
Steve Holland does not explain to these women that there will
undoubtedly be a shortfall. Whilst patients sign the document
it seems that they don't really expect to pay anything. That is
why it comes as something of a shock to them when they receive
The patient has signed an agreement to say that
she will pay the difference. AEI and the TCC whilst willing and
able to offer these women an alternative venue/surgeon cannot
mandate this nor can they control/manage how hospitals enter into
contracts with patients. The issue then would seem to be between
the hospital and the patient. (AEI).
C has suffered psychologically with the problems
over her breast implants...the further surgery will aid her mental
C attended for consultation again having previously
expressed some concern about the appearance of her breast and
once again stated that her breasts have become saggier since she
had her Trilucent implants removed. She does indeed have a significant
degree of ptosis. . . . I have advised C that the only way that
her nipples can be lifted is by carrying out a mastoplexy. . .
C told me that she has already spoken to the
Trilucent Care Centre who said that she required a letter from
her surgeon and that is why I am writing to you to add support
to her request that this should be considered favourably for funding
by the Trilucent Centre. (Plastic surgeon)
TCC . . . have declined funding as the surgery
is required for aesthetic reasons. (AEI's solicitors)
. . . these implants were exchanged following
which she developed a haemotoma in the right breast requiring
secondary surgery on 24 July 2000. In September of last year she
developed a lump in her left breast and I thought it prudent to
arrange an ultrasound scan to investigate this. The invoice for
this service was sent to AEI and I gather there is some dispute
about them paying. Over the last month she has developed capsular
contracture (hardening) of the right breast which is probably
related to the haemotoma. This is of course a risk after any breast
augmentation but it is becoming increasingly more common after
exchange of breast implants. It is likely that this lady will
need further surgery and again AEI have stated that they are not
responsible for such revisional surgery. (Consultant)
May I refer you to our policy with regard to
post-operative complications in general. AEI are committed to
reimburse immediate post-operative complications, for example
haemotoma and infection, up until removal of the patient's sutures
or occasionally for a longer period at the discretion of the company.
To this end we have prepared a policy statement which I hope will
make our position clear as follows: AEI Inc have agreed to cover
the reasonable costs associated with the removal of Trilucent
implants and their replacement if desired. They will also support
any complications arising as a result of surgery, prior to the
Thereafter as you will appreciate there are
a number of inherent risks associated with breast implants (including
capsular contracture). Whilst it is entirely appropriate for AEI
Inc to take responsibility for the costs associated with the surgery
to remove and replace the Trilucent implants, it would not be
reasonable for AEI Inc to also have to assume liability for all
risks on an ongoing basis and associated with other implants.
As such complications subsequent to the post operative consultation
should, if appropriate, be pursued with the manufacturer of the
current implant, as is normal practice within the industry. In
conclusion, following care full consideration of your letter we
do not feel that they fall within our reimbursement remit. (AEI
A student who experienced complications and
who had to stay a second night in hospital.
. . ." X was booked into the hospital by
the consultant as part of the Trilucent Care Programme. We had
received the relevant paperwork from the centre relating to the
claim and payment process, which I have checked personally and
thoroughly. I note that there appears to be no indication of any
financial limit on payment from the Trilucent Care Centre, which
quotes on page nine that "the Trilucent Care Centre will
pay `customary and resonable' expenses towards these costs".
As there appeared to be no limit on payment we are under no obligation
to negotiate with you prior to admission and the operation went
ahead as normal. All the paperwork was explained to X on arrival
and as no shortfall was expected on the account, X was advised
only of her liability for any additional personal expenses. X
stayed for two nights and again it is not documented that the
patient should have a limit in their length of stay, only that
"the patient will require at least a one night stay"
After discharge the account was calculated
and sent in accordance with your guidelines and it was only then
we received a letter from yourselves dated 5 September which outlined
the maximum limit payable on the account of £1,000 . . .
the account remains outstanding. As there was no indication at
any stage of a limit on payment towards the costs of this operation,
it is unreasonable to expect the hospital or the patient to pick
up any shortfall on the account. I must assure you that all our
charges are extremely competitive compared to other similar independent
hospitals, especially bearing in mind that we as a charitable
organisation remain a non-profit making organisation and in consequence
keep all costs to our patients as low as possible. (Hospital to
"Trilucent paid £1,000 of the
hospital's invoice . . . which leaves a shortfall of £957.55
due from your client. Despite request by the hospital, payment
of its fees has not been forthcoming either from your client or
We understand you are seeking payment from
Trilucent. However, this does not affect your client's liability
to pay the balance of the hospital's fees, which are long overdue.
We therefore request that your client sends
this firm a cheque for £957.55 within seven days . . . failing
which it is regret that our client has instructed us to issue
proceedings. (Hospital's solicitors to Freethcartwright 5 March
I proceeded to explantation . . . both Y and
I understood that Trilucent would be furnishing any accounts generated
from this process. . . . As you will see . . . account number
1424 has a shortfallof £645.00. (Consultant)
Thank you for your invoice 1424 (£1,600)...Payment
of £955 will follow shortly in settlement of this account.
A standard fee schedule for this surgery has been formulated...payment
of the account is within this schedule. (TCC to surgeon)
I enclose a further invoice from Mr G. As I
explained his business manager telephoned Friday warning me that
Mr G would be seeking payment of the outstanding £500 through
a debt collector...it is not my custom to receive services and
not pay for them . . . according to Annex 6 of the document issued
by the Medical Devices Agency in June 2000, AEI are responsible
for all medical bills. . . . Because of the dispute with Mr G
I felt unable to attend a post-operative consultation with him.
. . . If there are any factors that the surgeons had been told
to advise patients then I am unaware of them and this increases
my anxiety. To be bombarded for money and be "piggy in the
middle" has at times reduced me to tears.
I feel very strongly that the additional bill
submitted by Mr G was reasonable to rectify the damage caused
by the Trilucent implant and that AEI should have paid Mr G in
full. (Patient to Freethcartwright)
In a private plastic surgical pratice all patients
who are self-funding or have an insurance excess are asked to
settle their account in advance. Normally one would not proceed
to surgery until the account had been settled. I confirm that
if my account is not fully settled I will pursue Mrs X for the
balance. (Mr G)
AEI/TCC will not be providing the additional
monies charged by the surgeon...this is a matter between the surgeon
and the patient. (AEI)
The Trilucent Care Pprogramme was set up to
assist patients and doctors through the removal of Trilucent implants
and reimplantations if desired in response to the hazard notice
by the Medical Devices Agency.
Whilst I appreciate this lady's position we
have honoured our duty to remove the soya implants due to the
potential health risk which was only a precautionary step and
as such I have to inform you that we are unable to assist with
further funding in this case.
However if there are any problems with the new
implants we would suggest you contact the manufacturer of the
new prothesis. (TCC to surgeon who requested funding for further
operation due to capsular contracture)
"The hospital has remonstrated with the
care programme to ask it to pay our invoice in full, as our charges
are reasonable and customary. They have declined to pay more,
and I am afraid that I do have to ask you to settle this balance,
in line with the written undertaking you signed at the time of
your admission. It seems that you will have to take this matter
up with Trilucent in order to recover the whole cost of your treatment."
(Hospital to patient)
34 Letter TUV Product service to freethcartwright
24/10/00. See also description of TUV's services-Exhibit 16. Back
to Surgical Advisory Services of Florida. Back
24/12/1996; 08/05/2000-Exhibit 17. Back
Exhibit 19. Back
S3(1) Consumer Protection Act 1987. Back
See National Consumer Council Report PD 451D4195 Unsafe Products
Nov 1995 "The 1987 Consumer Protection Act has failed consumers
and action needs to be taken to make it work"-NCC press release-Exhibit
Unreported City of London County Court April 2000; Cherie Booth
Article 8. Back
Protocol in Appendix 2-clients Newsletter and Solicitors Bulletin. Back
See MDA announcement 6 June 2000. Back
BUPA letter 1-2-01 -Exhibit 20. Back
MDA DA 2000(07) and (08)-Exhibit 12. Back
Novamedical letter to freethcartwright 20/12/00-Exhibit 21. Back
PIP to freethcartwright 9/02/01 -Exhibit 22. Back