APPENDIX 9
Memorandum by Russell Levy, and Olive
Lewin and Nicholas Johnson on behalf of Leigh Day & Co, Solicitors
(B 17)
Leigh, Day & Co. was formed as a specialist
personal injury law practice in 1987. The firm is committed to
representing those who have been injured. The firm has a team
of over 100 people, including 60 lawyers, based in London and
Manchester. Several of the lawyers are members of the Law Society
Specialist Personal Injury and Clinical Negligence panels. A number
are also members of the AVMA (Action for Victims of Medical Accidents)
Clinical Negligence panel.
The firm, which is committed to carrying out
high quality work for its clients, also campaigns for improvements
in the law. Leigh Day & Co. tries to ensure that the rights
of those who have been injured are debated in society. The firm
has represented women involved in the US Breast Implant litigation
since 1992 with over 400 clients since 1994. As a matter of policy,
since 1992, the firm has only taken on as clients women who believe
they have actually suffered documented injuries caused by their
breast implants. Over 3,000 women who simply wished to register
in the litigation were referred to other firms of solicitors.
The women represented by Leigh, Day & Co have a very broad
spectrum of illness ranging from general fatigue, lethargy and
joint pain to crippling injuries and SLE. A high percentage had
reconstructive rather than augmentative breast surgery.
Russell Levy
Russell qualified as a solicitor in 1984, and
joined Leigh, Day and Co. as a partner in 1991. His principle
areas of practice since 1985 have been claimant clinical negligence
and medical devices (product liability) litigation. He has been
closely involved in many of the changes in clinical negligence
cases and procedure over the past 15 years. He has written for
various specialist publications and is a regular speaker on clinical
negligence and other legal topics. He is the lead solicitor dealing
with the Breast Implant cases at Leigh, Day & Co.
Olive Lewin
Olive is a partner within the clinical negligence
department. She has experience of working on complex medical claims
and multi-party actions. Prior to qualifying as solicitor she
was a registered general nurse, having trained at University College
Hospital, London. Olive joined Leigh, Day & Co. in 1991, becoming
a partner in 1998. She is responsible for the individual clients
in the US Breast Implant Litigation team at Leigh Day & Co.
Nicholas Johnson
Nicholas qualified as a doctor in 1983 at Charing
Cross Hospital Medical School, London. He worked in general practice
in Australia, becoming a Fellow of the Royal Australian College
of General Practitioners. In 1995 he returned to the UK to retrain
as a lawyer and was called to the Bar in 1998. Nicholas joined
the clinical negligence team in January 2001. He has day to day
responsibility for the management of the Breast Implant Litigation
cases. Prior to joining Leigh, Day & Co. he was the medical
support worker in the Lawyers Service at AVMA (Action for Victims
of Medical Accidents).
THE ROLE
OF THE
MEDICAL DEVICES
AGENCY
1. "The primary task of the Medical
Devices Agency (MDA) is to help safeguard public health by working
with users, manufacturers and legislators to ensure that medical
devices meet appropriate standards of safety, quality and performance
and that they comply with relevant Directives of the European
Union." [10]
It is our view that in the context of silicone
breast implants the Medical Devices Agency has not satisfactorily
discharged its duties as defined in the mission statement.
2. The Independent Review Group (IRG) concluded
in 1998 that there was insufficient epidemiological evidence for
any link between silicone gel breast implants and any established
connective tissue disease. The group did recognise that there
were a number of complications such as capsular contracture and
gel bleed associated with breast implantation. Unfortunately the
IRG did not address the issue of whether or not the various manufacturers
of breast implants had provided safety data of a standard acceptable
to the MDA to enable continued marketing of their products within
the United Kingdom.
3. Attached is a statement by Russell Levy
to the United States' National Academy of Sciences' Institute
of Medicine in August 1998. Regrettably, the concerns expressed
in that statement in relation to the constraints placed by the
IRG on its role and its consequent findings remains.
4. The MDA appears to be using the findings
of the IRG as the basis of its continuing permission for these
products to be marketed. This decision is in direct contrast to
the position adopted by equivalent agencies in other jurisdictions.
5. In 1991 the Food and Drug Administration
(FDA) in the United States requested the manufacturers of silicone
gel implants to submit evidence in a pre-market approval (PMA)
application that silicon gel-filled breast implants were safe
and effective. This evidence has never been provided and in the
absence of enough data on safety and effectiveness the FDA determined
that silicone gel-filled breast implants could not be approved.
The current position in the United States is that these products
are only available to women through FDA approved studies:
— an investigational device exemptions
(IDE) study.
These provisions allow women who are seeking
either breast reconstruction or revision of an existing implant
to use these products. Silicone gel-filled implants are not available
to women who are undergoing breast augmentation for cosmetic reasons.
6. The position in New Zealand is that although
silicone gel-filled implants are still available, the government
has issued an unequivocal statement to the effect that the use
of breast implants is not endorsed, and that the safety of such
implants cannot be confirmed or refuted.
7. In Canada the only implants available
are saline filled implants. In 1992 following concern about the
safety of silicone gel-filled implants a voluntary moratorium
was imposed on their use. To date the manufacturers have not filed
any applications demonstrating the safety, quality and effectiveness
of their products. As a consequence none of these products can
be sold legally as they have not obtained a Notice of Compliance
from Health Canada.
8. In Australia breast implants are regarded
as therapeutic goods under the terms of the Therapeutic Goods
Act (1989) which came into force in 1991. When this Act was implemented
silicone gel-filled breast implants were entered onto the Australian
Register of Therapeutic Goods (ARTG) as "grandfather status"
low risk devices. In 1991 following concerns about these products
the manufacturers were advised that the status of these products
would be changed from low risk (Listed) to high risk (Registrable)
devices. The manufacturers and suppliers were informed that adequate
data supporting the safety of silicone gel-filled implants would
need to be supplied to the Therapeutic Goods Administration (TGA)
by 31 January 1992 if they wished to continue marketing these
devices. At the time, no manufacturer or supplier had such information
and there are still no silicone gel-filled breast implants on
the ARTG. Silicone gel-filled breast implants cannot be legally
supplied in Australia, except on an individual patient use (IPU)
basis under certain circumstances.
9. It is our understanding that the MDA
has not sought adequate safety data from the manufacturers for
these products, nor attempted to impose any restrictions on their
use until this safety data has been provided. We would remind
that Committee that in the US, Australia and Canada manufacturers
have not made any significant attempt to re-enter the market and
would respectfully suggest that the Committee draws the inference
that it is possible that the manufacturers themselves have doubts
about the safety of their products. It is in any event clear that
the manufacturers are unable to demonstrate the safety of these
products.
10. The MDA has taken an inconsistent approach
to the licensing of breast implants. Trilucent implants were approved
for use in the United Kingdom by the MDA. Following concerns about
the lack of long-term safety data for this product, particularly
in relation to the breakdown of the lipid filler, the MDA required
the manufacturer to carry out further toxicological testing and
provide further safety data. It is not clear why the MDA has been
unable to adopt a similar approach in relation to silicone gel-filled
breast implants. The MDA say that they have taken action to prevent
the use of Trilucent breast implants because there is insufficient
evidence as to their safety. The MDA continue to say that they
see no need to take action to prevent the use of silicone breast
implants because there is insufficient evidence that they are
unsafe. We do not understand the difference.
11. Tracking adverse incidents is an important
function of the MDA. In contrast to comparable organisations overseas
the MDA does not appear to welcome reporting of adverse incidents
from lay people. This view is supported by the experiences of
a number of our clients when attempting to report problems with
their implants to the MDA.
12. The information booklet provided by
the FDA provides full details on how to contact the FDA and report
adverse events. The booklet provided by the TGA in Australia positively
encourages lay reporting, emphasising the importance of being
able to track the types of problems experienced with individual
implant types.
13. The booklet produced by the Department
of Health mentions the MDA but does not provide contact details.
THE PROCESS
WHEREBY INFORMATION
RELATING TO
RISK IS
DISSEMINATED
14. The MDA is charged with collecting and
analysing information relating to adverse events. On this basis
it is our view that the MDA is the most appropriate organ for
disseminating information relating to risks associated with medical
devices. The MDA has demonstrated with Trilucent that it is able
to provide appropriate information, both to the medical profession
and patients, concerning the risks of a medical device. This activity
is to be applauded, but at the same time we are of the view that
the MDA can take steps to improve its interface with the general
public. The experience of a number of our clients in attempting
to report adverse events is worrying. The FDA in the United States
and TGA in Australia both actively encourage patient reporting
of adverse events. It is our view that much could be achieved
if the MDA were to follow the lead of these organisations.
THE INFORMATION
PROVIDED BY
THE DEPARTMENT
OF HEALTH
DIRECTLY TO
THE PUBLIC
AND ACTION
TAKEN IN
RESPONSE TO
CONCERNS RAISED.
15. The IRG recommends that all patients
undergoing cosmetic breast augmentation surgery should be able
to obtain, free of charge, from a designated body, comprehensive
information about the benefits and risks of such surgery. This
information should be accompanied by a checklist of topics, which
should be covered when the possibility of an operation is discussed.
[11]
16. It is our view that this recommendation
has only been partially addressed. A common complaint of our 438
clients concerns the lack of Information provided to surgery.
The IRG recognised that the information provided to women to assist
them in making informed decisions about whether to proceed with
breast implant surgery was frequently inadequate, in terms both
of quality and quantity.
17. The IRG held an Open Day on 5 October
2000 when the progress on its recommendations was reviewed. With
regard to the recommendation concerning provision of information,
the IRG noted that an advisory group had produced a booklet for
women considering breast implant surgery. This can be obtained
from the Department of Health website. We have reviewed the information
provided in other jurisdictions and would consider that the Department
of Health booklet is less informative than similar publications
available in other jurisdictions. The Department of Health booklet
consists of thirteen pages of notes and tables. In contrast the
information provided in the United States is considerably more
detailed, but at the same time user friendly. The approach is
fair and balanced, and a bibliography of the sources of information
used is provided. Sample questions women contemplating breast
surgery may wish to ask are provided in contrast to the checklist
provided by the Department of Health. Adequate advice is given
on how to contact the FDA and how to report adverse events.
18. The TGA in Australia has also produced
a comprehensive booklet for persons considering the use of silicone
gel-filled breast implants. This booklet is far more detailed
than that available from the Department of Health.
19. Although the Department of Health booklet
does discuss the risks of breast implant surgery it is our view
that these risks are somewhat understated. It would be preferable
for information of the type available in Australia and the United
States to be available. The IRG has recommended that comprehensive
information about the benefits and risks of breast augmentation
surgery should be available. It is our view that although the
current information is an improvement on what was previously available,
it does not comply with the IRG recommendation.
GUIDANCE TO
HEALTH CARE
PROFESSIONALS
20. Current guidance to health care professionals
focuses on the findings and recommendations of the IRG. Our view
is that undue emphasis has been placed on the lack of any demonstrable
link between silicone gel-filled implants and connective tissue
disease. Insufficient attention has been paid to the lack of safety
data provided for these products. Despite the fact that silicone
gel-filled breast implants have been marketed for over 30 years,
manufacturers have organised no long term research or trials.
We suggest that the IRG and the MDA have failed to attach to this
failure the significance it warrants.
21. We would welcome a statement outlining
the position of the MDA in relation to the lack of safety data,
research and testing being included in guidance provided to health
care professionals in relation to silicone gel-filled breast implants.
22. If as we believe, the position regarding
the provision of safety data in the United Kingdom is no different
compared to Australia, New Zealand, Canada and the United States
then the MDA should state whether or not it intends to request
that the manufacturers provide this information. If the MDA does
not intend to request this information then any guidance issued
should explain why the MDA has decided that this information is
not required.
23. The MDA should also be encouraged to
give guidance on the relative and absolute contraindications of
all types of breast implants, and if silicone gel-filled implants
are to continue to be marketed in the United Kingdom guidance
should be issued as to the circumstances in which they may be
used. We refer again here to the guidance issued by the FDA and
TGA.
CONCLUSION
24. In 1994 when we first raised concerns
about the then Medical Devices Directorate's approach to the safety
of silicone breast implants our correspondence was immediately
passed to the Department of Health's solicitor. His answer was
that he had advised Dr Ludgate "...that it is not appropriate
for either her or I to become involved in a lengthy dialogue with
you about this, that or the other piece of scientific evidence..."
Regrettably, this refusal to delve into issues put forward by
women who believe they have suffered injuries from their silicone
breast implants and those representing them has continued. Since
the first position paper published by the Medical Devices Directorate
in 1993 the view taken by the MDA has been that there is insufficient
evidence for an association between the implantation of silicones
and connective tissue (and other) diseases. Accordingly, no action
restricting the use of silicone implants has ever been taken.
The conclusion we believe the Committee has to draw is that, as
unpalatable as it may seem, the main objective of the MDA since
1993 has been to stand by their initial view, thereby justifying
their inaction, rather than to protect and inform women contemplating
undergoing silicone breast implant surgery.
15 March 2001
10 Medical Devices Agency mission statement. Back
11
Silicone Breast Implants: Report of the IRG, 1998 (Recommendation1). Back
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