APPENDIX 8
Memorandum by the Consumers' Association
(B 12)
BACKGROUND
Consumers' Association (CA) is an independent
organisation that works on behalf of consumers to achieve improvements
in the quality of goods and services. CA's key health objectives
are to ensure that the public has excess to information to make
informed decisions about health services and policy, and to campaign
for positive change in those areas where we have identified concern.
These objectives are supported through health policy research
and reports published in consumer magazines Which? and
Health Which? Also, more recently, through the publication
of Treatment Notes, a bulletin designed to give patients
access to independent and thorough reviews of the effectiveness
of drugs and other treatments. Treatment Notes is produced
in conjunction with Drug & Therapeutics Bulletin (DTB),
which provides the same information for doctors and pharmacists.
We are very pleased that the Health Committee
has decided to conduct an inquiry into this important issue. CA
has closely followed the debate around the safety of breast implants,
in particular those made from silicone gel. We are not in a position
to comment on the safety of different types of breast implant
or on the role of the Medical Devices Agency. However, we have
strong views about the need for trustworthy information to be
available to women considering this type of surgery, and about
the way messages about risk are delivered to the wider public.
We explore these issues in more detail below.
CA has undertaken a number of specific investigations
into private clinics providing cosmetic surgery, walk-in GP services
and slimming advice. In 1999, we gave detailed evidence about
these investigations to the Health Committee inquiry into the
regulation of the private healthcare sector. These reports and
a copy of our evidence are attached for your information.
Our earlier investigations have found that a
lack of reliable information is available to women considering
breast implant surgery. Many of the very positive recommendations
made by the Independent Review Group into silicone gel breast
implants have not been implemented. The Department of Health has
produced an information booklet that goes some way to address
concerns about the shortage of reliable information about breast
implants, but this is of only limited usefulness. Also, it puts
the onus for accessing information on the patients, not the surgeon
or clinic.
We recommend that:
— the Department of Health make the
information needs of women considering breast implant surgery
a priority;
— there should be a designated body
to provide, free of charge, comprehensive information about risks
and benefits of treatment. As part of its remit, the designated
body should ensure that information is widely distributed;
— a checklist of topics which should
be discussed when the possibility of treatment is being discussed,
should be integrated into a consent form that requires both the
patient and surgeon to confirm that these subjects have been thoroughly
reviewed and discussed;
— the Department of Health should incorporate
the Independent Review Group recommendations into the independent
healthcare regulations and standards. The National Care Standards
Commission would then have responsibility for checking that these
standards are met and that information is available to women considering
implant surgery in the private sector;
— as part of its inspection programme,
the Commission for Health Improvement should check that information
is made available to women considering implant surgery via the
NHS.
An NHS Private Sector Issue
Breast implant surgery is largely undertaken
in the private sector. There are no centrally collated statistics
on the number of cosmetic surgery procedures carried out in the
UK, but anecdotal evidence suggests that the number of consumers
opting for cosmetic surgery—and in particular, breast implant
surgery—is growing. There are reports that this growth is
greatest among young women.
Availability of breast implants on the NHS is
limited. It is important to bear in mind, however, that breast
implant surgery is not just carried out on women seeking to enhance
their looks or redress imperfections. This type of reconstructive
surgery plays an important role in helping to restore a woman's
confidence and facilitate a return to normality following a mastectomy.
Therefore, the information needs of women considering
breast implant surgery apply to women using the NHS and the private
sector. Furthermore, their needs for information should be treated
the same, regardless of their motivations for having the procedure.
It is our view, however, that some of the specific problems we
have identified in our investigations are exacerbated in the private
sector.
Lack of Patient Safeguards
CA has been concerned for many years about the
general lack of patient safeguards within private hospitals and
clinics. We are very pleased that the Government has recognised
the need to strengthen the regulation of private healthcare through
the introduction of the Care Standards Act. However, we believe
that the lack of good quality, objective information to enable
patients to make informed decisions about their treatment continues
to be a particular issue in this sector.
Specifically, CA investigations into private
clinics have found that when people visit clinics it is not always
clear whether they are being given clinical or sales information.
In some cases sales staff are called consultants and some clinics
ask patients to sign-up for treatment before they have had the
opportunity to meet with a surgeon. As a result, patients often
feel pressurised to make decisions about treatment without the
benefit of adequate information.
Quality of Advice on Implants from Private Clinics
In 1998 we conducted a small-scale investigation
to examine the quality of advice given to women considering surgery
with silicone breast implants. A copy of this report is attached
for your information.[7]
A CA researcher visited three London based clinics
offering breast implant surgery. Following the visits an expert
advisor was asked to assess the quality of the consultations.
Our expert concluded that consultations at two of the clinics
were reasonable and that a fairly thorough explanation of the
risks of silicone breast implants was given. However, the consultation
at the third clinic was found to be much less satisfactory. Our
expert criticised the clinic nurse for making unprofessional comments,
and described the consultation as amateurish. Information about
implants was lacking, the side effects of the operation were barely
mentioned and long-term risks were not explained. Some of the
advice the nurse gave to our researcher was simply inaccurate.
Our researcher was also put under considerable pressure to agree
to undergo breast implant surgery without the benefit of good
information or time to fully consider the advantages and disadvantages
of the procedure.
The above case illustrates how unsatisfactorily
arrangements can be for providing pre- and post-operative information
about breast surgery.
INDEPENDENT REVIEW
GROUP (IRG) ON
SILICONE GEL
BREAST IMPLANTS
In July 1988, the Independent Review Group (IRG)
reported. While we had some concerns about the lack of lay representation
on the review panel and were disappointed that it didn't have
a lay chair, we supported a number of the recommendations made
by the Group. Furthermore, in our evidence to the Health Committee
inquiry into the regulation of independent healthcare, we strongly
recommended that a number of the IRG proposals for improving access
to information be extended to all procedures carried out privately.
In our view widespread implementation of the
following IRG proposals would put patients who use private clinics
for any procedure, but particularly for breast implant surgery,
in a much stronger position to make informed decisions about their
treatment.
— the establishment of a designated
body to provide, free of charge, comprehensive information about
the risks and benefits of treatment—this would ensure that
women have the benefit of good quality information regardless
of which clinic they attend;
— the development of checklists of
topics which should be covered when the possibility of the treatment
is being discussed—this would mean that women get insight
into the questions that they need to ask about breast implants;
— the development of a consent form,
which incorporates, as an integral part, the checklist of topics
which should be discussed and which requires both the patient
and surgeon to confirm that these subjects have been thoroughly
reviewed and discussed—this would ensure that surgeons meet
their obligation to ensure that women only give consent after
they have had the opportunity to fully consider the advantages
and disadvantages of the procedure.
This last point is key. Specifically, the IRG
report said that there is no uniformity in the approach taken
to counselling women and that, in some instances, women are given
far too little information about what to expect. The IRG also
raised specific concerns about the potential for civil action
where consent is deficient, and said that it was "strongly
of the opinion that doctors should give women comprehensive information
about the risks and benefits of silicone gel breast implants.
[8]
We also strongly supported the recommendation
for information on the financial implications of breast implant
surgery (including the costs of possible further treatments) and
a "cooling off" period of several days between initial
consultation and the operation. This would help to ensure that
women are able to reflect on the longer-term consequences of having
implant surgery.
The Review Group also stated that measures are
needed to ensure that "proper standards of care are implemented
in clinics carrying out breast implantation within the private
sector". It also wanted to see all silicone gel breast implant
operations held on a central register, along with proper monitoring
of side-effects. CA fully supports both these recommendations,
which strike a cord with the findings of our earlier investigations
into private sector clinics.
The IRG report wasn't specific about who should
be responsible for implementing these recommendations. A Department
of Health press release on 14 July 1998, said that the British
Association of Aesthetic Plastic Surgeons (BAAPS) supported the
recommendations and pledged to work "to ensure that women
get all the information they need, in an unpressurised environment,
before deciding on surgery." Yet when CA contacted BAAPS
to find out whether its support extended to monitoring and implementing
the recommendations, BAAPS implied that it was unable to do this
because "BAAPS is a professional association and not a regulatory
agency."
To our knowledge, many of the recommendations
made by the IRG relating to patient information have not been
implemented. We believe that the strength of the IRG report lay
in its rounded approach to tackling the information problem. We
have been extremely concerned about the lack of progress made
toward establishing a designated body to provide information,
and on a more general note, about the selective approach taken
to implementation of the IRG recommendations. This is unacceptable
and means that women considering breast implant surgery are still
being put at risk. The only area where progress has been made
is with regard to the development of a patient information booklet,
but even here we are disappointed that the leaflet will only be
of limited usefulness.
BREAST IMPLANT
PATIENT INFORMATION
ADVISORY GROUP
(BIPIAG)
The Department of Health set up the BIPIAG to
take forward the recommendations on preoperative information made
by the IRG. We do not believe that it was within the remit of
the BIPIAG to take the lead on all of the recommendations made
by the IRG, or to take a decision to extend these recommendations
beyond breast implant surgery. However, we have grave concerns
about the BIPIAG decision to develop a patient information leaflet
instead of an integrated checklist/consent form as was recommended
by the IRG.
The patient information leaflet developed by
the BIPIAG and published last October will be useful, but it will
not act in the way the integrated form would—as a "safety-net"
measure to ensure that women have adequate information about the
procedure before making a decision about treatment.
We are also concerned that this approach puts
the onus for accessing information on the patient without making
the clinic or surgeon take formal responsibility for ensuring
that this information is available. For example, of synthetic
implants the leaflet reads: "Ensure that you obtain full
information about the different types when you discuss your particular
situation with the surgeon." Similarly, of the need for consent,
the leaflet states: "When asked to sign a consent form, assure
yourself that you have had the following [information]."
A press release that launched the leaflet said
it would be available in GP surgeries and "other appropriate
clinics and practices." [9]
There is no guidance on how to ensure that clinics provide the
patient information leaflet to women. This is particularly concerning
as it cuts to the heart of one of the main criticisms about clinics
made by both the IRG and CA—that they do not perform well
when it comes to giving information to patients.
CA provided detailed comments on the draft and
set out our concerns about the approach being taken. We were dismayed
therefore that had it not been for the intervention of a lay member
of the BIPIAG, our response to the consultation of this leaflet
would have not have been available to the group for their full
and proper consideration. We expressed our concern to the chair
of the Group, Baroness Emerton, but never received a response.
We would encourage the Health Committee to ask the Chair of the
BIPIAG to account for the Groups' decisions with regard to the
implementation of the recommendations and the development of the
leaflet.
Communicating Risk
Finally, we have had some concerns about risk
communication with regard to breast implants. For example, the
IRG report found no "conclusive" evidence that women
with silicone gel implants are any more likely to have health
problems than any other women. This was the third review in six
years to conclude that there isn't enough evidence to find silicone
implants unsafe.
But this doesn't mean they are safe. As the
IRG report says "there is some risk associated with the use
of any implant". Also, silicone implants do have risks, including
infection, hardening and rupture—similar risks as for many
operations that involve putting foreign material into the body.
We're concerned that this complicated message may not reach women
considering this surgery. Certainly newspaper reports around the
time of the publication of the IRG report didn't always communicate
an accurate reflection of the level of risk involved—copies
of cuttings from July 1998 are enclosed.
This is precisely why the provision of good
quality, accurate and accessible information is so critical. The
reality is that this is a complex area where there is no conclusive
evidence to say that implants are safe or unsafe. In order to
take decisions people need to be aware of risks and potential
risks and these must be present in a way that is balanced, unbiased
and clear. It also reinforces the need for a designated—and
independent—body to be involved.
Conclusions and recommendations
Enabling consumers to make their own decisions
about the risks they are prepared to take requires that they have
sufficient information and understanding to do so. Our research
has shown that information provided by clinics is not always trustworthy
or reliable. Given the controversy surrounding the safety of breast
implants and the complicated messages around risk, it is essential
that the Department of Health makes the information needs of women
considering breast implant surgery a priority. Unless the IRG's
recommendations are fully implemented there will be no guarantee
that some of the main concerns identified will be addressed.
We echo the IRG recommendation for a designated
body to provide, free of charge, comprehensive information about
the risks and benefits of treatment. Women should be able to approach
this body directly for information. However, the designated body
should also see that information—such as the leaflet produced
by the BIPIAG—is distributed to:
— Breast clinics in NHS and private
hospitals
— Private cosmetic surgery clinics
— Private hospitals where cosmetic
surgery is carried out.
This information should include a checklist
of topics which should be covered when the possibility of treatment
is being discussed, and integrated into a consent form that requires
both the patient and surgeon to confirm that these subjects have
been thoroughly reviewed and discussed. This would ensure that
surgeons meet their obligation to ensure that women only give
consent after they have had the opportunity to fully consider
the advantages and disadvantages of the procedure. It would also
serve to ensure that surgeons take formal responsibility for ensuring
that this information is made available to patients—it is
wrong to put the onus on patients to seek out this information.
The Care Standards Act and the establishment
of the National Care Standards Commission should address concerns
that proper standards of care are implemented in clinics carrying
out breast implantation within the private sector. It is our understanding
that the Department of Health will be consulting within the next
few months on the standards that should be set for this sector,
which presents an ideal opportunity to take forward the recommendations
made by the IRG. Therefore, we recommend that the independent
healthcare regulations and standards incorporate the IRG recommendations
in the guidance for cosmetic/aesthetic surgery. This would also
allow for applying the recommendations to other cosmetic surgery
procedures in addition to breast implant surgery. The National
Care Standards Commission will have the power to inspect private
clinics and hospitals each year to see that the standards are
met. This should include checking that information is available
to women considering breast implant surgery.
Mechanisms are also needed to monitor the provision
of this type of information by NHS providers. We recommend that,
as part of its inspection programme, the Commission for Health
Improvement should check that information is made available to
women considering implant surgery in the NHS.
Until these measures are put in place, women
considering breast implants—particularly in the private
sector—will continue to be in a vulnerable position. A number
of sound recommendations were made by the IRG in 1998. CA supports
these and makes further recommendations of its own. What we need
now is action.
7 Not printed. Back
8
Independent Review Group, Silicon Gel Breast Implants: Report
of the IRG, 1998, p30. Back
9
Department of Health, Independent breast implants advice published,
4 October 2000 [press release]. Back
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