Select Committee on Health Appendices to the Minutes of Evidence


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:

    —  GP surgeries

    —  NHS Direct

    —  Health authorities

    —  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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