Select Committee on Health Fourth Report


SUMMARY OF RECOMMENDATIONS

  (i)  We regret that the Government refuses to insist that advertising for cosmetic surgery should carry health warnings. We are not suggesting that such warnings would necessarily substantially impact on the numbers of women choosing to have such operations. Nonetheless, we do think that appropriate warnings might at least disrupt some of the "spurious reassurance" pointed to in the note from the Centre for Social Marketing at Strathclyde University. We have on a number of occasions in recent years found the Advertising Standards Authority to be impotent in regulating the content of advertising in health related areas. We believe the Government should introduce measures to bring into effect the IRG's recommendations forthwith (paragraph 31).

  (ii)  On a related area, it seems to us that too much of the Government's - and the IRG's - focus has been on the medical aspects of cosmetic surgery. Too little effort has been made to analyse the psychological motivations of women having such surgery. Since we believe many of the procedures being undertaken are perhaps unnecessary, and since, as Mr Paul Balen of Freethcartwright Solicitors pointed out, even operations in the independent sector risk incurring costs to public funds in terms of potential lost income, benefits and the cost of corrective surgery, we think the Government should do more to investigate the social marketing of cosmetic surgery, and the influences which determine why women want this surgery. We recommend that the Government commissions the Centre for Social Marketing at Strathclyde University to undertake research into the impact of advertising in this area. We also believe that the Government should commission or evaluate other research to obtain a fuller profile of the motivation of the women undergoing cosmetic surgery to feed into the educational process. This might inform the PSE element of the school curriculum (paragraph 32).

  (iii)  We are not convinced that GPs are providing an adequate service to women consulting them prior to undertaking breast augmentation surgery. The fact that such an operation is usually undertaken for 'cosmetic' reasons, and not on the NHS, perhaps militates against GPs giving this matter as much attention as they should. Given that 10,000 women each year undergo this surgery, and that over half first consult their GP, we feel that this is an area where DoH could offer more guidance (paragraph 35).

  (iv)  We are not convinced that the DoH booklet Information for Women Considering Breast Implants gives sufficient information as to the risks of these products. We believe that a more precautionary approach is required. We recommend that the section "The Silicone Controversy" which gives some attention to anecdotal evidence of women reporting illness, should be included in the section "consequences and potential risks" rather than under its current heading of "General Issues" (paragraph 39).

  (v)  We recommend that the revised edition of the DoH booklet draws attention to those countries banning silicone gel implants. Women contemplating this operation are entitled to this information (paragraph 40).

  (vi)  We believe that a key area where the Government must play a role lies in the facilitation of access to a genuinely objective and informed source of independent advice and counselling for women contemplating breast augmentation surgery. It is difficult for us to be prescriptive as to how this might be achieved and we acknowledge that a solution is not straightforward. In the first instance, the Government should consider offering specialized training within each Primary Care Trust, to provide a trained nurse counsellor who can advise in this and related areas. A woman could refer herself, or be referred by the GP, to this service, and practices should have information available on how this should be done. The Government may also wish to forge links with some of the voluntary and charitable organizations working in this area, and offer contact details in the DoH Breast Implant booklet. Finally, in an effort to reach the many women who do not approach their GP, the booklet itself might more fully reflect our concerns that many women are currently seeking a surgical solution to a psychological problem (paragraph 44).

  (vii)  Patients are entitled to much more information about the practical aspects of breast augmentation surgery. We believe it is for the DoH to capture the data, via the Registry, relating to the rates of rupture of different implants, and to ensure that this information is readily available. We believe that women are entitled to objective information on the success rates of surgeons performing such operations and that they should be informed of the precise nature of these surgeons' qualifications since, as our inquiry into private healthcare revealed, there is much misinformation in this area. We recommend that women should be obliged to record that they have been clearly informed of all aspects relating to future failure rate and costs of implants as part of the fuller consent procedure we describe below (paragraph 47).

  (viii)  We recommend that it should be mandatory that women are given written information on the make and model of breast implant with which they have been supplied (paragraph 48).

  (ix)  We note that work is proceeding on the development of a more comprehensive form of consent. We welcome this, and hope that the form will be introduced: it is, after all, two and half years since the IRG recommended this should happen. We hope that the new consent form will encourage a more open dialogue between clinicians and patients and will ensure that issues relating to safety and costs are fully explored before a decision is taken to proceed with surgery (paragraph 52).

  (x)  We recommend that the new consent form should take account of the issue of the notification of the GPs. The DoH booklet tells women: "The surgeon will wish to write to your GP giving details of the operation so that if there are any problems associated with surgery in the short- or long-term, the GP is aware of the surgery." We recommend that the revised edition of the booklet endorses this approach, perhaps explaining that such information will be confidential between doctor and patient. Finally, we think that those regulating private clinics should assess the procedures relating to liaison between clinic and GP and should attempt to establish if there are particular clinics which have an especially low rate of surgeon-doctor contact, so that further action can be taken (paragraph 54).

  (xi)  We are far from convinced by the defence put up by the MDA of its course of action in banning implantation of Trilucent implants and then, over a year later, pronouncing the toxicological data to be sufficiently worrying to justify explantation. We are not impressed by the MDA's refusal to acknowledge that they had made a mistake. The key weakness exposed by this chain of events is the wholly inadequate nature of the regulatory procedures, a point which we develop below (paragraph 59).

  (xii)  No evidence was presented to suggest that the MDA considered banning Trilucent implants purely because they were difficult to remove. Once again this strikes us as indicative of the serious weaknesses of the regulatory procedures (paragraph 61).

  (xiii)  We welcome the Minister's assurance that information on how to contact the MDA to report an adverse incident will be included in the DoH booklet. We also think it would be helpful if the consent form included information on how to report adverse incidents (paragraph 67).

  (xiv)  We commend the DoH and MDA for their efforts to have breast implants reclassified as high risk devices and their push to achieve uniform standards in Europe's Notified Bodies. However, we feel that the current regulatory system is deeply flawed and may need an even more radical overhaul. We were very unhappy that the manufacturers themselves could choose which body to apply to for certification. We also think the manufacturers should be obliged to have a robust system in place to collate data relating to adverse incidents. In parallel with this, we think the MDA should operate a surveillance system along the lines of the yellow card system applying to drugs. This could lead to the construction of a central register, allowing early detection of problems. We would prefer a more precautionary system to be in place, where products could only come on to the market once they have been licensed by a regulatory authority which was itself satisfied that proper clinical trials had been carried out (paragraph 72).


 
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