Select Committee on Health Fourth Report

The form of consent

49. One of the recommendations of the IRG was that a consent form should be developed which incorporated a check list of issues including issues such as the cosmetic effects of the operation, the possible immediate and long-term effects, the impact on breast cancer screening and the financial implications. The suggestion was that both patient and surgeon would discuss these topics, then both sign a form to indicate that this discussion had taken place. In oral evidence, Professor Sturrock confirmed that the development of such a form should now be the priority:

"I think the next step is to construct a proper informed consent form that women would have to fill in prior to breast implantation augmentation and there has been considerable consultation with the Colleges of Surgeons and with the professional bodies in plastic surgery to produce an informed consent form, which is not finally there yet but which I gather is in preparation ..."[66]

Ms Irwin of AASGUK also supported the development of a much more comprehensive consent


"We know that consent in itself to have or not to have a treatment is legally binding, there is a legal obligation for that but in fact there is no actual legal obligation for people to have the information which makes them make that decision. I would certainly like to see some moves which tied up the consent with the information in terms of having some legal obligation for both ... In New Zealand it becomes a sort of disclaimer. The patient has to sign to say that they have read the information and this would seem to me like a reasonable compromise."[67]

50. The Consumers' Association (CA) felt that the strength of the IRG report lay in its rounded approach to the provision of information to consumers. In particular they felt that the consent procedure needed radical improvement:

"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."[68]

51. The CA affirmed that patients needed fuller information on the financial implications of implants. In addition they pointed to a lack of clarity as to who is currently responsible for implementing the standards recommended by the IRG. They drew attention to a DoH Press Notice of 1998 which said that the BAAPS would work to ensure that all women obtained the information needed, implying that this body would play an overseeing role; when the CA contacted BAAPS they found that it considered itself to be a professional body not a regulatory authority.[69]

52. 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.

Liaison with GPs

53. We were concerned to hear from several witnesses of a lack of liaison between private clinics and GPs in the area of breast implant surgery. Mr Balen told us that in his experience GPs only very rarely knew that their patients had undergone this operation.[70] Professor Sturrock told us that the IRG had been strongly of the opinion that there should be communication between surgeon and GP, in case there was anything in the patient's medical history which might suggest such an operation would be unwise. Yet the IRG had established that not only were many doctors not consulted prior to surgery, many were not told even when surgery had taken place. According to Ms Heasman, a common concern of women was not that the doctors would find out but rather that their receptionists would.[71]

54. Whilst we accept that a patient has a right not to inform her doctor that this procedure has taken place, we are extremely uneasy that this practice is so prevalent. We feel that the balance should fundamentally shift so that women are strongly urged to let their doctor know, not least so that future possible complications can be promptly diagnosed. 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."[72] 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.

The Regulatory Process

Device Alerts

Trilucent Implants

55. Soya oil implants, marketed under the name Trilucent, are now banned in the UK, though the highly confusing MDA memorandum is extremely tortuous in disclosing this information. Put simply, in March 1999 the MDA issued an Advice Notice regarding these implants to members of the relevant professional bodies which effectively banned further implantation because of concerns about potential health effects of the breakdown of soya filler in the body.[73] An independent review was sought from the DoH Committee on Toxicity in March 1999. The MDA's statement at the time (though not its memorandum to us) explains the basis of their doubts:

"Apparent irritation following rupture and the apparent increase in levels of degradation products over that upon which the manufacturer had undertaken their initial safety assessment."[74]

But the Advice Notice stated that "there was no safety information to suggest that removal of Trilucent breast implants was indicated but that women should be advised to seek an immediate clinical consultation if they noticed unusual breast swelling or inflammation associated with their Trilucent breast implants".[75]

56. Following the withdrawal from sale the MDA required the manufacturer to carry out further toxicological testing on the filler. The Advisory Group of toxicologists, plastic surgeons and a lay representative that the MDA set up analysed the data. Kevin Chapman, Professor of Cell Toxicology at the University of Birmingham, explained that "the products produced by the breakdown of the soya bean oil, which are known as aldehydes, were potentially carcinogenic".[76]

57. On 6 June 2000 the MDA issued a Hazard Notice recommending the removal of Trilucent breast implants because of potential genotoxic components. Dr Pat Troop, the Deputy CMO, was quoted at the time as saying the decision to advise women to have the implants removed was "precautionary" but that risks of cancer or damage to an unborn baby could not be ruled out. Dr Susanne Ludgate, Medical Director of the MDA was also quoted as saying that in retrospect, the decision to allow these implants should not have been taken, adding "the MDA has become quite concerned at this issue".[77]

58. The MDA's memorandum, however, reflects no such admission of error and instead presents itself as acting entirely properly and methodically through the series of events. This was also the line taken in the oral evidence session when both Dr Troop and Dr Ludgate were present. Dr Troop described the sequence of events as "a progression of understanding ... Each response was thought to be proportionate to the evidence that was there at the time".[78] Dr Ludgate for the MDA went so far as to suggest that the case of Trilucent implants "illustrates quite nicely factors about the adverse incidents system and how things can work quite positively".[79] She argued:

"We called for the dossier from the manufacturers, we looked at all their safety data, and we were not happy that they had carried out the full tests that we considered necessary at that time, so immediately we said that there should be no more implanted. But there was nothing in the evidence from the manufacturer that gave rise to any concerns at all at that time in terms of safety."[80]

59. 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.

60. The serious weaknesses in the regulatory mechanisms were also highlighted in a telling comment from Dr Ludgate that one of the reasons why explantation was not initially recommended was the difficulty in removing Trilucent Implants:

"They get very stuck down to the surrounding tissue, and it is a much bigger operation than just making a cut and whipping them out. It is actually quite a long operation and there is often a lot of bleeding and these patients need to stay in hospital for several days with drains etc."[81]

Mr Balen's memorandum drew attention to one major clinic which wrote to its patients after the recommendation came to explant Trilucent implants to notify them that this procedure would need to be carried out by a specialist plastic surgeon, rather than a cosmetic surgeon, an indication of the complicated nature of the operation and of the limitations of the surgeons often employed in breast augmentation surgery.

61. Given the fact that many implants rupture and that there may be a host of other reasons why women should choose to have implants removed, we asked why Trilucent implants had ever been accepted as safe to use in the first place. Dr Ludgate said that this was an argument in favour of pre-market clinical trials for the implants, a move she would favour as part of MDA's policy to have implants reclassified as 'high risk' medical devices (see below, paragraph 70). However, 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.


62. In December 2000, the MDA issued two separate Device Alerts, one on each make of hydrogel implant banning their implantation.[82] The MDA's memorandum is extremely vague on why these implants were withdrawn:

"As part of ongoing review of biological safety of all breast implants, MDA calls for and reviews manufacturers' safety data for two hydrogel-filled breast implants and concludes that there are serious concerns over long-term safety data. MDA's concerns confirmed by COT. Products withdrawn; MDA issues two Device Alerts."[83]

63. The MDA revealed that, although few adverse incidents with hydrogel implants had been reported, it had identified: "that the manufacturer's safety assessment was inadequate, due to lack of long term toxicity data or clinical data or clinical follow-up together with methodological flaws

in some of the pre-clinical tests." Once again, it was only retrospectively, that these products were removed.

64. The effect of these contradictory signals from the MDA on (often vulnerable) women contemplating surgery or having undergone surgery is not hard to imagine. Mr Balen indicated the sort of problems created:

"I certainly have a large number of clients who had the soya Trilucent implants put in instead of silicone, so they have had silicone removed and Trilucent put in because the soya was widely marketed as the safer alternative to silicone, and I have clients who have had to have them removed and have had hydrogel put in, only within a couple of weeks to be met by the notice that came out in December banning implantation of hydrogel implants."[84]

Again, these problems point to serious structural flaws in the regulatory process, a theme we develop below.

Adverse incidents

65. The MDA is the body responsible for recording adverse incidents in relation to breast implants. The regulations state that manufacturers "must report serious adverse incidents to the regulatory authority". Dr Ludgate told us that, in practice, as many reports were received from patients and doctors as from manufacturers. But we received ample evidence that the process was flawed and that the number of recorded adverse incidents fell well below those experienced. Dr Myhill wrote:

"Over the past twenty years I estimate I have seen over 1500 cases of chronic fatigue syndrome largely caused by viral infection but an important sub-group of over 100 patients are those whose chronic fatigue syndrome follows silicone breast implants. During the early years I reported these cases individually to the Medical Devices Agency, but when it became clear to me that they took no action whatsoever to investigate these cases further, I gave up reporting. More recently I have simply told them the numbers of patients affected and the symptoms from which they suffer. The Medical Devices Agency has not asked for any further information nor investigated any of these either as a group or singly."[85]

66. We put Dr Myhill's statement to Dr Ludgate. She told us that at one time the MDA had not investigated each case individually, and that they were looking for adverse incidents "of the devices" rather than the ill-health of individuals. Now, however, each woman was individually registered. A key objective here was to collate data to pass on to the IRG.

67. The Minister told us that our inquiry had prompted her to re-examine the Breast Implants leaflet and that she had noticed, in the context of the reporting of adverse incidents, that it contained no mention of the MDA. She assured us that this would be put right in the second edition.[86] 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.

Certification of devices

68. In Europe, medical devices are not licensed by a Regulatory Authority.[87] Instead they carry "CE marking to denote the manufacturer's claim that the device is safe and fit for its intended purpose and meets all the requirements of the Medical Devices Regulations".[88] CE marking is granted by 60 Notified Bodies throughout Europe. Issues of commercial confidentiality limit public disclosure of which body has licensed which product; moreover, conformity assessment documentation is not freely in the public domain.[89] The MDA describes its function as being to "take all reasonable steps to protect the public health and safeguard the interest of patients and users by ensuring that medical devices and equipment meet appropriate standards of safety, quality and performance and that they comply with relevant Directives of the European Union".[90]

69. Mr Balen voiced his concern 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".[91] He argued that the CE mark did not in any way represent a guarantee of safety such as consumers might expect. A further structural weakness was that notified bodies could be chosen by manufacturers anywhere in Europe: the consequence of this was that companies could "hawk themselves around Europe" targeting the least stringent body for certification, then freely market products throughout Europe "without further control".[92] Finally, notified bodies, "as profit centres are also likely to be under pressure not to fail products thereby risking a reduction in their income".[93]

70. We put these concerns to the MDA and the Minister and they agreed that there were serious flaws in the system. They acknowledged that the presence of the CE mark might be misconstrued as a guarantee of safety.[94] They agreed with us that the fact that these products could be marketed without clinical trials meant that the women actually purchasing the implants were themselves constituting a sort of clinical trial. The MDA - working in conjunction with other regulatory bodies - has secured a review of the operation of the European Directive for Medical Devices. Measures "under active discussion" include the establishment of a European Notified Body oversight group and the reclassification of breast implants into the "highest risk" product category (currently they are classed as "medium risk"), moves the MDA supports.[95] Such a reclassification would afford the most stringent controls under the regulations and would require the Notified Bodies to assess the manufacturer's design dossier for each device.[96]

71. The UK is also leading the drive to have a co-ordinating body which would seek to ensure uniform standards for all of the Notified Bodies scattered around the EU.[97]

72. 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.

66   Q6. Back

67   Q70. Back

68   Ev., p.69. Back

69   Ev., p.69. Back

70   Q84. Back

71   Q87. Back

72   Information for Women Considering Breast Implants, p.6. Back

73   Ev., p.13.; Ev., p.45. Back

74 Back

75   IbidBack

76   Daily Telegraph, 7.6.2000. Back

77   IbidBack

78   Q151. Back

79   Q151. Back

80   Q152. Back

81   Q152. Back

82   MDA DA 2000 (07) and (08). Back

83   Ev., p.45. Back

84   Q58. Back

85   Ev., p.61. Back

86   Q146. Back

87 Back

88   IbidBack

89   Ev., p.17. Back

90 Back

91   Ev., p.16. Back

92 Back

93   Ev., p.17. Back

94   Q116. Back

95   Breast implants were reclassified from 'low risk' to 'high risk' in Australia in 1991. "Manufacturers and suppliers were informed that adequate data supporting the safety of silicone gel-filled breast implants would need to be supplied to the Therapeutic Goods Administration 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 Australian Register of Therapeutic Goods" (Leigh, Day & Co: Ev., p.73). Back

96   Ev., p.17. Back

97   Q130. Back

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2001
Prepared 4 April 2001