PIP Breast Implants and regulation of cosmetic interventions - Health Committee Contents

3  Actions of the Department of Health and the MHRA

15. Recommendations in this section are relevant to Earl Howe's review of Department of Health and MHRA actions.

Action before March 2010

16. Concerns had been raised about the quality of PIP implants prior to March 2010. In 2008, following an increase in reports of adverse incidents, the MHRA raised concerns with the German Notified Body and with PIP itself. The MHRA was informed that the increase in adverse incident reports was due to an increase in sales and improvements in PIP's reporting criteria.[24] According to the Expert Group report, the MHRA raised further concerns in 2009.[25]

17. PIP implants appear to have been significantly cheaper than alternatives. Simon Withey told the Committee that he was "aware there were reports of a very significant price differential",[26] and estimated that PIP implants may have cost anything between one third and one fifth of the price of other implants (although this may take into account discounts for buying in bulk).[27] Certainly Mr Withey noted that PIP implants predominated in the "heavily commercial end of the private sector"[28] where procedures were price-sensitive.[29] Mr Withey also suggested that where surgeons were in a position to select implants themselves, they tended not to choose PIP implants.[30] He said:

    If you are running a business on a commercial basis and do not have sound clinical input into helping you make these decisions, the importance of some of the decisions can be less obvious than it might be to a clinician who is very aware of what he has to put in, what he is doing, and what his responsibilities are to his patients.[31]

18. A survey by the British Association of Aesthetic Plastic Surgeons (BAAPS) found that only 8% of BAAPS surgeons, who must have significant NHS experience to gain membership, had ever used PIP implants. Former BAAPS President and consultant plastic surgeon Nigel Mercer stated: "very few of our surgeons ever handled these controversial implants as they were known to be the cheapest option (though used in good faith)".[32]

19. The Committee is concerned that, given what was known about PIP implants and the issues raised by the MHRA, there wasn't greater vigilance, especially when PIP implants were significantly cheaper and were not the implant of choice for surgeons. Earl Howe's Review should seek to address whether the MHRA had information that ought to have prompted them to act sooner.

Action between March 2010 and December 2011

20. It was in March 2010 that it was discovered that PIP had been using industrial grade silicone. At that point, according to the report of the Expert Group

    the French regulator Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), discovered that the manufacturer had been using industrial grade silicone instead of the medical grade specified for the CE mark. AFSSAPS revoked the CE mark and the MHRA promptly issued a medical device alert to all UK clinicians and cosmetic surgery providers, asking them to cease using the implants.[33]

    Toxicology tests on samples of filler material in both France and the UK suggested that there was no significant health risk to women who had already received the implants.

21. The NHS was alerted to the withdrawal of PIP implants via a medical device alert, where recipients of the alert must respond within a given deadline to say that they have received the alert and acted upon it. Sir Kent told us that "penetration into the private sector is less certain. The other route that we used was the professional surgical associations, to ensure that those practitioners who were going to be using implants would have the information immediately".[34] But although all doctors would be registered with the GMC, not all doctors would be a member of the professional associations.[35] Mr Withey also noted that engagement with clinical governance issues was "perhaps, not as strong as it might be" for some doctors that work on a part-time basis or in various locations. Mr Withey also said:

    There is a huge variability in both record keeping and levels of personal responsibility—forgetting the NHS—across the private sector. There are individual clinicians who are clearly responsible and keeping a close eye on what they are doing. Then there are larger, more commercial organisations where the clinician is perhaps distanced from the executive decisions made and, as a result, does not feel quite as responsible in some cases.[36]

In evidence, Sir Kent Woods was asked whether he could be certain that private clinics had not used PIP implants after March 2010. He told us:

    I am afraid I cannot give you that assurance. [...] I honestly cannot say that no PIP implant was moved from store into an operating theatre after that date. One sincerely hopes that it did not happen, and I think the combined effects of the different routes of communication that we used were the best that could be done to make sure that it did not happen.[37]

22. "Sincere hope" is not an adequate basis for regulation. There needs to be a more reliable method of communicating Medical Device Alerts to the private sector, that requires a positive response that the instruction has been received and acted upon in the same way as in the NHS. Sir Bruce Keogh's review into the regulation of cosmetic interventions must set out how this could best be achieved. Using the professional associations as channels of communication will not cover all surgeons.

23. After March 2010, there was no significant activity until December 2011. On 20 December 2011, following a large increase in the number of reported ruptures and concerns over a possible cancer risk, the French regulator wrote to the European competent authorities alerting them to new data.[38] Then on 23 December 2011 the French Ministry of Health advised women to consider having their PIP implants removed, as a precautionary measure. The MHRA advised at that point that there was no scientific basis for recommending routine removal of implants in the absence of symptoms.[39]

24. Sir Kent told us that in the period between March 2010 and December 2011 the MHRA commissioned toxicology research on the nature of the silicone used to fill the implants, and worked with European counterparts to collate data on rupture of PIP implants.[40] Further action only happened after the French Government recommended routine removal of implants.

25. Sir Kent told us that he believed the MHRA's actions had been "appropriate" on the basis that the "consistent position" throughout the period (and confirmed by the Expert Group and SCENHIR) had been that there was insufficient evidence that PIP implants posed a greater risk to health than any other type of implant. Yet the very fact that evidence was insufficient ought to have been a prompt to gather further evidence, and urgently.

26. It is surprising that urgent action to gather evidence and communicate with affected women only gathered pace in December 2011, following the announcement of the French Government. Given the fact that 40,000 women were known to have received sub-standard implants, the very scale of the problem alone should have provoked a high-profile policy response much sooner, including urgent action to gather evidence that would allow the risks of these implants to be properly assessed. Earl Howe's review must examine why action was not taken sooner.

27. Sir Kent told us that in the period between March 2010 and December 2011 "there had been a continuous communication of risk information as we had it, but the advice had not changed".[41] The MHRA's advice during this period was that women "should seek to consult expert advice and be examined".[42] But the question is, how many women were aware of the problems with PIP implants? In the absence of a register of breast implants for private patients, the MHRA has no way of communicating directly with individual private patients, so it must instead seek to publicise the issue as widely as possible. Sir Kent told us "We use all the routes available to us. We have put out press releases, medical device alerts and we have worked through the professional associations".[43] This approach was used in March 2010 and later as toxicology results were published.[44] Sir Kent told us that the approach used in December 2011, when the issue was picked up by the media, was no different.[45] Sir Kent said that he believed the MHRA's communications had been "appropriate"[46] and noted that, ultimately, the responsibility for follow-up care sat with the healthcare professional who had carried out the procedure.[47]

28. The action taken to communicate with affected women after March 2010 was inadequate. The Committee recognises that private clinics had a duty to contact their patients directly, but the MHRA and the Department of Health also had a duty to raise public awareness. A more creative approach should have been used. Earl Howe's review should determine when the Department of Health and the MHRA contacted NHS patients directly, and the adequacy of strategies to communicate with the far greater body of private patients.

The NHS offer

29. On 11 January this year, the Secretary of State made a statement to the House outlining the support the NHS would offer to women who had received PIP implants on the NHS. He said:

    All those patients will receive the highest possible standard of care. First, they will be contacted to inform them and give them all the relevant information and advice. Women who wish to will be able to speak to their GP or the surgical team that carried out the original implant to get advice on the best way forward for them. If the woman chooses, that could include an examination by imaging. If, when informed by an assessment of clinical need of the risks involved and the impact of any unresolved concerns, a woman decides with her doctor that it is right to do so, the NHS will remove and replace the implants, if the original operation was done by the NHS.[48]

30. Statistics released by the Department of Health on 16 March 2012 show that the latest estimate of women with NHS PIP implants in place is 748, of whom 743 have been contacted. 37 scans had been completed. 112 women had decided to have their implants removed and 18 removal operations had taken place. 30 women "had completed their NHS offer".[49]

31. The vast majority of women who received PIP implants in the UK (37,000 of 40,000) were treated by private clinics. In March 2012 French authorities advised that implants used prior to 2001 might also have contained unauthorised silicone, in which case a further 7000 UK women could have been affected.[50] These women have been advised to seek treatment from their original clinics in the first instance, only turning to the NHS if the private clinic no longer exists or refuses to carry out treatment.

32. Sir Bruce told the Committee "we have taken a very clear view that the private sector should match that offer. We believe it has a moral duty of care to match that offer".[51] This echoed what the Secretary of State had said in the House of Commons in January.[52] Simon Burns MP, Minister of State for Health, had stated that the Government had "made clear that we expect private providers of cosmetic surgery to make the same provision [as the NHS], without cost, for their patients".[53] Sir Bruce told us that "by maintaining a very clear view about the moral imperative that we believe should be met by these providers, a number of providers have started to come into line".[54]

33. Sir Bruce told us, when we suggested that there was a legal obligation on private providers, that "We will be looking at that. Our early indications are that there are some opportunities for legal redress".[55] There is a notable uncertainty as to the legal obligations on private providers in these cases.

34. At the time of the Secretary of State's statement on 11 January, eight private health care companies, including Nuffield Health, Spire Healthcare and BMI, had confirmed that they would remove the implants without charge. Two private companies, Transform and The Hospital Group, had originally said they would charge for removal of the implants, but later announced they would only charge for the replacement implants.[56]

35. The Harley Medical Group (13,900 PIP patients) initially offered to pay the cost of new implants but only if the NHS paid the bill for surgery. It later changed its policy to an offer to remove ruptured implants free of charge (if implanted in the last 10 years). Ruptured implants fitted in the last six years would be replaced without charge, while ruptured implants fitted between six and ten years ago would be replaced at cost price.[57]

36. Press reports have suggested that some women are being asked to pay for scans and that there is general confusion over whether private clinics are charging for removal or replacement, or what criteria will have to be met for implants to be removed.[58]

37. Sally Taber, director of Independent Healthcare Advisory Services, the trade body representing many of the companies involved, said that the companies were "as much a victim of this fraud as the NHS and its patients" and that "if there is any moral or ethical obligation outstanding it lies with the government's regulatory agency, the MHRA".[59] There is also a question as to whether private clinics can provide treatment on the scale required. The Harley Medical Group, which provided implants to some 14,000 of the 40,000 women affected, and normally carries out 4,000 breast augmentation operations a year, said it simply did not have "enough hospitals, surgeons and staff to manage this alone. Nor does it have scanning facilities".[60] Private clinics used PIP implants in good faith because of the CE mark. Nevertheless, the Committee agrees with the Department of Health that private clinics have an obligation to provide care and should mirror the NHS offer.

38. The Department of Health has been very clear about the moral imperative—it would have been welcome to have had a clearer statement of the extent of the legal obligation on private clinics. The argument of a moral imperative may be compelling, but it is difficult to enforce. Sir Bruce's review should provide a clear statement of the legal responsibility of providers to meet their duty of care and to supply an appropriate product. The situation must be clear and consistent. It is unacceptable that there should be uncertainty when it comes to responsibility for a device implanted into the body.

39. The NHS offer must take into account matters of capacity. The overall number of women affected is significant, and single providers are responsible for a significant proportion of that number. There is no point having a policy stance if it cannot reasonably be carried through. The capacity to undertake the surgery must be assessed and the policy response tailored accordingly. The Committee asks the Department of Health to identify how to make the best use of any spare capacity, whether public or private.

40. In the case of women who received their implants outside the NHS, the Secretary of State for Health told the House:

    It is right that those who received their care privately should also receive a similar level of service and reassurance from their care provider. However, I do not think it fair to the taxpayer for the NHS to foot the bill for patients who had their operation privately. [...] However, I want to be absolutely clear that the NHS will continue to be there to support any woman. If a clinic that implanted PIP implants no longer exists or refuses to remove the breast implants, where that patient is entitled to NHS services, the NHS will, in consultation with their doctor, support the removal of PIP implants in line with the guidance that I have just outlined. Any NHS service in that instance would cover only the removal of the implant, which would not include the replacement of private cosmetic implants. In such cases the Government would pursue private clinics to seek recovery of our costs.[61]

41. Statistics released by the Department of Health on 16 March 2012 showed that 4,872 women with private PIP implants had been referred for NHS treatment. A total of 2,393 scans had been completed. A total of 252 women had decided to have their implants removed, and 64 removal operations had taken place. 1,303 women "had completed their NHS offer".[62]

42. The Chief Medical Officer wrote to GPs on 27 January with the following instructions:

    If a GP is consulted by a woman who originally received an implant from a private provider, they should encourage them in the first instance to go back to the original provider for advice, scanning if appropriate, and removal or replacement of the implant if desired. However, if the original provider has gone out of business, or is unwilling to help, the GP should carry out a clinical examination and refer onwards to specialist NHS services [...] They should make clear that the NHS is not offering to pay for a replacement implant.[63]

43. The advertisement published in national newspapers in order to advise members of the public stated more bluntly: "If your private clinic no longer exists or refuses to remove your PIP implants, speak to your GP. The NHS will remove your implants if your doctor agrees, but the NHS will not replace implants unless it is clinically necessary".[64]

44. The Chief Medical Officer goes on to say that for those patients who received their original implants from a private provider, "the criteria for replacement at NHS expense should be the same as for a request for primary breast augmentation".[65] Again, she notes that "such patients should be encouraged wherever possible to go back to the original provider".[66] The Expert Group supported the policy of not replacing private implants.[67]

45. As Sir Bruce told us, unless there is "a very significant clinical need" for replacement,[68] "the aim of the NHS offer is to restore somebody to their pre-implant condition as best as possible".[69] The panel did not agree with the view voiced by Lesley Griffiths, the Welsh Minister for Health, that there would invariably be a clinical need for replacement on the basis that not replacing the implants "could result in unsightly scarring, loose skin, and potentially the accumulation of fluids, needs for drainage and risk of infection",[70] and that the NHS should therefore provide replacements as a matter of course.[71] Sir Bruce stated that such a view "overestimates the problem and underestimates the quality of surgery offered by consultant NHS surgeons".[72]

46. On the other hand, the British Association of Aesthetic Plastic Surgeons (BAAPS) had suggested that the increased irritation caused by PIP implants means that immediate replacement may not always be advisable.[73]

47. The Committee agrees that replacement implants for private patients should only be provided on the NHS where there is a clinical need. Nevertheless there is a particular problem for women whose original clinic no longer exists or refuses to provide treatment.

48. The Chief Medical Officer notes in her letter of 27 January:

    We have received a number of queries from patients with PIP implants supplied by private providers where the provider has failed in its duty of care, causing these patients to turn to the NHS for removal of the implants. They have asked whether they can pay for the additional costs of a replacement as part of a single operation in which the NHS pays for the costs of removal.[74]

49. The CMO does not give a clear line for GPs to take in this situation, referring them instead to general guidance on top-up payments which states that private care should be carried out at a different time and in a different place to NHS care, and that it is only appropriate to divert from these principles "where there are overriding concerns of patient safety, rather than on the basis of convenience".[75]

50. In addition to the existing rules on separating NHS from private care, Sir Bruce told the Committee a number of reasons why it would not be possible to allow a procedure of this kind:

  • The fitting of replacement implants in this instance was an optional, cosmetic procedure, not one of clinical need.[76]
  • If the NHS fitted a replacement implant, it would then become responsible for a lifetime of care for the patient, which may include subsequent operations and surveillance.[77]
  • "Many women who have been let down by the private sector will see the NHS now as their preferred option. If they can have an operation at a vastly reduced cost in the NHS, that will impose a significant burden on the NHS. It will also have knock-on implications and opportunity cost for other patients".[78]
  • If the NHS were to facilitate the fitting of replacement implants in this way "why would any of the private providers feel the need to address their duty of care for that patient, except for purely commercial reasons for those patients who could afford it?"[79]

51. We understand the argument the Department put forward. Nevertheless the Committee feels that because of the scale of the problem, the NHS must find a way round this issue in the case of women whose original clinic no longer exists or refuses to provide treatment. Given the number of women likely to find themselves in this situation, and the potential risks for women undergoing two surgical procedures in rapid succession, a framework must be developed to allow women whose original clinic no longer exists or refuses to provide treatment to be able to pay for private fitting of privately-paid for implants in the course of the same surgery that begins with the NHS removal of the implants. It must be made clear to the patient that the implants are being fitted under a private procedure and that the NHS bears no responsibility for their future care. Such a procedure should, of course, not be carried out if the PIP implant has left the breast cavity in such a condition that it is not advisable to replace the implants immediately.

52. We appreciate that this step will need to be carefully thought through if it is to fit within existing structures and in order to avoid setting unhelpful precedents, but we invite the Department of Health to propose how it could be achieved. Barriers posed by accounting and administration should not be the cause of women putting themselves through two operations in quick succession.

53. Any additional costs incurred by the NHS in the course of this, or any other procedure that ought rightly to have been carried out by a private provider, must be recouped from that provider.

24   Department of Health, Poly Implant Prothèses (PIP) Breast Implants: Interim Report of the Expert Group, 6 January 2012, p6 Back

25   Ibid Back

26   Q 10 Back

27   Q 44 Back

28   Q 39 Back

29   Q 45 Back

30   QQ 42-43 Back

31   Q 41 Back

32   BAAPS press release, 13 January 2011, http://www.baaps.org.uk/about-us/press-releases/1026-survey-reveals-95-of-surgeons-believe-clinics-not-the-taxpayer-and-hospitals-should-pay-for-defective-implant-removal Back

33   Department of Health, Poly Implant Prothèses (PIP) Breast Implants: Interim Report of the Expert Group, 6 January 2012, p6. Back

34   Q 13 Back

35   Q 16 (Mr Withey) Back

36   Q 31 Back

37   Q 14 Back

38   Department of Health, Poly Implant Prothèses (PIP) Breast Implants: Interim Report of the Expert Group, 6 January 2012, p6 Back

39   MHRA press release, 23 December 2011 Back

40   Q 2 Back

41   Q 6 Back

42   Q 6 Back

43   Q 19 Back

44   Q 21 Back

45   Q 20 Back

46   Q 9 Back

47   Q 29 Back

48   Official Report, 11January 2012, cols 181-183. Back

49   Department of Health statistical press notice, PIP breast implants, 16 March 2012. Back

50   Department of Health press release, Update on PIP implants, 15 March 2012. Back

51   Q 51 Back

52   Official Report, 11January 2012, cols 181-183  Back

53   Written Answer, Breasts: Plastic Surgery, 91256. (asked by Jonathan Edwards, answered by Simon Burns).  Back

54   Q 56 Back

55   Q 66 Back

56   Health Service Journal, More private clinics to treat implant patients for free, 27 January 2012. Back

57   Harley Medical Group, statement, 17 January 2012. http://www.harleymedical.co.uk/breast-enlargement-pip-implant-patient-advice/ Back

58   See, for example, BBC Newsbeat, 'No more tests' for women with PIP breast implants, 23 January 2012, or BBC News, PIP breast implants women protest at Manchester clinics, 21 January 2012 Back

59   BBC News, PIP Breast implants: Pressure mounts on Lansley, 12 January 2012 Back

60   Harley Medical Group, letter to patients, 8 January 2012 http://www.harleymedical.co.uk/breast-enlargement-pip-implant-patient-advice/index.php Back

61   Official Report, 11January 2012, cols 181-183 Back

62   Department of Health statistical press notice, PIP breast implants, 16 March 2012. Back

63   Letter from the Chief Medical Officer, Professor Dame Sally C Davies, dated 27 January 2012, to General Practitioners, NHS Medical Directors, and Cancer and Plastic Surgeons. Back

64   Department of Health, newspaper advertisement, The NHS will support women with PIP breast implants, January 2012 Back

65   Letter from the Chief Medical Officer, Professor Dame Sally C Davies, dated 27 January 2012, to General Practitioners, NHS Medical Directors, and Cancer and Plastic Surgeons. Back

66   Ibid. Back

67   Expert group report, para 25. Back

68   Q53 Back

69   Q 76 Back

70   NHS Wales press release, Wales offers further support to women with PIP implants, 11 January 2012 http://www.wales.nhs.uk/news/21527 Back

71   QQ 54 and 55 Back

72   Q 54 Back

73   . BAAPS press release, Cross-selling to breast implant scandal victims "immoral", 10 February 2012 http://www.baaps.org.uk/about-us/press-releases/1136-cross-selling-to-breast-implant-scandal-victimes-immoral Back

74   Letter from the Chief Medical Officer, Professor Dame Sally C Davies, dated 27 January 2012, to General Practitioners, NHS Medical Directors, and Cancer and Plastic Surgeons. Back

75   Letter from the Chief Medical Officer, Professor Dame Sally C Davies, dated 27 January 2012, to General Practitioners, NHS Medical Directors, and Cancer and Plastic Surgeons, Annex D. Back

76   Q 76 Back

77   Q 76 Back

78   Q 78 Back

79   Q 80 Back

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© Parliamentary copyright 2012
Prepared 28 March 2012