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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