Select Committee on Health Minutes of Evidence

Memorandum by Rose Irwin (B 4)

  I submit my evidence as a casualty of silicone gel implants and as a campaigning partner with Brenda Livsey of AASG, UK. Ms Livsey and I have been in communication with, and read reports of a large number of silicone implant casualties. Our concerns lie primarily with the silicone implants involving silicone gel. These are the implants which by far outnumber any other breast implant used in the UK. It is from this type of implant that we receive the largest number of reports of adverse effects. We confer with fellow campaigners on the whole breast implant subject. We also try to consult with medical bodies. We have become conversant with the conflicting clinical studies and the many aspects-including the problematical area of patient information-which continue to surround this complex issue.


  As a casualty and campaigner for a moratorium on silicone gel implants it will be impossible for me to avoid any mention whatsoever of the disease aspects. I will strive to keep this aspect within the terms of reference of the inquiry. It will also be necessary for me to allude to my personal experience, but only in the light of its relevance to the general points which this, along with reports from fellow casualties, endorses.

  The overwhelming factor which has emerged for us has been the need for radical moves away from the didactic to the consultative approach in relation to medical bodies and many health professionals. This is integral to the best means of information based on a combination of professional expertise and patient feedback.

  A large part of this most welcome inquiry surrounds the issue of the dissemination of information—particularly with reference to risks involved. It is necessary to say here that the dissemination of information is crucially bound up with the ways in which that information is gathered, assessed and compiled. Much of our frustration in trying to represent silicone casualties lies in the great shortcomings in these components, as well as in the actual dissemination of the received information.

Our aims for the outcome of this inquiry are as follows:

  1.  Some form of moratorium on silicone gel implants, at least until the risks over benefits equation is more clearly established, along with a firmer policy on patient awareness of risk factors, this in line with the USA, Australia and Canada, Japan and France.

  2.  Failing the above, a binding obligation to patients contemplating silicone breast implantation (and possibly other types of breast implant), to read and sign to say they have read and understood the full list of risks drawn up from peer-reviewed evidence on both sides of the argument, as well as from anecdotal evidence. This would tally with the procedure used in New Zealand.

  3.  A method of take-up from patients' reports of ill advised procedures by surgeons, (for example closed capsulotomy) in terms of inspection and checks on such surgeons. At present there appears to be no body which is equipped for this purpose. It is outside the remit of the MDA. The GMC, which we thought might encompass this area, has proved to be far too generalised, bureaucratic and ineffective to fulfil such a role.

  4.  A more honest admission in PR information on the inconclusive results of clinical research to date. At present, for example, a careful reading of Independent Review Group (IRG) report's website detail shows many areas of "don't know" "further research needed" in terms of disease links. This is not sufficiently reflected in the message of the IRG Summary Report which comes across rather as: "silicone-gel-implants-safe". This, in turn, has been re-interpreted by many plastic surgeons as "proof positive of safety by the IRG".

  5.  Directives which will encourage medical professionals to take a consultative rather than a defensive approach with silicone implant casualties. This aim is linked to the need for appropriate therapy and continuing research take-up from existing peer-reviewed clinical studies indicating disease links.

  6.  An improved reportage system from the MDA on adverse incidents, including both medical professionals and patients. A proper take-up and investigation of all reports of adverse incidence as stated in the principles of the MDA Framework document. A change from the didactic to the consultative approach from the MDA towards patients and other members of the public concerned.

  7.  An improved method of arbitration in terms of consultative skills from the Parliamentary Ombudsman.

  I submit my evidence in order of the "Terms of Reference" of the Health Committee Press Notice:


  The Medical Devices Agency was formed as a whole agency absorbing the pre-existing Adverse Incidence Centre in 1963. It reviewed the evidence on disease links and silicone gel implants and recommended that the implants should remain in use in the UK, all this in advance of its official opening. When flesh and blood casualties attempted report in their/our problems, therefore, the MDA had acquired a closed-door attitude. Officials were scrupulous in replying to correspondence which, in my own case was prolific for I was, in part, attempting to convince them of the progression of disease with implant rupture and leakage; but the replies were politely didactic rather than in any way consultative. There were inconsistencies from different officials in replies to queries. (Letters of evidence of this on file). Sometimes I was given deliberate misinformation as, for example, when I enquired about the policy in other page countries on the use of silicone gel implants. The MDA official said that only the US had any restrictions. This, I found, through the efforts on Ann Clywd, MP, to be not the case. Most seriously of all, the MDA failed to confirm and investigate my persistent efforts over almost two years to report bi-lateral rupture and leakage of my implants. This technical failure constitutes an adverse incident. The MDA Framework Document states that reported adverse incidents with a medical device will be "taken up and properly investigated". When I reported my implant rupture I was simply thanked very much for the information and told how useful it would be, this without any initiatives by the MDA to confirm my report in any way! I put together my points of criticism of the MDA and sent them by letter to the then Chief Executive, Alan Kent. I sent a copy to the then CMO, Kenneth Calman. I asked the CMO about questions of accountability. I received, in reply, a solicitor's letter from the CMO's office forbidding further correspondence. I received no replies to my points of criticism. Later, communications with the MDA were resumed, but the attitude had not improved.

  Subsequently, I found through the SOS helpline (Elaine Coomber), six other women who had all tried without success to report implant rupture involving varying degrees of complexity of complications. In the summer of 1997, we applied to the Adverse Incident area of the MDA to confirm that implant rupture was indeed classified as an adverse incident. At last, our reports, in the context of the vigilance of the new Health Minister, Baroness Jay, were taken up, confirmed and taken through a form of investigation. We are aware that other people had tried to make reports by phone without success. We wrote around to some twenty plastic surgeons to discover a) whether or not they were aware of the MDA and b) whether they regarded and would report implant rupture as an adverse incident. The replies we received were varied. A letter from the Chair of BAAPS (which I have on file) told us that plastic surgeons would not regard or be likely to report implant rupture as an adverse incident to the MDA. Meantime, the MDA in a 1996 publication gave a figure of seven reported adverse incidents for silicone gel implants. This did not, for a start, include the reports which we and other women had attempted, in vain, to submit. It must be admitted that a number of casualties who rang the helpline said they would not report to the MDA after having heard of the futile attempts by other casualites.

The MDA/Parliamentary Ombudsman

  Seven women including myself complained against the MDA through our MPs to the Parliamentary Ombudsman about a) misleading letters from the MDA and b) failure to take up reports of adverse incidents. A couple of these women gave up this pursuit owing to failing health and the amount of paperwork involved. In the end our individual complaints were, in part, upheld by the Ombudsman and we received a form of apology from the Permanent Secretary. However, the most crucial aspect of our complaint-and that most pertinent to the compilation of information—that of the weakness of the MDA's ad hoc reportage system, was not solved or thoroughly examined by the Ombudsman. The MDA said they had "lost" the early letters of all seven of us in which we gave details of the rupture/leakage of our implants. I still had copies of mine. All referred to implant rupture and leakage. My first letter to the MDA, following my attempt to report by phone, I had, in fact, submitted along with my complaint to the Ombudsman. It was a one-page letter (on file) which clearly described details of implant rupture and leakage. Yet the ombudsman seemed satisfied with this "explanation" from the MDA. When asked by the Ombudsman about future policy on adverse incident reports, the MDA gave a vague and, we felt, under the circumstances arrogant reply. I attach the extract on this from the Ombudman's report. [48] In the interests of the research which is crucial to the gathering of information, I ask the Health Committee to compare this situation with that of FDA in the US which positively invites reports from patients with adverse effects from breast implants.

  At no point did any official from the Ombudsman's office come back to me following my written submission of my complaint until I received the written Report. There was, therefore, none of the dialogue necessary to a genuine process of arbitration. I mention this because the process of compliant and its outcome plays an important role in the continuing improvement of relevant information and its circulation.

The MDA/National Breast Implant Registry (NBIR)/Ombudsman

  The NBIR has played a confusing role so far in its relationship to research and information. It was hoped that it would help with information on the numbers of implant operations and on rupture rates etc. However, since the registry can only exist as a voluntary rather than compulsory facility, its effectiveness is considerably impaired. Casualties who tried to tell the MDA officials of their problems were told that the NBIR would act as the research facility to determine a) local problems and b) possible links with systemic illness, this latter after some ten years or so, to allow for to systemic disease latency period. The research on local problems was promised for 1997. It did not happen. In 1999, I took on further extensive correspondence with the MDA on this failure. One official assured us that an epidemiologist and statistician had been consulted in 1997 for the registry research project. I wrote for confirmation and contacts on this to another MDA official and was told that no such experts had at any stage been involved. Again, via the Ombudsman, I was eventually given the correct information on this. The MDA justified its own untruthfulness in terms of my prolific correspondence. The Permanent Secretary seemed to accept this without any sense of irony that here was an example of a situation that had required prolific correspondence, and, in addition application to the Ombudsman in order to obtain a small but telling detail of information to which I was entitled. (Letters on file)

The MDA/Biosil/Checks on Manufacturing Standards

  On 28 August 2000, a Scottish journalist, James Moncur published a number of serious allegations of negligence by the firm Biosil, manufacturers of saline implants which are sold to the USA. These were quoted from complaints on the firm's standards by the FDA. Biosil is the same firm as Nagor which also manufacturers breast implants for sale in the UK. This lack vigilance gave us great cause for concern with regard to the MDA's role in the Biosil case and in its role in checking manufacturing standards of other UK firms. We have written to the MDA as well as to the Health Ministers, asking for a point for point answer to the allegations. All we have received are letters telling us that the public health was not put at risk by this Biosil's procedures. I attach a list of some of the points of complaint made by the FDA from the newspaper extract. (Subsequent letters of ours with Ministers on file).

  During correspondence on this with MDA and Health Minister, Philip Hunt I was greatly supported by my MEP, Brian Simpson. Brian Simpson wrote to ask the MDA Chief Executive, David Jeffreys, about the accountability of the MDA. He was told that the MDA is accountable to a "notified body" and in this instance the notified body is the MDA itself. (Letter on file) Here, then, we have in the MDA a powerful, self regulating agency. This is an unsatisfactory situation, but one in which it is doubly imperative to ensure that the MDA gives detailed and honest information in reply to questions from patients, moreover, that it cultivate a genuinely consultative approach if it is to achieve credibility with the general public which it serves. It is true that, a few campaigners, as a result of an unrelenting persistence, have received the literature we applied for to the MDA and, recently, were sent an advance press statement on the withdrawal of hydrogel implants, but this does not relfect the general attitude of the MDA.


  The MDA, employed as a secretariat to the IRG, proved to have an overwhelmingly strong influence on this purportedly independent panel. Letters, Reports from interviewees, website detail in the IRG report, confusion even now in perception about the two bodies all testify to this. (Substantial evidence on file) Thus, the final message/information on the assessment of clinical evidence was passed from one body to another. During the review period, the IRG did not include a patient representative. We were unhappy about this omission. Two years later, Claire Rayner for a short time took on this role with the IRG. I received a letter recently from Claire Rayner to say that the pressure of her other commitments meant that she would have to stand down "from the MDA"! This confusion is symptomatic of the way in which these two bodies are inextricably bound. Information from each body is similarly bound, we feel by these links. Entirely due to the timing of the various reviews, the IRG became a kind of parent review body and, in turn, strongly influenced the final message of "inconclusive-means-safe" to subsequent review bodies such as the US IoM, and EU STOA review. The PR from advertisers and a number of cosmetic clinics has re-phased and hyped this message to the extent that we now have, at one end, an epidemic of young people undergoing cosmetic breast implantation, and at the other end, increasing queues for explantation operations.

  The mandate for the IRG was 1) to assess the clinical evidence for disease links with silicone gel implants and 2) examine the aspect of pre-operative patient information. The PR put out by the MDA, at times, misinterpreted this in information to the public (letter on file) giving the impression that the mandate consisted only of "patient information" aspect.

  Efforts were made to open up the review system with the IRG. For example, patients were invited to send in accounts. There was a large response from casualties (this was confirmed to us by the IRG Chair, Professor Sturrock) giving accounts of the disease damage they attributed to their implants. Representatives of groups, including Elaine Coomber and myself (SOS UK) were granted oral interviews with the panel. Elaine Coomber reported to the IRG some of the 2,500 calls she had received and logged from people with implant problems. In the IRG report these numbers were not given, nor was there any assessment or space given to the anecdotal evidence on health problems. I do not mention this in the expectation that the Health Committee will make clinical judgements, but as an example of the lack of balance of information. More recently, in response to our questions on new clinical evidence etc., the IRG reponded by holding an Open Day Meeting. Our questions were submitted in writing by the required deadline. In advance of the meeting I requested and was granted by the Chairman, Professor Sturrock undertakings that there could be a feedback take-up from questions arising from the meeting. At the meeting several vital questions were not sufficiently explored. After the meeting, I conferred with fellow casualties and submitted a carefully set out feedback letter from points arising (or having been missed) at the Meeting. I sent a short addendum, giving chapter and verse after having belatedly received a transcript of the meeting. Professor Sturrock now informs me that he does not intend to take up the feedback points after all. At the meeting the press were invited, but allowed to stay only until the end of Chairman's opening remarks. Clearly there was less than met the eye in this PR exercise.


  Most of my points relating to this heading have been covered under my previous headings. However, it is appropriate here to mention the DH booklet entitled, "Breast Implants—Information for women considering breast implants" as a member of the Patients Association, I was included in the Breast Implant Patient Information Group (BIPIG). Two other campaigners against silicone gel implants, as well as a campaigner in favour of them were included in the whole group which otherwise comprised plastic surgeons, a private clinic representative, breast care nurses, NHS and Bupa representatives etc. The booklet had been recommended in the IRG Report. In terms of numbers casualties were fairly represented, though, justifiably, in accordance with the conclusions of the IRG Report, anti silicone gel implant campaigners were vastly outnumbered by parties which approved of these devices. My personal Everest was the struggle and eventual achievement to have included (p6), a short paragraph on risks as reported by silicone casualties, surrounded thought it is by "reassuring" caveats from the DH. We feel that the booklet does not go far enough, particularly in the light of high profile current advertisements promoting cosmetic breast implantation. For example: there is no mention of the situation in the US with regard to its form of moratorium on silicone gel implants and the category iii (need for proof of safety) into which these have been placed by the FDA nor of those other countries which do not use silicone gel implants and never used trilucent or hydrogel implants. Point 8, Consent for Operation does not make it clear to the patient that although Patient Consent is legally binding Information to Patients in itself is not. There is absolutely no reference to the MDA as a body to whom one should report if things go wrong. I fought hard but unsuccessfully to have these last two items in the booklet. The omission of access to the MDA is nothing less than disgraceful. The heading "if things go wrong" on page 13 is printed as a question the patient must ask her surgeon. This is quite cruel because we know from experience that many surgeons would respond very defensively to such a question and it simply leaves the reader hanging in the air. It does not tell her where she should go or to whom she herself could report under such circumstances. The fact that the bodies to whom we should be able to report are not up to the job is no excuse. It is early days yet to say how effectively or otherwise the booklet has been distributed. But we must remember that there is at present in the UK no binding obligation for any medical body or individual surgeon to give out the booklet to the patient.


  Most of my points on this are covered under previous headings. However, I wish to stress the point that where there is massive inconvenience, involving interests of finance, status, and even the humanely based unwillingness for medical professionals to believe they may have harmed large numbers of patients, the forces against genuinely responding to concerns raised on safety are, likewise, massive. A most telling example of this occurred during the IRG review period in 1997, when on 22 August BBC "Newsnight" in drawing the publics attention to the review, the following statement was made: "A Department spokesman said no evidence emerged (then ie earlier MDA reviews) to support a ban and no new evidence is expected this time. At best this review will demand women are better informed about the operation they planned to undertake". This statement was highly prejudicial in relation to the IRG mandate. I rang the CMO press office and spoke to a Denise Shaw who confirmed that this precise statement had indeed been given by the CMO's office. I complained to her. She wrote to give me a revised statement for some hypothetical future reference. I complained to the then junior Health Minister, Margaret Jay. She replied personally by letter saying she, too, had been perturbed by the statement and had questioned CMO press staff, but that "no one in the Department of Health, CMO's office or MDA or press office had delivered any such quotation for this programme" I pursued the matter with Naomi Goldman, producer of the programme. She confirmed that this was a direct quote from a telephone conversation with an official of the Department of Health. I went back to Margaret Jay. Some time later I received a letter of apology from the MDA. One could not afford the stamina to follow up all misinformation in this way. This is just one of too many examples of behaviour which is symptomatic. One does not have the stamina to insist upon the true facts in this way in every case. But we are presented with a problem in trusting the information from official bodies on this issue. Going to Health Ministers, even through our MPs & MEPs, has been unproductive. Clearly Health Ministers have simply referred back to and supported their civil servants, endorsing a closed ranks system, particularly in relation to the MDA.


  My main point on this has been addressed in the Executive Summary of this letter, but it is worth emphasising the need for a more centralised circulation in terms method and approach. Occasionally, in response to a query, one suddenly hears of some new organisation intended to bring about reform. Some time later it seems to have disappeared into thin air. Such was the case with the "Interdisciplinary Group for the Supervision of Breast Implant Operations". This was mentioned to a member of staff from "Health Which" in response to some expressed misgiving by her to a DH official—and passed on by her to me. I tried through the Royal College of Surgeons, BAAPS, MDA, GMC etc, to follow this up. Nobody by this time had heard of it. I queried it several times over a period of a year in letters to Philip Hunt. Eventually, he gave me, through my MEP, the name Mr Michael Brough. I wrote to Mr Brough to ask about the remit of this group. He replied to my letter, but, to be honest, it was quite clear that there was no remit over and above any normal requirements for any operation—and certainly no clear plan in sight. At least, this and other aspects which have emerged, show lip service to the need for concerns on this problem to be taken seriously in terms of both information and action. I hope that the outcome of this inquiry will aid the direction of some positive steps towards this goal.

February 2001

48   Attachments not printed. Back

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