Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 39 - 59)




  39. May I welcome our next group of witnesses and may I ask you to briefly introduce yourselves to the Committee.

  (Ms Irwin) I am Rose Irwin and I belong to the campaign called Action Agaist Silicone Gel. I am a casualty of silicone gel implants. I am also part of the BIP information booklet group that discussed the composition of the booklet you have been discussing.
  (Miss Livsey) My name is Brenda Livsey. I am co-founder of Action Against Silicone and I am also a silicone casualty.
  (Ms Heasman) My name is Maxine Heasman. I am the founder of the Breast Implant Information Society and author of `The Ultimate Cleavage' and I was also involved in the creation of that booklet.
  (Mr Balen) I am Paul Balen. I am a partner in a firm of solicitors called Freethcartwright. I specialise in medico-legal work and I represent approximately 4,000/5,000 women who have experience of silicone, Trilucent and Hydrogel implants, many of whom have consulted me following, for example, the Trilucent hazard notice and the recent Hydrogel notice.

  40. May I thank you for your written information which has been very helpful to the Committee. I wonder if we could begin by hearing of your own personal experiences, if that is possible, if you would share with us the concerns that have arisen from your own personal experiences. Obviously you heard the areas that we were touching upon in the first session and perhaps now we need to look at the way in which women end up having operations that perhaps may not be the most appropriate course of action for them. Ms Irwin, would you like to start by briefly talking about your own personal background and your own concerns arising from what has happened to you.
  (Ms Irwin) I had silicone gel implants quite some time ago in the 1970s. I took a long time to recover from the operation, longer than I had been given any idea about. I was given absolutely no information about any possible risks such as ruptures which we have since learnt so much about, possibly because it was not known at that time. I was led to believe that they would last a lifetime and there was a great feeling of almost idealistic approach to them, that they were the most marvellous devices under the sun. After a time, the implants grew old, some 12 years in my case, and I felt what I thought was a sensation of rupture or leakage or something that I had not felt before but I took no notice. It seemed that coincidentally I developed symptoms some months later which became, to cut a long story short, classified as ME: tingling in the fingers, joint pains and so on. I did not associate them with the implants. I then began to hear some of the media reports about the symptoms that seemed to be going along with implants and I thought that perhaps mine were and so, of all people, I went to see a plastic surgeon. Incidentally, I was interested to hear Dr Stoate say that plastic surgeons could be reported to the GMC and that the GMC would be concerned because of course they are not; they obviously are not concerned. I went to a plastic surgeon without my GP knowing and explained my fears. He assured me that there was nothing at all in it, that it was all newspaper reports and people wanting money and so on. He offered at the same time to perform external/closed capsulotomy where you press the hardened implants and so on to soften them. In fact, what happened then was that they did soften but the leakage, as I perceived it, increased and the sensations I had had and my symptoms increased horrifically. I had bruising, swollen lymph nodes, lumps and illness. I finally had some x-rays taken and, when they were removed, it was discovered that there were in fact bilateral ruptures. I told the GMC all about this but the GMC were not interested—there were months of delay and no interest shown whatsoever. Therefore, I felt that I was able to put some cause and effect progress to the leakage and the continued leakage with the increasing symptoms that I had. After I had them removed, my health improved over a long period of time and I am very pleased about that.

  41. Going back to when the first operation took place in the 1970s and I appreciate that it is some time ago, was that done in the private sector?
  (Ms Irwin) Yes, it was.

  42. I am interested in what kind of information was available to you at that stage regarding the possible outcomes and possible problems because clearly this inquiry primarily relates to the information on safety and we are especially anxious to ensure that we look at the processes whereby women are made aware of what may or may not happen. Did you receive any independent advice at that time about what the possible outcomes might be?
  (Ms Irwin) No, I did not and I think a problem arises here in that this is a very private and intimate business and very often women do not want to go to a number of outside people. At that time, there were not the official bodies that one could consult. We now have some help-lines that we ourselves have set up and we are very aware of the confidential nature of the whole business but, at that time, there was not really anywhere else. The only thing I can remember that the surgeon said to me in the way of any warning note was that I had to tell any doctor if I was going to have an injection of any sort in the breast, otherwise everything was fine and dandy.

  43. So you had to tell them?
  (Ms Irwin) Yes, if ever in the future.

  44. You heard in the previous session the point that was made about frequently GPs not being aware of their patients having had augmentation, so it was left to you to give that information?
  (Ms Irwin) Yes, absolutely.

  45. Ms Livsey, are you able to share with us similar experiences or was yours a different experience?
  (Miss Livsey) It was similar to Rose. I came back from the States—I had been working out there as a beauty therapist—so I had done all my homework before returning to the UK. I decided to have breast implants because I had had a hysterectomy several years before and obviously a hormonal imbalance because, having been a rather well endowed lady, they just disappeared, so it was basically to mend the way I was. I went along to a private clinic and, within weeks, I had them done.

  46. Was any advice given to you at that stage?
  (Miss Livsey) No. I asked about the contra-indications. I had done my homework, I knew the questions to ask and I was given what I would consider were the correct answers. From the outset, I had nothing but trouble for two-and-a-half years. They either moved upwards, moved under my armpits or went hard. In fact, in the end, after the first year, they had to put a new set in. Then I started with a kind of fever; I collapsed, I was burning all over. I had blood tests. I had to give up my job as a beauty therapist because I became physically incapable. I used to do a lot of body massage and body work and I did not work for two years because I was so sick, but every blood test was negative. My GP said, "I know you are sick, I can see that you are sick but I cannot tell you why you are sick." I never ever related it to the breast implants. I was told when I had them inserted that they would last a lifetime, that I would go to my grave with the breasts of a young woman and that they do not rupture.

Dr Stoate

  47. Were you referred by your GP? Were your GPs kept informed at every stage?
  (Miss Livsey) No.

  48. You were not referred by your GP?
  (Miss Livsey) No. I went independently.

  49. Ms Irwin, is that the same position with you? Did you go to the clinic without being referred by your GP?
  (Ms Irwin) I am sorry, there is confusion here. I was referred when I had the implants done. I am talking about the process of capsulotomy much later, which was more distressing in a way because we are talking about 1991.

  50. But your GPs were not involved?
  (Ms Irwin) Not in that area when I had the capsulotomy performed.

  51. Were your GPs informed after this all happened?
  (Ms Irwin) No. And the GMC were not interested.
  (Miss Livsey) No. At one stage, I had a massive haematoma, my breast was absolutely black, and they wanted to take me back into theatre but I just said, "No, leave me alone" and I went to my own GP who just looked at it and said, "Well, the guy must know what he is doing" and left it at that. He did not want to look, so I coped with it myself and it is still happening.


  52. Ms Heasman, can I come to you and ask you the question as to whether you think women who were undergoing augmentation operations are fully aware of the risk now. Clearly we are talking about experiences that go back some years, but is the kind of experience we have just had recited still occurring?
  (Ms Heasman) Yes. Unfortunately, only last week I was speaking to a woman who had been told by the company that the implants have a lifetime guarantee. We all know—and this is fact—that that is not the case. Unfortunately, women are not being informed.

  53. So there is misinformation being given?
  (Ms Heasman) There is a great deal of misinformation and a great deal of misconceptions and myths as well.

  54. What more do you feel should be done to make them aware? Clearly we have this booklet that arose from the Independent Review Group's work, but that presumably is a small step in the right direction. What are the other areas that you feel need to happen? You heard us in the first session asking about the possibility of counselling so that people are made aware, are asked to sit down and look at whether it is really want they want or whether there are other reason why they have concerns and to see whether there might be other steps taken to treat people differently. What are your views on this?
  (Ms Heasman) I think the problem lies in the very first instance with the primary care sector. The General Medical Council prefer a women to visit her GP in the first instance for a referral to a surgeon. At the Society, I send out a questionnaire to ladies who have implants—you have a copy of it there—and this is how I get my facts, and a shocking 66 per cent of the women said that their GP did not make any effort at all to find out the reasons why they wanted the surgery. Unfortunately, there is a general lack of knowledge amongst GPs and they tend to be very judgmental and moralistic, which is what puts a number of women off going to their GP.

  55. Is that because primarily they are male?
  (Ms Heasman) Yes, I would say so. I have also had comments from female doctors. One doctor said to a patient, "What do you want implants for? Can you not wear a padded bra?" Now, ok, that is sensible advice but that is not what the patient wants to hear and that kind of attitude then pushes the women into the private sector where less questions are asked.

  56. So you raise serious questions about the role of the primary care sector in this?
  (Ms Heasman) Yes, I do.

  57. Are you basically not arguing that primary care should have a role to play but are you saying that they are not fulfilling that role in a proper way at the moment?
  (Ms Heasman) No, not at all. If women are to be encouraged to approach their GP, then GPs need to be educated and it is very severely lacking.

Siobhain McDonagh

  58. Earlier on, we had brief references to the various forms of implant and I just want to ask a question about what you think the effects have been of the various warning notices to women about Trilucent and Hydrogel implants and what your views are on the type and content of those notices.
  (Ms Heasman) From my experience, unfortunately the MDA announcements have had a terrible effect on the women concerned. Nobody had any warning. I myself as an organiser had no warning and I was suddenly inundated with calls and it was not until mid-morning that I actually had the documentation through to explain what was going on. I think it is difficult for the MDA because they have to present the facts as they are and, as Professor Sturrock said, the way the media get hold of it and translate it causes a great deal of distress to women. What I did was produce my own four page hot news bulletin which took the alert notice and put it into plain English so that ladies could understand it and I had many letters of thanks for doing that.
  (Miss Livsey) I am concerned that they were put on the market in the first place and a licence issued for them only to be taken off again. Why should it only apply to Trilucent and the Hydrogel and why not silicone?
  (Ms Irwin) Could I come in on that because I think we felt from where we were standing, or where we were lying at the time, that it was in some ways possible to cope with the Hydrogel and the soya problem, in being slightly cynical, in terms of taking cautious measures by the MDA but really to evade the far larger problem because, let us face it, far more people have silicone gel implants than they do these others and, to some extent, in spite of the difficulties which I think Maxine rightly states, it could be contained in that there were 5,000 people in the UK who had the soya implant and the manufacturers here did make some attempt to pay for the operations and so on and we felt, that is Brenda and I and others, that in some ways this could have been used as a sort of way of masking the much greater problem and appearing cautious and so on, but the very same principles that applied to the Hydrogel, for instance, not enough evidence and so on and warnings, applies to the silicone gel implants, but that is such a big problem to deal with and we felt that in some ways the withdrawal of these and the seemingly cautious actions involved masked the greater problem of the silicone gel implants.
  (Ms Heasman) Could I just say as well that, in my own opinion, it is the misconceptions and the misinformation about silicone, the very public misinformation, that was the main agent in a number of these women going for the Trilucent and the Hydrogel.
  (Mr Balen) 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 then 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. What is missing from all these notices is a recognition that actually we are dealing with, as you say, 80/85 per cent of women who are in the private sector, exposed to the private sector, and there is not an agency that has the ability to force co-ordination of how these women will react. They will want medical counselling, they will want medical advice and, in the private sector, that costs money. They may require operations in the private sector and that costs money and so, not only the health agencies but myself as a solicitor known to represent these clients are in fact now involved and virtually 100 per cent of my time is taken up with trying to organise operations, payment for operations and payment for consultations without anyone having any control over the sector that is supposed to be providing it.

Dr Stoate

  59. Obviously these devices are approved medical devices and as such have a CE marking. Do you think that sends out any sort of message to people, in that well it must be an approved medical device, it must have been tested, it must have been tried because it has a CE approval stamp on it? Do you think that that possibly sends out a false sense of security?
  (Mr Balen) I think it does and it is patently obvious that it does because how can you have a CE marking for a device that is then the subject of a hazard notice or a warning notice which says the reason for this notice is concern at the lack of safety data? That safety data must, in all logic, be supplied before you have any Government authorised marking on it.

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