Select Committee on Health Minutes of Evidence

Examination of Witness (Questions 20 - 38)



John Austin

  20. Given that that may be the case in some cases, is there not therefore some argument for saying that there should be some independent source of counselling and advice?
  (Professor Sturrock) Yes, I agree with you and whether that should be the general practitioner in the first instance or whether it should be some independent counsellor is another matter, but I do agree that there should be some other independent advice given. I know that, for certain forms of plastic surgery, often the surgeon in the Health Service will refer the patient to a clinical psychologist to discuss the issues that might be involved prior to the surgery and maybe this is one kind of route that one could think about.

Dr Stoate

  21. I would like to just follow up on that issue briefly before I go onto my main question. Personally, as a doctor, I take an extremely dim view of a surgeon who would treat and operate on a patient without the GP being involved somewhere along the line, perhaps not involved in the decision making but certainly informed of the decision making. I would personally have great difficulties with a surgeon who refused to do that and I am very disturbed to hear that there are surgeons out there who will carry out quite major surgery, often with quite far reaching consequences, with the GP knowing nothing about it. I think that is extremely worrying. To follow on from that, we are talking about a group of often very vulnerable women who have been swayed by all sorts of pressures and facts to have surgery in the first place, maybe against their own better judgment in some cases, and I think that to then have the operation explained by somebody who has a personal interest in that operation and the GP being kept out of the referral altogether is a recipe for disaster.
  (Professor Sturrock) I could not agree with you more and that was one of the concerns that we had and you have probably seen in our report that we said that communication should take place between the surgeon and the general practitioner because the general practitioner, as you know, is the gate-keeper and he or she must be informed, but I am sad to say that it does not always occur.

  22. My training in medicine always led me to believe that a surgeon would refuse to see a patient without a letter from a GP. I am extremely disturbed to hear that there are incidents where this has happened. It certainly would not happen within the Health Service because if, for example, I referred somebody to a surgeon and the letter went astray, that surgeon would ring me up saying, "I am sorry, I cannot see your patient because I do not have the referral unless you give me the personal go-ahead that in fact you have sent that letter and it has been lost somewhere."
  (Professor Sturrock) That is absolutely correct and obviously in private practice that should normally occur as well, but we are aware that, in this particular situation, that does not always take place.

  23. We are of course talking about sometimes the fringes of medical practice, particularly when this tips over into cosmetic clinics rather than true surgical indications for operation, and I think it gets much more confused and much more worrying. One of the things I ought to explore is in fact the frame of mind of women who undergo this operation and the fact that some of them may already have quite significant psychological problems that drive them to think that an operation might solve their problem. I really fail to see how a surgeon with a surgeon's training could possibly be the right person to help that woman, with all the ramifications, to decide whether to undergo the operation or not.
  (Professor Sturrock) I think that is true and this is why I made the suggestion about the possibility of a clinical psychologist being involved, once the initial approach has been made, to talk through issues which might need to be dealt with which are part of the whole reason for the initial consultation in the first place.

  24. The main criticism that I wanted to come onto was in fact the scientific and the medical data about the safety of breast implants. I have read through your report and, in your summary, you state quite categorically that there is no conclusive immunological evidence for an abnormal immune response to silicone, that there is no epidemiological evidence for any link between silicone gel breast implants and any established connective tissue disease, that there is no evidence of a condition such as silicone poisoning and that there is no evidence that children, for example, of women who have had breast implants should get any further problems, so you are fairly confident in your recommendations that there is no established proven medical problems from these breast implants. Could you perhaps elaborate on that.
  (Professor Sturrock) Yes. Obviously we took a very thorough review of all the literature. As you will see from the report, we heard evidence; we took personal evidence from patients and reviewed the literature. In terms of established connective tissue disease for example like scleroderma, which in itself is an extremely rare disease—and Professor Carol Black is here and will be able to give you more detailed epidemiological data—we are talking of an incidence of between two to 20 cases per one million per year, so it is a very, very rare disease. Then, when you are trying to see whether there is an increased incidence of that in the context of a group of women who have had a breast implant, you need quite a considerable rise in the incidence of scleroderma, for example, before you can pick that up statistically. The relative risk of developing an established connective tissue disorder compared with a group of women who have not had a breast implant are certainly no greater than 1.5, but the statistics suggest that it could go the other way, in other words the error could mean that in fact there is a protective effect of about 1.5. So certainly there is nothing to suggest that there is a major risk from established connective tissue disease and silicone gel breast implants. That does not mean that they are safe. It depends what you mean by "safe" because obviously there are local problems which can occur, but one of our remits was to look at the effect on general health in terms of established connective tissue diseases and the evidence at the moment does not suggest that there is a significant risk.

John Austin

  25. Having looked through, you have concluded that there is no evidence in certain areas, particularly the evidence of harm that may be done to children. Your report actually says that there is no evidence that the incidence of abnormalities is any greater than in the general childhood population, but you also said that there are no epidemiological cohort of case control studies comparing the symptoms of children born to women who had had implants to those of children who were born to women who had not. Would you say that there is a case for such a study being made?
  (Professor Sturrock) Yes, I think there is. We made some recommendations about further research and this could well be one of the areas. I think one has to be aware of the fact that babies are exposed to silicone, not just from women who have had breast implants but also from bottle feeding and even from the baby foods which are prepared. All involve, to a certain extent, a degree of silicone base, so that we are all, in daily living, exposed to small quantities of silicone as part of modern living.

Mr Burns

  26. If a female child were born suffering from Poland's Syndrome, would you feel that at some point in that child's development, possibly when they reach puberty, an implant would be the best way of seeking to rectify the problem or do you think there are other better ways of trying to rectify the problem?
  (Professor Sturrock) Of course I am not an expert in this area but I think one has to take each case on its merits. Obviously one cannot make a general comment. Plastic surgery is developing rapidly with new techniques of breast augmentation and so on, so that using breast silicone implants is only one of the strategies that one might use in that situation. In some instances, it is very effective and very acceptable to patients but there are of course other ways of augmenting breasts.

Dr Stoate

  27. You have been quite clear that there is no solid scientific evidence for any association between breast implant and negative disorders, yet this Committee has received evidence from people who are convinced that their particular problems have been caused by breast implants. Obviously those are anecdotal—and you are saying that there is no scientific proof of that—but I want to ask something that is a little contentious and sensitive. Do you think there is a possibility that, in some of these cases, there was an underlying psychological problem in the first place that could have been related or do you think there genuinely is a medical effect that we have just not discovered yet? I am trying to tease out why women are getting those problems if you are saying there is no conclusive evidence of any damage.
  (Professor Sturrock) I think the answer to your question is "yes" to both parts. There may well be a group of women who have had previous problems which continue to manifest themselves after breast implantation, but there may also be a group of women who have genuine breast implant related illness which as yet is ill defined. One of the issues which we raised in the report was the question of low grade infection because some of the symptoms that some of the women have complained of would fit with the presence of low grade infection and that is an area that we recommended for further research.

John Austin

  28. Could I go on to the issue of informed consent. The Consumers' Association have suggested that there should be a checklist of topics which should be discussed which requires both the surgeon and the patient to confirm that various subjects have been thoroughly discussed. What are your views on the current level of informed consent and how available is it?
  (Professor Sturrock) This is a very big issue as well about what is meant by informed consent and it is, as you know, very topical at the moment. I think that, in the past, informed consent has not been very well developed generally in medicine and surgery and I think the steps to improve that recently have been very much in the right direction. The problem is, how far do you go with informed consent in terms of detailing all the possibilities that a particular procedure or drug might lead to if a patient embarks on that particular treatment or on that particular surgery because some of the information is of a very technical nature which is quite difficult to comprehend unless you have some kind of professional background and you understand all the potential risks, so it is difficult. Some of these informed consent forms are very daunting to patients. I have seen some of them myself and seen some from other areas and looked at them myself and thought that, even with my own medical training, they looked pretty daunting in terms of reading all the detail and trying to weigh up the implications. Having said that, I think patients do need to be provided with the relevant information and it needs to be properly explained to them. Certainly in my own clinical practice for clinical trial situations, we give informed consent forms and then we get one of our nurses to sit down with the patient and talk through all the issues and, in my experience, they are far better than doctors in doing this kind of thing.

  29. That is precisely the point I was going to make. In the Department of Health brochure, I just opened it at one page and it refers to potential risk of capsular contracture. I am not sure that most women would know what capsular contracture was and probably they would not be inclined to ask the surgeon to explain it, whereas if there were an opportunity to go through the whole procedure afterwards with a nurse or someone with some special experience and expertise, then you are more likely to get more informed consent.
  (Professor Sturrock) Yes, absolutely and it is in my own clinical practice and I would certainly recommend that a properly trained nurse or some other health care professional, rather than the doctor, should go through with the patient after the initial consultation and discuss all these issues.

  30. Do you think that this could be written in more simpler language as well or with a more detailed explanation of some of the terms that are used in it?
  (Professor Sturrock) I think it could be. It is always very difficult because you do not want to leave anything out. Having seen many other kinds of booklets, I think this booklet is quite a good first stab at it. Obviously it is not perfect and it is going through a second edition and I think it will need to be modified, but I think this information together with the consultation and discussion with a health care professional, is probably as good as we are likely to get.

  31. One of the questions that a patient may wish to put to the surgeon may be in relation to the number of implant operations that that surgeon may or may not have undertaken. Do you think that perhaps there should be some requirement from the clinic or the surgeon to give the information without having to be asked for it and putting the onus on the individual patient?
  (Professor Sturrock) Yes, I think you are right. It is very intimidating and daunting for patients to have to ask a surgeon about his or her expertise in a particular area and many patients obviously do not have the confidence to do that. Maybe a way forward is in clinics and in hospitals where there is an established website so that you can click on Surgeon X or Dr Y and you can have a series of information about the number of operations they have done in this area, the infection risk or whatever. I know that this happens in places in the States where you can actually do this and determine how proficient a particular clinic or doctor is in this particular area, but we are quite a long way behind in this country yet with going down that line.

  32. Whose responsibility is that? Is that the GMC's?
  (Professor Sturrock) It could be that the local hospital institution, the trust, might produce that kind of information in agreement with the surgeon, but again these are big areas which are not entirely within my remit. However, I certainly feel that more information of that nature should be available to patients.

Mr Burns

  33. In your view, what do you feel has been the effect of the various alert notices that the MDO has put out about different types of implants?
  (Professor Sturrock) Obviously they do produce a degree of panic amongst women and confusion, not just amongst women but amongst the members of the media who have been unable to distinguish between the various different types of breast implants and the risks associated with them. For example, problems with Trilucent implants or soya bean implants have been automatically translated across to silicone gel breast implants, so there has been a great deal of confusion over this issue. For example, when the problems came up with the Trilucent implants, I received a number of phone calls from the media and others because they felt that this was all to do with silicone gel implants. I think it is difficult for the general public and for the media to sort these different implants out in terms of their risks and benefits and, when a warning notice goes out with one, the assumption is made that it applies to all.

  34. I know you have partly given your view on this document from the Department of Health but may I go back to clarify something because I believe I am right in saying that this document purports to be based very much on your Committee's findings, but many of those who have been submitting evidence to us in advance of this hearing have criticised this booklet. Do you think it is a useful document or do you think some of the criticisms are valid and that it needs to be updated?
  (Professor Sturrock) I think it will need to be updated. I think the strength of this document is that it was produced by a committee which included a whole range of people, health care professionals, women who had had silicone gel breast implants and been through the surgery, so that the group that produced this document was as comprehensive as one could get it. However, no document is ever perfect and it will need to be revised in the light of comments and any new evidence that might develop with time. I think it is a good start but it is certainly not perfect.

  35. Do you know if this document is under constant review?
  (Professor Sturrock) The second edition is in the process of being put together in the light of comments that have already been made and there are some factual inaccuracies, minor ones, within this document relating to some of the organisations in the booklet, so it is about to go into a second edition and comments can still be made to the Department of Health so that they can be taken on board if necessary and I suspect there will be more iterations of this document as time goes on.


  36. Before we conclude, can I look again at this area picked up by questions from Siobhian and Howard regarding how people may be counselled and I am interested in broadening this beyond breast augmentation because certainly the picture we have had in other inquiries is that increasingly there are interventions available, some of rather dubious value, that are marketed coming over from the States and in the private sector. I am interested in your views on how one deals with the tension between the freedom of the individual to do whatever they want to their own body and the duties, in a sense, of governments to protect people from rather unscrupulous operators within the private sector. You have talked about clinical psychologists. In a previous inquiry, I recall that we picked up on the increasing marketing of penis extensions, so it is not purely and simply relating to women, men are being drawn into this area as well. I wondered what your views were on whether, within a society that permits a free market in health, there can ever be a system that protects people from those who are unscrupulous in that private market.
  (Professor Sturrock) That is a huge question. I think probably one has to begin with basic health education and I think that, to a certain extent in the long term, you need to begin with children and we need to improve the general public's awareness of health and health matters and what medicine is about. To a certain extent, perhaps doctors have not been particularly good at explaining what they can and cannot do. There is a perception amongst the general public that, if you have a problem, it can and must be fixed. I think that is a culture which needs to be changed and it is also partly related to the public's understanding of science, not just the public but the media as well, which also needs to be addressed. So these are very big issues. Coming back to your specific question as to whether, in a free society, one ever regulate for this kind of problem, I think the answer is "probably not" but perhaps the way to start is by attempting to improve the general public's awareness and understanding of science, medicine and health and maybe one should begin with children in the first instance.

Dr Stoate

  37. If I may just follow up on that very briefly by saying that I would go further than that because I am very concerned indeed to hear your findings that a number of surgeons are not involved with general practitioners and are quite happy to carry out quite extensive operations on people. Personally as a GP, I would like to put on record that I would refer such a surgeon to the General Medical Council if I found that a patient had been operated upon without informing a GP. I personally would be in touch with the General Medical Council to have their general practice reviewed and I think that the GMC would take quite a robust view of that sort of practice.
  (Professor Sturrock) I would hope that they would and I entirely agree.


  38. There are no further questions and I thank you for a most interesting discussion and I am grateful for your co-operation this morning. Thank you very much.
  (Professor Sturrock) Thank you.

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