Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 80 - 99)



  80. All implants?
  (Ms Irwin) I mean on silicone gel implants in particular, possibly all. I only know my field is knowing more about the silicone implants, I have to say, than I do about the others, so that is my platform in a way. A form of moratorium rather similar to that in the US where there is a definite control in particular strictures and regulations as to who should have them and how that will be monitored so that you are, in fact, doing some research at the same time. I make that plea because I felt we were working towards it a little bit in this conversation here.

John Austin

  81. Going back to the handbook again and leaving aside your criticism about shortcomings of the handbook, do you have evidence to suggest that women who are contemplating implants do actually get it?
  (Ms Heasman) I have no evidence as such. Unfortunately I have not been given a list of who it was being distributed to but I will say whenever I get an inquiry to the Society I ask how they heard about us. The numbers are increasing on a weekly basis who have the Department of Health booklet. Somehow it is getting out there but I do not know how.

Mr Burns

  82. Can I just pick up on that. Do you have any idea of where these booklets might be available when you ask people how they hear about you?
  (Ms Heasman) No, perhaps I should say "how did you get the booklet?" From what I can work out, it seems to be BUPA hospitals, private hospitals, that actually seem to be handing them out, that is all I can figure out so far.

Siobhain McDonagh

  83. We have talked about the sorts of things which can go wrong with these particular implant operations. I wondered if you had encountered any problems in actually finding out information on the numbers of adverse incidents involving them? Do you have a problem getting the information together or the statistics on it? Is it dependent on people getting together?
  (Ms Heasman) That is a very good question. It is not possible to have a compulsory Registry because of the Human Rights Act, etc.
  (Ms Livsey) That is what we have been told. We do not know how true it is.
  (Ms Heasman) There were no controls in the past over which surgeons were telling the Registry or not. We have no comprehensive figures at all.
  (Mr Balen) We desperately need, I think, the vigilance area of the Medical Devices Agency to be made compulsory and extended to things like ruptures and so on which my suspicion is that manufacturers do not report because they just accept it is one of the things which happens. I see no problem as a lawyer with the Human Rights Act because it is anonymised data and anonymised data should be sufficient. I think there should be publicly published league tables, products against side effects, risks and so on, in the same way there should be surgical league tables so that we can map "Does implant A tend to rupture after one year, two years, three years? What is this surgeon's rate of re-operation?" and so on. It ought to be made compulsory that it should happen and linked with that it should be compulsory to give a woman an identification card so she knows what implant she has, what number of that implant it is.
  (Ms Heasman) I have this in the back of my book. It is like a passport, I encourage them to write this down.
  (Mr Balen) The soya implant manufacturers introduced that scheme. It has worked pretty well. It fell down when it was used in the National Health Service, the National Health Service did not appear to register the implants in that way. Certainly there is no reason for it not to be extended and every benefit for it to be extended to all implants.


  84. It would be helpful if that was included on the patient's medical records?
  (Mr Balen) Not necessarily.

  85. Would it not be helpful?
  (Mr Balen) Yes, it would, yes.

  86. We have heard already often a GP knows nothing about this operation.
  (Ms Heasman) That is right.
  (Mr Balen) GPs in my experience usually do not know. It is very rare they will know.

  87. It is the norm?
  (Mr Balen) It is the norm that the GP does not know.
  (Ms Heasman) They are more worried not about the GP but about the receptionist in the GP's surgery finding out. You know, you would not believe how private this is.

Siobhain McDonagh

  88. On the other side of that surely if women do not want to tell anybody they are going in for the operation, they are not going to search around for information about it. If in the end it goes wrong they will probably put up with a great deal before they will tell anybody.
  (Ms Livsey) Absolutely. There are two ways of looking at that. When Rose and I had ours, as we have said it is a very private thing, we did it merely to mend. Today it is a fashion accessory. I was on a TV programme with Ester Rantzen the other week and there were young girls there who were delighted to have these implants and wanted everybody to know and touch them. (Mr Balen) Your point is very relevant if you think there are a very large number of women who do not tell their GPs, do not tell their spouses or boyfriends, even their families, that does raise a real question, how can they possibly have given informed consent because we all know it is a very high probability they will need further operations? How could they possibly have thought they would get away with it later in life? That does suggest that there has not been proper informed consent.

  89. I suppose if you are 20 and having it done to help your career and whatever, as you perceive it at that time, you do not think about ten years' time.
  (Ms Livsey) No, you do not.

  90. Ten years' time will take care of itself.
  (Ms Heasman) The attitude is I might get run over by a bus tomorrow.
  (Ms Livsey) When I had mine taken out, they put mine under the pectoral muscle and it was adhered to my ribcage. Now I had to go into the Christie Cancer Hospital in Manchester and I was there for five days because it was such a mess and I really thought I was going to have a mastectomy.
  (Ms Irwin) That happened to you and when we had our explantations, we know for a fact that an eminent and good plastic surgeon, very well known, did not put this on the register that exists today. It is a very ad hoc business the National Implant Register. In terms of the adverse incidents again, could I take up the point that the MDA are very reluctant to take on patients' reports about ruptured implants, for instance. When I wrote to David Sharp, who was at that time President of BAPS, to ask about how he considered rupture in relation to an adverse incident, he said that no plastic surgeon that he knew in the country, and I have the letter, would regard implant rupture as an adverse incident. Another official in the MDA said that it was an adverse incident. In terms of your question about adverse incidents, nobody quite seems to know how to categorise what is and what is not an adverse incident.
  (Ms Livsey) Actually there is no total commitment in this country.
  (Mr Balen) One of the suggestions I would make is that this year the Medical Devices Agency I have seen has published a guide on reporting adverse incidents with coronary stints. It actually lists what would be regarded as adverse incidents and what would be regarded as clinical errors and what is regarded as one of those things you should not report. I think it would be of great assistance to women and the medical profession dealing with breast implants if they did that for breast implants.


  91. Can I come back, Mr Balen, to you on the question I put to Professor Sturrock at the end which is about the tension between the right of people to have whatever they want done and how we protect them from harm. How do you, as a lawyer, view that dilemma? Do you have any thoughts yourself, picking up some of the experiences we have heard of, bearing in mind, quite clearly, Ms Livsey, you talked about the situation and presumably you had the operation in the private sector?
  (Ms Livsey) Yes.

  92. Then went into the National Health Service to have it repaired.
  (Ms Livsey) Yes.

  93. Now there is a significant burden on the National Health Service from things which have gone wrong in the private sector. In looking at how we protect the public interest clearly the Committee is charged with looking at how we spend our money. How do you see us developing a process which would as well as indirectly protecting the public interest and the public purse also protect people from unscrupulous people in the market who want to entice people into operations which quite often they did not want to have?
  (Mr Balen) First of all, you start with products, you do what you can through your Government Agencies to make sure that the products you allow to be used in this country are safe. You have appropriate data, appropriate licensing and appropriate monitoring, appropriate vigilance.

  94. Is not the process further back than that? Professor Sturrock talked about education, women's perception of how they should or should not look, should that not be challenged somewhere perhaps? It is a very big question, I appreciate. That is what it comes down to in a sense.
  (Mr Balen) Education I think is needed about some of these implants, of all varieties, and that could start with your PSE or whatever it is classes at school when you are talking particularly to young women about changes in their body and so on. You could give them examples. Yes, you can have your body changed and altered but every operation has a risk and this is what we know and so on. It is very far removed from the kind of work which I do which tends to be pick up the pieces and try and draw, if you like, lessons from that, which is why I am here, to try and prevent it happening again. There is an awful lot that can be done to try and help individuals pick up the pieces themselves and to reduce the burden on the state and so on, not only preventing what went wrong but, as we have seen with the problems that have arisen both post soya withdrawal and post Hydrogel withdraw, actually trying to get the pharmaceutical industry in with the Government Agencies as well as the private health care sector to reach a consensus on how they are going to deal with these patients. At the moment certainly it is an enormous amount of my time, and that must be reflected in an enormous anxiety amongst the population affected. It will mean more consultations with GPs, more calls on the private sector, more people not being able to go to work because of concerns of the impact of Government announcements and so on. I have illustrated, for example, the announcement saying "All your medical costs will be paid" when I do not think the Government, firstly, had secured that and, secondly, probably has any power to secure that. The same with the Hydrogel announcement, yes, but what happens to the women now? There must be recourse somewhere which allows women affected by such announcements to actually seek medical advice and so on. There is a problem that has occurred, you are dealing with the private sector, I know you have taken steps with your new law and so on but we do not know how regulated it is going to be. If you are a woman who has borrowed money to fund it—as a lot of women have—and they think it has gone wrong, they know if they go back it is going to cost them more money. They are driven into a vicious circle. I think that is something that is a very great concern.

Mr Burns

  95. Ms Livsey, if my memory is right, you had your operation in the 1970s.
  (Ms Livsey) 1980s.

  96. Was it you, Ms Irwin?
  (Ms Irwin) Yes, the 1970s.

  97. Sorry, I will ask you the question. You had your operation in the 1970s and it was for medical reasons, not for cosmetic reasons?
  (Ms Irwin) It was for cosmetic reasons, after childbirth and so on.

  98. It was for cosmetic reasons. I do not want to ask you the question. I will start again. Ms Livsey, you had your operation in the 1980s which may not be quite as relevant.
  (Ms Livsey) Yes.

  99. It was for medical reasons, it was not for cosmetic reasons?
  (Ms Livsey) Well, it was cosmetic but it was because of a hormonal imbalance. I lost my breasts. I did not have them surgically removed, they just vanished.

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2001
Prepared 4 April 2001