Transcript of Interview - ABC 702 Sydney Morning Program with Linda Mottram - PIP Breast Implants - 9 February 2012
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9 February 2012
Topics: PIP Breast Implants
Linda Mottram: Well, the Federal Parliamentary Secretary for Health, who's responsible for the TGA, Catherine King, has joined us this morning, thank you so much, Catherine, for your time.
Catherine King: Good morning, Linda, sorry to be a bit late on the phone for you…
Linda Mottram: No, no, no, you're right, I'm really appreciative that you've been able to get to us.
Catherine King: Sure.
Linda Mottram: You heard that grab there…
Catherine King: Yes, sure…
Linda Mottram: …from Lorraine Long, what do you say to that?
Catherine King: Well, I guess - I want to say the first thing, it's really important to understand what the advice is, and where that advice has come from…
Linda Mottram: Sure.
Catherine King: …and the TGA has obviously provided its data and information, but it's provided that to the Chief Medical Officer, also all of the clinical experts in the field, and they have provided advice to government as to what the advice to women should be.
And the current advice to women is very, very clear, we want women to ascertain what sort of breast implants they actually have, so we've established a hotline to assist with that, to rule whether they've got PIP implants in or not, many women don't know what sort of implants they've got.
We want the women who have a PIP implant, or are definitely not sure about what implant they've got, to contact either their surgeon or their general practitioner, we want them to get a clinical assessment, which may include, or should include, a radiological assessment, to see whether their implant is leaking or not, then they need to have a discussion with their surgeon whether their implants need to be removed, and if removal is recommended, then women should go and do that.
Now that's the advice that we have been given by the Chief Medical Officer, and the clinical experts, they continue, there is a lot of data being gathered at the moment by the TGA, and the TGA in fact is leading internationally the testing on PIP, and has set up protocols between other countries on the testing of PIP implants, so they're actually doing a substantial amount of work, and that's still underway, and we expect to start to get some of the results of that in the next few weeks or so.
So that's the advice on the basis - based on the evidence that we have before us at the moment.
Now I understand two other countries have given different advice, we obviously are aware of that, but on the basis of the advice from our clinical experts, who have looked at what's happened internationally, that is the advice we're given, and it's also consistent with the advice being given by the UK as well.
Linda Mottram: The advice though in those other countries, France and Germany, I thought the Netherlands as well, about removal, certainly France and the German medicos as well have said, look, they just should be removed, I mean those are very, you know, advanced countries that, you know, are on a par with Australia, it is a bit surprising, isn't it, that our advice isn't matching theirs?
Catherine King: Well, we obviously have to look at the advice that we're given, and obviously the advice also reflects that of the World Health Organisation as well, it's a matter, I guess, for the French authorities and for the German authorities as to why they've taken different decisions, and they've taken a different approach to this country, and to others.
Linda Mottram: Yes. Do you think there is a case for mandatory removal? Are you…
Catherine King: No, all of the advice that we're getting at the moment, based on the evidence we have available, and as I said, that evidence is continuing to be collected, is that there is no evidence to suggest the routine removal of these breast implants, certainly if they have not ruptured, but we want women to absolutely go and get a check, get a clinical evaluation, and discuss that with their surgeon, and obviously if they are ruptured, and the surgeon is recommending their removal, then they should be removed.
Linda Mottram: A German expert that we spoke to last week, said that the implants don't have to have ruptured to be causing issues, and that women don't have to have symptoms, you can have bleeding out from the implants…
Catherine King: Yes, and that's obviously the other issue as well, and I do want to say, you know, when you look at breast implants overall, and I haven't known very much about this space before, but now know a lot about it, the best piece of information is actually on the FDA website in the US, which has done an extensive study, obviously they had some major issues a while ago, in terms of breast implants there, breast implants overall.
They have over a 10 year life span, a 10 per cent rupture rate, it's pretty high, all of the clinical advice to women when they're getting breast implants, is to have them regularly checked for whether they're bleeding, or whether they've ruptured, obviously a clinical evaluation will detect whether there has been either a rupture, or there has been bleeding, and that's obviously the silicon gel, the membrane, some of it, if the particles are quite small, can get out of the actual breast implant, so you need to have a clinical evaluation to determine that.
But all breast implants, you know, if you look at the evidence around them, they do, in general, 10 per cent of them do rupture in 10 years.
Linda Mottram: I'm just thinking back to what Lorraine Long has said there, she was clearly very critical of the TGA, are you concerned about the TGA's response to her?
Catherine King: Yes, look, certainly we'll get in touch with Lorraine to find out what evidence she was providing, and there is a process in terms of adverse event reporting, I have had some work done on the way in which that works, and the TGA is looking to strengthen the way in which adverse event reporting occurs, I'm not overly happy with it across a range of areas, not just this one.
So what I want to know is - and we'll get some details from Lorraine about what it was she was reporting, what the TGA's response to that will be, because my view certainly, if people have concerns about, or they have evidence that they need to put to the TGA, then the TGA needs to treat that seriously.
Linda Mottram: So when you say adverse event reporting, that's something like Lorraine calling and saying, look, you know, we're working in this area, here are our concerns, and the TGA not hearing them, that's what you're talking about?
Catherine King: Yes, certainly, an adverse event report is when someone has evidence to say well look, I've got - so if Lorraine had a number of people who were ringing her saying, I've had to have my breast implants replaced because they've ruptured, they've only ruptured after this amount of time, then that's an adverse event, and the TGA then goes and does some clinical investigations as to, you know, what's actually happened, what's happened to the actual medical device. So those sorts of reports.
Consumer organisations do raise a number of concerns, and that's obviously part of the information the TGA needs to take into account, but it also has to act on the basis of evidence, so it needs to actually have detailed clinical assessments of actual cases, and that's what the adverse - it's a formal adverse event reporting system.
Linda Mottram: And what, you're saying they're not fast enough for your liking?
Catherine King: I think certainly in terms of adverse event reporting, and we had this investigation, I asked John Horvath to have a look at the issue when Fluvax came about, and I think there's a lot of people in the public who are not aware that they can report immediately to the TGA directly when they've had an adverse event, I don't think that's advertised very well, I don't think it's very clear, I also don't think it's as clear, you know, when the trigger points are for the TGA to then say, well there needs to be a Chief Medical Officer response in this instance.
So we've done some work on that with the TGA, and certainly I think we need to be really clear about how the adverse event system actually works. General practitioners as well, obviously they make a substantial number of reports, as do specialists as well, but to my view, and I've said it previously, I think it's not as good as it could be.
Linda Mottram: Sure, okay. I guess, you know, what sort of a timeline are you looking at in terms of the PIP implants?
Catherine King: Yes, well we're actually - there's no sort of timeline in terms of that, we're actually actively working on it at the moment, so there's substantial testing being done at the TGA, they're doing some irritability testing, because at the moment the only data that's come out in terms of adverse events with the PIP implants is other than obviously they're rupturing, but in terms of health outcomes is irritability, and that's come out from the French, and they only provided that data late last year.
So we're doing that testing, we're obviously testing some explants as we get those, there's obviously some issues around biological hazards with those as well, so we're working through that.
Interestingly enough, obviously when the recall occurred back in 2010, all medical devices have been completely destroyed in Australia, so we're having to source PIP implants from Brazil and I think some other countries, we've got them to actually do some of the testing, where I was obviously getting information about the gels that have been used and those sorts of things, so all of that's currently underway.
The Senate I think has taken the decision, Nick Xenophon moved it, and I talked to him, we've supported that, to reopen there with an inquiry that was handed down in November last - late November last year…
Linda Mottram: But that's not going to affect the [inaudible] any of the action...
Catherine King: Not at all, nor should it, absolutely nor should it, but I think - so that's a medical devices inquiry overall, and they've reopened that, I think they're going to have a half-day of hearings in May, to have a look at this.
I am very interested, if there are lessons to be learned from this, then we absolutely need to learn them, and reform the system, but that should - that is not slowing down anything that's happening in the PIP space. Really important for women to get the clinical assessment…
Linda Mottram: Sure, yes.
Catherine King: …obviously if we get more evidence and the clinical advice we get from our expert group changes, we will be out there saying that as quickly as we can.
Linda Mottram: Sure. Lovely. Look, thanks for your time, Catherine, much appreciated.
Catherine King: Good to talk to you, Linda.
Linda Mottram: Thank you. Catherine King is the Parliamentary Secretary for Health, who's responsible for the Therapeutic Goods Administration, just talking about the PIP breast implants there.
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