Reporter: Allison Langdon
Producers: Gareth Harvey, Hannah Boocock
Right now, across the country, thousands of Australian women are worried sick.
They're living with the terrible possibility that a toxic time bomb is ticking away inside their bodies.
For the last ten years, one of the largest manufacturers of breast implants has been involved in a monstrous fraud — filling its products with cheap industrial gels.
What makes this scandal so alarming is that no one fully understands the health implications of what's happened. But the signs are certainly not good.
Read Allison Langdon's blog on this story and have your say
LINKS AND ACKNOWLEDGEMENTS:
After months of inaction, the Australian government has finally shifted some ground this weekend by announcing that Medicare will subsidize scans of PIP implants to assess if they're ruptured.
For more information about recieving a scan, visit the Department of Health website.
In Europe meanwhile, they've already begun removing thousands of the implants. Medical authorities there stress that the risk of leaving them in far outweighs the risk of taking them out.
Many thanks to Tindall Gask Bentley lawyers – who were invaluable in helping us contact hundreds of women at risk across Australia, and who are preparing a civil class action:
Tindall Gask Bentley lawyers website
Darlene Watkins – whose Facebook support group is providing comfort and shared experiences to many women with PIP implants:
Facebook support group
24 hour Breast Implant Information Line: 1800 217 257
TGA website: PIP breast implants
Medical Journal of Australia report on the TGA
News article: reports slams medical device alerts
ALLISON LANGDON: For two months, we’ve been trying to track down the truth behind the biggest medical scandal in years. A criminal operation that’s put industrial-grade silicone into the bodies of women across the world – including thousands of Australians who feel abandoned by their Government.
FORUM PARTICIPANT: I’m just sick of being sick. It’s just awful.
FORUM PARTICIPANT: All I want the Government to do is help these women, just to help.
JODIE: My days feel black. My days just feel black.
ALLISON LANGDON: Jodie Black decided she wanted breast implants after breast-feeding three kids and having a tumour removed. The operation was sold as simple, if expensive – the implants would be made from high quality, medical-grade silicone. But the truth would be very different.
JODIE: It is all the way around the pain, yeah. It goes all the way through to my shoulder.
ALLISON LANGDON: A year ago, Jodie began experiencing mysterious symptoms with no apparent cause.
JODIE: It’s horrible to hop out of the shower and you know, clumps of my hair’s falling out. Clumps and clumps of hair are falling out and you know, it’s quite devastating.
ALLISON LANGDON: But it was only a sign of worse to come. Just before Christmas, news broke of a shocking crime. Jodie and 300,000 other women around the world learned that their breast implants were potentially toxic. Jean Claude Mas, the owner of French company Poly Implant Protheses or PIP – confessed to police that he’d been making the implants with industrial-grade chemicals. How do you feel now?
JODIE: I feel gutted, absolutely gutted.
ALLISON LANGDON: Are some days harder than others?
JODIE: Much harder.
FORUM PARTICIPANT: This is just a small group of us. There are so many more. So it’s not just us 13 women, there’s hundreds and hundreds of us.
ALLISON LANGDON: Jodie Blake’s not alone – an estimated 6,000 Australian women have PIP implants. We’ve been in contact with over 300 of them – and brought together this group in Brisbane.
SHERIE: A lot of hair loss, a lot of back pain.
ALLISON LANGDON: Their symptoms are remarkably – and alarmingly - similar.
FORUM PARTICIPANT: Just lots of burning sensation.
FORUM PARTICIPANT: I have had a lot of burning and heat coming out of my chest, um soreness under my arms.
FORUM PARTICIPANT: A lot of burning all around my left side.
FORUM PARTICIPANT: Thyroid problem.
FORUM PARTICIPANT: Night sweats, hair loss, headaches.
FORUM PARTICIPANT: Skin irritation, headaches, constantly feeling fatigued.
FORUM PARTICIPANT: Tiredness, vomiting.
ALLISON LANGDON: You don’t think that any of you are sort of linking the pain that you’re experiencing now to the PIP implants, just because this scandal has erupted?
FORUM PARTICIPANT: No.
MEG: We all have PIP implants, we all have the same or similar symptoms. You can’t tell me that it’s got nothing to do with the implants.
ALLISON LANGDON: France is where the scandal erupted. It’s here, more than anywhere else on earth where scientists have scrambled to try to discover just how dangerous the PIP implants are. Those same scientists have now delivered a chilling verdict. Is it a crisis?
LAURENT: It is a crisis, yes. Yes, it is a health crisis, clearly.
ALLISON LANGDON: Professor Laurent Lantieri is one of the world’s leading plastic surgeons. He’s seeing firsthand the damage the implants are doing. When the PIP scandal broke, the French government turned to him for advice.
LAURENT: We know that it’s industrial silicone. Let’s just remove it – it’s common sense.
ALLISON LANGDON: So you’re adamant that any woman who has PIP implants should have them removed?
ALLISON LANGDON: The now-abandoned PIP factory in La Seyne sur Mer in the south of France is hiding a terrible, toxic secret – what exactly, went into the PIP implants? After months of investigation, we’ve identified several key chemicals: Basilone, Silopren and Rhodorsil. Commonly used for rubber tubing, computer components – even mattress-filler. Enough for some European governments, leaving nothing to chance, to order all PIP implants be removed – and at government expense.
JAMES: We don’t know who’s got the good ones and who’s got the bad ones, so we’ve got to treat them all as bad.
ALLISON LANGDON: Eminent plastic surgeons, like Britain’s Professor James Frame, insist there’s no such thing as a safe breast implant – when you don’t know exactly what’s in it.
JAMES: We don’t actually know what’s in there. Um sure, there may be some totally pure implants, but the spectrum runs right the way down to the totally impure, which could be just paraffin. It could be anything to do with the petrochemical industry. It could be anything that’s in there.
ALLISON LANGDON: You do believe that any woman who has these implants should have them removed?
JAMES: Definitely – without any hesitation.
ALLISON LANGDON: But the Australian Government isn’t just hesitating – it’s flatly refusing. The medical regulator, the Therapeutic Goods Administration will not pay for PIP implants to be removed.
DANIEL: What I’m suggesting is that the French government made a panicked response to this.
ALLISON LANGDON: Australian cosmetic surgeon Dr. Daniel Fleming is advising the TGA on PIP implants.
DANIEL: What I need is evidence, not anecdote, not the opinions of individual plastic surgeons. They may be right, they may not be right.
ALLISON LANGDON: But you’re dismissing the clinical observations of some of the world’s leading plastic surgeons –
DANIEL: I’m not dismissing it.
ALLISON LANGDON: Of their actual patients.
DANIEL: No, I’m not dismissing their observations at all. I’m saying we need to make evidence-based decisions.
ALLISON LANGDON: What we normally do is do very rigorous testing before we put something in the human body. You’re saying, “let’s do the testing before we take it out.”
DANIEL: If removing these implants was a harmless procedure with no medical or health care consequences, what you say might be a reasonable proposition, but it isn’t.
ALLISON LANGDON: See, I think what the world sees is that the TGA is playing dice with women’s lives.
DANIEL: What an extraordinary statement to make. Australians should be reassured that the TGA is taking this most seriously.
FORUM PARTICIPANT: We’re like lab rats. They’re sitting back with their microscopes watching us closely to see what’s gonna happen to us. When it’s gonna be classed as too late?
ALLISON LANGDON: And adding to the anxiety of Australian women, plastic surgeons are reporting that PIP implants are actually rupturing inside women’s bodies in alarming numbers. So you actually have a ruptured implant, is that correct?
FORUM PARTICIPANT: On the right side.
ALLISON LANGDON: How do you feel, knowing that you have a gel inside your body that is industrial-grade?
FORUM PARTICIPANT: Sick. Scared, frightened and still – what effects it might have on my life down the track.
ALLISON LANGDON: And you’ve been breastfeeding?
FORUM PARTICIPANT: I was, yes.
ALLISON LANGDON: Do you worry that you’ve harmed your baby?
FORUM PARTICIPANT: Yes. All the time. Sorry. When I first became aware that I had a rupture I felt utterly sick. I started crying.
ALLISON LANGDON: Jodie Blake’s now discovered that she too, has a ruptured implant. And no-one can tell her just what industrial chemicals may be leaking into her body. All she is being told is that the Government won’t pay the $10,000 that the operation will cost.
JODIE: What are they waiting for? Are they waiting for somebody to die?
ALLISON LANGDON: Unprepared to sit and wait, she’s paying for it herself.
JODIE: I’m very nervous.
ALLISON LANGDON: It’ll be fine you know. It’ll be fine. It’s a straightforward operation. First to be removed is Jodie’s intact implant from her right breast. Then it’s her left breast – where the implant has ruptured.
DOCTOR: You can see the ruptured implant coming out.
ALLISON LANGDON: So that’s just free silicone. It’s shocking to think that this substance about which we know so very little was floating free in Jodie’s body for months – and is still inside thousands of other women around the world. Here is an implant that has ruptured, I mean, look at that…
ALLISON LANGDON: And just touch it.
DANIEL: What’s your point? To try and pretend that this – showing this implant, squeezing it, showing it’s sticky – is some kind of evidence, is exactly the kind of anecdotal nonsense which may have the risk of leading to tens of thousands of women having surgery which may not be indicated. We need better evidence than this.
ALLISON LANGDON: The difference is, if that was any other implant, I would know that what was in it was medical-grade silicone. I have no idea what’s in that.
DANIEL: That’s exactly why we need to do the tests that we have been doing. We need to continue to do the tests to see if the non medical-grade silicone has any health consequences.
ALLISON LANGDON: Common sense would suggest that having a product that is used to make computer equipment, to fill mattresses, does not belong in the human body.
DANIEL: It doesn’t belong in the human body, but that doesn’t mean necessarily that it’s harmful to the human body and that’s why we need to do the tests.
ALLISON LANGDON: In the end – only the man who owned PIP, Jean Claude Mas, really knows what he put into his tainted implants. We went to his mansion in the French Riviera where Mas is on bail awaiting trial – to put the question straight to him. Mas’ son – who was also a director of PIP – wasn’t talking. We’re talking about an implant that’s now the centre of a criminal fraud investigation. Do you accept that we’re not talking about a normal breast implant here?
DANIEL: No, we’re not talking about a normal breast implant. There’s no question that in some of the PIP implants, gel was used which was not the authorised gel and that’s a very bad thing, it’s a very worrying thing and we need to get to the bottom of whether or not that has health consequences for patients.
ALLISON LANGDON: Can you see at some point that the TGA will change its mind and that the PIP implants could be removed?
DANIEL: If the evidence changes, most certainly the TGA will change its mind and that would be quite appropriate.
FORUM PARTICIPANT: I spent endless nights crying my eyes out, wondering how I would deal with this. After I had my implants taken out, my health was so much better. I had been very sick; soon as I had the implants out I was – it was good.
ALLISON LANGDON: But unable to afford the operation, many Australian women have no option but to wait as the experts bicker. And that’s taking an extraordinary toll. Cherie, are you okay?
FORUM PARTICIPANT: Cherie has a son, she wants to be there for him. She’s a sole parent, you know what I mean? She cannot afford to have them out. It’s up to the TGA to help them get them out. Simple as that.
FORUM PARTICIPANT: They have let thousands of women down. They know it. They need to stand up, put their hand up and say “yes, we failed you.”
ALLISON LANGDON: The Australian Government has shifted some ground this weekend, by announcing that Medicare will subsidise scans of PIP implants to assess if they’re ruptured. Meanwhile in Europe, they’ve already begun moving thousands of the implants at Government expense. Medical authorities there stress that the risk of leaving them in far outweighs the risk of taking them out.