Allison Langdon: PIP breast implants

Sunday, March 11, 2012

By Alison Langdon

When you set out to tackle a story as complex and sensitive as the PIP breast implant scandal now impacting around 300,000 women worldwide – you have to leave no stone unturned. It’s not enough to take for granted the assurances of government authorities that the crisis is ‘under control.’

Nor is it enough to base your story on what has been written before.

To find out the truth behind the biggest medical fraud in years, a 60 Minutes research team worked for months in Australia and Europe – translating scientific and criminal reports, speaking with experts, and above all contacting hundreds of women with the suspect PIP breast implants.

In February, my crew and I (producer Gareth Harvey, cameraman Mark Munro and soundman Michael Breen) traveled through the UK and France to interview plastic surgeons, chemists, lawyers and criminal investigators. We visited the scene of this shocking medical crime: a now abandoned factory near Toulon, which once pumped out hundreds of thousands of silicone breast implants that we now know were made of potentially toxic industrial chemicals.

Finally, we gathered some of the three hundred-plus Australian women we’d contacted together in our Brisbane television studios, to hear their experiences. The chilling highlight of this forum was when the women (most of whom had never met before) recounted the symptoms they had suffered since receiving their implants: ‘hair loss’, ‘joint pain’, ‘extreme fatigue’ – each woman had almost exactly the same symptoms.

The PIP scandal broke in earnest in early December, 2011, with the French medical regulator AFSSAPS announcing a possible cancer link to silicone implants made by Poly Implant Prosthese – once the world’s third-largest supplier of breast implants. PIP’s owner, 72-year-old Jean Claude Mas, confessed to French police that for 10 years he’d been running a criminal fraud – substituting medical grade silicone gel for an ad-hoc compound he and his staff created using industrial-grade gels and as-yet unknown additives.

The French Health Ministry later withdrew the PIP cancer link as unproven – but on December 7 presented its government with a weighty 170-page scientific report – État des Lieux des Contrôles Opérés par les Autorités Sanitaires sur la Société Poly Implant Prothèse – detailing a range of health problems connected to Jean Claude Mas’ suspect implants. These included tests proving Jean Claude Mas’ tainted implants caused inflammation in laboratory animals, and other symptoms that mirrored what thousands of women were beginning to report to their doctors: “…the inflammatory responses in rabbits under experimental conditions are consistent with the observations reported in … women with PIP breast implant silicone gel.”

The report also chronicled the clinical observations of France’s leading plastic surgeons – like Professor Laurent Lantieri (the pioneer of some of the most advanced surgical procedures ever performed, including the world’s first full face transplant) – who reported PIP implants rupturing inside women’s bodies at an alarming rate. Not only did this rupturing mean that the suspect PIP gel came into direct contact with breast tissue, it also made the removal of the implant (and the leaking gel) far more difficult.

The report recommended the wide scale removal of PIP implants from women, stating: “Proven risks associated with these implants are ruptures and irritation caused by the gel, which may lead to inflammation and make their removal difficult.”

Faced with this report and with the support of the country’s most senior plastic surgeons, the French government acted. In an unprecedented step, it called for all 30,000 Frenchwomen with PIP implants to have them removed – at government expense, citing: “Non-compliance with international standards, lack of quality, variability in quality and composition from one batch to another, and irritancy are four elements which justify, as a precautionary measure, the removal of the implants…”

The French Ministry of Health set up a hotline to help women find hospitals where “…any woman who wishes to opt for preventive removal [can] do so.”

When I interviewed Professor Laurent Lantieri in Paris he was adamant that the French government had not overreacted, instead describing the PIP scandal as a “health crisis.” He told me: “We [must] have some common sense. We know that it is industrial silicone in a small shell and it can rupture, let’s just remove it. It’s common sense.”

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Also shadowing the French government’s extraordinary announcement was further scientific research, which concluded that the full cocktail of industrial chemicals used by Jean Claude Mas would probably never be isolated with enough certainty to risk leaving the implants inside women. It found that the various chemicals and gels used by Mas were diverse and not comparable with medical-grade silicone. It also stated that a “…small number of implants [were] made from the same batch of gel and [there is] variability between these batches… Each batch appears to be unique”, adding: “…It is impossible to connect a date of manufacture or a physico-chemical characteristic to an implant….”

In other words – as Professor James Frame, an eminent British plastic surgeon – told me: “We don’t actually know what’s in [the PIP implants.] There may be some totally pure implants, but the spectrum runs right the way down to the totally impure. It could be anything that’s in there.”

Frame’s expert view is: “The concern we’ve got for all the ladies … is that 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.”

Various other governments across Europe and around the world including Germany, the Czech Republic and Venezuela have followed France’s lead – calling for all women with the suspect implants to have them removed at public expense, whether they are ruptured or not. Under pressure from experts like Professor James Frame and both the British and International Societies of Aesthetic Plastic Surgeons, the UK government announced that women who had received their implants through the National Health Service could have them removed by the NHS. It called on private clinics that had used PIP implants to remove them from their patients for free, but if those clinics refused (and many have) the British government would also foot the bill. So the situation in the UK is that any woman with PIP implants can be confident of having them removed at no cost if her doctor agrees.

All of which leaves Australia adopting a rather lonely – some say callous – ‘wait and see’ attitude towards its 6000 female citizens with PIP implants. (CONTINUED...)

READ PART TWO HERE

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

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