In the 1940s Japanese prostitutes injected themselves with non-medical grade silicone or paraffin, or inserted sponges into their chests because they thought larger breasts would attract the American servicemen.
It’s not clear whether the results of the DIY cosmetic surgery were alluring, but it is clear that it was dangerous, and occasionally fatal.
It’s also clear that increasing numbers of women – and men – are prepared to take on the risks of invasive surgery to look better. The Australasian College of Cosmetic Surgery estimates it’s now a billion-dollar-a-year industry, and that’s not counting people seeking cheap new boobs, teeth, or tummies in Asia.
Reality television touts extreme makeovers, the possibility of shedding years in minutes, and in the process normalises very serious procedures. On the other side of the screen, people start to think it’s normal to pop into a surgery, slap down the credit card, and walk away with new breasts, smaller thighs, or a flatter stomach.
You’d think the Government would be in total control of such a booming medical industry. You’d be wrong.
This erupting Poly Implant Prosthese (PIP) implants scandal has highlighted problems with the Australian cosmetic surgery industry.
The Therapeutic Goods Administration says about 5000 Australian women had the French-made breast implants put in between 2000 and 2010, when they were recalled because of concerns over high numbers of ruptures, and the use of an unapproved, industrial grade silicone, and fears of a connection with cancers.
The French, German and Czech Governments are advising women to have the implants removed. The Australian Government suggests women call a hotline or talk to their doctor. Meanwhile, The Australian highlights a study that found the toxic implants rupture at a rate 16 times higher than that claimed by the industry – a rate as high as one in three.
Still, the Australian Government says there’s nothing to see here. The TGA says there’s no evidence of an increased rupture rate. Acting Health Minister Nicola Roxon says there is “no particular additional risk”. The Australian Society of Plastic Surgeons, unsurprisingly, agrees.
But they admit they are working from limited data. Ms Roxon said:
(One) of our concerns is, in Australia, we do not and cannot easily identify today which women have had which implants.
And the TGA says its expert panel worked with “relatively limited available data”.
What the situation highlights are the dangers of having potentially vulnerable, often ill-informed or naive people seeking help from big business in a largely self-regulated industry. While medically indicated surgeries (such as post-mastectomy reconstructions) go through Medicare, purely cosmetic surgeries do not. Then when things go wrong the government tries to find a balance between too much fear and too much calm, and circling lawyers hum the phrase ‘class action’.
The answer? More information, more data, more control.
Associate Professor Rhian Parker, author of Women, Doctors and Cosmetic Surgery, told The Punch that there is a long history of problems with breast implants, that the government “hasn’t really got to grips with the industry”, and that the medical lobby is very strongly against further regulation. She said there needs to be more transparency on adverse events, so patients are more aware of how and how often things can go wrong.
Michael Moore, head of the Public Health Association of Australia, was scathing about the TGA’s role, writing in the Sydney Morning Herald that they needed to look at the overseas experience:
This does little to encourage confidence in the organisation - how many Australian women will need to suffer before the TGA determines that it has enough evidence to make similar recommendations to its European counterparts?
Other countries may be being overly cautious, but the TGA seems to be putting itself in a very precarious position by using ‘limited data’ to determine that all is fine, when overseas thousands of women are being told all is not fine.
Ah well, at least they’ve set up a hotline.
Update:
The Punch asked the TGA if they had plans to improve their processes. Chief Medical Officer Professor Chris Baggoley, responded by email, saying:
The TGA is internationally acknowledged as a world leading regulator and Australians should feel confident about the advice it gives. In line with this, the Government has recently agreed to a set of further reforms to the TGA that will increase its transparency as well as its level of communication with consumers.
Regarding the advice given on the PIP breast implant, the TGA called together a panel of expert physicians to assess the current situation. The group of experts, which met on 4 January 2012, comprised clinical, scientific and epidemiological experts from the TGA’s statutory medicine and medical device safety committees along with additional surgical experts from the Royal Australasian College of Surgeons, the Australian Society of Plastic Surgeons and the Australasian College of Cosmetic Surgeons.
The experts concluded that there is currently no evidence of an increased rupture rates for PIP implants in Australia, and at this stage there is insufficient evidence of a problem with the Australian supplied implants to warrant routine removal of the implants that have not ruptured. The TGA will continue to investigate this matter over coming months and the expert group will also continue to meet to examine any new information
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