Previous posts in this blog have noted the TGA's bureaucratic incapacity, with suggestions that it lacks the will and/or wherewithal to proactively address substantive concerns regarding the safety of devices (eg breast implants, artificial hip joints, stents) , alternative medications such as Sensaslim (associated with a notorious scammer) and the production of mainstream pharmaceuticals. The TGA's initial response to revelations about injury in French-manufactured implants was dismissive. Not our problem. Not here. The organisation is now shifting ground, with the ABC reporting that
start a new batch of tests on breast implants that were the subject of a national safety recall almost two years ago.Let's not celebrate too quickly.
In April 2010, the TGA recalled PIP breast implants after French authorities discovered that the manufacturer had been caught substituting an unauthorised silicone gel in the breast prosthesis.
The gel had not been tested for safety in humans.
The renewed activity by the watchdog comes amid growing concern about the health risk the PIP implants pose to women.
Late last year the French government recommended 30,000 women with the implants have them removed, while British government says it will remove the implants if women want them removed. ...
In June 2010 the TGA conducted a range of laboratory tests on eight PIP samples they had obtained from Medical Vision Australia.
The samples tested had expiry dates over just three different years, which indicates the testing was not extensive. ...
On January 4 the TGA said the reported rupture rate of PIP implants was just 0.4 per cent
the TGA's assurances over the rupture rate have come under fire from a former TGA adviser, Professor John McNeil from the School of Public Health at Monash University.Time to ask some hard questions about the TGA's operation and its history of misplaced reassurance.
Professor McNeil says the TGA should not be reporting rates of rupture based on such flimsy data.
He says the TGA was relying on a spontaneous system of reporting which was not mandatory and therefore an inadequate tool with which to calculate a rupture rate.
Asked if the statement about a 0.4 per cent rupture rate provided false sense of reassurance for women, Professor McNeil said, "Yes, but it's a false reassurance".
In recent days, the TGA has played down its pronouncements on the rupture rate, preferring to emphasise confirmed ruptures.
The TGA's acting national manager, Dr Brian Richards, says the TGA is not moving away from its statements, but the shift is to provide better information to women and doctors.
In the meantime, Perth plastic surgeon Dr Timothy Cooper says he has conducted a study of all his patients whom he implanted PIP breast prosthesis and discovered a rupture rate of 20 per cent. ...
In early 2011, the French also discovered that the silicone in the implants failed intradermal irritation tests in rats, fuelling fears that the implants were the cause of inflammation in women's tissue that doctors and women were reporting.
The TGA did not mention that the PIP implants had failed this irritation test until last month, a year after the test results were published by French authorities.
The TGA says it is now in the process of conducting its own intradermal irritation tests in the PIP implants and the results will be made public soon.
