SYDNEY - Australian women do not face an increased risk of rupture from French-made silicone breast implants that are at the centre of a global health scare, the country's medical regulator said on Thursday.
Some 4,500 Australian women have the breast implants made by Poly Implant Prothese (PIP), which was ordered by French authorities to withdraw its implants from the market in 2010 after it was revealed it used unapproved industrial-grade silicone in some products.
French authorities are investigating possible links to cancer from the gel used in PIP implants after a woman died in 2010.
PIP - once the third-biggest breast implant maker in the world - is facing a lawsuit by 2,400 women in France.
As many as 300,000 women worldwide may have received the gel products, used to enhance breast size or repair lost tissue, and health authorities have called for users to consult their doctors for checks.
Australia's Therapeutic Goods Administration (TGA) said all breast implants, not just PIP implants, have a 10 per cent risk of rupture over a 10-year period after insertion.
The PIP rate of rupture reported to the TGA was approximately 0.4 per cent or 37 ruptures in 9,054 implants between 2002 and 2011.
"This rate remains well within the expected performance of breast implants based on historical and international trend data," said TGA National Manager Rohan Hammett.
Hammett added that testing in Australia and Britain found that PIP implant gel used in both countries was non-toxic to the tissue around the implant even if the implant ruptured.
"We know that breast implants won't last a lifetime in many women, and rupture is relatively common but the results of laboratory analysis both here and in the UK are reassuring in that even when rupture occurs the risk with PIP implants appears no different to other implants," he said.
PIP breast implants were recalled from the Australian market in April 2010.
PIP, which began selling implants in 1991, went bankrupt and its doors shut in 2010 after an inspection revealed it was using industrial-grade silicone in some products that was not approved by health authorities but which was cheaper than the medical-grade equivalent.
Colombia said on Wednesday that it would pay for the removal of breast implants made by PIP if a doctor recommends it.