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Currently no evidence of increased rupture rate for PIP breast implants in Australia, further investigations ongoing
After re-examining adverse events information with PIP breast implants in Australian women and following advice from an expert panel which met this afternoon to assess the relatively limited available data, the Therapeutic Goods Administration (TGA) advises Australian women that there is currently no evidence of increased rupture rate for PIP implants in this country.
Ongoing analysis of new data will continue over coming months as more information becomes available here in Australia and internationally.
The National Manager of the TGA, Dr Rohan Hammett, said all breast implants, not just the PIP implants, have a risk of rupture with about one in 10 implants (10%) rupturing over a 10 year period after insertion.
The current rate of rupture of PIP implants reported to the TGA is approximately 0.4% (37 ruptures in approximately 9054 implants between 2002 and 2011).
"While these figures are based only on reports to the TGA, this rate remains well within the expected performance of breast implants based on historical and international trend data," Dr Hammett said.
"Testing of PIP implants supplied in Australia by TGA in July 2010 indicated that the outer shell of the implant complied with international standards and regulatory requirements for strength and rupture resistance.
"Importantly, laboratory testing of the silicone gel contained in the PIP implants done both in Australia and in the UK using cytotoxicity and genotoxicity studies has indicated the gel is non-toxic to the tissue around the implant even if the implant does rupture.
"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."
Dr Hammett said testing by the UK regulator shows no evidence of cancer forming chemicals in the implants and there have been no reports to the TGA of the rare cancer, anaplastic large cell lymphoma (ALCL), associated with PIP implants in Australia.
"Despite the fact that the TGA has issued several public statements and information has been provided to implanting surgeons by the sponsor about the PIP implants over the past 18 months, the TGA has not received reports of increased rupture rates with PIP implants in Australia."
Dr Hammett said it is not clear that the problem of substandard implants manufactured by PIP affects any implants supplied in Australia but that the TGA is working with surgical experts, state and territory departments of health, private insurance providers and the TGA's expert advisory committees to obtain further comprehensive data on breast implant revision rates in Australia.
"The advice from the TGA and clinical experts at this stage is that there is insufficient evidence of a problem with the Australian supplied implants to warrant routine removal of the implants," he said.
"The best available expert clinical advice is that there is no current evidence in Australia to support removal of PIP implants in women in whom the implant has not ruptured.
"Women who have had breast implants and are concerned should see their surgeon for advice regarding the need for clinical follow up or radiological investigation.
"The TGA will continue to investigate this matter over coming months as more data becomes available within Australia and internationally and will issue updated advice as it continues its investigation and analysis of data."
The Expert Panel, convened today by the TGA 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 and will continue to meet to examine any new information.
PIP breast implants were recalled from the Australian market in April 2010 and the TGA has issued advice on its website in April 2010, May 2010, July 2010, October 2010 and December 2011.
Further information is available on the TGA website at Poly Implant Prothese (PIP) breast implants - the Australian perspective.