Defective silicone gel breast implants manufactured by the now-defunct French company Poly Implant Prothese (PIP).
Defective silicone gel breast implants manufactured by the now-defunct French company Poly Implant Prothese (PIP). Photo: Reuters
THE national medical regulator today will convene an expert panel to investigate the health risks faced by the 4500 Australian women who received defective French breast implants.
The Therapeutic Goods Administration announced yesterday it would bring together representatives from its expert advisory committees to investigate the risks posed by the implants, which were made with industrial products instead of medical-grade silicone.
The TGA is asking overseas regulators and local implant manufacturers for data on implant rupture rates. The regulator says it is making the appeal because information from France is not available as the case is under criminal investigation.
The TGA says it has not yet received reports the implants have high rupture rates or are linked to cancer.
French breast implant manufacturer Poly Implant Prothese (PIP) used a fuel additive in its now-banned implants that the company knew were defective as early as 2005, it has been revealed.
The growing chorus of accusations against the company has triggered a worldwide scare and several countries have advised thousands of women to have the implants removed. Between 300,000 and 400,000 women in 65 countries have implants made with the sub-standard gel.
France's RTL Radio obtained a breakdown of the materials used in the faulty implants, including Baysilone, Silopren and Rhodorsil, all of which are industrial products not tested or approved for clinical use.
Generally used in the oil or rubber industries, they allegedly contribute to the silicone gel implants having a high rupture rate.
French health authorities already knew the implants contained industrial rather than medical quality silicone, but this is the first time the use of petroleum industry additives has been reported.
''According to the [French health and safety agency] AFSSAPS, it was known that this was an unsuitable gel, usually used in food manufacturing or for computers,'' Dominique-Michel Courtois, a doctor advising implant wearers, said.
But ''there was no way of knowing that the gel contained an additive for fuel. That's why we want implants removed from patients to be analysed themselves,'' Philippe Courtois, a lawyer for implant wearers, said.
The health and safety agency tested implants seized at PIP's factory in the south of France in March 2010. A lawyer for PIP's founder Jean-Claude Mas played down the significance of the use of oil and rubber additives.
''These are food products, used to make beauty products, bought from [chemical company] Rhone-Poulenc and its competitors,'' Yves Haddad said, adding Mr Mas met AFSSAPS representatives on Monday.
Lawyer Mr Courtois called for tests on implants sold abroad, after the British media revealed rupture rates on the PIP products were seven times higher than previously thought.