Silicone gel breast implants manufactured by Poly Implant Prothese (PIP) of France - update, 1 October 2010
The TGA is aware that the French authorities have now released an updated statement in regard to the testing of the PIP implants:
- Silicone filled breast implants from Poly Implant Prothèse Company: Tests results (pdf,657kb)
Their testing is in 2 parts - one relates to the toxicity of the gel contained within the implant. The other relates to the strength of the shell material.
The French authorities (AFSSAPS) have confirmed the TGA's results with respect to gel cytotoxicity. AFSSAPS' testing in relation to genotoxicity has proven inconclusive and further testing will be undertaken by AFSSAPS, with results expected in early 2011.
Testing by the UK regulatory authority found no evidence for the gel being genotoxic.
The TGA has tested the tensile properties (strength) of the shells of a range of PIP implant models and has found they all comply with the relevant international standard (ISO 14607). These results differ from those obtained by the French authorities. TGA has sought further information from AFSSAPS in relation to their testing. The TGA's tensile strength test results are consistent with the relatively low number of reports of rupture that the TGA has received for these implants.
The TGA continues to seek further advice from overseas regulators and to actively monitor developments.
Based on this information the TGA's advice to Australian consumers remains the same - patients with these silicone gel implants who have concerns should contact their treating breast implant physician for advice and follow-up.