Testing on Australian samples of implants supplied by the French manufacturer Poly Implant Prothèse (PIP) has been undertaken by TGA to provide assurance to Australian patients that their breast implants meet relevant safety and quality requirements.
The results of TGA testing to date indicate that the PIP breast implants supplied in Australia conform to the relevant international standards for this type of product including those for gel cytotoxicity and shell strength.
The TGA is conducting further tests on the gel and is continuing to liaise with French Authorities investigating the incident.
The TGA has not received any additional reports of product failure associated with these implants in Australia since its May 2010 update.
