Regulatory Focus™ > News Articles > TGA: PIP Implants in Australia not Likely to Rupture

TGA: PIP Implants in Australia not Likely to Rupture

Posted 04 January 2012 | By Alexander Gaffney, RAC 

The Australian Therapeutic Goods Administration (TGA) today releasedstatements indicating that, "there is no evidence of an increased rupture rate for PIP [Poly Implant Prothese] silicone gel breast implants used in Australia."

TGA indicated that they have received 37 reports of PIP implant ruptures (.4%), which is in line with the expected rupture rate of all implants (1% per year). Approximately 8,900 Australian women have the implants.

TGA had already recalled all un-implanted PIP breast implants from the market on 6 April, 2011 after concerns from the French regulatory authority, AFSSAPS, were brought to its attention. Further testing by the TGA confirmed that the implants met ISO 14607 standards for tensile properties, and additional testing in conjunction with Britain's Medicines and Healthcare products Regulatory Agency (MHRA) confirmed the silicone used in the implants was neither cytotoxic nor genotoxic.

TGA is continuing its investigations in to the product.

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