Silicone gel breast implant
Consumer information
2 July 2010
Testing on Australian samples of implants supplied by the French manufacturer Poly Implant Prosthese (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.
19 May 2010
The TGA is continuing its investigation into issues relating to overseas reports of increased rupture rates of PIP silicone gel-filled breast implants manufactured by Poly Implant Prosthese (PIP) (France). TGA has reviewed all reports of failure in Australia of this product. The rate of reported failures appears to be within industry norms for this type of product and the rupture rate for these implants in Australia is not reflective of the overseas rupture rate. The TGA is also awaiting results from tests being conducted on the implants.
6 April 2010
Silicone Gel Breast Implants manufactured by Poly Implant Prosthese (PIP) of France
Medical Visions Australia Pty Ltd following consultation with the Therapeutic Goods Administration is undertaking the recall of all non implanted silicone gel breast implants manufactured by Poly Implant Prosthese (PIP). The recall applies to all models of this type of implant.
The product is being recalled following concerns by the French medical device regulatory authority (AFSSAPS) that there may be an increased incidence of ruptures with this product. The TGA is urgently investigating the product and reports of its failure. The TGA will provide further information on this website.
Consumers with these silicone gel implants who have concerns should contact their treating breast implant physician for advice and follow-up.
Information of the type and model of implant you have received should be on the Consent to implant silicone gel–filled breast implant form completed at the time of implant.