Poly Implant Prothese silicone gel breast implants

Safety advisory

21 December 2011

The Therapeutic Goods Administration is aware that the French regulatory authority is continuing to investigate adverse events reported in patients with silicone gel breast implants manufactured by Poly Implant Prothèse (PIP). This includes a recent report in France of the death of a woman from anaplastic large cell lymphoma (ALCL), a rare form of cancer of the immune system.

There have been approximately 8,900 PIP breast implants used in Australian women. The TGA has received 45 reports relating to PIP implants, 39 of which relate to rupture. It should be noted that the cause of rupture may be due to factors other than the device itself.

Women with breast implants should continue to routinely monitor their breast implants and consult their implanting surgeon if they have any concerns.

The TGA has not received any reports of ALCL in Australian women with silicone gel breast implants that were manufactured by PIP.

The TGA issued a statement regarding ALCL associated with breast implants on 27 January 2011. The advice in this statement remains current and TGA continues to monitor the situation in Australia and overseas. The TGA has contacted the French regulatory authority seeking further information about these matters.

Information on how to report a suspected problem with a medicine or medical device to the TGA can be found at Reporting Problems.