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 Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.