Tag: medical devices

Breast Implants – national recall

CONSUMER ALERT – The Therapeutic Goods Administration (TGA) continues to review and assess breast implants available in the Australian market. For more information and the latest updates, see the TGA’s online breast implant hub.

  • On 2 August 2019, the Allergan company voluntarily recalled their un-implanted Biocell macro-textured breast implants and tissue expanders due to a risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer of the immune system. Another company also cancelled their product (Emergo Airxpanders Aeroform tissue expanders)
  • On 26 September 2019, the TGA published its decision to recall and suspend a number of other breast implants and tissue expanders. The full list of recalled and suspended products can be found on the TGA’s Breast Implant Hub.

The TGA has developed a fact sheet for consumers regarding the Allergan recall. The TGA fact sheet states that:

If you have symptoms such as pain, swelling, a rash or a lump in your breast, armpit or elsewhere or you are not sure about changes in your breast, please discuss these with your general practitioner (GP), surgeon or other appropriate medical professional as soon as possible.

Patients can also call HealthDirect on 1800 022 222 for further information.