Update regarding breast implants and BIA-ALCL

July 2019

The TGA is proposing to take regulatory action in relation to a number of breast implants that have been associated with Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

The TGA has formed a view regarding proposed regulatory action in relation to 31 of textured implants. The TGA is required by law to provide the sponsors of affected implants with an opportunity to make submissions in response to proposed regulatory action. The TGA will then take into consideration each sponsor’s submission when deciding what, if any, regulatory action should be taken in relation to particular sponsor’s device(s).

Further information.