During the course of the TGA review, two companies chose to cancel the inclusion of their implant devices in the Australian Register of Therapeutic Goods (ARTG). On 2 August 2019, the Allergan company voluntarily recalled their un-implanted Biocell macro-textured breast implants and tissue expanders.
The TGA has developed a fact sheet for health professionals about the Allergan recall, which provides guidance on how to manage patients with and without symptoms as well as information on implant identification, investigations (including diagnostic imaging) and referral.
A fact sheet has also been developed by the TGA to help consumers understand what the recall means for them. The TGA fact sheet advises consumers to see their GP as soon as possible if they have symptoms such as swelling, pain, a rash or a lump in their breast, armpit or elsewhere, or if they are not sure about changes in their breast.
The TGA has also imposed new conditions on product sponsors for all breast implant devices that remain available in Australia, including requiring sponsors to provide information on the risk of BIA-ALCL in patient information leaflets and clinician instructions for use. A list of all affected devices is available from the TGA website.
Implanting surgeons should be alert to the issue of BIA-ALCL and review the relevant literature in the context of their patients on a case by case basis. For more information, see the TGA’s Information for Health Professionals.
Patients can also call HealthDirect on 1800 022 222 for further information.