This is an update to the safety alerts on "Association between Breast Implants and Anaplastic Large Cell Lymphoma (ALCL)" issued on 23 December 2016 and 5 September 2019.
The Therapeutic Goods Administration (TGA) has reviewed information from extensive laboratory testing and statistical review of Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) cases in Australia. It also considered evidence submitted by the sponsors and manufacturers of breast implants and tissue expanders, as well as advice from the Breast Implant Expert Working Group and submissions and information from other stakeholders and patients.
The TGA has decided to take the following regulatory actions in relation to all breast implants and tissue expanders sold in Australia:
- Suspension and recall
This means that the implants will not be available on the Australian market for the next six months. During this period, the sponsor will have the opportunity to provide additional information to the TGA about their implants' safety and performance. Suspended implants are those that are "macrotextured" - grade 3 and 4 and some "microtextured" implants associated with higher incidences of BIA-ALCL and other clinical concerns. The affected products are identified as follows:
- Allied Scientific Products Pty Ltd (Nagor) – Nagor Mammary Implants Gel-filled-TEXTURED; 9-cell CoGel gel-filled Nagor mammary implant range - textured; Impleo gel-filled Nagor mammary implant range – textured
- Emagin Pty Ltd (Groupe Sebbin SAS) – Anatomical Breast Implants - Textured - High Cohesive Gel
- Euro Implants Pty Ltd (Eurosilicone SAS) – Cristaline I Aptex/Vertex Paragel Natural Cohesive Gel Implant; Cristaline Paragel Cohesive Gel Implant
- JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH) – Sublime Line, Microthane, Silicone gel filled Mammary Implants; 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants
- Conditions on supply
New conditions for inclusion in the Australian Register of Therapeutic Goods (ARTG) have been imposed on all breast implant devices that remain available, including tissue expanders. Sponsors have increased requirements for providing information to practitioners and consumers and for reporting adverse events, including cases of BIA-ALCL.
- Removed from market
In some cases the sponsor has chosen to cancel inclusion of their implant during the course of the Review. The Allergan Biocell macro-textured breast implants and tissue expanders and the Emergo Airxpanders Aeroform tissue expanders are no longer available on the Australian market.
For details related to the advice given by the TGA, please refer to the following link:
https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma
If you are in possession of the products, please contact your suppliers for necessary actions.
Posted on 27 September 2019