Current status of breast implant products in Australia
In October 2019, the TGA took steps to improve the safety of breast implant products in Australia. The list below outlines the current status of breast implant devices and will be updated as needed.
|Sponsor (Manufacturer)||Device/ARTG number||Product Name||Status|
|Allied Scientific Products Pty Ltd (Nagor Ltd )||142863||Nagor Mammary Implants Gel-filled-TEXTURED||Cancelled by the Sponsor|
|277757||9-cell CoGel gel-filled Nagor mammary implant range - textured||Cancelled by the Sponsor|
|277758||Impleo gel-filled Nagor mammary implant range - textured||Cancelled by the Sponsor|
|142860||Gel Filled Mammary Implant||Cancelled by the Sponsor|
|277759||Impleo gel-filled Nagor mammary implant range||Conditions imposed|
|Emagin Pty Ltd (Groupe Sebbin SAS)||309613||Anatomical Breast Implants - Textured - High Cohesive Gel||Cancelled by the Secretary|
|309614||Textured, Round, Firm, High Cohesive Gel Mammary Implant||Conditions imposed|
|309615||Textured, Round, Soft Classic, Cohesive Gel, Mammary Implants||Conditions imposed|
|309616||Microtextured, Round, Firm High Cohesive Gel, Mammary Implants||Conditions imposed|
|309617||Microtextured, Round, Classic, Cohesive Gel, Mammary Implants||Conditions imposed|
|309618||Smooth, Round, Firm High Cohesive Gel, Mammary Implants||Conditions imposed|
|309619||Smooth, Round, Classic, Cohesive Gel, Mammary Implants||Conditions imposed|
|Euro Implants Pty Ltd (Eurosilicone SAS)||132040||Cristaline I Aptex/Vertex Paragel Natural Cohesive Gel Implant||Cancelled by the Sponsor|
|132036||Paragel Cohesive Gel Implant||Conditions imposed|
|132037||Cristaline Paragel Cohesive Gel Implant||Cancelled by the Secretary|
|JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH)||171782||Sublime Line, Microthane, Silicone gel filled Mammary Implants||Cancelled by the Secretary|
|185060||4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants||Cancelled by the Secretary|
|171783||Sublime Line, Textured, silicone gel filled Mammary Implants||Conditions imposed|
|185059||4Two Line, Single Lumen, Textured, Silicone gel filled Mammary Implants||Conditions imposed|
|171781||Sublime Line, Smooth, Silicone gel filled Mammary Implants||Conditions imposed|
|Spiran Pty Ltd (Establishement Labs SA)||282776||Sterile Silicone Breast Implants Motiva Implant Matrix SilkSurface PLUS with Qid||Conditions imposed|
|282777||Sterile Silicone Breast Implants Motiva Implant Matrix Ergonomix Round SilkSurface with Qid||Conditions imposed|
|282778||Sterile Silicone Breast Implants Motiva Implant Matrix SilkSurface PLUS||Conditions imposed|
|Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV)||110588||Siltex Round Cohesive I||Conditions imposed*|
|110589||Siltex Round Cohesive II||Conditions imposed*|
|110592||Siltex Round Becker Cohesive I||Conditions imposed*|
|119809||Siltex Contour Becker Cohesive II||Conditions imposed*|
|130678||Siltex Contour Gel Breast Implants Cohesive III||Conditions imposed*|
|226977||Mentor® CPX™4 Breast Tissue Expander||Conditions imposed*|
|226982||Mentor® CPX™4 with Suture Tabs Breast Tissue Expander||Conditions imposed*|
|110587||Smooth Round Cohesive I||Conditions imposed|
|119646||Smooth Saline Mammary Prostheses with Diaphragm Valve||Conditions imposed|
|319150||Smooth Round XTRA Gel Breast Implants||Conditions imposed|
|326144||Siltex Round XTRA Gel Breast Implants||Conditions imposed|
|Allergan Australia Pty Ltd (Allergan)||218869||BRST Round Microcell Textured Responsive gel filled breast implant||Conditions imposed|
|220900||BRST Round Microcell Textured Cohesive gel filled breast implants||Conditions imposed|
|171393||Natrelle Truform1 Gel, Smooth Single Lumen Breast Implants||Conditions imposed|
|175421||Natrelle INSPIRA, Truform 1 gel, Smooth, Single Lumen Breast Implants||Conditions imposed|
|175426||Natrelle INSPIRA Truform 2 gel, Smooth, Single Lumen Breast Implants||Conditions imposed|
|220696||BRST Round Smooth Responsive gel filled breast implants||Conditions imposed|
|Removed from ARTG 2019||Biocell Natrelle range macro-textured implants||Legacy implant|
|Device Technologies Australia Pty Ltd (Silimed Industria de Implantes LTDA)||Removed from ARTG 2016||Mammary Implant-Silicone Gel-Polyurethane Foam Coated||Legacy implant|
|Mammary Implant-Silicone Gel-Smooth Surface||Legacy implant|
|Mammary Implant - Silicone Gel - Textured Surface||Legacy implant|
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
|Removed from ARTG 2019||Aeroform Patient Controlled Tissue Expander||Legacy implant|
|AeroForm™ Tissue Expander System Dosage Controller Kit - Remotely-controlled tissue expander remote control||Legacy implant|
|Medical Vision Aust Plastic & Cosmetic Pty Ltd (Cereplas)||Removed from ARTG 2014||CEREFORM Silicone Gel-Filled Breast Implant (Smooth Texture)||Legacy implant|
|CEREFORM Silicone Gel-Filled Breast Implant (Intermediate Texture)||Legacy implant|
|CEREFORM OPTIMA Silicone Gel-Filled Breast Implant||Legacy implant|
|Medical Vision Australia (Poly Implant Protheses (Pip) SA)||Removed from ARTG 2010||Poly Implant Prosthese PIP||Legacy implant|
|Surgitek||Removed from ARTG 2002||Polyurethane-coated breast implant||Legacy implant|
*Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders
What does it mean to say a product has been suspended?
When the TGA suspends a product, it means it is temporarily not allowed to be included on the Australian Register of Therapeutic Goods (ARTG). It will not be available for supply until the sponsor has made the requested adjustments to the product, or improved the information available about their product. If these requirements are met, a suspended product may be re-added to the ARTG at the discretion of the TGA.
In the case of breast implant products, the sponsors/manufacturers of the suspended products have six months to make the required adjustments. If they do not do this, the products will be cancelled and new patients will not be able to receive those products.
What does it mean to say new conditions have been imposed on some products?
All breast implant devices will now have the following tighter conditions imposed on them in order to be included on the ARTG:
- all cases of BIA-ALCL must be reported to the TGA within 10 days of being notified.
- new six monthly reports from sponsors – covering supply data, details of all adverse events, and all complaints, both in Australia and world-wide.
- the risk of BIA-ALCL must be included in clinicians' Instructions for Use of all breast implant and tissue expander devices.
- patient information leaflets must include warnings about the risks of BIA-ALCL.
What are the additional clinical data conditions (marked with an *)?
The sponsor of these ARTG entries must provide to the TGA, by 1 July 2020 with:
- immunotoxicology studies, and
- updated risk assessment documentation and processes with appropriate hazard controls implemented.
What is a 'legacy implant'?
Legacy implants are breast implants that women may have had implanted, but are no longer available. This could be for various reasons; for example, the company may have removed them from the market themselves, or the TGA may have cancelled them for other reasons such as manufacturing concerns. Not all legacy implants are listed here, only those which Australian consumers may still have implanted. Breast implants are not a life-time device and are designed to be replaced every 10 to 15 years.