Current status of breast implant products in Australia
In October 2019, we took steps to improve the safety of breast implant products in Australia. The list below outlines the 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 Implant | 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
| |
Euro Implants Pty Ltd (Polytech Health & Aesthetics GmbH)
Formerly JT Medical Pty Ltd | 171781 | Sublime Line, Smooth, Silicone gel filled Mammary Implants | Conditions imposed |
171783 | Sublime Line, Textured, silicone gel filled Mammary Implants | Conditions imposed | |
185059 | 4Two Line, Single Lumen, Textured, Silicone gel filled Mammary Implants | Conditions imposed | |
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
| |
Life Healthcare Pty Ltd (Establishment Labs SA) Formerly Spiran Pty Ltd | 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 | |
| 373251 | Motiva Implants Anatomical Truefixation SmoothSilk Sterile Silicone Breast Implants with Qid - Silicone gel-filled breast implant, smooth-surface | 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 | |
393728 | Smooth MemoryGel™ XTRA Breast Implants - Silicone gel-filled breast implant, smooth-surface | Conditions imposed | |
393729 | Smooth MemoryGel™ Breast Implants - Silicone gel-filled breast implant, smooth-surface | 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 (Airxpanders Inc) | 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 |
New conditions imposed
All breast implant devices have the following conditions imposed on them:
- All cases of BIA-ALCL must be reported to the TGA within 10 days of being notified.
- Sponsors are required to provide six monthly reports 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.
- Some ARTG entries also had a condition to provide additional clinical data to the TGA by 1 July 2020 with:
- immunotoxicology studies, and
- updated risk assessment documentation and processes with appropriate hazard controls implemented.
- For all ARTG entries that had this condition imposed, the condition has been met.
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.