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) 142863 Nagor Mammary Implants Gel-filled-TEXTURED Suspended
277757 9-cell CoGel gel-filled Nagor mammary implant range – textured Suspended
277785 Impleo gel-filled Nagor mammary implant range – textured Suspended
142860 Gel Filled Mammary Implant Conditions imposed
277759 Impleo gel-filled Nagor mammary implant range Conditions imposed
Emagin Pty Ltd (Groupe Sebbin SAS) 309613 Anatomical Breast Implants – Textured – High Cohesive Gel Suspended
132036 Paragel Cohesive Gel Implant Conditions imposed
Euro Implants Pty Ltd (Eurosilicone SAS) 132040 Cristaline I Aptex/Vertex Paragel Natural Cohesive Gel Implant Suspended
132037 Cristaline Paragel Cohesive Gel Implant Suspended
JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH) 171782 Sublime Line, Microthane, Silicone gel filled Mammary Implants Suspended
185060 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants Suspended
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
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
Silimed Removed from ARTG 2016 Mammary Implant-Silicone Gel-Polyurethane Foam Coated Legacy implant

Emergo

Airxpanders

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
Cereform 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 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, un-implanted stock will be recalled 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.

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