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 numberProduct NameStatus
Allied Scientific Products Pty Ltd (Nagor)142863Nagor Mammary Implants Gel-filled-TEXTUREDSuspended
2777579-cell CoGel gel-filled Nagor mammary implant range – texturedSuspended
277785Impleo gel-filled Nagor mammary implant range – texturedSuspended
142860Gel Filled Mammary ImplantConditions imposed
277759Impleo gel-filled Nagor mammary implant rangeConditions imposed
Emagin Pty Ltd (Groupe Sebbin SAS)309613Anatomical Breast Implants – Textured – High Cohesive GelSuspended
132036Paragel Cohesive Gel ImplantConditions imposed
Euro Implants Pty Ltd (Eurosilicone SAS)132040Cristaline I Aptex/Vertex Paragel Natural Cohesive Gel ImplantSuspended
132037Cristaline Paragel Cohesive Gel ImplantSuspended
JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH)171782Sublime Line, Microthane, Silicone gel filled Mammary ImplantsSuspended
1850604Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary ImplantsSuspended
171783Sublime Line, Textured, silicone gel filled Mammary ImplantsConditions imposed
1850594Two Line, Single Lumen, Textured, Silicone gel filled Mammary ImplantsConditions imposed
171781Sublime Line, Smooth, Silicone gel filled Mammary ImplantsConditions imposed
Spiran Pty Ltd (Establishement Labs SA)282776Sterile Silicone Breast Implants Motiva Implant Matrix SilkSurface PLUS with QidConditions imposed
282777Sterile Silicone Breast Implants Motiva Implant Matrix Ergonomix Round SilkSurface with QidConditions imposed
282778Sterile Silicone Breast Implants Motiva Implant Matrix SilkSurface PLUSConditions imposed
Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV)110588Siltex Round Cohesive IConditions imposed*
110589Siltex Round Cohesive IIConditions imposed*
110592Siltex Round Becker Cohesive IConditions imposed*
119809Siltex Contour Becker Cohesive IIConditions imposed*
130678Siltex Contour Gel Breast Implants Cohesive IIIConditions imposed*
226977Mentor® CPX™4 Breast Tissue ExpanderConditions imposed*
226982Mentor® CPX™4 with Suture Tabs Breast Tissue ExpanderConditions imposed*
110587Smooth Round Cohesive IConditions imposed
119646Smooth Saline Mammary Prostheses with Diaphragm ValveConditions imposed
319150Smooth Round XTRA Gel Breast ImplantsConditions imposed
Allergan Australia Pty Ltd (Allergan)218869BRST Round Microcell Textured Responsive gel filled breast implantConditions imposed
220900BRST Round Microcell Textured Cohesive gel filled breast implantsConditions imposed
171393Natrelle Truform1 Gel, Smooth Single Lumen Breast ImplantsConditions imposed
175421Natrelle INSPIRA, Truform 1 gel, Smooth, Single Lumen Breast ImplantsConditions imposed
175426Natrelle INSPIRA Truform 2 gel, Smooth, Single Lumen Breast ImplantsConditions imposed
220696BRST Round Smooth Responsive gel filled breast implantsConditions imposed
Removed from ARTG 2019Biocell Natrelle range macro-textured implantsLegacy implant
SilimedRemoved from ARTG 2016Mammary Implant-Silicone Gel-Polyurethane Foam CoatedLegacy implant

Emergo

Airxpanders

Removed from ARTG 2019Aeroform Patient Controlled Tissue ExpanderLegacy implant
AeroForm™ Tissue Expander System Dosage Controller Kit – Remotely-controlled tissue expander remote controlLegacy implant
CereformRemoved from ARTG 2014CEREFORM 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 ImplantLegacy implant
Medical Vision AustraliaRemoved from ARTG 2010Poly Implant Prosthese PIPLegacy implant
SurgitekRemoved from ARTG 2002Polyurethane-coated breast implantLegacy 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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