As part of ongoing work regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL), the Therapeutic Goods Administration (TGA) has completed its review and laboratory assessment of textured breast implants on the Australian market. The review was announced on 3 May 2019 and involved both laboratory testing and statistical analysis of supply information and the known cases of BIA-ALCL to estimate the risks associated for each type of implant.
What is BIA-ALCL and what should you do if you have concerns?
BIA-ALCL usually involves a swelling of the breast, typically 3 to 14 years after the operation to insert the breast implant. This swelling is due to an accumulation of fluid. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit.
It is a rare condition, with expert opinions estimating the published risk of BIA-ALCL at between 1-in-1,000 and 1-in-10,000.
TGA’s proposed regulatory action – textured implants only
Based on the laboratory and statistical review, the TGA has proposed regulatory action in relation to a number of textured implants only. Those proposed regulatory actions are either a proposal to cancel or a proposal to suspend. The TGA has also imposed new conditions on the inclusion of a number of other textured implants in the Register. The TGA has notified each of the sponsors of the relevant proposed regulatory action (or imposition of conditions, where conditions have been imposed) on 9 July 2019.
It is important to understand that the proposed cancellations and suspensions set out below are proposed. No decision has been made to suspend or cancel the relevant products at this time.
The next steps are for the sponsors to respond to the TGA’s notification and invitation to comment by 24 July 2019. The TGA will, as a matter of priority, consider the sponsor’s submissions before reaching any decision on whether to proceed to the proposed regulatory action.
Proposed Cancellation
Sponsor (Manufacturer)
Allergan Australia Pty Ltd
ARTG Number: 169956
Product Name: Natrelle Double Lumen Gel/Saline Breast Implants
ARTG Number: 171387
Product Name: Natrelle Truform Dual gel, Textured Single Lumen Breast
ARTG Number: 171388
Product Name: Natrelle Saline-filled, Textured Breast Implants
ARTG Number: 171475
Product Name: Natrelle Soft Touch, Truform 2 gel, Textured, Single Lumen Breast Implants
ARTG Number: 171512
Product Name: Natrelle Truform 3 gel, Textured Single Lumen Breast Implants
ARTG Number: 175420
Product Name: Natrelle Truform1 gel, Textured, Single Lumen Breast Implants
ARTG Number:175422
Product Name: Natrelle INSPIRA Truform 1 gel, Textured, Single Lumen Breast implants
ARTG Number:175425
Product Name: Natrelle INSPIRA Truform 2 gel, Textured Single lumen Breast Implants
ARTG Number:175797
Product Name: Natrelle Tissue Expanders
If the entries of the above products are cancelled, the products would no longer be able to be imported, manufactured or exported from Australia by the sponsor. The TGA is also proposing to require the sponsor to recall the products to remove all remaining products from the market. The recall would only apply to product that is waiting to be implanted.
There is not a recommendation to surgeons to remove implants in the absence of a BIA-ALCL diagnosis.
Proposed Suspension (on the basis that it is likely that there are grounds for cancelling the entries of the products)
Sponsor (Manufacturer)
Adirel Consolidated Pty Ltd T/A Surgiplas Medical
(Nagor)
ARTG Number:142863
Product Name: Nagor Mammary Implants Gel-filled-TEXTURED
ARTG Number:277757
Product Name: 9-cell CoGel gel-filled Nagor mammary implant range – textured
ARTG Number:277758
Product Name: Impleo gel-filled Nagor mammary implant range – textured
ARTG Number:277758
Product Name: Impleo gel-filled Nagor mammary implant range – textured
Sponsor (Manufacturer)
Emagin Pty Ltd (Groupe Sebbin SAS)
ARTG Number:309613
Product Name: Anatomical Breast Implants – Textured – High Cohesive Gel
Sponsor (Manufacturer)
Emergo Asia Pacific Pty Ltd T/a Emergo Australia (AirXpanders)
ARTG Number:216704
Product Name: Aeroform Patient Controlled Tissue Expander
Sponsor (Manufacturer)
Euro Implants Pty Ltd (Eurosilicone SAS)
ARTG Number:132040
Product Name: Cristaline I Aptex/Vertex Paragel Natural Cohesive Gel Implant
ARTG Number:132037
Product Name: Cristaline Paragel Cohesive Gel Implant
Sponsor (Manufacturer)
JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH)
ARTG Number:171782
Product Name: Sublime Line, Microthane, Silicone gel filled Mammary Implants
ARTG Number:185060
Product Name: 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants
Sponsor (Manufacturer)
Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV)
ARTG Number:110588
Product Name: Siltex Round Cohesive I
ARTG Number:110589
Product Name: Siltex Round Cohesive II
ARTG Number:110592
Product Name: Siltex Round Becker Cohesive I
ARTG Number:119809
Product Name: Siltex Contour Becker Cohesive II
ARTG Number:130678
Product Name:Siltex Contour Gel Breast Implants Cohesive III
ARTG Number:226977
Product Name:Mentor® CPX™4 Breast Tissue Expander
ARTG Number:226982
Product Name:Mentor® CPX™4 with Suture Tabs Breast Tissue Expander
If the entries of the above products are suspended, the products would no longer be able to be imported, manufactured or exported from Australia by the sponsor for the duration of the suspension. A suspension can be revoked if concerns about the products are addressed to the TGA’s satisfaction. Alternatively, where concerns persist the duration of the suspension may be extended or the entries of the products may be cancelled. If any of the products are suspended, it is proposed to recall all remaining product to remove it from the market. The recall would only apply to product that is waiting to be implanted surgically.
There is not a recommendation to surgeons to remove implants in the absence of a BIA-ALCL diagnosis.
Reminder: next steps
The TGA is required by law to provide the sponsors of affected implants with an opportunity to make submissions in response to proposed regulatory action. The TGA will then take into consideration each sponsor’s submission when deciding what, if any, regulatory action should be taken in relation to particular sponsor’s device(s).
Sponsors were notified of the TGA’s preliminary view on 9 July 2019 and have been given until 24 July to respond. The TGA will then evaluate the submissions as a priority, and more information on regulatory actions will follow.
At this time relevant products will continue to be included on the ARTG (i.e. approved by TGA) and available for use in Australia.
BIA-ALCL is more likely to occur in rougher surfaced implants, and the TGA is proposing to either cancel or suspend particular products. There are alternative smooth implants available and these have not been associated with known cases of ALCL in Australia.
Because the risk to women who already have these implants is very low, experts do not recommend that women who already have them need to have them removed unless there is a confirmed diagnosis of ALCL. The proposed action by the TGA does not change this advice. If you have concerns you should speak to your surgeon.
Consumers with concerns about their breast implants can access information about BIA-ALCL, its symptoms and treatments through the TGA’s breast implant hub.