TGA Implant List and information on the sale of textured implants in Australia

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.

On this page: What is BIA-ALCL and what should you do if you have concerns? | TGA’s proposed regulatory action – textured implants only | Reminder: next steps | Previous updates | Information for consumers | Information for health professionals| Reporting problems

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.

Although fatalities have been recorded, the vast majority of BIA- ALCL are cured by removal of the implant and the capsule surrounding the implant.

If you notice any of these problems (swelling or a lump), or you have any other concerns with your implants, you should seek medical attention.

Because BIA- ALCL is rare, experts do not recommend removal of breast implants where there are no problems with the implant.

Information for consumers about BIA-ALCL, its symptoms and treatments is available on the TGA’s breast implant hub.

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.

More information will follow after the TGA has had an opportunity to finalise its deliberations.

The TGA is providing breast implant recipients, the wider public and medical practitioners, this information identifying the breast implants, mammary implants or tissue expanders affected by the identified proposed regulatory action in the interests of public health and safety. This publication also communicates the preliminary outcomes from the extensive body of laboratory testing and statistical analysis carried out by TGA over the last 2 months.

If you have concerns, please speak with your medical practitioner. The proposed regulatory actions for particular products and the affected brand(s) of implants are as follows:

Proposed Cancellation

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)

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.

Imposition of conditions – patient information leaflet

To support informed patient choices, the TGA has imposed a condition on the ARTG entries of the products in the table below that the sponsors are to make available to patients a patient information leaflet that includes information about the therapeutic good including warnings and risks associated with the product.

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.