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Australian regulatory action on breast implants and breast tissue expanders

26 September 2019

The Therapeutic Goods Administration (TGA) has today released the findings of its review into breast implants and breast tissue expanders following reports of around 100 cases of Breast Implant Associated Anaplastic Large Cell Lymphoma in Australia, including four deaths. The TGA undertakes its role in balancing patient safety with the availability of medical devices for patients very seriously.

The TGA has decided to take regulatory action on all breast implant and breast tissue expanders currently included in the Australian Register of Therapeutic Goods (ARTG).

Eight models of breast implants are to be suspended from supply in Australia for six months, while a number of safety and performance concerns are addressed. This means that these devices will not be able to be imported, exported, or supplied within Australia while the TGA works with industry sponsors to ensure the devices meet all the necessary requirements for patient safety. Any stock of these un-implanted devices in the market will also be recalled during the suspension period. No models of breast tissue expanders have been suspended.

In addition to the suspensions, two industry sponsors have cancelled the supply of their highly textured implants and tissue expanders since the Review was initiated.

All other breast implant and tissue expander devices, that have not been suspended, will require strict conditions of supply to be met:

  • all cases of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) must be reported to TGA within 10 working days of the sponsor being aware of the case
  • six monthly reports of Australian and world-wide supply data, complaints and adverse events are to be provided to the TGA
  • clear, written information about the risk of BIA-ALCL must be provided with all devices, to both clinicians and patients

The suspensions and cancellations affect thirteen per cent of the supply of breast implant devices on the Australian market by volume (based on 2018 data).

If the safety and performance concerns around the suspended implants are not resolved, or the conditions of supply for the other products are not complied with, the devices may be cancelled from inclusion in the ARTG and thus not be able to be supplied in the Australian market.

This review was prompted by an increasing number of cases of BIA-ALCL detected in women with a history of breast implants and tissue expanders. As part of the review, laboratory testing has been undertaken in combination with a full statistical review of all BIA-ALCL cases reported until the end of May 2019. As well, information from industry sponsors and manufacturers, advice from our Breast Implant Expert Working Group and submissions and information from stakeholders and patients were taken into account.

As BIA-ALCL is very rare, the consensus clinical advice is that the removal of breast implants is not required in a person who has no symptoms or concerns. Patients who have breast implants, or have previously had breast implants should regularly check their breasts and see their doctor if they notice any changes or have any concerns.

Detailed information on the decision is available at Breast implants and anaplastic large cell lymphoma and Breast implant hub.