Update: Breast implants and anaplastic large cell lymphoma

Update – Outcomes from the TGA’s (Therapeutic Goods Administration / Australian Government) review of breast implants and breast tissue expanders

The TGA has decided to take regulatory action in relation to all un-implanted breast implants and tissue expanders sold in Australia. However, even if your breast implants are being cancelled, suspended or recalled, medical experts do not recommend removing them if you do not have symptoms of BIA-ALCL. This is because BIA-ALCL is very rare, and the risk of undergoing surgery could be higher than the risk of developing BIA-ALCL.

If you have a breast implant and detect any change in the breast or armpit such as swelling, a lump or pain, you should consult your doctor.

The breast implant hub has information to support people with any concerns about their implants, or those considering implants.

Un-implanted stock removed from market

In some cases, the sponsor has chosen to cancel the inclusion of their implant devices in the Australian Register of Therapeutic Goods (ARTG) during the course of this review.

Suspension of un-implanted devices

Some breast implant devices have been suspended.

New conditions for breast implant devices

To ensure the highest level of patient safety possible, the TGA has imposed ‘conditions’ on all breast implant devices that remain available in Australia. This means that for a sponsor to supply a breast implant device in Australia, they must meet a range of new requirements. If a sponsor fails to comply with any condition of inclusion, the device may be removed from the ARTG.

What are the conditions?

  1. Reporting of BIA-ALCL: To support the on-going monitoring of BIA-ALCL, all cases of BIA-ALCL must be reported to the TGA by the sponsors within 10 working days of becoming aware of the adverse event.
  2. Six monthly reporting: To support greater vigilance and increased awareness and data collection on this issue, the TGA is requiring reports to be provided every six months from the sponsors. The reports must include supply data and detail all adverse events and complaints received regarding breast implant and tissue expander devices, both in Australia and worldwide, including BIA-ALCL, capsular contracture, or rupture of the implant.
  3. Instructions for use: To promote clinicians’ awareness, the risk of BIA-ALCL must be included in the Instructions for Use of all breast implant and tissue expander devices.
  4. Patient information leaflet: To support informed patient choices, all breast implant and tissue expander devices must have access to a patient information leaflet that includes information about warnings and risks associated with the product. Information relating to the Australian Breast Device Registry must also be included, to support on-going reporting and monitoring.
Author(s)Source
Australian Government, Therapeutic Goods Administrationwebsite Therapeutic Goods Administration, 28 Nov 2019
This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register.
Comments: n/a
let us know
Scroll to Top