Breast implants and anaplastic large cell lymphoma

Breast implants

The TGA has released the latest results from a review into breast implants and tissue expander.

Following the extensive laboratory testing, evidence submitted by the sponsors and manufacturers of breast implants and tissue expanders, advice from the Breast Implant Expert Working Group, and submissions and information from other stakeholders and patients; the TGA have decided to take regulatory action in relation to all breast implants and tissue expanders sold in Australia.

The regulatory action has taken place at three levels: suspension and recall, conditions on supply, and removed from the market.

Suspension and recall
Eight breast implant devices, from four manufacturers have been suspended. These implants are all “macrotextured” – grade 3 and 4 and some “microtextured” implants associated with higher incidences of Breast Implant Associated Anaplastic Large Cell Lymphoma (or BIA-ALCL) and other clinical concerns.

The suspension will mean that effective from the 25 October 2019, these implants will not be available on the Australian market for six months. During this period, the sponsor will have the opportunity to provide additional information to the TGA about their implants’ safety and performance.

In the meantime, all un-implanted products will be subject to recall to remove them from the market (i.e. on hospital shelves or doctors’ clinics).

The next stages will be for the TGA to work with sponsors of the suspended implant devices to address the safety and performance concerns. Given the information provided the TGA will decide what, if any, further regulatory action should be considered.

Conditions on the supply of breast implant devices
For all products no affected by the suspension and recall, the TGA have imposed additional conditions of inclusion.

The conditions include:

  1. All cases of BIA-ALCL are required to be reported to the TGA within 10 working days of becoming aware of the adverse event.
  2. All devices will be subject to six-monthly reporting on 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. The Instructions for Use of all breast implant and tissue expander devices must include the risk of BIA-ALCL.
  4. Patient information leaflet must be made available to patients who are considering or have breast implant and tissue expander device ahead of the original TGA timelines for implantation of existing implantable devices. The patient information leaflet will need to include 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.

Removed from market
During the course of the review, some sponsors elected to remove their implant products from the market. The Allergan Biocell macro-textured breast implants and tissue expanders and the Emergo Airxpanders Aeroform tissue expanders are no longer available on the Australian market.

For further details on breast implants, the TGA have a Breast Implant Hub that can be accessed here.

If you have any questions about any of the condition on the supply of breast implants be sure to reach out to Brandwood CKC for a no-obligation discussion.

We offer deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)

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