17th October 2019 TGA Update

TGA review of breast implants

What action has the TGA taken?

The TGA has decided to take regulatory action in relation to all un-implanted breast implants and tissue expanders sold in Australia.

The TGA has reviewed a range of inputs to inform decisions about the quality and performance of breast implant and tissue expander devices, and their compliance with the Essential Principles for Medical Devices that require that the benefits of devices outweigh risks. Evidence considered includes:

• results of extensive laboratory testing on surface texture and analysis of manufacturing processes
• statistical review of BIA-ALCL cases in Australia
• advice from the Breast Implant Expert Working Group
• submissions and information from other stakeholders and patients
• evidence submitted by the sponsors and manufacturers of breast implants and tissue expanders including:
  • clinical evidence reports
  • biocapatibility testing
  • risk management frameworks
  • vigilance data
  • quality management systems for manufacturing processes

Consumers should speak with their medical practitioner if they have any concerns about their breast implants.

Further information can be found in our consumer information or on the breast implant hub.

Affected brands of breast implant devices and the regulatory actions to be imposed are as follows.

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. 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. This means no new patients will receive these implants.

Suspension of un-implanted devices

Some breast implant devices have been suspended. This means that these implants will not be able to be implanted into new patients over the next six months. During this period, the sponsor will have the opportunity to provide additional information to the TGA about the safety and performance of their products.

Suspended implants are those that are “macrotextured” – grade 3 and 4 and some “microtextured” implants associated with higher incidences of BIA-ALCL and other clinical concerns.

To recap:

• The above breast implant devices have been suspended.
• The devices will not be able to be supplied, imported, or exported from Australia for the duration of the suspension (6 months), effective 25 October 2019.
• A suspension can be withdrawn early if the sponsor can address concerns to the TGA’s satisfaction.
• If concerns persist, the suspension may be extended or the entries of the devices may be cancelled.
• All un-implanted products will be subject to recall to remove them from the market (i.e. on hospital shelves).
• If a decision is made to recall the above breast implants, this will only apply to un-implanted stock, not devices that have already been implanted.

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.

** Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders

Next steps

If you have any of the above breast implants, you do not need to do anything except be aware of the symptoms of BIA-ALCL and seek advice from a health professional if you notice any changes.

The sponsors of suspended implants have an opportunity to make submissions at any time during the period of suspension to demonstrate that the safety and performance concerns raised by the TGA have been addressed.

The TGA will take into consideration each sponsor’s submission when deciding what, if any, further regulatory action should be taken in relation to particular sponsor’s device(s).

Background

The evidence available at present indicates that while causes are likely to be multi-factoral BIA-ALCL is more likely to occur in implants with a greater surface area and roughness of their wall. The degree of texturing in the surface is a result of the materials used in the production of the device or the manufacturing processes.

The TGA is taking a precautionary approach and suspending particular breast implant devices which have a higher degree of texturing, or a higher risk of BIA-ALCL, or deficiencies in evidence to demonstrate the manufacturer has adequate risk detection and mitigation measures in place.

Over the past few years there has been a change in the type of breast implants used in Australia with a decrease in macro-textured implants and an increase in supply of micro-textured and smooth implants. The suspensions imposed by the TGA do not impact on the supply of the smooth implants available and to date there are no known cases of BIA-ALCL in Australia where only smooth devices were implanted.

References

1. Knight R et al. Epidemiology and risk factors for Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in Australia & New Zealand. Plastic & Reconstructive Surgery Global Open 2016;4(9S):82-83.
2. Swerdlow SH, Campo E, Pileri SA et al. The 2016 revision of the World Health Organisation classification of lymphoid neoplasms. Blood 2016; 127(2):2375-2390
3. Rothman KJ, Greenland S. Causation and causal inference in epidemiology. Am J Public Health. 2005;95(Suppl 1):S144-S151.
4. Deva AK, Adams WP, Jr., Vickery K. The role of bacterial biofilms in device-associated infection. Plast Reconstr Surg 2013;132(5):1319-1328.
5. American Society of Plastic Surgeons FAQ. https://www.thepsf.org/.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.