TGA Suspends Sale of Textured Breast Implants in Australia over concerns about BIA-ALCL
TGA moves to finalise the decision on the sale of textured implants in Australia
The TGA announced on Thursday 11th July 2019 that it had completed its review and laboratory assessment of textured breast implants on the Australian market.
As the pre-eminent body representing Specialist Plastic Surgeons who specialise in cosmetic surgery, the Australasian Society of Aesthetic Plastic Surgeons (ASAPS) supports any move by the Therapeutic Goods Administration (TGA) made in the name of patient safety.
The next steps are either a proposal to cancel or a proposal to suspend certain types of textured implants by specific manufacturers. The TGA has also imposed new conditions on the inclusion of several other textured implants in the Register. You can find the full list of implants in question on the TGA’s website.
The TGA has notified each of the sponsors of the relevant proposed regulatory action (or imposition of conditions, where conditions have been imposed). 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.
Understandably, many patients with breast implants have been alarmed by the increase of coverage in the news regarding Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) following the announcement that the TGA were reviewing the safety and ongoing availability of textured breast implants in Australia.
We would like to remind patients however, we are in a fortunate situation in Australia to have a Commonwealth government funded Breast Device Registry (ABDR) and this year, more than 90 per cent of eligible surgeons input into the registry, making it one of the most robust systems in the world tracking the long-term safety of breast implants in patients. The registry provides invaluable data for the regulator, the TGA, acting as an early warning system to help protect patients.
Approximately 1,000 new patients join the ABDR every month, with more than 34,000 patients currently enrolled in the registry. The registry produces anonymised public reports on complications and revision rates for all devices, such as breast implants, breast tissue expanders and acellular dermal matrices/mesh, and will be the primary point of contact for reporting Anaplastic Large Cell Lymphoma (ALCL), a rare and mostly treatable form of cancer of the immune system linked to breast implants.
The latest information on ALCL can be found in the TGA’s breast implant hub.
ASAPS supports the move by the TGA to put conditions on textured breast implants if they have been deemed to risk patient safety. As the national regulator, the TGA is empowered to make decisions in the interest of public safety based on sound scientific evidence.
Specialist Plastic Surgeons take this responsibility seriously and are dedicated to acting in the best possible interest of all patients by prioritising their safety.
Which Breast Implants are Being Investigated?
For a full list of which breast implants are in question visit the TGA’s website.
NOTE: BIA-ALCL is Not Breast Cancer
It is important to note that BIA-ALCL is not breast cancer. It is a rare type of lymphoma that develops adjacent to breast implants, usually as a swelling of the breast 3-14 years after insertion. This swelling is due to fluid building up in the fibrous capsule that surrounds the implant and does not develop in the breast tissue itself. It can also present as a swelling or lump in the breast or armpit.
The incidence of BIA-ALCL is very low – in the millions of breast implants used worldwide, the American FDA reported 660 cases with nine deaths as of September 30, 2018. In Australia and New Zealand, 92 patients have been diagnosed with the condition, which has caused five deaths.
Read More Information – BIA-ALCL and it’s Risks
 TGA figures as of 9 April 2019 that arose from research co-ordinated by Australian Plastic Surgeons however data collection and analysis is ongoing, and the numbers are reviewed continually