Last Thursday, 11 July 2019, the Therapeutic Goods Administration (TGA) announced that it has completed its review and assessment of textured breast implants in Australia and will move towards taking the appropriate measures to ensure patient safety based on those findings. The exact action that will be taken is yet to be advised, but it is expected that the next steps will be the cancellation or suspension of certain types of textured implants by specific manufacturers. The TGA has also stipulated new conditions on several other textured implants.
The Australasian Society of Aesthetic Plastic Surgeons (ASAPS) have said they support any move by the TGA that promotes patient safety.
For anyone who may have missed it, there has been a huge increase in media coverage of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) in recent years, with many patients alarmed of the link between this rare form of cancer and implants. Dr Rohit Kumar, Specialist Plastic Surgeon regularly featured as a health expert in Channel 7, Foxtel and Netflix programs, as well as in Vogue, Harper’s Bazaar, Woman’s Day and Who magazine says it’s important to remember, “BIA-ALCL is a rare condition, with expert opinions estimating the published risk at between 1-in-1,000 and 1-in-10,000. As such, experts do not recommend removal of breast implants where there are no problems. It’s also important to note that BIA-ALCL is different and unrelated to breast cancer.”
It’s also important to remember that Australia has one of the most comprehensive breast implant tracking systems in the world monitoring their long-term safety. The Breast Device Registry (ABDR) is a Commonwealth government funded initiative with more than 90percent of eligible surgeons contributing to the registry providing invaluable data for the TGA.
The TGA has contacted each of the implant manufacturers of the proposed regulatory action and will now wait for them to respond to the notification before reaching any final decisions. You can find a full list of the implants under review here.
Dr Kumar says the TGA findings are still only proposed regulatory actions. “They are just that, proposed. No decision has been made to suspend or cancel the relevant products at this time. However, if you notice any swelling or lumps, or you have any other concerns with your implants, please call Sydney Cosmetic Sanctuary rooms for a Free Breast Implant Check.”
We will know more after the TGA finalises it’s findings so we will continue to monitor the situation and report on any information as soon as it comes to light.