The Australian Therapeutic Good Administration (TGA) has released a public statement of the preliminary outcomes from its review of textured implants on July 11, 2019. The notice proposes certain actions the TGA may take in relation to textured implants used in Australia. GC Aesthetics is surprised about this public statement, given the overall very low occurrence rate of BIA-ALCL compared to other medical conditions. It is important to notice that no final decision has been taken at this stage. GCA, as well as other responsible manufacturers, are transparently communicating with TGA and stand by our robust data and clinically proven safety
GC Aesthetics’ implant safety has been proven through a number of large scale, long term prospective clinical studies in over 1000 patients, including the only two large scale prospective European study of breast implants with 10-year patient follow up. With over 3 million implants sold over the last 10 years across 70 countries GCA’s safety record is quite clear:
- The global rate of BIA-ALCL associated with GCA textured implants is <0.0007%
- The global rate of BIA-ALCL associated with GCA smooth implants is 0%
GCA is at the forefront of the industry with a prominent and permanent focus on patient safety. We will continue to closely monitor the incidence of BIA- ALCL and participate in collaborative global research. We also remain committed to transparency with our doctors and patients about this and any other safety concerns.
Carlos Reis Pinto CEO