The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning breast implants.
As part of the TGA's ongoing monitoring of the association between breast implants and anaplastic large cell lymphoma (ALCL), consumers and health professionals are advised that Australian experts in cosmetic and reconstructive breast surgery, cancer epidemiology, and lymphoma (i.e., the expert advisory panel) was convened to discuss the issue on 16 November 2016 and has been providing ongoing advice.
Breast implant-associated ALCL is a rare type of lymphoma that develops near breast implants.
According to the TGA, 46 cases of breast implant-associated ALCL have now been confirmed in Australia, including three that resulted in death. These cases have all occurred since 2007. Most cases of breast implant-associated ALCL are cured by removal of the implant and the capsule surrounding the implant, however a small number are more aggressive.
The TGA is also aware of a small number of unconfirmed cases, and these are being investigated. The TGA will work with research groups and Australian experts to obtain better estimates of the risk of breast implant-associated ALCL and to evaluate the benefit-risk balance of the various types of breast implants, respectively.
For details related to the advice given by the TGA, please refer to the following link:
https://www.tga.gov.au/alert/breast-implants
Posted on 23 December 2016