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BCNA News 12 Jul 2019

Australian authorities a step closer to banning some textured breast implants

Australia’s medical device regulator, the Therapeutic Goods Administration (TGA), is proposing to suspend, cancel and recall some textured breast implants from the Australian market. The move follows an extensive review conducted by the TGA after evidence from around the world, including Australia, showed apparent links between textured breast implants and a rare form of blood cancer, Anaplastic Large Cell Lymphoma (ALCL).

The TGA will make a final decision on whether to ban the implants after 24 July, giving breast implant manufacturers and distributors an opportunity to respond to the review findings.

The risk of breast implant associated lymphoma is rare (between 1 in 1,000 and 1 in 10,000) and is associated only with textured implants, not smooth implants.

Experts do not recommend the removal of breast implants where there are no problems with the implant. If you notice any sudden changes around your implant, however, such as new swelling or a lump, it is important to raise this with your doctor. If you are concerned about your implant/s, or are not sure if you have textured or smooth implants, you should contact your surgeon or the hospital where you had your reconstruction surgery.

BCNA will update this advice once the TGA announces its decision on the use of textured implants in Australia.

The Therapeutic Goods Administration is the independent Australian body responsible for regulating medicines and medical devices and ensuring they are safe for use.