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TGA update on breast implants

Latest research 20 Dec 2016

TGA update on breast implants

UPDATE 14 September 2017: The TGA has provided a further update and advised that there are now 56 known cases of breast implant-related anaplastic large cell lymphoma to date. For more information, please see the Australian Government's TGA website


Australia’s Therapeutic Goods Administration* (TGA) has updated its information about the link between the use of breast implants and a rare form of non-Hodgkin lymphoma called anaplastic large cell lymphoma (ALCL). The announcement follows ongoing monitoring by the TGA over a number of years.

While the TGA announcement does confirm a link between breast implants and ALCL, it is important to understand that the risk is very small. In Australia, 46 women have been diagnosed with this rare form of lymphoma in the last 10 years. Hundreds of thousands of breast implants have been used in women in this time. Some of those 46 cases have been women who had implant reconstruction after surgery for breast cancer, and some are women who have had breast implants for cosmetic reasons.

Cases have been reported in women with saline and silicon implants. All cases were in women who had implants with a textured surface, which is the most common type used in Australia. There are no cases reported in women with smooth-surface implants.

The TGA does not recommend the routine removal of breast implants because ALCL is a very rare event. Women who have a breast implant and are concerned should talk to their surgeon or breast care nurse, or contact the breast clinic where they had their treatment.

The TGA is also recommending women report any sudden changes around their implant to their doctor. Changes may include new swelling around the implant (not associated with the post-surgery recovery period) or a lump.

Regulatory authorities around the world, including the TGA, are continuing to monitor the association between breast implants and ALCL.

The Therapeutic Goods Administration is the Australian regulatory body responsible for assessing and approving new medicines and medical devices for use in Australia.

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