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News & Trends - MedTech & Diagnostics

TGA announces implant decision

Health Industry Hub | October 2, 2019 |

Australia’s Therapeutic Goods Administration (TGA) announced that a range of micro-textured and smooth breast implants and breast expanders will continue to be available on the Australian market.

This follows a review of all textured implants and expanders due to a link with a rare form of lymphoma called Anaplastic Large Cell Carcinoma (ALCL). Evidence-based recommendations are that removal of breast implants is not required in a person who has no symptoms or concerns.

Over the past few years there has been a change in the type of breast implants used in Australia with a decrease in macro-textured implants and an increase in supply of micro-textured and smooth implants. The suspensions imposed by the TGA do not impact on the supply of the smooth implants available and to date there are no known cases of BIA-ALCL in Australia where only smooth devices were implanted.

All macro textured implants and expanders have however been suspended or withdrawn from the market. The TGA will continue to review the evidence around macro textured devices and make a further decision on these in six months.

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New conditions on supply

New conditions for inclusion in the ARTG have been imposed on all breast implant devices that remain available, including tissue expanders. Sponsors have increased requirements for providing information to practitioners and consumers and for reporting adverse events, including cases of BIA-ALCL.

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