Australia’s TGA said last week that it concluded breast implants do not need to be removed as breast implant-associated anapestic large cell lymphoma (BIA-ALCL) is rare.
The regulatory body said in April that is was considering implementing a ban on textured breast implants and was seeking new data from suppliers of the implants to decide on whether or not to suspend or cancel those products from its Register of Therapeutic Goods.
Australia TGA’s ban proposal came after the convening of a breast implant expert on April 8, following decisions made in Canada and France to remove implants from the market because they were linked to BIA-ALCL.
New data found that the occurrence of BIA-ALCL is rare and experts do not recommend removing breast implants if there are no issues with the implant. Experts estimate that the risk of BIA-ALCL is between 1-in-1,000 and 1-in-10,000. The Australia TGA said the majority of BIA-ALCL is cured by removing the implant and capsule surrounding the implant.
Sponsors were notified of the preliminary decision on July 9 and were given until July 24 to respond. Relevant products will continue to be listed on the TGA approval list and will be available for use in Australia, according to the TGA.
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