The Therapeutic Goods Association (TGA) has imposed a 6 month suspension on Cereform silicone gel-filled breast implants and associated sizers from the Australian Register of Therapeutic Goods.
Since 2009, about 4800 of the implants were sold in Australia. The action taken by the TGA will now prevent the devices from being supplied to the Australian market.
Earlier this year the French government recalled the Cereform silicone gel-filled breast implants and associated sizers as a result of the manufacturer’s failure to comply with international sterilisation standards. However, French authorities have stated that the issue is one regarding regulatory non-compliance and have emphasised that no specific risks have been associated with the devices.
Initially the TGA contacted surgeons and ensured that any planned procedures involving implanting the devices were cancelled. However, in March this year the Australian distributor, Medical Vision Australia Plastic & Cosmetic, took further action and launched its own recall of the implants and associated sizers.
Although the TGA has now supported this recall by suspending the devices from the Australian Register of Therapeutic Goods, the TGA maintains that it is not aware of any specific risks to Australian consumers. The TGA has clarified that while there has been an identified issue of regulatory non-compliance with international sterilisation standards, this does not mean that the implants or associated sizers were unsterile at the time of manufacture or supply.
The recall and suspension of the Cereform breast implants and associated sizers has given rise to renewed calls for the establishment of an Australian national breast device registry. Supporters emphasise the need for a registry in order to ensure any issues with breast devices are detected as soon as possible. Although the Federal government had committed $3.6 million to the initiative, the registry has not yet advanced beyond a pilot project, and further action is required to enable its development.
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Written by Shine Lawyers. Last modified: September 20, 2017.