The Silimed implants ARTG suspension ended on 4th November 2016. The suspension was to allow completion of the necessary re-certification activities ongoing in Europe within a maximum 12 month period. Throughout the suspension, we have worked closely with the TGA and SILIMED in preparation to resume supply.
Unfortunately the European CE certification has not yet been re-instated and therefore the ARTG inclusions were automatically cancelled on 5th November 2016. This means that the Silimed Silicone implants are no longer available for supply in Australia under the previous ARTG inclusions.
It is important to reiterate that there are no safety concerns for already implanted devices.
Media Contacts: Brent van den Berg and Kevin Ryan 02 9975 5755