Device Technologies, the Australian and New Zealand distributor of Silimed silicone implants, including breast implants, has voluntarily suspended the distribution of these products and has accordingly advised surgeons not to use these products until further notice.
Following a routine inspection by European authorities of the Silimed manufacturing facility in Brazil, the criteria for defining acceptable particle levels that may be found on the external surface of the implants was questioned. Particles have been identified as being a combination of silica and cotton fibres. The presence of particles does not mean that the product is contaminated, however until such time that the European authorities are satisfied with the criteria, the CE certificate for all Silimed products has been temporarily suspended.
A CE certificate confirms that a product meets regulatory requirements for distribution in Europe and is a necessity for Silimed’s Therapeutic Goods Administration (TGA) compliance. As such, the TGA has temporarily suspended Silimed’s Australian Register of Therapeutic Goods (ARTG) entries. This is a formalisation of the existing arrangements and means that supply of Silimed devices in Australia has been officially suspended.
Device Technologies prioritises patient safety and continues to work closely with the TGA and Medsafe, the New Zealand Ministry of Health, and will keep them fully informed of ongoing developments and communications from the manufacturer.
We emphasise that there is no evidence or indication of safety concerns for patients who have previously received Silimed implants. At this stage, we have no reason to believe there is a need for surgeons to contact patients that have been implanted with Silimed devices.
If patients have any concerns about their implants, they should contact their surgeon, as required, for further information. Health Professionals requiring additional information on Silimed products are encouraged to contact Device Technologies directly.
Silimed products have been available in Australia since 2007 and have been distributed by Device Technologies since 2010. Silimed products have been available in New Zealand since 2010 through Device Technologies. Silimed is a Brazilian company manufacturing silicone implants for 37 years. To date, the company has no record of instances of this nature.
Media Contact: Jay Pleass (+61 412 623 578) or John Morton (+61 416 184 044)