Voluntary suspension of supply of Silimed implants

25 Sep 2015 11:04 AM AEST - Device Technologies confirms voluntary suspension of supply of Silimed implants

Device Technologies confirms voluntary suspension of supply of Silimed implants

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. 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.

Device Technologies prioritises patient safety and has informed the TGA and The Ministry of Health, Medsafe, in New Zealand and will keep them fully informed of developments and communications from the manufacturer as it becomes available.

We emphasise that there is no evidence or indication of safety concerns for patients who have previously received Silimed implants.

Patients 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 is a Brazilian company manufacturing silicone implants for 37 years. To date, the company has no record of instances of this nature.

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