The Therapeutic Goods Administration (TGA) of Australia posted a medical device safety alert concerning all medical devices manufactured by Silimed.
The TGA is aware that European Union (EU) health regulators have suspended approval for all devices manufactured by the Brazilian company Silimed following an inspection of a manufacturing site.
Silimed's CE certificate was suspended after German health officials inspected Silimed's manufacturing plant and found that the surfaces of some devices were contaminated with unknown particles. In general, a medical device cannot be marketed in Europe without carrying a CE mark of conformity.
As a precautionary measure and in consultation with the TGA, the Australian distributor has been contacting surgeons who have been supplied with these implants to recommend any planned implant surgeries be postponed.
The TGA has had no adverse event reports relating to these products and there has been no indication that these issues would pose a threat to the implanted person's safety.
For details, please refer to the following link:
http://www.tga.gov.au/alert/silimed-medical-devices-all-including-breast-implants
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 25 September 2015