Silimed medical devices suspended
The Therapeutic Goods Administration (TGA) is aware of the suspension in Europe of devices manufactured by Silimed that followed an audit of its manufacturing procedures. The TGA is urgently investigating to determine what action is required in Australia including testing of samples.
As a precautionary measure, Device Technologies (the Australian distributor) has stopped any further supply of the products in Australia, and surgeons are being informed and advised to postpone scheduled surgeries.
Patient safety is always our priority. At this time there is no indication that these issues pose a threat to patient safety.
ASPS advises patients who have concerns about their implants to seek advice from their implanting Surgeon.
TGA's Safety advisory states:
- Patients are advised to consult their implanting surgeon if they have any concerns
- TGA is working with professional groups to provide as much information to patients as possible
- The Brazilian manufacturer was inspected in March 2014 and found to comply with all requirements. The annual re-inspection identified the present issues
- TGA has had no adverse event reports for these products
Read more: ASPS Media Release (24 Sept 2015)
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