Silimed - Update from MHRA

8th January 2016

 

The Medicines and Healthcare Products Regulatory Agency have published an update on the suspension of devices made by Silimed:

"We are contacting you to reiterate our previous advice about the harmonized European Competent Authorities’ position on the distribution of Silimed products. EU health experts are evaluating test results to establish if there are potential health risks associated with particles on the surface of these implants.

We are aware that Silimed have issued communications to suggest that there is no risk to patients however this is yet to be determined through our evaluation of testing. We will communicate the conclusions shortly. In the meantime our previous advice that devices should be quarantined continues to apply.

The CE suspension by Tüv Süd has been prolonged until the end of June 2016 due to the exceptional circumstances and occurrences in particular the fire in the main manufacturing site."

To view updates on Silimed, visit the MHRA website

 

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