Latest update: 8 January 2016
Updated 23 November 2018
© Crown copyright 2018
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/devices-made-by-silimed/latest-update-8-january-2016
MHRA has issued the following statement today to UK distributors of Silimed implants reiterating the existing advice that implants should continue to be quarantined:
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.