Silimed Update - 15/10/2015

MHRA update: Silimed
15 October 2015
MHRA is working with other European regulators and national experts on the testing and risk assessment of the products.
Based on the current available information we have no evidence that this issue poses a threat to patient safety. We will provide an update when we have investigated and have a fuller understanding. To ensure thoroughness, testing is being conducted as a 5-stage process which takes time.
These 5 stages include:

• collection of the required spread of samples
  
• determining the testing methodology
  
• undertaking the testing
  
• analysing the results
  
• evaluating any clinical implications
  

Today we issued a second MDA on implants made by Silimed. These implants are testicular implants and vaginal stents which are made for Coloplast by Silimed and are sold under the Coloplast brand name.
We will continue to provide updates via this channel as soon as new information becomes available. We have also published a page on GOV.UK that includes all updates from MHRA on Silimed
You can report a problem with a medicine or medical device to us so we can investigate further.

Thanks Charlii xx