Latest update: 15 October 2015
Updated 23 November 2018
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This publication is available at https://www.gov.uk/government/publications/devices-made-by-silimed/latest-update-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.