Suspension of Silimed medical devices
24 Sep 2015
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced it is suspending the CE certificate of all medical devices made by the Brazilian manufacturer Silimed. Further detail is available here.
At this stage the MHRA and other regulatory agencies are investigating the devices produced by this manufacturer. They have recommended none of these devices should be implanted until further advice is issued and we are helping the MHRA to communicate this to surgeons. At the present time there is no indication that these issues would pose a threat to the safety of someone implanted with one of these devices.
Further queries should be directed to the MHRA.