Final update: 22 November 2018
Updated 23 November 2018
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This publication is available at https://www.gov.uk/government/publications/devices-made-by-silimed/final-update-22-november-2018
The CE certificate for devices made by Silimed was suspended, and they have not been sold in the EU since 2015.
Since this time, we have worked closely with other European regulatory agencies, the European Independent Clinical Expert Advisory Group and Silimed on the safety of these devices.
The Dutch Health Care Inspectorate (IGZ) with other European health care authorities including MHRA commissioned independent testing, conducted by the Dutch National Institute for Public Health and the Environment (RIVM). The report into the safety of Silimed breast implants has been published by RIVM and indicates the risk to patients is low.
All evidence was carefully considered by an EU independent expert panel who concluded people who have Silimed breast implants did not need to have them explanted, because of the very low risk of problems, nor did they need any additional clinical follow-up.
MHRA Director of Devices John Wilkinson said:
Protecting public health is our highest priority and we take our duty of care very seriously.
We are committed to making sure we are using the best sources of information to understand areas where concerns have been raised regarding medical devices and to ensure our regulatory response is pragmatic and proportionate.
If any people with these implants have any questions, they should speak to their implanting surgeon or clinic.