Devices made by Silimed
Updates from MHRA on the suspension of devices made by Silimed
Documents
Details
Introduction
The CE certificate for all medical devices made by Silimed was suspended in 2015 by the notified body after particles were found on their surface.
We issued a medical device alert (MDA) on 25 September 2015 to ensure the clinical community are aware of the actions to take:
- do not implant/use affected devices
- quarantine devices
- await further advice from the distributor(s) and/or MHRA
- reassure patients
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.
Silimed products have not been sold in the EU since 2015.
Products covered by the suspension
The following products by Silimed covered by the suspension:
- silicone implants for plastic surgery: implants: breast implants, pectoral implants, gluteal implants, calf implants, implants for hand surgery, tissue expanders, facial implants, nostril retainers, suspension sheets for breast surgery
- bariatric surgery: gastric bands and balloons
- implants for urology: testicular implants, penile implants, vesical conformers, periuretheral constrictors, tubes for hypospadias, vaginal stents
- silicone implants for general surgery: blocks and sheets
- silicone invasive devices: sizers for silicone implants
The following implants are made for Coloplast by Silimed and are sold under the Coloplast brand name:
- testicular implants
- vaginal stents
Conclusion and advice to patients
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.
What to do if you have questions
If you have questions about your implants you should seek advice from your implanting surgeon or clinic.
If you have had an issue with any healthcare product you should report it via the Yellow Card Scheme so we can investigate further.
Updates to this page
Last updated 23 November 2018 + show all updates
-
Updated to add final conclusions and advice to patients.
-
Latest MHRA statement on Silimed (17/10/2016).
-
MHRA update: Silimed
-
First published.