Notice

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 has been temporarily suspended 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.

Products covered by the suspension

The following products by Silimed continue to be 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

What to do if you have questions

If you have questions about your implants you should seek advice from your implanting surgeon or clinic.

We will be updating this page with the latest information, register for updates.

If you have had an issue with any healthcare product you should report it via the Yellow Card Scheme so we can investigate further.

Published 15 October 2015
Last updated 17 October 2016 + show all updates
  1. Latest MHRA statement on Silimed (17/10/2016).
  2. MHRA update: Silimed
  3. First published.