Medical Device Alerts issued in December 2018

A notice was issued by Allergan about the availability of textured breast implants in the UK.

In this monthly update, we highlight selected Medical Device Alerts or Field Safety Notices that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.

In December, a Field Safety Notice was issued by Allergan to announce it was suspending sales of textured breast implants and tissue expanders and withdrawing any remaining supply in European markets.

The withdrawal decision follows a compulsory recall request from Agence Nationale de Sécurité du Médicament (ANSM), the French regulatory authority. The suspension of sales stems from the expiration of the company’s CE Mark for these products.

See the Urgent Field Safety Notice for more information.

Article citation: Drug Safety Update volume 12, issue 6: January 2019: 5.

Published 9 January 2019
Last updated 9 January 2019 + show all updates
  1. Re-published.
  2. First published.