The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a medical device safety alert concerning injectable dermal fillers HYAcorp L (Ref BS067), HYAcorp H 1000 (Ref BS068) and HYAcorp H-S 500 (Ref BS078) manufactured by BioScience GmbH.
BioScience has decided to recall HYAcorp H 1000 and HYAcorp H-S 500 from European market after identifying a trend related to off-label use of the products. HYAcorp H 1000 and HYAcorp H-S 500 have been used for volume enhancement in the face which is against the intended use defined by the manufacturer.
The manufacturer explains that off-label use of the products has led to serious complications such as long lasting swelling, redness, formulation of thyroid nodules and inflammation.
In order to prevent mix-up with HYAcorp H 1000 and HYAcorp H-S 500, HyAcorp L, which is intended and approved for facial areas will be withdrawn as well.
For details, please visit the following MHRA website:
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 October 2013