HYAcorp L, HYAcorp H 1000 and HYAcorp H-S 500 의 안전성 경고

Safety alert

2013-10-16

2013-10-16

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016.html

Medical device safety alert: bioscience hyacorp l, hyacorp h 1000 and hyacorp h-s 500 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mix-up with hyacorp h 1000 and hyacorp h-s 500, hyacorp l, which is intended and approved for facial areas will be withdrawn as well.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: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con321967 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 october 2013.