Novabel Dermal Filler 의 안전성 경고

Safety alert

2010-07-31

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20100802.html

Caution on novabel dermal filler the department of health (dh) has drawn public attention to reports of adverse reactions as a result of using novabel dermal filler, an implantable material for reconstruction and body contouring. dh, through its routine surveillance, found that the uk's medicines and healthcare products regulatory agency (mhra) announced that a manufacturer in germany had issued a notice to advise clinicians not to use novabel because of the dissatisfactory aesthetic outcome. the agency is assessing the adverse reactions. the affected products included all batches of novabel, dermal filler (1x1ml, art.-nr. 40800) and novabel, dermal filler (2x1ml, art.-nr. 49021). according to the manufacturer, an overall number of 70 cases of adverse reactions were reported from about 24,000 syringes sold. the reactions included redness, bruising, pain and swelling. some patients had visible and palpable nodules and indurations. many of these have resolved since being reported. while dh is obtaining more information from mhra, as precautionary measures, dh has informed healthcare professionals of hospital authority, private hospitals, and relevant medical professional associations about the alert. the spokesman said members of the public who have these reactions after using the concerned product should consult their healthcare providers. dh will monitor future developments. ends/saturday, july 31, 2010.