Caution on Novabel Dermal Filler
Hong Kong (HKSAR) - 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.
Source: HKSAR Government
Published on: 2010-07-30
Limited copyright is granted for you to use and/or republish any story on this site for
any legitimate media purpose as long as you reference 7thSpace and any source mentioned in the story above. Please
make sure to read our disclaimer prior to contacting 7thSpace Interactive. To contact our editors, visit our online helpdesk. If you wish submit your own press release, click here.
Social Bookmarking
RETWEET This! | Digg this! | Post to del.icio.us | Post to Furl | Add to Netscape | Add to Yahoo! | Rojo
|
|
