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Traditional ChineseSimplified ChineseText onlyPDARSS
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July 31, 2010
Safety
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Alert issued on implantable material
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Department of Health

The Department of Health has reminded the public to pay attention to reports of adverse reactions as a result of using Novabel Dermal Filler, an implantable material for reconstruction and body contouring.

 

The UK's Medicines & Healthcare Products Regulatory Agency announced that a manufacturer in Germany has advised 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, 70 adverse-reaction cases were reported from about 24,000 syringes sold. The reactions included redness, bruising, pain and swelling. Some patients had visible and palpable nodules and tissue hardening. Many of these have disappeared since being reported.

 

The department is obtaining more information from the agency and has informed the Hospital Authority, private hospitals, and relevant medical professional associations of the alert.

 

People who have these reactions after using the product should consult their healthcare providers.

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