Cosmetic facial filler suspended in the EU

An injectable cosmetic filler that smooths out facial wrinkles has been suspended from use after it was found to cause painful redness, bruising and swelling in some patients.  

Novabel is marketed as “the gentle, powerful, versatile dermal shaper” by its manufacturer, Merz.

Since its introduction in January the algae-based product has been used by cosmetic surgeons to fill out lines, reduce hollowness below the eyes and plump out cheeks.

According to Merz, 17 clinics use the substance and about 1,700 people across Britain have been treated with it.

But on Thursday the Medicines and Healthcare Products Regulatory Authority (MHRA) issued an alert that it should be withdrawn immediately from use.

It stated that Merz had “received reports of adverse reactions to the filler including redness, bruising, pain, swelling and histologically confirmed granuloma”. The last is an immune system response that results in small raised nodules under the skin.

Stuart Rose, managing director of Merz Pharma UK, said of 12,000 people treated with it across seven European countries, they had received 70 reports of problems. Of these, 40 were “transient” and faded quickly while the other 30 resulted in “a degree of lumpiness”, he said.

He stressed only three had “confirmed granuloma” and said Merz had decided to suspend it while it sorted out the problem.

“If we get one case like this, one is too many,” he said.

He said Merz hoped to resume marketing of it after it had devised a solution.  

Source:  By Stephen Adams, 12 Aug 2010 for http://www.telegraph.co.uk/health/healthnews/7941157/Cosmetic-facial-filler-suspended.html