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A new class of biodegradable, injectable filler made of alginate, Novabel (Merz Aesthetics, Merz Pharma, UK), was launched in the European market in 2010. This product was supposed to be perfect to fill hollow eye rings and practitioners were immediately enthusiastic. Unfortunately, complications occurred as firm inflammatory nodules after a few months. Histological examinations revealed granulomatous reactions around spheroidal deposits. Treatment by triamcinolone injections was effective in some cases. Because of these complications, the company withdrew the alginate Novabel from the market. This is a didactic example of how a well-meant development with an insufficient test phase can turn into its opposite. Health authorities are exhorted to supervise not only drugs, but also injectables and other medical devices before they are launched, and during their application.
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| http://dx.doi.org/10.1055/s-0034-1396702 | DOI Listing |
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Alginate (novabel): a new class of injectable filler.
Facial Plast Surg
December 2014
Av Mathurin Moreau, Paris, France.
A new class of biodegradable, injectable filler made of alginate, Novabel (Merz Aesthetics, Merz Pharma, UK), was launched in the European market in 2010. This product was supposed to be perfect to fill hollow eye rings and practitioners were immediately enthusiastic. Unfortunately, complications occurred as firm inflammatory nodules after a few months.
View Article and Find Full Text PDFGranulomatous reaction after injection of a new resorbable filler Novabel.
Am J Dermatopathol
October 2011
Cabinet d'Histopathologie Cutanée, Mathurin Moreau, Paris, France.
A new resorbable filler, Novabel, became commercially available in January 2010 in France. A 52-year-old general practitioner injected 0.1 cm3 of a 1 cm3 alginate solution (Novabel) into the deep dermis of her left arm to test it before using it on her patients.
View Article and Find Full Text PDFEarly granulomatous foreign body reactions to a novel alginate dermal filler: the system's failure?
J Eur Acad Dermatol Venereol
January 2013
VENEX - Vein and Dermatology Centre, Vienna, Austria.
Background: Cutaneous granulomas after a soft filler injection represent one of the worst scenarios for both patient and injector.
Objectives: To present clinical and histopathological features of granulomatous nodular reactions induced by a new alginate-based dermal filler (Novabel(®)), and put it in context of the process of injectable soft tissue fillers approval and promotion in the EU.
Methods: A case series of four patients injected with Novabel(®) for volume restoration of the face and hands, who developed severe foreign body reactions.
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