Early granulomatous foreign body reactions to a novel alginate dermal filler: the system’s failure?

Abstract

The status of dermal fillers as class III medical devices, and the process of their approval and marketing in the EU need to be seriously reconsidered to avoid unnecessary and serious adverse reactions.

Late-Onset Adverse Reactions Related to Hyaluronic Acid Dermal Filler for Aesthetic Soft Tissue Augmentation

“…16,20,21 Despite that, slight variations might occur depending on quantity, anatomy, and individual characteristics. Hyaluronic acid has no organ or species specificity; thus, it theoretically does not present any risk for allergic reaction.…”

“…In terms of histopathology, these lesions are composed of a granulomatous foreign body reaction, with a variety of multinucleated giant cells surrounding an extracellular basophilic amorphous material (HA). 16,17,20 If HA is able to perpetuate chronic inflammatory reaction as well as the development of inflammatory nodules and abscesses, it will initially also be able to be treated with empiric antibiotic therapy. In cases wherein there is fluctuation, bacteriological cultures can be indicated for correct antibiotic treatment, and if there is no satisfactory response, biopsy specimens will be obtained for histopathologic examination.…”

Foreign Body Granulomas

“…44,45 Purified polysaccharide alginate Five cases of granulomatous reactions to a new resorbable filler consisting of the purified polysaccharide alginate (Novabel) have been described when injected into tear troughs and/or the dorsa of hands. 46,47 No systemic complications have been described as secondary to the injections of this filler. Histopathologically, the granulomatous reaction was confined to the deep dermis and subcutaneous fat, which were involved by numerous multinucleated giant cells and histiocytes.…”

Cutaneous Deposits

“…329,330 Histopatologically, the granulomatous reaction was confined to the deep dermis and subcutaneous fat, which were involved by numerous multinucleated giant cells and histiocytes. Within this granulomatous reaction, a nonpolarizing exogenous material was identified consisting of slightly bluish deposits of variable size and shape, some of which were well delineated, others with a blurred or spiky perimeter, and frequently showing retraction in a clear vacuole.…”