{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T22:04:43Z","timestamp":1794002683895,"version":"4.8.0"},"reference-count":16,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2011,9,20]],"date-time":"2011-09-20T00:00:00Z","timestamp":1316476800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2013,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>Background\u2002<\/jats:bold> Cutaneous granulomas after a soft filler injection represent one of the worst scenarios for both patient and injector.<\/jats:p><jats:p><jats:bold>Objectives\u2002<\/jats:bold> To present clinical and histopathological features of granulomatous nodular reactions induced by a new alginate\u2010based dermal filler (Novabel<jats:sup>\u00ae<\/jats:sup>), and put it in context of the process of injectable soft tissue fillers approval and promotion in the EU.<\/jats:p><jats:p><jats:bold>Methods\u2002<\/jats:bold> A case series of four patients injected with Novabel<jats:sup>\u00ae<\/jats:sup> for volume restoration of the face and hands, who developed severe foreign body reactions.<\/jats:p><jats:p><jats:bold>Results\u2002<\/jats:bold> Four patients injected with Novabel<jats:sup>\u00ae<\/jats:sup> into tear troughs and\/or dorsa of hands developed severe granulomatous reactions within months after injections. As we injected with the new filler into a total of 10 patients, a high incidence of 40% of the disfiguring adverse effect was observed. The inadequate response of manufacturer to our reporting the side\u2010effects along with the available data on registration process of dermal fillers confirmed that the area is not well\u2010regulated.<\/jats:p><jats:p><jats:bold>Conclusions\u2002<\/jats:bold> 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.<\/jats:p>","DOI":"10.1111\/j.1468-3083.2011.04264.x","type":"journal-article","created":{"date-parts":[[2011,9,20]],"date-time":"2011-09-20T09:05:18Z","timestamp":1316509518000},"page":"121-123","source":"Crossref","is-referenced-by-count":13,"title":["Early granulomatous foreign body reactions to a novel alginate dermal filler: the system\u2019s failure?"],"prefix":"10.1111","volume":"27","author":[{"given":"S.","family":"Schuller\u2010Petrovi\u0107","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.D.","family":"Pavlovi\u0107","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.S.","family":"Schuller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"Schuller\u2010Luki\u0107","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Neuhold","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,9,20]]},"reference":[{"key":"e_1_2_4_2_2","volume-title":"Cosmetic Surgery National Data Bank 2009 Statistics. [WWW document]","author":"American Society for Aesthetic Plastic Surgery","year":"2009"},{"key":"e_1_2_4_3_2","first-page":"1","article-title":"Novabel reshapes the face of aesthetic medicine","author":"Wilson KA","year":"2010","journal-title":"The European Aesthetic Guide, Merz Supplement"},{"key":"e_1_2_4_4_2","doi-asserted-by":"publisher","DOI":"10.1042\/bst0200027"},{"key":"e_1_2_4_5_2","doi-asserted-by":"publisher","DOI":"10.3727\/000000002783985774"},{"key":"e_1_2_4_6_2","unstructured":"Merz Aesthetics.What is Novabel\u00ae? [WWW document]. 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