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[Survey of incidents associated with injectable dermal fillers reported to the German Medical Devices Vigilance System].

Authors
  • Heinz, B C
  • Ladhoff, U
  • Kahl, Ch
  • Rzany, B
  • von Mallek, D
Type
Published Article
Journal
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
Publication Date
Jul 01, 2008
Volume
51
Issue
7
Pages
787–792
Identifiers
DOI: 10.1007/s00103-008-0587-5
PMID: 18560778
Source
Medline
License
Unknown

Abstract

The purpose of this study was to address the experience gained from the risk assessment of incident reports associated with the use of dermal filler materials. In total, 136 incident reports were registered between January 1, 2000, and September 30, 2005. A retrospective survey of all reports was conducted. 143 patients were concerned; the symptom most frequently reported was the formation of nodules (n = 89). The majority of cases resulted in either conservative or surgical treatment (n = 93). In 4 cases the implementation of corrective action with respect to the medical device became necessary. As a result of the severity or the incidence of undesired effects of wrinkle correction deficiencies of the products involved may become obvious. Thus, following German medical device legislation, the criteria for an incident to be reported may be met.

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