[Survey of incidents associated with injectable dermal fillers reported to the German Medical Devices Vigilance System].
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.
Heinz
B C
BC
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger Allee 3, Bonn, BRD. bheinz@bfarm.de
Ladhoff
U
U
Kahl
Ch
Ch
Rzany
B
B
von Mallek
D
D
D001672:Biocompatible Materials / Q000008:administration & dosage / Q000009:adverse effects*; D003357:Cosmetic Techniques / Q000009:adverse effects*; D003625:Data Collection; D005858:Germany; D006801:Humans; D007267:Injections / Q000009:adverse effects* / Q000379:methods; D007279:Injections, Subcutaneous; D019221:Mandatory Reporting; D011358:Product Surveillance, Postmarketing; D019736:Prostheses and Implants / Q000009:adverse effects*; D012060:Rejuvenation; D018570:Risk Assessment; D012307:Risk Factors; D012871:Skin Diseases / Q000209:etiology* / Q000517:prevention & control*
D001672:Biocompatible Materials