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A Cross-sectional Analysis of Adverse Events and Litigation for Injectable Fillers
Hani M Rayess1, Peter F Svider1, Curtis Hanba1
1Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Detroit, Michigan.
Injectable filler complications like swelling and infection are common. Severe events, including blindness and necrosis, are linked to specific fillers and injection sites, and are central to litigation, highlighting informed consent importance.
Area of Science:
- Dermatology
- Aesthetic Medicine
- Medical Device Safety
Background:
- Injectable fillers are increasingly popular for facial rejuvenation.
- Large-scale analyses of adverse events and litigation are lacking.
Purpose of the Study:
- To determine the risks associated with injectable fillers.
- To analyze factors involved in litigation concerning filler injections.
Main Methods:
- Cross-sectional review of FDA MAUDE database (2014-2016) for filler complications.
- Analysis of Westlaw Next database for jury verdicts.
- Complications categorized by filler type, injection site, and severity.
Main Results:
- 1748 adverse events analyzed; most common were swelling (43.2%) and infection (41.5%).
- Cheek and lip injections were most frequent sites.
- Blindness linked to dorsal nasal injections; vascular compromise/necrosis/blindness linked to Radiesse.
- 9 malpractice cases identified; two-thirds alleged inadequate informed consent; median award $262,000.
Conclusions:
- Common filler complications include swelling and infection.
- Severe events (vascular compromise, necrosis, blindness) are significant and litigated.
- Comprehensive informed consent is crucial to outline these risks.
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