A Cross-sectional Analysis of Adverse Events and Litigation for Injectable Fillers

Abstract

are increasing in popularity as a noninvasive option to address concerns related to facial aging and volume loss. To our knowledge, there have been no large-scale analyses of adverse events and associated litigation related to filler injections. OBJECTIVES To determine risks of injectable fillers and analyze factors raised in litigation related to injectable fillers. DESIGN, SETTING, AND PARTICIPANTS In this cross-sectional review, the US Food and Drug Administration's (FDA) manufacturer and user facility device experience (MAUDE) database was evaluated for complications from the use of the following fillers: Juvederm, Restylane, Belotero, Sculptra, Radiesse, Artefill, Bellafill, and Juvederm Voluma from 2014 to 2016. The Westlaw Next database was used to identify jury verdicts. MAIN OUTCOMES AND MEASURES Complications were organized by type of filler used, location of injection, and severity. Intra-arterial injections without sequelae and those resulting in blindness or necrosis were considered severe complications. Factors raised during the litigation process were also analyzed. RESULTS Of 1748 adverse events analyzed, most cases stemmed from cheek (751 [43.0%]) or lip (524 [30.0%]) injection. Commonly reported adverse events reported included swelling (755 [43.2%]) and infection (725 [41.5%]). Among FDA-reported complications, blindness was significantly associated with dorsal nasal injections (P < .001). Vascular compromise with and without sequela of dermal necrosis and blindness were significantly associated with Radiesse injections P < .001. Of the 9 malpractice cases identified, two-thirds involved allegations of inadequate informed consent, and the median award in cases resolved with payment was $262 000. CONCLUSIONS AND RELEVANCE Although specific complication profiles vary by material and injection site, common adverse events associated with injectable fillers include swelling and infection. More serious events include vascular compromise, resulting in necrosis and blindness; these events are also raised in cases involving litigation. This analysis illustrates the importance of outlining these risks in a comprehensive preoperative informed consent process. LEVEL OF EVIDENCE NA.

Risk Comparison of Filler Embolism Between Polymethyl Methacrylate (PMMA) and Hyaluronic Acid (HA)

“…Individual differences may include vascular diameters, collateral circulation, hemodynamics, etc. The existing clinical data [1] show that in some cases no skin necrosis appeared although fillers were found in the artery after injection, which may be associated with lower injection doses and individual differences in patients.…”

Public Perception of Facial Fillers

“…Previous studies have shown litigations in plastic surgery are commonly due to a practitioner's lack of expertise, lack of informed consent, and poor cosmetic outcome. 19,20 With the mean monetary award totaling $242,000 and greater than 50% of patients sustaining permanent injury, 14 further regulation of what defines "qualified" is paramount to our healthcare system. Particularly with the exponential increase in facial filler demand and its interdependence with popular media, future news coverage both locally and internationally can play a vital role in public perception and government policies.…”

Risks of Ghaderi’s Phenomenon

“…Fillers for tissue enhancement are acquiring great popularity (11). For this purpose, the filler injection is used in the lip, especially the upper lip (12)(13)(14)(15). Hyaluronic acid soft tissue fillers consist a range of productions (i.e., Voluma, Restylane Silk, Restylane, Restylane Lyft, Juvederm Ultra, Juvederm Ultra Plus, and Belotero Balance) that are applied frequently for the augmentation of facial features and facial rejuvenation.…”

“…There have been no large-scale analyses of complications related to filler injections (12). Liquid silicone which is also known as polydimethylsiloxane relates to a group of polymeric compounds that are frequently called silicones.…”

“…Despite the fact that specific adverse event profiles differ by material and injection site, common complications, such as swelling and infection are related to injectable filling agents. More severe complications include vascular events resulting in necrosis and visual loss; these complications are also increased in cases involving legal proceedings (12). Uncertified productions based on oleic solutions are used by uneducated personnel, thereby increasing the risk for specific adverse events, such as lipogranuloma formation, irritant and allergic contact dermatitis, and infections (15).…”