Complications and Litigation Associated With Injectable Facial Fillers: A Cross-Sectional Study.

PURPOSE

Soft-tissue injectable fillers are a popular treatment option for patients seeking minimally invasive facial rejuvenation. The use of soft-tissue fillers has increased significantly in the past 10 years. In 2017 alone, clinicians administered nearly 2.7 million soft-tissue fillers, up from 1.3 million in 2007. Although injectable fillers have a relatively high safety profile compared with more invasive rejuvenation procedures, serious adverse events, including intra-arterial injections, necrosis, and visual symptoms such as blindness, have been documented. Complications from injectable fillers have also been a source of litigation, which has been shown to be associated with a perceived lack of informed consent. We sought to document the reported complication rates associated with injectable facial fillers from a national database and to report on the available cases of malpractice litigation.

MATERIALS AND METHODS

The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was used to collect the reported complications from 2013 to 2017 for the following injectable fillers: Artefill, Bellafill, Belotero, Juvederm, Radiesse, Restylane, Sculptra, and Kybella. Complications were organized by filler type, injection location, and complication type. The Thomson Reuters Westlaw Edge database was used to collect the reported jury verdicts and settlements from 2008 to 2017 for injectable facial fillers.

RESULTS

A total of 2813 adverse events were analyzed. The most common locations for complications were the cheek (915 [32.5%]), lips (503 [17.9%]), and nasolabial fold (412 [14.6%]). The commonly reported adverse events were swelling (1,691 [60.1%]), nodule (948 [33.7%]), and pain (636 [22.6%]). Severe complications included intra-arterial injections resulting in necrosis and visual symptoms (eg, blurred vision and blindness). Forehead and dorsal nasal injections were significantly associated with intra-arterial complications resulting in necrosis and visual symptoms (P < .01). Injections with Radiesse were significantly associated with intra-arterial injections resulting in necrosis and visual symptoms (P < .01). A total of 11 malpractice cases were analyzed. The median award in the cases resolved by a verdict in favor of the plaintiff or settlement was $600,000. In 10 of the 11 cases, a lack of informed consent had been alleged.

CONCLUSIONS

The complications associated with injectable facial fillers varied greatly, depending on factors involved with their application. The most common adverse effects were swelling, nodule formation, and pain. Serious complications stemming from intra-arterial injections included necrosis and visual disturbances, including blindness. These complications have been raised in legal cases, in which the lack of informed consent was frequently alleged. The present analysis has documented some of the potential risks involved with injectable facial fillers and demonstrated the need for a thorough informed consent process before their administration.