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.
Objective: To identify characteristics of pediatric sickle cell disease (SCD) hospitalizations and to examine admission demographics and medical expenditures.
Objectives/Hypothesis To evaluate hospital course and associated complications among pediatric patients undergoing thyroidectomy. Study Design and Setting Retrospective database review of the Kids' Inpatient Database (2009, 2012). Methods The Kids' Inpatient Database was evaluated for thyroidectomy patients for the years 2009 and 2012. Surgical procedure, patient demographics, length of stay, hospital charges (in US dollars), and surgical complications were evaluated. Results Of an estimated 1099 nationwide partial thyroidectomies and 1654 total thyroidectomies, females accounted for 73.5% and 79.1% of patients, respectively. Children <1 year of age had significantly longer hospital courses ( P < .0001), and patients 1 to 5 years of age had a significantly greater length of stay than individuals 6 to 20 years of age (7.8 vs 2.1 days, P < .001). The most common complications overall included hypocalcemia, respiratory complications, vocal cord paresis/paralysis, postoperative infection, and bleeding. Vocal cord paralysis was noted in 1.7% of pediatric thyroidectomy patients. The presence of these complications among total thyroidectomy patients significantly increased one's length of stay and hospital charges. A neck dissection was reported in 22.9% of malignant thyroidectomy patients. Conclusion Nearly 20% of children who underwent total thyroidectomy experienced postoperative hypocalcemia, positing a need for the development of postoperative calcium replacement algorithms to minimize the sequelae of hypocalcemia. A greater incidence of respiratory and infectious complications among younger patients (<6 years) suggests a need for closer monitoring, possibly encompassing routine postoperative intensive care unit utilization, in an attempt to minimize these sequelae.
There are well-described racial, sex, and age differences related to osteoporosis and hip and/or extremity fractures. Nonetheless, there has been virtually no inquiry evaluating whether these findings carry over to facial fracture. OBJECTIVE To characterize the incidence of facial fractures by patient demographics and injury mechanism, focusing on whether differences are noted with race, sex, and advancing age. MAIN OUTCOMES AND MEASURESRetrospective analysis of the National Electronic Injury Surveillance System (NEISS) was performed in October and November 2015, specifically evaluating adult emergency department (ED) visits from 2012 to 2014 related to facial trauma. Entries were organized by age groups (both individual decades as well as younger adults [18-59 years] vs older adults [60-89 years]), sex, and race (white, black, Asian, other/unspecified). Incidence of facial fractures and mechanism of injury were also evaluated. RESULTS There were 33 825 NEISS entries correlating to 1 401 196 ED (range, 1 136 048-1 666 344) visits for adult facial injury, with 14.4% involving fracture. A greater proportion of facial injuries among younger men (<60 years) were fractures relative to younger women (15.5% vs 12.5%; difference of the mean [DOM], 3.0%; 95% CI, 2.8%-3.1%; P < .001); however, on comparison by sex in elderly populations (Ն 60 years), women had an increased fracture predilection (15.0% vs 14.0%; DOM, 1.0%; 95% CI, 0.8%-1.2%; P < .001). Also, older women had a significantly greater risk of fracture relative to those younger than 60 years (15.0% vs 12.5%; DOM, 2.5%; 95% CI, 2.4%-2.7%; P < .001), a comparison that was significant among whites and Asians. Black women had a significantly decreased risk of fracture in the older aged population. (8.4% vs 9.1%; DOM, 0.7%; 95% CI, 0.2%-1.3%; P = .001). Both on individual comparisons of younger and older cohorts, white and Asian individuals of either sex had significantly greater rates of facial fracture injury than blacks. Among younger cohorts in either sex, injuries sustained during participation in recreational activities were a significant factor, replaced largely by injuries due to housing structural elements and falls among older cohorts. CONCLUSIONS AND RELEVANCEThere is an increase in the risk of facial fracture among postmenopausal women sustaining facial injuries, with these results significant among whites and Asians. In contrast, a decreased risk was noted on comparison of younger and older black women. Mechanism of injuries also varied significantly by age, race, and sex.LEVEL OF EVIDENCE 4.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.