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.
A biomechanical model utilizing polystyrene mandibles was devised to evaluate the fixation efficacy of various plating techniques for repair of mandibular angle fractures. A simple angle fracture was created in the mandible models at a standardized location and was repaired using five different plating techniques. Each experimental group consisted of 15 mandibles, with fracture site, plate placement, load application, and fracture displacement measurement standardized to ensure consistency among experimental groups. Measurement of fracture distraction under load application generated a load deformation curve and corresponding slope for each technique. Comparison of load deformation slopes allowed assessment of fixation stability. When applied with a subapical, medially placed monocortical tension band, bicortical compression plating demonstrated the most stable fracture fixation. The data show that biplanar plate placement in both monocortical noncompression and bicortical compression techniques yields a stronger fixation than monoplanar placement.
The dramatic rise in the number of cosmetic procedures performed during the past 5 years reflects a heightened public awareness of and interest in facial rejuvenation. Concomitant with this rise has been the addition of new injectable fillers, lasers, and minimal incision techniques to the surgeon's armamentarium. Perhaps the greatest applicability of these modalities has been the rejuvenation of the perioral region, neck, and jawline, with reduced "downtime" but visible results. Signs of aging that are clearly visible in the lower third of the face include the loss of elasticity and descent of fat in the jowl region; laxity of the neck skin, muscle, and fat; development of perioral rhytids, deep nasolabial folds, and marionette lines; and the loss of definition of the lips. The purpose of this article is to highlight our approach to rejuvenation of these areas, elucidate the role of newer technologies, and provide special techniques and pearls utilized in rhytidectomy.
Hematoma formation has persisted as the most common complication in rhytidectomy. The objective of this study is to determine the efficacy and safety of Artiss (Baxter) for use in rhytidectomies. In addition, we determine the use of fibrin tissue sealants by facial plastic surgeons. In this retrospective chart review, 120 patients in a single private practice were identified who underwent a rhytidectomy from August 2013 to January 2015 by a single facial plastic surgeon. The last 60 rhytidectomies performed with Tisseel (Baxter) were compared with the first 60 rhytidectomies performed with Artiss.All perioperative or postoperative complications were identified and recorded, focusing on the incidence of hematoma. In addition, a six-question survey was created and sent to all members of the American Academy of Facial Plastic and Reconstructive Surgery. Results of the survey were recorded and analyzed for trends or patterns in the data. In total, 120 patients were assessed. In the Tisseel group, two complications of fluid collection requiring needle aspiration were recorded. No other complications were found. In the Artiss group, 10 complications were recorded, including 9 fluid collections requiring needle aspiration and 1 hematoma. In total, 179 members of the American Academy of Facial Plastic and Reconstructive Surgery completed the six-question survey. Of all respondents, 61 (34%) use tissue sealants for rhytidectomies, whereas 118 (66%) do not. Artiss is efficacious and safe for use in rhytidectomies. Its use obviates the need for surgical drains, and complications are minimal and similar in rate to the use of Tisseel.
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