Adverse Events in Facial Implant Surgery and Associated Malpractice Litigation.

IMPORTANCE: Facial implants represent an important strategy for providing instant and long-lasting volume enhancement to address both aging and posttraumatic defects. OBJECTIVE: To better understand risks of facial implants by examining national resources encompassing adverse events and considerations facilitating associated litigation. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study reviewed complications following facial implants. The procedures reviewed were performed on patients at locations throughout the United States from January 2006 to December 2016. Data collection was completed in March 2017. The Manufacturer and User Facility Device Experience database, which contains medical device reports submitted to the US Food and Drug Administration (FDA), was searched for complications that occurred from January 2006 to December 2016 involving facial implants made by Implantech, MEDPOR, Stryker, KLS Martin, and Synthes. Furthermore, the Thomson Reuters Westlaw legal database was searched for relevant litigation. MAIN OUTCOMES AND MEASURES: The complications of facial implants were analyzed in relation to the location of implant and severity of complication. Litigation was analyzed to determine which factors determine outcome. RESULTS: Thirty-nine instances of adverse events reported to the FDA were identified. Sixteen (41%) involved malar implants, followed by 12 chin implants (31%). The most common complications included infection (18 [46%]), implant migration (9 [23%]), swelling (7 [18%]), and extrusion (4 [10%]). Thirty-two patients (83%) had to have their implants removed. Infection occurred at a mean (SD) of 83.3 (68.8) days following the surgery. One-third of complications involved either migration or extrusion. The mean (range) time to migration or extrusion was 381.1 (10-2400) days. In 12 malpractice cases identified in publicly available court proceedings, alleged inadequate informed consent and requiring additional surgical intervention (ie, removal) were the most commonly cited factors. CONCLUSIONS AND RELEVANCE: Infection and implant migration or extrusion are the most common complications of facial implants. Most of these complications necessitate removal. These considerations need to be discussed with patients preoperatively as part of the informed consent process, as allegedly inadequate informed consent was cited in a significant proportion of resultant litigation, and there were overlapping considerations among adverse events reported to the FDA and factors brought up in relevant litigation. Cases resolved with settlements and jury-awarded damages encompassed considerable award totals. LEVEL OF EVIDENCE: NA.

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

IMPORTANCE: Injectable fillers 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.

Impact of Postreconstitution Room Temperature Storage on the Efficacy of IncobotulinumtoxinA Treatment of Dynamic Lateral Canthus Lines.

BACKGROUND: The efficacy of botulinum neurotoxin type A after prolonged storage at room temperature is currently unknown. This randomized, double-blinded, split-face study investigated the impact of postreconstitution 25°C storage for 1 week on the clinical efficacy of incobotulinumtoxinA in the treatment of lateral canthus lines. PATIENTS AND METHODS: Twenty-one participants with at least mild to moderate crow's feet at maximum contraction on the Crow's Feet Grading Scale (CFGS) underwent injection to each lateral canthus area with 10 U of freshly reconstituted and room temperature-stored product and followed for 4 months. Responders were defined as those demonstrating at least a 1-point improvement on their CFGS score. RESULTS: At each visit (2 weeks and 1, 2, 3, and 4 months), there was no statistical difference in the rate of responders between the fresh and the stored products. In addition, the percentage of responders displaying a 2-point versus a 1-point improvement and response longevity did not statistically differ between both products for the entire 4-month study duration. CONCLUSION: Prolonged storage of incobotulinumtoxinA at room temperature does not appear to significantly alter its efficacy or longevity in the treatment of dynamic lateral canthus lines.