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.

Evaluación de la deformación de dos siliconas para prótesis faciales, influencia de la pigmentación y desinfección química / Assessment of initial and the permanent deformation of two silicones (Silved Selant and Brascoved) for facial prostheses under the pigmentation and chemical disinfection influence

La propuesta de este estudio fue analizar el efecto de la pigmentación y de la desinfección química sobre la deformación inicial y permanente de dos siliconas (Silved Selant y Brascoved) utilizadas en la confección de prótesis faciales. Las muestras para los analisis de deformación inicial y permanente (20 mm × 12,5 mm) fueron confeccionadas de acuerdo con las instrucciones del fabricante. Para cada silicona (n= 40), diez muestras fueron pigmentadas con polvo de maquillaje, diez con óxido de hierro, diez con polvo de cerámica y diez sin pigmentación. Cinco muestras de cada grupo fueron sometidas a desinfección química, con clorhexidina al 2 por ciento por aspersión. Todas las muestras fueron inmersas en suero fisiológico y almacenado en estufa a 35 º ± 1 ºC. Después de 90 días, las muestras fueron sometidas a los exámenes de deformación inicial y permanente. Para ambas propiedades, los datos fueron analizados por el test de Tukey (a= 0,05). Los resultados mostraron que todos los materiales presentaron deformación inicial y permanente independiente de la desinfección química y pigmentación. Los grupos pigmentados con óxido de hierro fueron los que presentaron menor deformación, inicial y permanente, cuando fueron sometidos a desinfección química, independientemente de la silicona usada(AU)

The purpose of present study was to analyze the effect of pigmentation and chemical disinfection on the initial and the permanent deformation of two silicones (Silved Selant and Brascoved) for facial prosthesis. Initial and permanent deformation tests samples (20 mm × 12.5 mm) were made following the manufacturer's instructions. For each silicone (n= 40), ten samples were used for pigmentation with make up power, ten with iron oxide, ten with ceramics power and tem were tested without pigmentation. Five samples of each group were submitted to chemical disinfection using a 2 percent Chlorhexidine spray. All samples were immersed in physiological saline and stored in an oven at 35 º ± 1 ºC. After 90 days, the samples were submitted to initial and permanent deformation tests using a dial indicator. For both properties, data were analyzed by Tukey's test (a= 0.05). The results showed that all the materials had initial and permanent deformation regardless of pigmentation and chemical disinfection. The groups were used for pigmentation with iron oxide showed less initial and permanent deformation when were submitted to the chemical disinfection regardless the silicone used(AU)