Hani M. Rayess

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 .

The rapid proliferation of online health care resources means that an increasing number of patients obtain material from the internet. Consequently, more than 80% of Americans use online resources to obtain health information.¹ Interest in aesthetic surgery and procedures also has been growing at record levels, with approximately 1.7 million aesthetic surgical procedures performed in 2013 in the United States.² Online material originates from a diverse array of resources, including academic medical centers, private practice physicians, and online reference resources.³ Internet users typically visit the first 3 to 8 websites from the top of a set of search engine results when looking for health-related resources.⁴ Almost 95% of cosmetic surgery patients use the internet to obtain information before their first consultation, and 46% of these patients use social media.⁵ Because websites on the internet are unregulated and heterogeneous and influence decisions regarding surgery,⁶ an understanding of available online resources is paramount for the practicing surgeon.