According to new research published in the Journal JAMA Facial Plastic Surgery, 39 adverse events reported to the US FDA were reported with infection the most common complication reported and 32 patients requiring removal of their implants. Half of malpractice cases involved allegedly inadequate informed consent. Hence, before facial implant surgery, it is critical to have a thorough discussion of possible complications and techniques to treat them.
Facial implants represent an important strategy for providing instant and long-lasting volume enhancement to address both aging and posttraumatic defects. The researchers wanted to better understand risks of facial implants by examining national resources encompassing adverse events and considerations facilitating associated litigation. 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. The Manufacturer and User Facility Device Experience database, which contains medical device reports was searched for complications that occurred from January 2006 to December 2016 involving facial implants. Furthermore, the Thomson Reuters Westlaw legal database was searched for relevant litigation.
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. 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.
In conclusion, 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.