More serious adverse events include vascular compromise resulting in necrosis, blindness
THURSDAY, Dec. 21, 2017 (HealthDay News) — The most common adverse events associated with injectable fillers are swelling and infection, according to a study published online Dec. 21 in JAMA Facial Plastic Surgery.
Hani M. Rayess, M.D., from Wayne State University in Detroit, and colleagues analyzed adverse events reported to the U.S. Food and Drug Administration’s manufacturer and user facility device experience database. The authors also reviewed litigation related to filler injections based on jury verdicts in the Westlaw Next database.
Based on the 1,748 adverse events analyzed, the researchers found that most cases stemmed from cheek (43 percent) or lip (30 percent) injection. Swelling (43.2 percent) and infection (41.5 percent) were the most commonly reported adverse events. Among FDA-reported complications, blindness was significantly associated with dorsal nasal injections. Radiesse injections were significantly associated with vascular compromise with and without sequela of dermal necrosis and blindness. Nine malpractice cases were identified, and the median award in those resolved with payment was $262,000. Two-thirds of the malpractice cases involved allegations of inadequate informed consent.
“This analysis illustrates the importance of outlining these risks in a comprehensive preoperative informed consent process,” the authors write.
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