PMID: 30172248Mar 1, 2009Paper

Medical Bioethics in Dermatologic Procedures

Journal of Drugs in Dermatology : JDD
Macrene Alexiades-Armenakas

Abstract

The US Food and Drug Administration (FDA) held a hearing on the safety of dermal fillers in November of 2008 which generated a great deal of media attention and, more importantly, got our attention. The adverse reporting data came from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database and numbered 930 cases over the past 6 years, bringing the complication rate to an estimated 1 in 10 000. Some of the complications were severe, such as facial palsy or anaphylaxis; while others included scarring. Such rare but grave complications are generally considered acceptable risks for treatments of medical illnesses (eg, infections or carcinomas); but are these rare complications for elective cosmetic enhancement acceptable?

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