Medical Bioethics in Dermatologic Procedures
Alexiades-Armenakas, M.
Journal of Drugs in Dermatology Jdd 8(3): 214-215
2009
ISSN/ISBN: 1545-9616 PMID: 30172248 Document Number: 17640
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?
Document emailed within 1 workday
