Medical Bioethics in Dermatologic Procedures

March 2009 | Volume 8 | Issue 3 | Editorials | 214 | Copyright © 2009

Macrene Alexiades-Armenakas

New York, NY

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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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? It is a matter of opinion, discussion, and philosophical thought that instructs our ethical and legal views."First, do no harm," or primum no nocere, is probably the most memorable phrase of the Hippocratic Oath. It is actually a Latin paraphrase, by Galen, of the third phrase of the Hippocratic writing: Hippocratic(ironically, Galen wrote in Greek rather than Latin). Just as books of religion help guide our moral compass today, despite drastic differences in the modern world views when compared to ancient times, so does this dictum echo as a reminder of our moral compass in medicine: one towards which we aspire towards knowing medicine as an imperfect science. To most doctors the aspiration to do no harm means to do no harm within the realms of medical our knowledge and to the best of our ability when treating a patient, but still some may view this as an inadequate fulfillment of our obligation.How do we fulfill this dictum while treating patients in the cosmetic field, who, in most instances, are not suffering from disfiguring diseases but simply striving to look "good"? To answer these questions, we need to revisit medical ethics, a term first coined by British physician Thomas Percival (1740-1804). In 1847, the American Medical Association adopted the first code of ethics, based on Percival’s writings. In the past 3 decades, ethics have increased its role in medicine, engrained in the advent of institutional review boards and hospital-based and society-based ethics committees. The 6 principles of medical ethics include:

  • Autonomy—the patient has the right to refuse or choose treatment (voluntas aegroti suprema lex).
  • Beneficence—the physician should act in the best interest of the patient (salus aegroti suprema lex).
  • Nonmaleficence—“First, do no harm” (primum non nocere).
  • Justice—the fair and equal distribution of health resources.
  • Dignity—the right of the patient and doctor to respect.
  • Truthfulness and honesty—the concept of informed consent.
(Adapted from: Ethics manual. Fourth edition. American College of Physicians. Ann Intern Med. 1998;128(7):576–594).Many believe that it is more important for a physician to not harm the patient, rather than do them good; yet, these concerns must be weighed against each other. The onus of responsibility lay on the physician to evaluate treatments adequately and to ensure they do no harm or only acceptable levels of harm. The following are 4 imperatives for balancing nonmaleficence with beneficence: 1) the physician must know how the likely it is for the treatment to harm the patient; 2) the physician should not treat unless it is known that the treatment is unlikely to be harmful; 3) the patient must understand the risks and benefits (informed consent); and 4) the likely benefits outweigh the likely risks. Thus, the principle of nonmaleficence is not absolute and must be balanced against the principle of beneficence.The most critical components to defining nonmaleficence (harm) and beneficence (good), are the

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