Ethical Issues in Aesthetic and Reconstructive Surgical Innovation

Perspectives of Plastic Surgeons

Z-Hye Lee, M.D.; Patrick L. Reavey, M.D.; Eduardo D. Rodriguez, M.D.; Ernest S. Chiu, M.D.; Arthur L. Caplan, Ph.D.

Disclosures

Plast Reconstr Surg. 2019;143(1):346-351. 

In This Article

Abstract and Introduction

Abstract

Innovative surgery is defined as a novel procedure, a significant modification of a standard technique, or a new application of an established technique. Although innovation is a crucial part of improving patient care in plastic surgery, there are various ethical considerations and dilemmas in performing unvalidated techniques and procedures, especially for non–life-threatening indications. The aim of this study was to gain a better understanding regarding the motivations and ethical considerations of plastic surgeons in their decision to perform innovative operations. An anonymous, institutional review board–approved, online survey was sent to members of the American Society of Plastic Surgeons and other international plastic surgeons worldwide. The survey asked respondents to rank various factors that influence their decisions to perform innovative plastic surgery, both reconstructive and aesthetic, on a five-point Likert scale. Seven hundred thirty-three of 26,028 plastic surgeons (response rate, 2.9 percent) responded to the survey. Although similar factors were considered to be important for both reconstructive and aesthetic operations, only approximately 50 percent of respondents considered institutional review board approval to be an important factor when considering innovation in both reconstructive (50 percent) and aesthetic surgery (51 percent), suggesting that respondents do not consider innovation a form of research that ought be subject to standard research protections. Overall, the authors' survey suggests that more effort must be extended to ethical training in plastic surgery to create a stronger professional atmosphere regarding innovation and, possibly, to the creation of a more formal group charged with oversight of innovation.

Introduction

Innovative surgery is defined as a novel procedure, a significant modification of a standard technique, or a new application of an established technique.[1] Although innovation is a crucial part of improving patient care in plastic surgery, there are various ethical issues in performing unvalidated techniques and procedures. All cosmetic procedures and most reconstructive operations are performed rarely for life-threatening conditions but rather for improvement in aesthetic and functional outcomes. More compelling reasons and judicious considerations may be necessary to justify experimentation in plastic surgery compared with other fields, especially where innovation may be the only option. In contrast to medical therapies, which require approval use by regulatory agencies based on the demonstration of safety and efficacy by means of clinical trials, new surgical techniques almost never undergo such rigorous examination before they are attempted. Furthermore, although the regulatory process for formal research—a systematic investigation designed to expand current knowledge—is well defined, there is a lack of such standards for innovation, which is simply a departure from current standard practice performed on an individual basis.

Potential benefit, patient safety, informed consent, and economic implications are all issues relevant to surgical innovation. These ethical questions suggest that certain rules must accompany surgical innovation. However, several issues pose challenges in implementing a formalized regulatory process for surgical innovation. Demonstrating a clear difference in outcomes for surgical interventions often requires large numbers and long-term follow-up. In addition, it is often difficult to accurately quantify risks and benefits of different surgical techniques; thus, plastic surgeons, influenced by the potential economic or academic benefits of innovation, may skew the potential advantages and harms. Therefore, the feasibility of a more stringent regulatory process is uncertain. Perhaps a more informal approach of increasing awareness and encouraging ethical behavior among plastic surgeons can enhance patient safety.

The aim of this study was to gain a better understanding regarding the motivations and ethical considerations of plastic surgeons in their decision to perform innovative surgery. In addition, we sought to compare the differences in attitudes of surgeons in their decision to perform innovation in reconstructive versus aesthetic surgery. We hypothesized that there would be some differences in the types of factors considered in operations for mainly cosmetic versus reconstructive procedures. This article reports our first-of-its-kind survey findings on the ethical views and attitudes of plastic surgeons towards surgical innovation.

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