Goals/Purpose: We sought to characterize the attitudes of plastic surgeons to various ethical issues that arise with stem cell-based aesthetic surgery.
Methods/Technique: An electronic survey was distributed to the members of the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS). Demographic data (age, geographic location, time spent in practice, practice description, practice arrangement, and ratio of time spent between aesthetic and reconstructive surgery) was collected. Fifteen statements were developed to address concerns pertaining to stem cell-based aesthetic surgery within the following domains: 1) Informed Consent; 2) Conflict of Interest; 3) Advertising; 4) Regulation; 5) Stem Cell Tourism. Respondents indicated their agreement to each statement based on a 5-point Likert scale. Weighted averages were calculated in order to assign an overall agreement score (as a percentage) to each statement.
Results/Complications: The survey was distributed to 4,592 members of both societies. We received a total of 764 responses (16.6%). Age, geographic location, time spent in practice, and ratio of aesthetic/reconstructive procedures were evenly distributed among respondents. Most surgeons were in solo practice (53%). For each statement, majority agreement was set to a score of 65% or greater and majority disagreement was set to a score of 35% or lower. Results are displayed in Table 1.
Conclusion: A majority of members reported that not enough is known about the risks and benefits of stem cell procedures in order to obtain a valid informed consent. Additionally, 77% of the membership disagreed that direct-to-consumer advertising for this technology is appropriate and ethical at this time. Regarding challenges of stem cell tourism, 86% of respondents indicate that patients should be actively warned about traveling abroad to receive cellular therapies, and that registries and evaluations of these clinics should be made publically available (72%). The clearest consensus was seen to conflict of interest issues, where 96% agreed that industry relationships should be fully disclosed to patients. Interestingly, the membership seems divided on what role the FDA should have in regulating these procedures and what level of regulation unduly restricts the practice of medicine. However, on balance, the plastic surgery community is in favor of leadership by its professional societies in establishing standards for these new technologies as they traverse the research landscape into clinical practice.
Table 1.
Majority Disagreement (<35% agree)
| Divided (35%-65%)
| Majority Agreement (>65% agree)
|
The use of stem cells for aesthetic purposes is currently supported by scientific evidence (33%)
| A growing number of patients are inquiring about stem cells in aesthetic surgery (53%)
| Patients should be actively discouraged from travelling abroad to receive stem cell therapies for aesthetic purposes (86%)
|
The risks and benefits of stem cell based aesthetic surgery are sufficiently known such that a potential patient can be adequately counseled and can give a full informed consent (30%)
| Regardless of proven efficacy, as long as patients are willing to bear the costs and risk, stem cell-based aesthetic surgery should be made available now in the USA (37%)
| Any physician who performs stem cell based aesthetic procedures should disclose industry relationships or conflicts of interest to their patients (96%)
|
Direct to consumer advertising of the availability of aesthetic stem cell procedures is appropriate and ethical (23%)
| Restricting my ability to use stem cells for aesthetic procedures is an unacceptable violation of my right to practice medicine (52%)
| It is the responsibility of plastic surgery professional societies and organizations to participate in setting standards to help regulate the use of stem cells for aesthetic purposes (93%)
|
| The FDA does not do enough to regulate stem cell therapies in the USA (60%)
| There ought to be a publically evaluation/registry of stem cell clinics providing aesthetic procedures compiled by one or more professional societies (72%)
|
| There ought to be an official certification process required of plastic surgeons in order to provide these procedures (51%)
| Based on current evidence, requiring training in stem cell procedural techniques during plastic surgery residency is premature (73%)
|
|
| More than other specialties (e.g. dermatology, ENT, etc.), plastic surgery is best suited to responsibly develop and promote stem cell therapies for aesthetic purposes (81%)
|
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| There ought to be restrictions on which physicians and clinics can offer stem cell procedures in the USA and internationally (68%)
|