Ethical Challenges With Nonsurgical Medical Aesthetic Devices.

The medical device industry is an incredibly profitable and rapidly growing sector of health care. In plastic surgery, the nonsurgical medical aesthetic device industry presents ongoing ethical challenges, specifically related to the principles of nonmaleficence and respect for autonomy. The purpose of this article is to increase awareness of the ethical challenges the nonsurgical medical aesthetic device industry presents, including use of deceptive or misleading language in advertising, limited evidence of efficacy, and lack of public and professional understanding of the U.S. Food and Drug Administration regulation of medical devices. Practical application of ethics is presented through the lens of the Code of Ethics for Nurses With Interpretive Statements () and the Code of Ethics of the American Society for Aesthetic Plastic Surgery ().

Medical ethical standards in dermatology: an analytical study of knowledge, attitudes and practices.

BACKGROUND: Dermatology practice has not been ethically justified at all times. OBJECTIVE: The objective of the study was to find out dermatologists' knowledge about medical ethics, their attitudes towards regulatory measures and their practices, and to study the different factors influencing the knowledge, the attitude and the practices of dermatologists. METHODS: This is a cross-sectional comparative study conducted among 214 dermatologists, from five Academic Universities and from participants in two conferences. A 54 items structured anonymous questionnaire was designed to describe the demographical characteristics of the study group as well as their knowledge, attitude and practices regarding the medical ethics standards in clinical and research settings. Five scoring indices were estimated regarding knowledge, attitude and practice. Inferential statistics were used to test differences between groups as indicated. The Student's t-test and analysis of variance were carried out for quantitative variables. The chi-squared test was conducted for qualitative variables. The results were considered statistically significant at a P > 0.05. RESULTS: Analysis of the possible factors having impact on the overall scores revealed that the highest knowledge scores were among dermatologists who practice in an academic setting plus an additional place; however, this difference was statistically non-significant (P = 0.060). Female dermatologists showed a higher attitude score compared to males (P = 0.028). The highest significant attitude score (P = 0.019) regarding clinical practice was recorded among those practicing cosmetic dermatology. The different studied groups of dermatologists revealed a significant impact on the attitude score (P = 0.049), and the evidence-practice score (P < 0.001). CONCLUSION: Ethical practices will improve the quality and integrity of dermatology research.

[Treatment of the human body : the possibilities and limits of plastic surgery]. / Die Bearbeitung des menschlichen Körpers : Möglichkeiten und Grenzen der plastischen Chirurgie.

The desire for authenticity is often cited as a motive for making use of plastic surgery. This article aims to elaborate on the meaning of this particular authenticity. At the same time, it discusses reasons that justify or forbid a plastic surgery intervention in the light of ethics. For this purpose, a distinction is made between "objective body" (Körper) and "subjective body" (Leib), and the objectives of medical actions are questioned. Through the terminological differentiation between integrity (Integrität), prosperity (Wohlergehen), and well-being (Wohlbefinden), these objectives are qualified and the limits of medical actions are determined.

Wish-fulfilling medicine in practice: the opinions and arguments of lay people.

BACKGROUND: Wish-fulfilling medicine appears to be on the rise. It can be defined as 'doctors and other health professionals using medical means (medical technology, drugs, and so on) in a medical setting to fulfil the explicitly stated, prima facie non-medical wish of a patient'. Some instances of wish fulfilling medicine can be understood as 'human enhancements'. AIM: The aim of this study is to map the normative opinions and arguments of lay people about wish-fulfilling medicine. METHODS: We conducted a qualitative study with lay people (five focus groups). We asked their opinions about five cases and the arguments for these opinions. Furthermore, we enquired about the role of the medical profession and the treating physician, and whether the participants saw a role for the government. RESULTS: The opinions and arguments used varied according to the example discussed. For instance, increased familiarity with a procedure like breast enhancement seems to garner more acceptance for that procedure, whereas completely new examples were considered less acceptable. Various different arguments were raised in focus groups; these included: people should be allowed to make up their own minds about this (autonomy); payment of the treatment; and concerns about risks. DISCUSSION: An ethical analysis of the emerging practice of wish-fulfilling medicine should take the normative views of all parties involved into account. Thus, it is important to establish what lay people think about wish-fulfilling medicine and in particular their arguments.

The Ethics of Stem Cell-Based Aesthetic Surgery: Attitudes and Perceptions of the Plastic Surgery Community.

BACKGROUND: The emerging field of stem cell-based aesthetics has raised ethical concerns related to advertising campaigns and standards for safety and efficacy. OBJECTIVES: The authors sought to characterize the attitudes of plastic surgeons regarding the ethics of stem cell-based aesthetics. METHODS: A cross-sectional electronic survey was distributed to 4592 members of the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons. Statements addressed ethical concerns about informed consent, conflicts of interest, advertising, regulation, and stem cell tourism. An agreement score (AS) from 0 to 100 was calculated for each statement. Majority agreement was designated as ≥60 and majority disagreement as ≤40. RESULTS: A total of 770 questionnaires were received (16.7%). The majority of respondents indicated that knowledge regarding the risks and benefits of stem cell procedures is insufficient to obtain valid informed consent (AS, 29) and that direct-to-consumer advertising for these technologies is inappropriate and unethical (AS, 23). Most respondents reported that patients should be actively warned against traveling abroad to receive aesthetic cell therapies (AS, 86) and that registries and evaluations of these clinics should be made publicly available (AS, 71). Even more respondents noted that financial conflicts of interest should be disclosed to patients (AS, 96) and that professional societies should participate in establishing regulatory standards (AS, 93). CONCLUSIONS: The plastic surgeons surveyed in this study support a well-regulated, evidence-based approach to aesthetic procedures involving stem cells.

Cosmetic neurology: the role of healthcare professionals.

In an age of modern technology and an increasing movement towards a 24-h working culture, life for many is becoming more stressful and demanding. To help juggle these work commitments and an active social life, nootropic medication, (the so-called 'smart pills') have become a growing part of some people's lives. Users claim that these drugs allow them to reach their maximal potential by becoming more efficient, smarter and requiring less sleep. The use of these medications and the role of health professionals in their distribution raises many ethical questions.

Female genital cosmetic surgery.

OBJECTIVE: To provide Canadian gynaecologists with evidence-based direction for female genital cosmetic surgery in response to increasing requests for, and availability of, vaginal and vulvar surgeries that fall well outside the traditional realm of medically-indicated reconstructions. EVIDENCE: Published literature was retrieved through searches of PubMed or MEDLINE, CINAHL, and The Cochrane Library in 2011 and 2012 using appropriate controlled vocabulary and key words (female genital cosmetic surgery). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to May 2012. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table). Recommendations 1. The obstetrician and gynaecologist should play an important role in helping women to understand their anatomy and to respect individual variations. (III-A) 2. For women who present with requests for vaginal cosmetic procedures, a complete medical, sexual, and gynaecologic history should be obtained and the absence of any major sexual or psychological dysfunction should be ascertained. Any possibility of coercion or exploitation should be ruled out. (III-B) 3. Counselling should be a priority for women requesting female genital cosmetic surgery. Topics should include normal variation and physiological changes over the lifespan, as well as the possibility of unintended consequences of cosmetic surgery to the genital area. The lack of evidence regarding outcomes and the lack of data on the impact of subsequent changes during pregnancy or menopause should also be discussed and considered part of the informed consent process. (III-L) 4. There is little evidence to support any of the female genital cosmetic surgeries in terms of improvement to sexual satisfaction or self-image. Physicians choosing to proceed with these cosmetic procedures should not promote these surgeries for the enhancement of sexual function and advertising of female genital cosmetic surgical procedures should be avoided (III-L) 5. Physicians who see adolescents requesting female genital cosmetic surgery require additional expertise in counselling adolescents. Such procedures should not be offered until complete maturity including genital maturity, and parental consent is not required at that time. (III-L) 6. Non-medical terms, including but not restricted to vaginal rejuvenation, clitoral resurfacing, and G-spot enhancement, should be recognized as marketing terms only, with no medical origin; therefore they cannot be scientifically evaluated. (III-L).

Objectif : Fournir aux gynécologues canadiens des directives factuelles en matière de chirurgie esthétique génitale chez la femme, en réponse au nombre grandissant de demandes (et d'interventions) de chirurgie vaginale et vulvaire se situant bien au-delà des reconstructions traditionnellement indiquées sur le plan médical. Résultats : La littérature publiée a été récupérée par l'intermédiaire de recherches menées dans PubMed ou MEDLINE, CINAHL et The Cochrane Library en 2011 et en 2012 au moyen d'un vocabulaire contrôlé et de mots clés appropriés (« female genital cosmetic surgery ¼). Les résultats ont été restreints aux analyses systématiques, aux essais comparatifs randomisés / essais cliniques comparatifs et aux études observationnelles. Aucune restriction n'a été appliquée en matière de date ou de langue. Les recherches ont été mises à jour de façon régulière et intégrées à la directive clinique jusqu'en mai 2012. La littérature grise (non publiée) a été identifiée par l'intermédiaire de recherches menées dans les sites Web d'organismes s'intéressant à l'évaluation des technologies dans le domaine de la santé et d'organismes connexes, dans des collections de directives cliniques, dans des registres d'essais cliniques et auprès de sociétés de spécialité médicale nationales et internationales. Valeurs : La qualité des résultats est évaluée au moyen des critères décrits dans le rapport du Groupe d'étude canadien sur les soins de santé préventifs (Tableau). Recommandations 1. Un des rôles importants des obstétriciens-gynécologues devrait consister à aider les femmes à comprendre leur anatomie et à en respecter les variantes qui leur sont propres. (III-A) 2. Lorsqu'une femme demande la tenue d'interventions esthétiques vaginales, une anamnèse médicale, sexuelle et gynécologique exhaustive devrait être obtenue et l'absence de tout dysfonctionnement sexuel ou psychologique majeur devrait être établie. La présence possible de coercition ou d'exploitation devrait également être écartée. (III-B) 3. Le counseling devrait constituer une priorité dans le cas des femmes qui demandent la tenue d'une chirurgie esthétique génitale. Les sujets abordés dans le cadre du counseling devraient comprendre les variations normales et les modifications physiologiques qui se manifestent au cours de la vie, ainsi que la possibilité de connaître des conséquences imprévues à la suite de la tenue d'une chirurgie esthétique visant les organes génitaux. Le manque de données en ce qui concerne les issues de la chirurgie et les effets des modifications subséquentes attribuables à la grossesse ou à la ménopause devrait également faire l'objet de discussions et être considéré comme faisant partie du processus de consentement éclairé. (III-L) 4. Peu de données soutiennent l'amélioration de la satisfaction sexuelle ou de l'image de soi qui serait attribuable aux interventions de chirurgie esthétique génitale chez la femme. Les médecins qui choisissent de procéder à de telles interventions esthétiques ne devraient pas en faire la promotion à des fins d'amélioration de la fonction sexuelle; de surcroît, le recours à la publicité pour promouvoir les interventions de chirurgie esthétique génitale chez la femme devrait être évité. (III-L) 5. Les médecins qui reçoivent des demandes de chirurgie esthétique génitale de la part d'adolescentes doivent chercher à obtenir des compétences additionnelles en ce qui a trait à l'offre de services de counseling aux adolescentes. De telles interventions chirurgicales ne devraient pas être offertes avant l'atteinte de la pleine maturité physiologique (y compris la maturité génitale); le consentement parental n'est alors pas requis. (III-L) 6. Les termes non médicaux (y compris, entre autres, le rajeunissement vaginal, le resurfaçage clitoridien et l'augmentation du point G) devraient être reconnus comme n'étant que des termes de marketing, sans aucune origine médicale; ainsi, ils ne peuvent faire l'objet d'une évaluation scientifique. (III-L).

[The modern body image as ethical device for biomedical enhancement]. / Das körperbild der neuzeit als ethisches dispositiv für biomedizinisches enhancement.

Ovid's "De medicamine faciei feminae" contains the astonishing sentence "Culta placent - all that is artificial is beautiful". In his "Éloge du maquillage" Baudelaire, buidling on Ovid's argument, states that first culture as picture and construction of beauty brings forth the truth of Nature and claims that cosmetics that allow errors of beauty to disappear artificially produce the true fulfillment of human nature. The present article looks into the historical roots of the body images that have emerged in modern times and attempts to derive structural devices for an ethical assessment of the potential we have to enhance human nature.

Human adjuvant disease induced by foreign substances: a new model of ASIA (Shoenfeld's syndrome).

OBJECTIVE: To investigate the clinical, laboratory and histological manifestations of patients who received illegal injections of foreign substances for cosmetic purposes. PATIENTS AND METHODS: We studied patients who met the following inclusion criteria: 1) history of application of foreign substances for cosmetic purposes, 2) clinical data of autoimmune disease or non-specific autoimmune manifestation (i.e. arthralgias, myalgia, malaise, fever, and weight loss), 3) detection of autoantibodies in patients' sera, 4) histological evidence of chronic inflammation and/or granulomatous reaction to foreign body. RESULTS: Fifty female patients aged 44.4 ± 10 years were studied. The mean time between application of foreign substances and onset of symptoms was 4.5 ± 4.3 years. Patients were followed for 12 ± 7.5 years. Forty-one patients were injected with mineral oil, nine patients received other substances: three iodine gadital, one guayacol, one guayacol plus silicone fluid, two collagen, two silicone fluid. The sites of application were: buttocks (36), legs and/or thighs (11), breasts (eight) hands and face (one), face (two) (seven patients received an injection to more than one site). Thirty patients presented with non-specific autoimmune manifestations, whereas 20 patients fulfilled the criteria for a defined autoimmune disease such as systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, overlap syndrome, autoimmune hemolytic anemia, autoimmune thyroiditis, autoimmune hepatitis, and ulcerative colitis. CONCLUSIONS: Cases of human adjuvant disease following illegal injections of oil substances for cosmetic purposes are reported. Patients presented with defined autoimmune diseases as well as with non-specific autoimmune manifestations. Illegal injection of these substances could lead to serious local and systemic complications, even to death. These cases represent another model of Autoimmune/inflammatory Syndrome Induced by Adjuvants (ASIA). The use of these substances should be prohibited.

Wish-fulfilling medicine in practice: a qualitative study of physician arguments.

There has been a move in medicine towards patient-centred care, leading to more demands from patients for particular therapies and treatments, and for wish-fulfilling medicine: the use of medical services according to the patient's wishes to enhance their subjective functioning, appearance or health. In contrast to conventional medicine, this use of medical services is not needed from a medical point of view. Boundaries in wish-fulfilling medicine are partly set by a physician's decision to fulfil or decline a patient's wish in practice. In order to develop a better understanding of how wish-fulfilling medicine occurs in practice in The Netherlands, a qualitative study (15 semistructured interviews and 1 focus group) was undertaken. The aim was to investigate the range and kind of arguments used by general practitioners and plastic surgeons in wish-fulfilling medicine. These groups represent the public funded realm of medicine as well as privately paid for services. Moreover, GPs and plastic surgeons can both be approached directly by patients in The Netherlands. The physicians studied raised many arguments that were expected: they used patient autonomy, risks and benefits, normality and justice to limit wish-fulfilling medicine. In addition, arguments new to this debate were uncovered, which were frequently used to justify compliance with a patient's request. Such arguments seem familiar from conventional medicine, including empathy, the patient-doctor relationship and reassurance. Moreover, certain arguments that play a significant role in the literature on wish-fulfilling medicine and enhancement were not mentioned, such as concepts of disease and the enhancement-treatment dichotomy and 'suspect norms'.

[Human enhancement: three uses, three issues]. / L'amélioration humaine - Trois usages, trois enjeux.

The term human enhancement refers to a set of actual or proposed actions that aim to increase the potential of the human body, and even create new ones. Most of these actions are based on a reorientation of biomedical techniques used in medical practice, but now also appeal to converging technologies. This article distinguishes three uses of the English term, according to the meaning given to the adjective "human": improvement of human capacities, improvement of human nature, self-improvement. These layers of meaning stem from different contexts but all draw on longstanding currents of thought. It is this collusion of old ideas and new means that is expressed in the term human enhancement.

[Ethical aspects of aesthetic medicine]. / Ethische Aspekte der ästhetischen Medizin.

The article examines the question whether and - if - under which conditions physicians should perform purely esthetic interventions. Starting point of the considerations is the special character of the medical profession and the necessity of the anticipated confidence in the system of medicine. The medical measures for aesthetic improvement are systematized. Medical measures to increase the wanted, positively felt attention of others are not compellingly required according to the medical ethic. Nevertheless they do not offend the ethos if high quality standards are insured: The measures must be presumably helpful for the patient; a thorough informed consent and avoidance of damage must be insured. Esthetic measures, in particular operations which are totally cosmetic, should be limited strictly if performed with children and adolescents. Nevertheless convincing arguments support medical-esthetic measures with children and adolescents to avoid stigmatization.

Stem cells in aesthetic dermatology: bioethical and professional obligations.

Recently, stem cells in aesthetics have attracted increased attention, especially as they have become a popular trend that is being mass-marketed to consumers on the Internet and social media. Unfortunately, studies have shown this marketing to be misleading as it portrays many purported benefits of stem cells that have yet to be proven in the limited studies that are available. It is important for clinicians to understand the evidence and marketing behind any new trends, especially in the fast-paced world of aesthetics, where treatments often outpace current medical understanding. As clinicians, we have bioethical and professional obligations to educate ourselves on current trends, ensure adequate patient safety, and advocate for continued consumer education.

The Public's Preferences on Plastic Surgery Social Media Engagement and Professionalism: Demystifying the Impact of Demographics.

BACKGROUND: Social media discussions are alive among plastic surgeons. This article represents a primer on beginning to understand how the public would seek out plastic surgeons and how demographics shape their preferences. METHODS: An anonymous 31-question survey was crowdsourced by means of MTurk. RESULTS: There were a total of 527 respondents. Of these respondents, 33 percent follow plastic surgeons on social media, with those aged younger than 35 years 3.9 times more likely to do so. Google was the first place people would look for a plastic surgeon (46 percent). When asked what was the most influential of all online methods for selecting a surgeon, practice website ranked first (25 percent), but social media platforms ranked higher as a whole (35 percent). Those considering surgical or noninvasive procedures are thee times more likely to select social media platforms as the most influential online method in selecting a surgeon and five times more likely to follow a plastic surgeon on social media. The majority would prefer not seeing the surgeon's private life displayed on social media (39 percent). Respondents were evenly split regarding whether graphic surgical images would lead them to unfollow accounts. Ninety-six percent of the general public were unclear of the type of board certification a plastic surgeon should hold. CONCLUSIONS: Clear differences in engagement and perception exist in the public based on age, sex, parental status, and reported country of origin. Social media will soon become a critical strategy in outreach and engagement and a valuable tool in clearing misconceptions within plastic surgery.