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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_612_Библиотеки_им_академика_М_И_Перельмана
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Medical journals adopted the practice of inclusion of levels of
evidence earlier than did surgical journals. The majority of articles in
Plastic and Reconstructive Surgery (PRS), the primary plastic
surgery journal in the United States, are levels 4 and 5.16 Level 1
studies are increasing, albeit slowly, and fewer than 5% of published
studies in PRS are level 1. The quality of the study also affects its
level. A less rigorously designed RCT will qualify as a level 2 study
rather than a level 1. Poorly designed studies are ethically
problematic as they have consumed time, money, and effort, and
subjects may have been exposed to nonstandard treatments through
participation. Subjects may also feel an ethical obligation to help
others through participation in research, and by not respecting this
contribution on the investigator side, any potential sacrifice on their
part is devalued.
As was noted previously, the quality of the best evidence in the
field of plastic surgery is low. In the absence of high-level evidence,
scouting the literature to identify themes in current evidence may
provide improved guidance for the care of the individual patient over
sole reliance on historical precedent and expertise.15 Wieten
discusses the epistemic challenges of considering expertise as a
type of evidence as seen in the initial pyramidal model of evidence.
Expertise is the professional skill applied to using evidence in patient
care; it itself is not evidence.
15
Evidence-based medicine (EBM) comprises the combination of the
highest level of existing research evidence, a clinician’s expert
knowledge, and patient preferences. Research evidence is what
many physicians think of when thinking of EBM, and there has been
historical hesitancy in the adoption of EBM when it is viewed as a
threat to professional autonomy. Rather than diminishing
professional autonomy, incorporating the best evidence with
personal experience and patient goals should result in a mutually
agreeable care plan. Shared decision-making (SDM) is yet another
recent development in optimizing communication between patient
and provider. Autonomy alone is inadequate without the education
and knowledge provided by the physician. As opposed to a
traditional one-sided discussion of treatment options, SDM is a more
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fluid, mutual, and natural discussion of options, risks, and benefits,
but there is little evidence that it is being routinely practiced in
medical encounters. The inherent power differential between
physician and patient, limited clinic time, and patient preferences for
a more paternalistic style all compete with the worthy goals of SDM.
Galasinski et al proposed that the action of SDM is one of justice: it
treats patients as autonomous agents and provides them the
opportunity to learn as much as they can about the complexities of
their care while reaping benefits of comprehension and
engagement.17 A shared conversation is the true beginning of
informed consent.
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ETHICAL ISSUES AT THE INTERSECTION OF
PLASTIC SURGERY AND THE LARGER MEDICAL
SYSTEM
The goals of medicine, broadly, are moral ones: to prevent disease,
promote health, relieve pain and suffering, care and cure when
possible, and avoid premature death.18 Setting such goals creates
boundaries around the actions which are considered medical, and
which are the responsibility of medical professionals. There has
been goal creep over several decades, made slightly more
problematic by the World Health Organization’s definition of health:
“a state of complete physical, mental and social well-being and not
merely the absence of disease or infirmity.”19 This broad definition
could technically make most aspects of life and society the
responsibility of the field of health care. Over the past century, health
and life span have been markedly (though far from globally)
improved through public health measures (eg, safer water supplies,
access to plumbing, and vaccinations), medications, improved
surgical technique, and application of medical technologies.
Transplantation Medicine
Plastic surgeons have contributed to the goals of medicine in novel
and powerful ways. At the forefront was Joseph Murray, MD, who
was awarded the Nobel Prize for his work in transplant
immunology.20 In the past several decades, plastic surgeons have
carried on with the work, performing basic science investigations
which have translated to successful composite tissue allografting of
the face and hands. Despite a significant degree of initial resistance
related largely to ethical concerns, work persisted, and complication
rates were found to be lower than expected in both hand and facial
allotransplantation. Hand transplantation has now become the
standard of care in certain situations.21 Facial transplantation was
met with greater pushback. To build support for the procedure,
surgeons at the University of Louisville created an interdisciplinary
team to create ethics guidelines for facial allotransplantation. The
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guidelines were sent to multiple reviewers, feedback was
incorporated, and the document was published in multiple journals.
20
Their methods and principles could be translated to other complex
and controversial high-risk topics crossing disciplinary lines. Key
points include (1) broad preparatory preclinical research, (2) creation
of a team with all necessary skills, (3) transparent plans discussed
with professional and lay audiences with consideration of concerns,
(4) doing the work in an ethical environment, (5) adequate
preparatory animal research, (6) having informed subjects, (7)
assuring an appropriate risk-benefit ratio, (8) demonstrating a valid
medical need, (9) maintenance of patient confidentiality, and (10)
obtaining regulatory approval. Research into patient values and
preferences has shown that the procedure, despite its risks, is
preferable to a life without a socially acceptable face. Few penile
transplantations have been performed worldwide, but this is likely an
area of unmet need given recent war injuries. Pathways like those
for hand and face transplantation have also been proposed.
22
Gender-Affirming Care
Gender-affirming surgery has been pioneered by plastic surgeons,
and this field has grown rapidly since the middle of the 20th
century.23 The World Professional Association for Transgender
Health is a multidisciplinary, international organization with the
mission to develop evidence-based care, perform research, develop
policies, and promote respect for transgendered and gender-diverse
persons. Affected persons historically have been marginalized and
discriminated against, resulting in high rates of interpersonal
violence, stress, chronic medical disease, social isolation, and
suicide.
24,25
Achieving gender congruence has been shown to
improve mental status and decrease suicidal ideation.25 An
inadequate number of trained surgeons are available to care for this
patient population, and few specialized training programs exist.
Surgical educators have discussed the need to be able to provide
equitable care for this underserved group, but more program
directors feel that training in top (ie, cephalad to the umbilicus)
surgery rather than bottom (ie, perineal) surgery is more valuable.
24
Bottom surgery has less long-term outcomes data and greater
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associated surgical risks, and there are plastic surgeons and
trainees who do not believe that the risk-benefit profile has been
adequately reached. For these reasons, trainees could make a valid
ethical argument against participating in bottom procedures.
24
Cosmetic Surgery
Philosophers have raised the question whether cosmetic surgery lies
within the scope of medicine. If we review the goals of medicine
listed above, cosmetic surgery has no preventive or curative
functions, and no obvious promotion of health or delay of death,
though it may relieve suffering.
26,27
The reason for determining what
lies within the scope of medicine (the inside-outside question) is
important given the global increase in need for medical care, the
increasing breadth and expense of options available to disease, and
whether a nation’s health care is primarily privately or publicly
funded. Although most cosmetic surgery procedures are paid for outof-pocket, the care is usually performed within hospitals and
hospital-owned surgery centers, and complications may be paid for
by health insurance or public health systems. It has been argued that
cosmetic surgery patients are using resources that could be used for
patients with traditionally diagnosed diseases and that their surgical
fees do not cover indirect costs of nursing care, materials, or the use
of physical space. It is probable that society is subsidizing the care of
patients who choose to have cosmetic surgery. Given the above
ethical questions, cosmetic surgery has been placed at the edge of
medicine by philosophers.27 Two practices that have been used to
attempt to expand the scope of what is defined as disease, and,
therefore, which should be considered within the sphere of medicine,
are medicalization and pathologizing.
Medicalization and Pathologizing
Medicalization is the practice of defining a phenomenon in medical
terms rather than in “social, political, or existential ones.”28 If one of
the goals of medicine is to promote health, the broad WHO definition
of health makes it possible for most aspects of life to be viewed
under a medical lens. Potential problems arising from this viewpoint
include (1) “blurred lines of responsibility between and among the
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professions”, (2) a view that socially mediated unhappiness is
something which can and should have a medical treatment, and (3)
disease mongering (creation of and marketing for diseases that “do
not exist”). Examples of conditions which fall under the category of
medicalization are mild restless legs syndrome, mild attentiondeficit/hyperactivity disorder, male pattern baldness, and asymmetry
of labia as an indication for labiaplasty.
28
Pathologizing is defined as viewing normal variation as a disease
that must be addressed by medical or surgical means (disease
framing). Nonsurgeons have expressed concern that language
commonly used in association with disease (eg, hypertrophy,
proliferating, gaunt, disfiguring, bulbous) has been co-opted to
describe normal-variant anatomic features in patients who are
diagnosed with cosmetic problems.26 This is thought by some
ethicists to be an attempt to create medical “legitimacy” in a setting
of questions of cosmetic concerns. As all physical conditions exist on
a spectrum, so can all viewpoints regarding the treatment of what
can be subtle distinctions. Given that some critics have never had
direct interaction with plastic surgeons or plastic surgery patients,
external viewpoints are usually more often based on theory rather
than practice.
Discussions by ethicists, feminists, and legal scholars have
focused on the contrasting arguments that cosmetic surgery is a
form of oppression by society requiring that its members conform to
a society-mediated norm versus the argument that cosmetic surgery
empowers people and facilitates them to take control over their
lives.
26,28
It is true that attractive people are usually more socially and
financially successful and that broad social forces increasingly
attribute positive characteristics to the attractive, creating a market
and desire for cosmetic surgery procedures. Ethicists have also
questioned whether cosmetic surgery creates lasting happiness and
whether the “client/service provider” relationship differs from the
standard doctor/patient one.
29
Labiaplasty as a Case Example
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Labiaplasty is a relatively small procedure which has generated
considerable worldwide controversy. The numbers of women
undergoing the procedure have increased rapidly over the past
20 years. The number almost tripled in the United Kingdom from
1998 to 2008, and data are similar in the United States.30 In 2008,
six cases of labiaplasty were submitted by all candidates to the
ABPS for the Oral Examination. The numbers have steadily
increased to a total of 96 cases in 2022 (data provided by the
ABPS). Popularization of the procedure has been related to an
increased rate of pubic hair removal and making the labia more
visible; furthermore, the increased exposure to pornography has
created new norms of “ideal,” prepubescent-appearing, vulvas.
Patients with physical complaints of pain and chafing may have
become more aware of the surgical option. Female genital cosmetic
surgery, a broader group of procedures which includes labiaplasty,
vaginal tightening, labial augmentations, hymen reconstruction,
perineum rejuvenation, and clitoral hood resection, has also become
widely advertised and performed, and just as widely maligned by
obstetricians’ and gynecologists’ professional organizations.31 ACOG
professional organizations in at least five countries have spoken out
against the practice because of a lack of sufficient evidence
supporting utility, an undetermined degree of risk, and variable and
imprecise surgical indications.
30,31
Prospective outcomes studies are
lacking (though this is not unusual in the field of plastic surgery) and
research has primarily consisted of techniques papers and small
case reports and case series. No validated outcomes measures
have been developed, and outcomes are generally only documented
in the short term. Additionally, psychological evaluation is not
commonly discussed. Research has documented large variations in
normal anatomy, raising questions about the definition of normal. For
instance, one study found no difference in the size of labias between
women who wanted labiaplasty compared to those who did not.32 In
applying the ethical principles of autonomy, nonmaleficence, and
beneficence, labiaplasty appears ethical: adult women have agency,
published complication rates are low, and published benefits
demonstrate a high rate of patient satisfaction with the procedure.
Published complication rates range from 2% to 28% and are
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generally minor. Outcomes are generally based on satisfaction rather
than functional improvement.
33,34
A recent meta-analysis of 3804
labiaplasty patients showed a high satisfaction rate (99%), a large
degree of study heterogeneity, and a relatively low complication rate
(8% hematomas, 5% dehiscence, 2% transient pain, and 4%
revision).35 Arguments against the autonomy claim are that coercion
in the form of advertising, testimonials, and social pressure may
negate a truly autonomous choice.30 An additional argument against
the procedure is that advocating a uniform appearance promotes
another potential source of social anxiety. Investigators have
expressed disagreement with the critic’s recommendation for
counseling alone, as the procedure appears to be reasonably safe
and effective with a high reported satisfaction rate. As with many
conditions treated by plastic surgeons, the degree of abnormality in
patients presenting for treatment ranges from that causing pain and
dysfunction to more subtle differences causing psychological
dissatisfaction.
It may be tempting to discount the viewpoints of nonsurgeons, but
plastic surgeons do have a societal and professional obligation to
demonstrate that treatments are indicated, safe, and effective. If our
practices are viewed as unsafe or unethical, our professional rights
and responsibilities of self-regulation could be challenged. Recent
patient safety concerns related to cosmetic surgery in Australia led to
creation of a new “endorsement of registration in cosmetic surgery”
pathway, more stringent rules on advertising, and the mandatory use
of general practitioners (GP) as gatekeepers before referrals to
cosmetic surgeons can be made.36 Patients will be required to
discuss their motivation for cosmetic surgery with their GP as a
safety measure. In the state of Florida, the rate of complications
related to gluteal fat grafting led to the emergency passage of a law
requiring the use of ultrasound during gluteal fat augmentation to
avoid inadvertent penetration of the superficial gluteal fascia and
risking fat embolization and death.
37
Within the world of plastic surgery, we believe that we provide
effective and appropriate surgical care, whether cosmetic or
reconstructive, but we have yet to demonstrate much of our
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knowledge to the medical world in an evidence-based manner. To
epistemically know that we are providing effective, reproducible, and
individualized patient care—especially in the cosmetic surgery realm
—requires improved research as well as communication with our
critics.
SOCIAL MEDIA
The rapid growth of social media has been viewed as useful for the
marketing of plastic surgery practices and for patient education, but it
has also raised ethical concerns about physician professionalism,
appropriateness, and patient privacy. Patients may not be able to
distinguish trained plastic surgeons from other cosmetic surgeons
and may be subjected to misleading advertisements.38 Patients may
not understand that once photographs of themselves are on the
internet, there is no way of ensuring their removal. Live streaming
surgical procedures has been used as a format for patient education,
but can easily cross the border into entertainment (“medutainment”),
which may appear to trivialize surgery, diminish patient dignity, and
weaken the doctor-patient relationship.39 It is important that surgeons
be thoughtful and professional when discussing with their patients
about the potential risks of posting images online while also
behaving in a manner respectful of patients’ dignity. A social media
toolkit has been created by the ASPS which covers key ethical
issues such as misrepresentation, the use of photographs, obtaining
informed consent, and interacting with followers. It should be
reviewed by all surgeons, their office staff, and companies hired to
create web content for their practices.
INNOVATION
Plastic surgeons often use the words creative, innovative, and
artistic to describe their work, and efforts to curb actions that are
seen as part of our heritage may be met with resistance and
concerns of infringement on our surgical autonomy. It is common
and expected that practices will change over time, but when does
this become an ethical concern? Adoption of novelty falls along a
spectrum ranging from variations to innovation to research.
40
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Variations are small alterations that may be dependent on the
patient’s particular anatomy and are unlikely to add risk. If a decision
is made preoperatively to choose one of the several equivalent
options once the anatomy is better identified, that should be
discussed with the patient and documented in the medical record.
Examples of variations could be adding a derotational Kirschner wire
(K-wire) after plating a fracture to add stability or identifying a large
perforating vessel that changes the planned position of a
fasciocutaneous flap. At the other end of the spectrum, research is
designed to contribute to generalizable knowledge and requires
Institutional Review Board (IRB) approval and informed consent for
participation by the patient. Examples include randomizing patients
to one of the two surgical treatments or to different methods of
chemoprophylaxis for deep venous thrombosis. Innovation lies
between and can be a modification of a standard technique or the
use of a novel technique. Innovations may not be completely novel
but may be novel to an individual surgeon, and innovations may be
made because an initial operative plan was not found to be
workable. An example of the former could be using an intramedullary
screw for fracture fixation rather than a bouquet of multiple K-wires.
An example of the latter could be wrapping a nerve repair site with
muscle because the hospital’s supply of nerve wraps had expired.
The patient may be subject to increased risk with innovations, and
the innovation should be disclosed to the patient or their
representative. To aid surgeons in understanding when an innovation
should be reviewed by an IRB, the Society of University Surgeons
created a position statement regarding ethical practices surrounding
innovation and refers surgeons to a list of innovations on the
American College of Surgeons website.
40
CONCLUSION
Plastic surgery is a fascinating and broad field that has tremendous
capacity to improve our patients’ quality of life. Key areas of focus
should be to act in our patients’ best interest, treat patients and
colleagues with respect, communicate appropriately and sensitively,
and act in ways that maintain the dignity of our profession. As is
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