Keywords
facial plastic surgery - emerging technologies - minimally invasive - facelift - face
tightening
The practice of facial plastic surgery lends itself more completely to a scientific
art form than, arguably, any other field of medicine. Several factors come into play
when deciding the most optimal course of action in any respective clinical situation.
And, like the most complicated and integral fields, each variable can have its own
set of consequences.
Facial plastic and reconstructive surgery (FPRS) includes both surgical and nonsurgical
aspects, adding both a secondary arsenal of care and an additional layer of complexity
in decision-making for the best course of action. A patient who presents with an aesthetic
nasal complaint can be presented with a variety of options ranging from less invasive
filler sculpting to various types of rhinoplasty approaches; oftentimes, patients
bring specific requests such as a particular type of filler for a “liquid rhinoplasty”
or an off-label use of a new laser device. These sorts of situations and several others
require sober-minded approaches to determine the best and safest way to approach and
satisfy patient goals and wishes. This is particularly true when incorporating a new
tool into the care plan.
In our field, a series of options can exist for patient complaints or desire. The
decision process in determining the “best course” of action is a complex one and may
seem mired by situational settings. A discussion of factors that come into play when
assessing and determining the best options, in the evaluation of emerging technologies
and treatments, is the objective of this article. A basic and practical method of
analyzing a new technology would include identifying and investigating questions that
relate to the risk/benefit assessment, utility, and outcomes compared with others.
In addition, an exclusive set of introspective questions should be asked in regard
to the ethical dilemmas that may arise from incorporating a new technology into your
practice. Finally, the informed consent is the most crucial part of the determination
of whether or not to employ an emerging technology in each specific case.
Risk–Benefit Assessment
Risk Analysis
In practical terms, the author begins with assessing the risks and possible untoward
consequences. This is the most consistent method following the overarching physician
tenet, “first do no harm.” Familiarize yourself with all of the possible complications
and negative aspects. Be prepared for situations where your consideration does not
go beyond this stage, and certain risks should be considered beyond the comfort zone
of the surgeon to consider proceeding.
An up-to-date empirical analysis of data that would allow the surgeon to determine
and assess the risk-to-benefit profile should be developed. For medical devices, use
the Food & Drug Administration's (FDA) up-to-date medical device safety Web site https://www.fda.gov/medical-devices/medical-device-safety. This can help to determine if there are any glaring risks or recent warnings about
the device in question. A search for the name of the device or technology on the FDA
Web site may help gather more information. Any liabilities that are listed should
be further investigated and considered a very serious risk. Similarly, for medications
or biologic products, the FDA Web site should be visited to determine if there is
any additional information such as medication guides.
Next in the thought process is a focused literature search for knowledge of any and
every possible adverse consequence that could occur. These focused searches are not
as straightforward as one would imagine. PubMed searches are an excellent way to begin;
use of key terms such as “adverse effects,” “risks,” or “complications” in association
with the type of technology is often more productive than searching a specific brand
or product name. For example, prior to incorporating resurfacing lasers into one's
practice, a PubMed search of “complications of resurfacing lasers” gives a variety
of information that could be thoroughly reviewed. These articles include literature
reviews of complications,[1] comparisons of the downtime and effectiveness of different types of resurfacing
and fractional lasers,[2] and assessment articles of the current state of resurfacing.[3] This is a very time-consuming and difficult exercise but one that is a core necessity
to gain insight. Additionally, this can be a very biased exercise if one chooses not
to go through all of the available information and assess it with appropriate credence
insofar as its level of evidence is concerned. It should be noted that these focused
literature searches may also provide further information such as utility and efficacy.
Next, trusted colleagues and mentors, who do not have conflicts of interest with your
practice, are a great source of reliable information. These colleagues would ideally
be ones who have direct experience with the same or similar technology. What they
can potentially offer is an honest opinion about any complications that they did not
consider when they purchased or began utilizing the new technology.
Finally, local and regional specialty society meetings are a great place to have an
open conversation about risks associated with new technologies. However, close attention
should be focused on the sources of information that you use and trust. In particular,
sponsorships of meetings by companies or colleagues who may have a vested interest
should be ascertained by noting financial disclosures.
At this point, you should have established a safety profile based on the extensive
risk analysis that you conducted.
Benefit Evaluation
This is generally the easiest part of your research. In particular, manufacturers
of the product or technology will emphasize what the benefits are and routinely provide
positive studies or data accordingly. Although this may be helpful, it should be assessed
with a careful level of skepticism on account of the one-sidedness that may be provided.
Although patients tend to ask for particular products, the benefits that they are
often presented may often seem overly ambitious.
One objective method of benefit determination, in our field, is photo analysis. You
may be presented with before and after photos of a minimally invasive radiofrequency
device that promotes skin tightening/facial rejuvenation. Alternatively, you may be
presented with literature on a new injectable filler whose viscosity is claimed to
be ideal for lip augmentation and given molecular composition data to support this.
Either of these situations requires you to be a clinical investigator and determine
whether or not this makes sense. Photos can be deceiving if they do not follow standardized
methods, and data on the properties of an injectable require attaining a certain knowledge
base prior to making an informed decision (i.e., an understanding of the rheology
involved in different fillers).
An additional source of excellent information comes from the American Academy of Facial
Plastic and Reconstructive Surgery's (AAFPRS) Emerging Trends & Technology Committee.
Their stated goal is to “review and disseminate information on innovations in treatment,
surgical procedures, implants and other devices; recommend policies relating to surgical
techniques and devices in the interest of providing the best possible care for patients”[4]
At this point, you can formulate a risk–benefit assessment. This can be quite difficult
because individual clinicians have unique perspectives. It must be emphasized that
the role of determining the risk-to-benefit profile is on the physician and should
be explained to the patient with full disclosure in understandable terminology for
informed consent (discussed further in the Ethical Considerations section). FPRS practitioners
are accustomed to situations where patients have an excellent knowledge of what they
want; however, it should be understood that a lot of the information that a patient
may have on new technologies/products is often based on direct to consumer advertising.
In a 2018 study that sought to evaluate the risk versus benefit information provided
in television ads for prescription drugs, Fahim et al determined that a lack of consistency
exists and even found that a large number of those with black box warnings did not
communicate these in advertising.[5] This highlights the point that sufficient risk-to-benefit information is not always
available to our patients without direct physician input. Because there is no universally
accepted exact formula for the risk-to-benefit ratio that is acceptable for adopting
a new technology, a detailed explanation to the patient can help them determine their
wishes and assess what is acceptable to them.
Utility and Outcomes
Several factors are involved in determining whether or not there is utility in employing
a new technology. First, the practitioner has to determine whether it will add a useful
instrument to their arsenal of care and/or whether it can hinder their other tools.
As surgeons, we often consider surgical intervention as the highest yield method for
achieving maximal results, albeit understanding that this is the more invasive approach.
Cosmetic surgeries such as rhinoplasty, facelift, necklift, and blepharoplasty are
generally considered the gold standards for facial enhancement.[6] Accordingly, we may tend to consider effective newer technologies as “temporizing
measures” to achieve some positive results with less risk than surgery until such
time that the patient would prefer to pursue surgery.
Certainly, a very useful new technology is one that would offer improvements without
hindering any future surgical care. As an example, I have offered patients microfocused
ultrasound with visualization (MFU-V) tightening device procedures as a nonsurgical
option to face and neck rejuvenation over the past 8 years. I found that many patients
came requesting this procedure or had this done elsewhere and wanted to consider additional
treatments. Though generally positive (particularly in those with lower body mass
index), the improvement in skin laxity varied at all ages, as consistent with clinical
studies.[7]
[8]
[9] Furthermore, I offer a variety of surgical rhytidectomy procedures tailored to individual
patients. These face and neck lifts span the gamut from plication with local anesthesia
to comprehensive deep plane rhytidectomy under general anesthesia. I found that all
of these surgical options were somewhat altered in patients who had thermal tightening
procedures. Specifically, the dissection and elevation of tissue planes were more
akin to those of revision rhytidectomy procedures, secondary to the thick scar tissue
formed. This led to longer surgical time and more difficult rhytidectomies than what
would be expected in a typical primary aging face patient. This was a finding that
was anecdotally confirmed by several colleagues who have performed similar surgeries.
I came to understand that although there are benefit and utility to the emerging technology
of heat-based skin tightening devices, there is an element of deterrence to the tool
that I consider the gold standard: rhytidectomy. Nonetheless, the technologically
advanced minimally invasive devices do play a significant role in several situations
both as a temporizing measure in certain cases and as an instrument of comprehensive
care in patients who do not plan on undergoing surgery. They add utility in a variety
of settings and certainly add to the armamentarium of the facial plastic surgeon.
Second, in determining utility is a physician examination of the cost-effectiveness
of employing an emerging technology. The answer to this is very intertwined in the
likely settings and patient cohorts that would optimally benefit from this procedure.
In keeping with the prior example, a determination of how many total patients in your
practice would benefit from a new thermal tightening procedure at a particular price
point as compared with the associated costs. To consider this fully, one must start
by examining the capital costs, time/opportunity costs to the physician and their
employees, maintenance and disposable costs, and, of course, the total cost to the
patient. The capital investment involved in purchasing a new thermal skin tightening
device can be upwards of US $100,000. A minimum of 1 hour of time is required for
an effective procedure, and additional time for numbing, patient experience, and comfort
factors. Depending on the setting of your practice, this may be the time that is largely
occupied by the physician themselves and/or an additional essential employee. Disposable
costs can range from hundreds to thousands of dollars per procedure. Patient cost
per treatment can vary in range but would need to be priced in the thousands of dollars
per treatment range just to cover overhead. Offering these sorts of treatments on
occasion is not necessarily cost-effective to a facial plastic surgery practice, whereas
more routine use in the correct patient population would make the most sense. Although
there are options to try to minimize capital costs such as leasing devices, there
should also be consideration of having a reliable subspecialist whom you can trust
to refer these procedures to. Over the years, I have personally evolved from trying
to offer my patients every possible service to appreciating that there is significant
merit and cost-effectiveness in focusing largely on the surgical interventions that
I consider the gold standards, and relying on expert, trusted nonsurgical colleagues
to offer my patients advanced minimally invasive procedures.
Third, even after deciding to employ the new technology, there should be a constant
and up-to-date analysis of outcomes performed by the physician. As physicians, we
strive to be endless learners, and there is no better way to achieve this than to
study and question our own outcomes. Analyzing and reanalyzing long-term results,
standardized before and after photos, and patient experience surveys help achieve
the best possible outcomes. These are methods of gathering data that may help improve
and, in some instances, may lead to changing or abandoning a technology. Further analysis
in comparison with the rest of our surgical arsenal can help us give our patients
the most accurate presentation of options. For example, after analyzing results of
thermal tightening devices used over several years in comparison to my deep plane
rhytidectomy results over those same years, I came to realize that in the very best-case
scenarios the results were approximately 15% as effective. This was approximately
10 to 20% less effective than I had previously realized, and I would not have been
able to learn this without constant comparative analysis. In fact, one of the most
common questions that I receive from patients is one of comparing the effectiveness
of thermal tightening devices to facelift surgery. I make it very clear that there
is no exact science to determining this, but my estimations are based on self-analyzing
prior results and that in my hands, in the best-case scenarios, they are approximately
15% as effective as a surgical rhytidectomy.
At this point, you have determined that the risk-to-benefit profile is favorable,
there is utility in employing this emerging technology, and you anticipate advantageous
outcomes. An ethical analysis of whether adopting the technology in question will
be foremost for the benefit of the patient is the next step.
Ethical Considerations
This may be the most difficult of considerations and requires a significant amount
of clinician introspection to perform effectively. Three specific ethical situational
considerations should be examined: business model, unrecognized health risks, and
informed consent.
Cosmetic Business Models
Cosmetic practitioners earn their income and livelihood from performing elective consultations
and procedures for direct payment. There is no third-party involvement that approves
or denies a procedure based on medical necessity, as is the case with common functional
procedures. This can potentially, even subconsciously, create an inherent bias in
the treatment options our patients are offered. Atiyeh et al describe that “aesthetic
surgery that works only according to market categories runs the risk of losing the view of the real need
of patients … aims to sell something, not to help people.”[10] By their very nature, inherent economic biases can make the clinician feel that
they are promoting the best option by offering a recently acquired emerging technology
to a patient rather than a less expensive and less glamorous option. This is particularly
true if the cost-effectiveness of incorporating a new technology into your practice
requires a large volume of use. A constant self-reflection that involves asking yourself
as a scientist and clinician to eliminate the business aspects involved and determine
which option is the unique patient in front of you most likely to benefit the most
from.
Unrecognized Health Risks
Emerging technologies are so named because they are by definition “becoming apparent.”
Though there is a positive and advantageous connotation associated with emerging technologies,
there are also potential emerging risks that may not become apparent until they have
had sufficient time to declare themselves. The recent history of aesthetic medicine
has proven time and time again that some treatments hailed as advanced beautification
techniques turned out to have terrible consequences. One example is that of facial
injectables for volume restoration. Paraffin injections were utilized in different
parts of the world for decades in attempts to restore facial youthfulness and caused
delayed, severe, and debilitating complications. Public anger to these complications
was so great that historians believed this to have slowed the advancement of cosmetic
surgery.[11] Even modern-day hyaluronic acid fillers, whose safety profiles we often tout as
excellent, have the potentially life-altering risks of vascular compromise, skin necrosis,
and blindness. Though there is no way to predict the future and determine what will
and what will not cause previously unrecognized consequences, watchful waiting for
a short period of time can be paramount to avoiding serious risk. I often counsel
patients and trainees that being one of the first to undergo or use an emerging technology
may be academically exciting but practically problematic.
Informed Consent
The most important ethical aspect of performing an elective procedure is patient consent.
There are subtle discrepancies between the definition of “consent” and that of “informed
consent,” but these play a particularly important role in plastic surgery.[10]
[12] For a patient to make an “informed” decision and consent, they often rely on the
physician explanation. However, when a new technology is involved, there is simply
limited information. Practical and important discussion points include an honest assessment
of your research of and overall experience, no matter how limited, with this new technology.
Certainly, a clear explanation risk-to-benefit analysis, attempted goals of treatment,
and alternatives of care are essential components.
Conclusion
Employing emerging technologies into your practice can be very helpful to your patients
and professionally rewarding. These can open up avenues of growth in your practice
and can allow you to offer more alternatives to patient care. However, prior to adopting
any new technology, a comprehensive and focused assessment needs to be performed.
Risk-to-benefit analysis, utility, clinical outcomes, and ethical considerations should
be the cornerstones of your focused assessment. If and when the decision to employ
an emerging technology into your practice is made, constant monitoring and reevaluations
over time should be performed to assure that it is foremost achieving the goal of
benefiting patients.
