1
Plastic surgery and innovation in medicine
SYNOPSIS
There is a major difference between research and innovation,
though the two are often interrelated.
Most advances in surgery come from innovation rather than basic
research.
Surgical innovation is one of the defining features of plastic
surgery.
Surgical innovation is made safe by defining principles.
A detailed knowledge of anatomy is a major factor on which these
principles are based.
A balance between out-of-the-box thinking and conservative
deliberation is the perfect milieu to effect change yet keep
perspective.
Introduction
We often tell our students that the great thing about
plastic surgery is that we are the last real general sur-
geons. We are not confined to a body area or linked to
a disease, unlike almost every other medical specialty.
Similarly, while there are some operations that are rea-
sonably standardized, plastic surgery is the one spe-
cialty in which this is more the exception than the rule.
We often perform operations that weve never exactly
done before and will likely never do in precisely the
same way again. We almost always have completed
2013, Elsevier Inc. All rights reserved.
Peter C. Neligan
elements of the surgery before, or we may add elements
from another sphere of surgery to create a new approach
to a problem. Sometimes this is born of necessity, the
challenge of solving a unique problem for which there
is no standard or well-accepted solution. Sometimes it
is born of the will to do something better, to solve a
problem in such a way that is better than the accepted
means of dealing with it. When I tell nonmedical people
this they are usually shocked and somewhat appalled.
To the uninitiated it may seem cavalier, even dangerous.
However these innovations are based on principles that
we learn in our training and that we come to apply in
our practice. That is the magic of plastic surgery. Of
course this type of surgical innovation raises ethical
issues and it is something with which many institutions
are struggling, not merely in the domain of plastic
surgery but in the field of surgery in general. Many
institutions already have processes and protocols in
place to oversee and regulate innovation.1 When is
innovation in surgery ethical and when is it not? This
has already been the source of much discussion in the
literature.24 How far can we safely push the envelope?
That particular discussion is beyond the scope of this
chapter. Suffice it to say that it is important to strike a
balance between necessary oversight of research prac-
tices and a supportive environment where research can
flourish.
2 1 Plastic surgery and innovation in medicine
Innovation and research
What is the difference between innovation and
research? Wikipedia (http://en.wikipedia.org/wiki/
Research) defines research as follows: Research can be
defined as the search for knowledge or any systematic
investigation to establish facts. Here (http://en.
wikipedia.org/wiki/Innovation) is the definition for
innovation: Innovation is a change in the thought
process for doing something or new stuff that is made
useful.5 It may refer to an incremental emergent or
radical and revolutionary change in thinking, products,
processes, or organizations. Innovation can come from
research but does not necessarily need to. This is true in
other fields. For example, innovations in the computer
industry are often simple changes introduced to facili-
tate a task, only to sometimes completely change how
things are done. Most of the surgical innovations we see
are not the result of research. In fact, not infrequently,
an innovation is subsequently subjected to more rigor-
ous study. A surgeon may design a new operation or,
for example, a new flap. This may be a variation on an
old procedure or sometimes something completely new.
As already mentioned, it may have been forced on the
surgeon because of the circumstances of the case. There
may be no other way to solve the problem. When it
works the surgeon decides to design a study to explain
why the procedure worked or to describe the blood
supply of the flap. Though one could argue that this is
not the ideal way to do things, it certainly happens6,7
and is merely a reflection of the dynamic nature of sur-
gical innovation. Innovation may be planned or, in the
case of this example and as happens probably more
frequently, be made on the fly. Research may be innova-
tive. A researcher may design a novel experiment to
probe a theory, an approach to the problem that has not
been explored before. This is also innovation and is
more commonly how research and innovation are
linked. An innovative idea is subjected to the scientific
method that research demands. What makes an innova-
tor? It has been said that the characteristics than most
major innovators have in common include: (1) the
ability to recognize an idea; (2) persistence in develop-
ing the strategy; and (3) commitment to the project, and
final completion of a response to the problem or prob-
lems in question.8
Innovation and plastic surgery
The history of plastic surgery, at least the history of
modern plastic surgery, is one of constant development.
We regularly devise new ways of dealing with a particu-
lar problem. We develop a technique, perfect it, and
then either lose it to some other group or give it away.
There are numerous examples of this, from cleft surgery
to microsurgery, from hand surgery to craniofacial
surgery. While some see this as a major problem, I would
argue that it is the lifeblood of plastic surgery. We are
constantly developing new solutions for diverse prob-
lems. Some of these problems are generated from within
our own practices; some come from our interaction with
other specialties. We develop solutions and frequently
allow those other specialties to run with the ball while
we go on to something else. The facility to adapt is
important in all spheres. For example, this ability to
adapt, change, and incorporate new ideas is what has
made English such a dominant language. It is the reason
that Apple Computers has become an industry leader.
This is the essence of innovation. There are numerous
examples in biology that underline how the power of
adaptation is the power of survival. For plastic surgery
the same holds true and, while some fear the demise of
the specialty, I would argue that while we adapt and
develop, there will always be a place for plastic surgery.
Composite tissue allotransplantation
In research we work with models models of disease,
models of a procedure. Animal models provide a means
by which we can study the process that we are inter-
ested in addressing in our patients. Occasionally, in
order to solve a problem, we move to models that are
perhaps less relevant to our everyday clinical practice.
For example, most people dont realize that the first
kidney transplant was performed by Dr. Joseph Murray,
a plastic surgeon at the Peter Bent Brigham Hospital in
Boston9 (Fig. 1.1). People are generally intrigued by this
snippet of information. What was a plastic surgeon
doing transplanting kidneys? How could this be? His
practice as a plastic surgeon raised questions in his
mind surrounding transplantation. His experience treat-
ing burn patients sent back from the war during World

Fig. 1.1 Joseph Murray. (Courtesy of National Kidney Foundation.)
War II gave him wide exposure to skin grafting and
raised issues of immune rejection that he would later
find ways to address. In trying to work out the immu-
nology of skin grafts he moved to a single-organ model,
the kidney, in order to answer the question he had origi-
nally conceived. This culminated in the first successful
kidney transplant performed from one twin to another
by Dr. Murray at the Peter Bent Brigham Hospital in
Boston in 1954. Having helped develop the specialty of
transplantation, he went on to perform the worlds first
successful allograft in 1959 and the worlds first cadav-
eric renal transplant in 1962. Dr. Murray ultimately
returned to his roots, the practice of plastic surgery,
and was awarded the Nobel Prize in Physiology or
Medicine in 1990 for his contribution to the science of
transplantation.
Now that wheel has turned full circle and plastic
surgery is, once again, in the mainstream of transplant
innovation (Ch. 34). Hand and face transplants have
become a reality and, though still not in the mainstream
of practice, it is likely that composite tissue allotrans-
plantation (CTA) will become more common in the
foreseeable future. In fact, even now, some would argue
that hand transplantation is the standard of care (see
Volume 6, Ch. 38). Face transplantation is sure to follow
(see Volume 3, Ch. 20). Furthermore, it is likely that
CTA will address those reconstructions that we cannot
realistically achieve with conventional reconstructive
Collaboration 3
techniques. This would include transplantation of func-
tioning eyelids, noses, ears, tongue, and other special-
ized organs. While total nasal reconstruction, as an
example, has attained a high level of sophistication, the
truth is that elegant nasal reconstructions are achieved
by only a small number of expert surgeons utilizing
very complex techniques in a series of operations over
a period of months or years. The concept of a surgeon
being able to transplant a nose in a single stage and
achieve an elegant result is very attractive. Obviously
many obstacles remain before we will see this in prac-
tice. CTA is a perfect example of how an innovative
technical advance engenders increased research activity.
The barrier to successful transplantation is not a techni-
cal one, it is an immunologic one and current interest
in CTA has spawned a new wave of research activity in
the field of immunology. This demands a collaborative
and multidisciplinary approach, something that, again,
plastic surgeons do well.
Collaboration
Plastic surgeons cannot lay claim to being the only inno-
vators in medicine. Medicine is full of innovators. Yet
it is true that the nature of the plastic surgeons work,
more than many other specialties, demands innovation.
And that is what most plastic surgeons do every day of
the week. Because so much of what we do, particularly
in reconstructive surgery, is in collaboration with other
specialties, innovation in those areas of practice often
lead to innovations in our field. Most of the innovations
we see are incremental. A surgeon incrementally changes
how (s)he practices or how (s)he does a particular oper-
ation. Every now and again the innovation is radical.
The development of craniofacial surgery is an example
of radical innovation. Paul Tessier (Fig. 1.2) was the first
to describe a combined intra- and extracranial approach
for the correction of hypertelorism,10,11 breaking the pre-
viously held taboo of exposing the intracranial environ-
ment to the upper aerodigestive tract. Going against the
surgical mainstream demands unimaginable courage. It
takes pioneers like Dr. Tessier to have the courage of
their convictions and push the envelope beyond the
general comfort level. Apart from spawning the spe-
cialty of craniofacial surgery, Dr. Tessiers advances led
to advances in related fields. One such example is that
4 1 Plastic surgery and innovation in medicine
Fig. 1.2 Paul Tessier. (Courtesy of Barry M Jones.)
of skull base surgery. The craniofacial principles devel-
oped by Dr. Tessier literally opened up the field of skull
base surgery. Tumors that were previously considered
inoperable and inaccessible became treatable. That
progress led to further innovations. So, continuing with
the example of skull base surgery, the radical resections
and approaches that were developed in the 1970s and
1980s12,13 created problems such as meningitis and brain
abscesses and problems related to delayed wound
healing. Smaller defects could be closed with local
flaps such as pericranial flaps, or galeafrontalis flaps.14
However larger defects remained a problem until free
flaps were used to close these defects.15,16 Then the inci-
dence of all of the complications, the brain abscesses,
meningitis, and wound-healing problems, were all
dramatically reduced and the surgery became safer. So
microvascular surgery made skull base tumor surgery
safer.
More recently, in this field we have seen innovations
in the surgical approaches to the skull base facilitate the
development of endoscopic skull base surgery. Large
resections are now feasible through an endoscopic
approach. This development has had a large impact on
these patients because extensive open approaches with
the associated risks of scarring and deformity are no
longer necessary. However, with these large endoscopic
resections, we are seeing the re-emergence of problems
such as meningitis and abscess because of the difficulty
in reconstructing these defects endoscopically.17 This
has led to the development of new reconstructive
techniques and approaches in order to address these
complications.1820
This is an excellent example of how a multidiscipli-
nary approach can advance a field. An innovation in one
area can create a problem in another area that forces
further innovation. Progress in surgery, regardless of
specialty, demands a balance between innovators and
conservatives. Innovators push the envelope and work
best when they are paired with conservatives who rein
them in to a degree. Thus, a balance between out-of-the-
box thinking and conservative deliberation is the perfect
milieu to effect change, yet keep perspective.
Drivers of innovation
Innovation is also forced in times of upheaval and
change. The classic examples are war and natural disas-
ters. More surgical advances are made in wartime than
in peacetime. This is because specific problems are seen
in unprecedented numbers and demand a solution. In
this sort of environment it becomes reasonable to break
the rules. One simply has to cope. Out of this generally
comes a change in practice. Most of the advances in how
we manage major trauma have come from the arena of
war. The MASH units of the Korean conflict taught us
that initiating treatment early, in the field, saves lives.
The ultimate progression of that concept has been the
development of robotic surgery, bringing high-level
expertise to the field so that skilled intervention can be
effected at the earliest possible opportunity. The fact
that this can be achieved using robotic technology
makes it feasible for a highly skilled surgeon located in
some central site to treat multiple injuries in separate
locations. The types of injury seen in war also lead to
changes in practice. Plastic surgery, as we know it today,
was born during the first world war. Sir Harold Gillies
(Fig. 1.3) developed techniques for facial reconstruction
initially at Aldershot and later at the Queens Hospital
in Sidcup, Kent, UK. (It later became Queen Marys
Hospital.) His innovative solutions for some of the

Fig. 1.3 Harold Gillies.
Fig. 1.4 Archibald McIndoe. (Courtesy of Blond McIndoe Research Foundation,
registered charity no. 1106240.)
injuries he saw led to the development of modern plastic
surgery.
During the Second World War the Plastic Surgery
Unit at the Queen Victoria Hospital in East Grinstead,
UK, headed by Sir Archibald McIndoe (Gillies cousin)
(Fig. 1.4) became famous for treating severely burned
airmen. This surgery was so experimental that McIndoes
Principles of innovation 5
patients formed a club known as the Guinea Pig club.
The club was initially formed as a drinking club and
its membership was made up of injured airmen in the
hospital as well as the surgeons and anesthesiologists
who treated them. Airmen had to have gone through a
minimum of 10 surgical procedures before being eligi-
ble for membership in the club. By the end of the war
the club had 649 members. The club itself was socially
innovative because McIndoe conceived it as a way of
integrating injured airmen back into society. He con-
vinced some of the local families in East Grinstead to
accept his patients as guests and other residents to treat
them as normally as possible. It was very successful
and East Grinstead became known as the town that
doesnt stare.
Innovation and development in other spheres have
also changed the face of plastic surgery and brought
further reconstructive challenges to surgeons. For
example, the development of effective body armor has
led to an increase in the types of injury we see in unpro-
tected areas such as the limbs and the head and neck. It
is not that these injuries didnt occur before. It is simply
that before the military had effective body armor, sol-
diers were dying of their injuries and we did not have
to deal with their devastating facial or extremity inju-
ries. Limb amputations are surprisingly common. In the
US it is estimated that there are 10000 new upper limb
amputees every year. This has led to the development
of innovative prosthetics as well as innovative tech-
niques to power these prosthetics. Use of myoelectric
technology has led to innovations in the surgical
approach to amputations and amputation stumps.21,22 It
is likely that CTA will change the reconstructive land-
scape for these devastating injuries.
Principles of innovation
I mentioned that innovations are based on principles.
What are those principles and on what are they based?
Obviously the specific principles will depend on the
area under study. The principles on which innovation
are based will be different for plastic surgeons as com-
pared to gastrointestinal surgeons, for example. Central
to everything and what I consider the core of plastic
surgery is a detailed knowledge of anatomy. As a
specialty and in general, plastic surgeons have a more
6 1 Plastic surgery and innovation in medicine
detailed knowledge of anatomy than any other spe-
cialty. Of course the cardiac surgeon knows the heart
better than anyone and the orthopedist knows bones
better than anyone but neither of these specialties is
likely to be in each others domain very often. Yet, the
plastic surgeon is frequently asked to cover exposed
fractures or to provide vascularized cover for an infected
sternotomy wound. Neither of these tasks is possible
without a detailed knowledge of the anatomy of the
region. Regardless of the area of subspecialty practice
one is in, whether it is cosmetic surgery or hand surgery,
a detailed knowledge of anatomy is the most important
core understanding that is required to do the job well.
To drill down and define the single element of ana-
tomic knowledge that is most vital to us, the answer
would have to be vascular anatomy. So much of what
we do involves the rearrangement of tissue, whether
locally, regionally, or from afar. We have to know what
keeps that tissue alive and we have to preserve that
element. It is interesting to look at the advances that
have been made in plastic surgery over the past 50
years. Many of them are directly related to a better
knowledge of vascular anatomy. The most tangible of
these is the development of flap surgery. We have come
from an era when all flaps were random to the present
time when we know not only which blood vessel is sup-
plying our flap but how much of that tissue is being
perfused by that blood vessel.
Innovations in imaging technology allow us the
luxury of a road map to the vascular anatomy of our
planned reconstruction using computed tomography
and/or magnetic resonance imaging technology.2325
Even better, we have a surgical GPS that allows us to
visualize perfusion in real time using indocyanine
green.26 Technical advances allow us to transfer the
tissue and perform a microvascular anastomosis to
restore its blood supply. However it goes beyond that.
We can also restore function, sometimes using microsur-
gical techniques, other times, once again, utilizing our
knowledge of anatomy, by robbing Peter to pay Paul.
Tendon transfers, for example, have long been a tech-
nique for restoring function to a compromised limb.2729
More recently, nerve transfers have been utilized and
are proving to be a valuable addition to our reconstruc-
tive armamentarium.29 These are all examples of inno-
vation, describing a new solution to an otherwise
insoluble problem.
We have also combined our knowledge of vascular
anatomy with our knowledge of genetic engineering.
The science of genetics is covered in Chapter 11 of this
volume. Using genetic engineering we can program
cells to perform certain tasks. We can suppress certain
functions and stimulate others: in other words, we can
manipulate cells. This is a very powerful science and
has potential applications across all of medicine. The
process of transfection, whereby DNA or RNA is intro-
duced into cells to modify gene expression, is widely
used in molecular research. Geoff Gurtner, Editor of this
volume of Plastic Surgery, introduced us to the concept
of biologic brachytherapy.30 Using techniques of viral
transfection, he has been able to design flaps that not
only close a surgical defect but introduce a therapeutic
element to the reconstruction by having the flap produce
peptides appropriate to the disease entity being treated,
producing probiotics for infected wounds, or antiang-
iogenic peptides for oncologic reconstructions. This
innovative approach combines the best of plastic surgery
with the best of genetic engineering to provide a new
and better solution to an existing clinical problem.
Biologic brachytherapy represents the melding of ana-
tomic knowledge with tissue-engineering principles
and is a very exciting development.
The concept of flap prefabrication is another imagina-
tive way of providing a better solution to a clinical
problem.31 Using these techniques, the most appropriate
reconstructive construct can be assembled prior to the
definitive reconstruction. While flap prefabrication is an
elegant approach to a complex problem, it demands a
high level of expertise, imagination, and an innovative
outlook. It also demands multiple stages and increased
time to complete the reconstruction. In some disease
states such a delay may not be feasible. Engineering
body parts introduces us to the concept of spare-parts
surgery and is yet another approach that is currently
being developed. Wayne Morrison, working in the
Bernard OBrien Institute in Melbourne, Australia, has
been able to grow functioning cardiac muscle32 as well
as functioning islet cells.33 Spare-parts surgery, while
still not a reality, is no longer the stuff of science fiction.
The concept of making new tissue constructs is not
new and is the basis, for example, of bone distraction
and tissue expansion. Tissue expansion has been around
since the 1980s. In fact, like many things in medicine, it
was originally described long before that,34 but was only

popularized in the 1980s.35 It has become one of the
standard ways to reconstruct a breast following mastec-
tomy and, of course it has multiple other uses. When
first introduced by Radovan, it was considered with
a great deal of skepticism, like many innovations.
Unfortunately Radovan did not live to see his idea
become widely accepted.
Innovation also involves the application of estab-
lished techniques in new areas. Bone distraction is an
example of that. Devised by Ilizarov for the treatment
of long bones, the technique has been adapted to the
craniofacial skeleton. The applications of bone distrac-
tion in plastic surgery are more recent. Popularized by
McCarthy,36 bone distraction has changed the practice
of craniofacial surgery, minimizing the extent of surgery
required to treat certain conditions while improving
outcomes. Such developments occur all the time and
sometimes there is a disconnect between the develop-
ment of the original idea and its ultimate application.
An example of this is the Brava bra. This was first devel-
oped as a means of achieving breast augmentation non-
surgically.37 Applying a vacuum to the breast caused
swelling and enlargement. This was somewhat of a
transitory enlargement but, nevertheless, an enlarge-
ment. Several other innovations led to a rethinking of
what was happening with the Brava system and ulti-
mately led to a very innovative approach to breast
reconstruction that is still in the initial stage of skeptical
interest but that may well become an established tech-
nique. This association of ideas is often how innovation
works. What were these different ideas? Each in its own
right is a major innovation.
The first is fat grafting. This is an old idea and one
with a checkered history. Dermal fat grafts have long
been an accepted method of correcting small contour
defects. Attempts at engrafting larger fat deposits have
generally been unsuccessful. The concept of fat injection
as a means of engrafting fat is another idea that was
greeted with skepticism until Coleman showed us that
it does work when the fat is deposited in small aliquots
with a fine cannula.3840 This technique is now widely
practiced in both aesthetic and reconstructive arenas
and has become an invaluable addition to our
armamentarium.
The second innovation is tissue expansion, already
mentioned above. Though tissue expansion has been
around for a long time, we have thought of it in terms
Principles of innovation 7
of internal expansion, i.e., expansion produced by
the implantation of an expanding device. The suction
system used by the Brava bra introduces us to the
concept of external expansion, i.e., expansion caused by
external forces, the application of a vacuum to the skin.
The third innovation is that of vacuum-assisted
closure, the VAC system. This is an idea so simple
that we all wish we had thought of it. However, as
with many things in medicine, it is not as simple as
it first appears. Not only, it appears, does the VAC
mechanically remove debris and exudate from the
wound, but it also promotes angiogenesis and cell
proliferation.4143
Putting all these concepts together, Khouri and Del
Vecchio44 developed a system for both breast reconstruc-
tion as well as breast augmentation. The Brava system,
married to the structural fat-grafting concept, is used,
in the belief that the external expansion induced by the
Brava vacuum produces edema, angiogenesis, and cell
proliferation that permit larger volumes of fat to be
deposited in a favorable matrix, thereby increasing graft
take and fat retention. To date, the results of this
approach are remarkable. Undoubtedly there are many
unanswered questions and here, once again, we have an
example of an innovation that has already found clinical
application but that requires extensive research to
elucidate the mechanism of the clinical picture we are
seeing.
Fat grafting, as well as providing a clinical solution
to many problems, both aesthetic and reconstructive,
has also engaged our curiosity in another area, that of
stem cell research. This again represents an association
of ideas from disparate fields. Many of the changes we
see as a result of fat grafting are not readily explained
by the injection of fat alone. As an example, it has been
reported that many of the skin changes associated with
radiation seem to be reversed when fat is injected into,
for example, a breast defect resulting from lumpectomy
and radiation.45 Why should this be? The answer, stem
cells, may be a simplistic solution to explain something
we dont understand. The answer may also be our intro-
duction to a whole new area of development for plastic
surgery. Of course, as weve seen before, not only does
this innovation (fat grafting) solve a clinical problem,
it raises numerous questions and opens the door to
new areas of research and quite likely to even newer
innovations.
8 1 Plastic surgery and innovation in medicine
External influences and innovation
In order to achieve some of our surgical results not
only do we rely on our own expertise as surgeons; we
also rely on our tools, our instruments and devices.
Microsurgery could not have developed without the
development of the operating microscope and appropri-
ate instrumentation. One of the biggest barriers to
modern microsurgery was the inability to swage an
ultrafine suture to a sufficiently small needle. Similarly,
the manufacture of implants of any kind demands an
expertise that we, as surgeons, do not have. Bioengineers,
chemists, physicists, and all manner of experts are
required to help bring our ideas into clinical practice.
None of these developments are possible without the
partnership of industry. Of course this is a double-edged
sword as it introduces other interests and possible con-
flicts. Nevertheless, it is a vital part of the development
of any specialty.
Ive already mentioned how microsuture develop-
ment led to the development of reconstructive micro-
surgery. Once it was possible to do microanastomoses,
it became possible to replant amputated digits. The new
technology spurred the advance of flap surgery and our
interest in vascular anatomy was again renewed. This
inspired the likes of Mathes and Nahai46 to elucidate
and classify the blood supply of muscles and others to
describe new myocutaneous flaps. Ian Taylor47 started
his classic cadaver injection studies that led to the devel-
opment of the angiosome theory. Later, Isao Koshima
and Soeda48 described perforator flaps and that devel-
opment and innovation is ongoing.
Craniofacial surgery is another subspecialty area that
could not have developed without the help of industry.
When Joseph Gruss recognized the importance of inter-
nal fixation for the craniofacial skeleton in the early
1980s,49 he was using wires to piece together commi-
nuted fractures painstakingly. This led him and others
to the recognition of the concept of facial buttresses and
to the development of plating systems for the face. This
approach is now standard of care but could not have
happened without the expertise of the engineers and
implant biologists who worked with surgeons to
develop the plating systems and instrumentation that
make it all possible. Once again, this is an ongoing
process.
Every aspect of plastic surgery has undergone such
change and development. In cosmetic surgery we have
also seen these changes evolve. In each area, surgeons
have developed a better understanding of anatomy and
function and developed, with industry, ways to improve
and develop the field. Endoscopic techniques were
adapted from other areas of practice and applied to the
face; minimally invasive techniques led to the develop-
ment of barbed sutures and suspension systems. Implant
biology has brought is various injectable fillers and
broadened the scope of cosmetic surgery in a way that
was once unimaginable.
So innovation is a natural consequence of practice. In
every sphere people strive to improve things surgeons
to do better operations, anesthesiologists to improve
pain control, industry to provide better materials and
instruments. These innovations occur in all specialties
and, as we have seen, innovation in one specialty can
influence how another develops. What about innova-
tion itself? How can we ensure that innovation is as safe
as possible and conducted in some sort of organized
fashion and with some form of structure? Do we need
such organization and such structure? As I mentioned
at the outset, a discussion on the ethics of innovation is
beyond the scope of this chapter. However there are
some things that are useful to consider.
Documentation, data gathering,
and regulation
It is important to document change. If one asks a surgeon
how many procedures (s)he has done, the answer is
usually a gross exaggeration. Similarly we tend to
underestimate our complications. Were not good at
remembering stuff though we think we are. It is surpris-
ing when one starts to keep a database how sobering it
is to see the actual numbers. Its also surprising how
much information one can glean and this information
is vital if we are to change and improve. Innovation
implies change and in times of change it is imperative
to document results. How else can one evaluate the
effects of the innovation? So documentation and data
gathering are important aspects of innovation.
The difficulty with innovation arises in that gray
zone between innovation and research. Small changes
are easy to effect, large changes more difficult! Most

institutions regulate change through the institutional
review board (IRB). Regulation is necessary yet it is also
restrictive. The IRB process varies from institution to
institution but, in general, is becoming more and more
stringent. This can have a significant effect on the devel-
opment of medicine as a whole. It is widely believed,
for example, that the reason the first heart transplant did
not occur in the US was because of the stringent regu
lations governing experimental surgery in the US as
compared to South Africa, where Dr. Christiaan Barnard,
an American-trained cardiac surgeon, performed this
operation. Institutions also grapple with the dilemma of
allowing some degree of innovation, yet controlling
quality and risk exposure. The latter is an important
consideration for institutions and individuals alike.
Apart from protecting the individual and the institu-
tion, regulation also introduces and enforces an element
of objectivity. When one is involved in developing a
theory, an operation, or some sort of change, it is very
easy to lose objectivity and that is a serious issue.
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Because great interest in an efficient range of effective
medicinal innovations and achievements has arisen, many
countries have introduced procedures to regulate the adoption
of innovative nonmedicinal technologies into the benefit
catalogue of solidly financed healthcare insurances. This
report describes procedures for the adoption of innovative
nonmedicinal technologies by solidly financed healthcare
insurances in Germany, England, Australia, and
Switzerland.
2. McCulloch P, Altman DG, Campbell WB, et al. No
surgical innovation without evaluation: the IDEAL
recommendations. Lancet. 2009;374:11051112.
This paper proposes recommendations for the assessment of
surgery based on a five-stage description of the surgical
development process. Achievement of improved design,
conduct, and reporting of surgical research will need
concerted action by editors, funders of healthcare and
research, regulatory bodies, and professional societies.
Documentation, data gathering, and regulation 9
Regulation enforces objectivity and the difficulty lies in
the balance between creativity and objectivity. Just as
one can become obsessed with creativity and freedom
of expression, however, one can also become obsessed
with objectivity and regulation. Finding a balance
between the two is sometimes difficult. Added to that
is the conflict of interest that is sometimes introduced to
the process when a commercial value is associated with
the innovation, particularly when a significant sum may
already have been invested in developing it. That intro-
duces the ethics of practice and this subject is covered
in another chapter.
So we have seen that innovation is an important part
of medicine. It is separate from research, though often
stimulates research. It is as difficult to regulate as it is
to define and, at least in some instances, may be stifled
by regulation. From all of the innovations I have touched
on in this chapter we can see that innovation is vital to
the development of medicine in general and to the
evolution of plastic surgery in particular.
3. Ergina PL, Cook JA, Blazeby JM, et al. Challenges in
evaluating surgical innovation. Lancet. 2009;374:
10971104.
Research on surgical interventions is associated with
several methodological and practical challenges of which
few, if any, apply only to surgery. This report discusses
obstacles related to the study design of randomized
controlled trials and nonrandomized studies assessing
surgical interventions. It also describes the issues related
to the nature of surgical procedures. Although difficult,
surgical evaluation is achievable and necessary. Solutions
tailored to surgical research and a framework for
generating evidence on which to base surgical practice
are essential.
4. Barkun JS, Aronson JK, Feldman LS, et al. Evaluation
and stages of surgical innovations. Lancet. 2009;374:
10891096.
Surgical innovation is an important part of surgical practice.
Its assessment is complex because of idiosyncrasies related to
surgical practice, but necessary so that introduction and
adoption of surgical innovations can derive from evidence-
based principles rather than trial and error. A regulatory
framework is also desirable to protect patients against the
10 1 Plastic surgery and innovation in medicine

potential harms of any novel procedure. In this first of three
series papers on surgical innovation and evaluation, we
propose a five-stage paradigm to describe the development of
innovative surgical procedures.
8. Toledo-Pereyra L. Surgical innovator. J Invest Surg.
2011;24:47.
To be a surgical innovator is to be someone who has the
capacity to modify established concepts in surgery. C Walton
Lillehei, Owen H Wangensteen, William S Halsted, and
Alfred Blalock are a few of many good examples of American
surgeon innovators whose contributions can help us to
discern how they thought about innovation within the
surgical sciences. These four innovators readily contemplated
the essence of innovation but mostly dedicated themselves to
search for the appropriate answers to serious and difficult
clinical tasks.

References
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Because great interest in an efficient range of effective
medicinal innovations and achievements has arisen, many
countries have introduced procedures to regulate the adoption
of innovative nonmedicinal technologies into the benefit
catalogue of solidly financed healthcare insurances. This
report describes procedures for the adoption of innovative
nonmedicinal technologies by solidly financed healthcare
insurances in Germany, England, Australia, and
Switzerland.
2. McCulloch P, Altman DG, Campbell WB, et al. No
surgical innovation without evaluation: the IDEAL
recommendations. Lancet. 2009;374:11051112.
This paper proposes recommendations for the assessment
of surgery based on a five-stage description of the surgical
development process. Achievement of improved design,
conduct, and reporting of surgical research will need
concerted action by editors, funders of healthcare and
research, regulatory bodies, and professional societies.
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evaluating surgical innovation. Lancet. 2009;374:
10971104.
Research on surgical interventions is associated with several
methodological and practical challenges of which few, if any,
apply only to surgery. This report discusses obstacles related
to the study design of randomized controlled trials and
nonrandomized studies assessing surgical interventions.
It also describes the issues related to the nature of surgical
procedures. Although difficult, surgical evaluation is
achievable and necessary. Solutions tailored to surgical
research and a framework for generating evidence on which
to base surgical practice are essential.
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Surgical innovation is an important part of surgical practice.
Its assessment is complex because of idiosyncrasies related to
surgical practice, but necessary so that introduction and
adoption of surgical innovations can derive from evidence-
based principles rather than trial and error. A regulatory
framework is also desirable to protect patients against the
potential harms of any novel procedure. In this first of three
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