Synthetic Biomaterials in Facial

Plastic and Reconstructive Surgery

Peter D. Costantino, M.D., Craig D. Friedman, M.D.,
and Alexis Lane, M. D.

Downloaded by: University of British Columbia. Copyrighted material.

The first reported use of a synthetic biomaterial
in facial plastic and reconstructive surgery occurred
around 1600 when Fallopius implanted a gold plate
to repair a calvarial defect.' Although we have had
several hundred years of experience with synthetic
biomaterials, very few implants have proven to be
ideal. The difficulty in developing biocompatible
materials underscores the complex interactionbetween
the body and any implant. Materials that initially
seem to be appropriate and successful frequently fail
to remain integrated with the surrounding tissues or
are degraded by the body over time. A recent exam-
ple of this is the silicone gel breast implant. Although
there is not yet a definitive answer as to the safety of
this implant, it is clear that within certain individ-
uals, problems may develop after many years of
implantation. The problem of potential implant fail-
ure over time is made more complex by the current
medicolegal situation in the United States. Surgeons
who implanted the silicone gel protheses neither
designed nor tested the implant, yet they were held
liable for the product's failure. In today's malpractice
environment, any surgeon who uses synthetic bio-
materials must be intimately familiar with its poten-
tial for long-term failure.
It is the intention of this short article to provide
a foundation on which the facial plastic and recon-
structive surgeon can make informed decisions con-
cerning implant composition, physical structure,
and appropriate application. Synthetic biomaterials
that are currently being used in facial plastic and
reconstructive surgery will be reviewed and new
synthetic biomaterials that show promise will be dis-
cussed. Because any new biomaterial does not be-
come generally useful until after it is approved by
the Food and Drug Administration (FDA), we will
limit our discussion of new synthetic biomaterials
to those that are within approximately 3 years of
achieving FDA approval.
BACKGROUND CONCEPTS
Biomaterials can be natural, semisynthetic, or syn-
thetically produced. Numerous natural and semi-
synthetic materials are available in the form of xeno-
grafts (from a different species), allografts (from the
same species), or autografts (from the same organism),
and function well in facial plastic and reconstructive
surgery. These materials will not be addressed in
this article. Instead, we will focus on those bio-
materials that are synthetically produced. Any syn-
thetic biomaterial can also be referred to as an allo-
plast. There are a wide variety of alloplasts, most of
which are specifically designed for either soft tissue
or skeletal applications.
The success or failure of any alloplast hinges on
many factors, such as its chemical composition, bio-

Departments of Otolaryngology-Head and Neck Surgery, Loyola University Stritch School of

Medicine, Maywood, Illinois, Yale University School of Medicine, New Haven, Connecticut, and
Wilford Hall USAF Medical Center, Lackland Air Force Base, Texas

The opinions or assertions contained herein are the private views of the authors and are not to be
considered as official or as reflecting the views of the USAF or the Department of Defense

Reprint requests: Dr. Costantino, Loyola University Stritch School of Medicine, 2160 S. First
Avenue, Maywood, IL 60153

Copyright 01993 by Thieme Medical Publishers, Inc., 381 Park Avenue South, New Yc~rk,NY 10016. All rights reserved.
FACIAL PLASTIC SURGERY Volume 9, Number 1 January 1993
stability, physical form, mechanical properties, site
of implantation, and presence of impurities. Al-
though it would seem that the chemical composition
of the implant would be of primary importance, its
physical form is equally critical in determining bio-
compatibility.2 In fact, an implant with excellent bio-
compatibility on a chemical level can fail just because
its physical form is not appropriate. Furthermore, an
alloplast with excellent chemical and physical bio-
compatibility can fail if inappropriately implanted.
Focusing on chemical composition, physical form,
and appropriate application are good starting points
when evaluating any new biomaterial for potential
use, since most have not yet demonstrated long-term
biocompatibility in humans.
Implants that are largely composed of chemical
elements that are found in the body usually perform
well. Since the physical structure of the human body
is composed of just a few chemical elements, the
realm of molecules that can be used to fabricate any
biomaterial is somewhat limited. The skeleton is
largely composed of calcium, whereas soft tissues
are primarily carbon and water. These two chemical
elements, calcium and carbon, and those elements
immediately surrounding them on the periodic table
are generally well tolerated by the body over time.
Carbon holds position number 6 on the periodic
table, and of those elements surrounding it, only
silicon (element 14, immediately below carbon on the
table)-has physical characteristics that allow it
to be fabricated into an implant appropriate for
use in soft tissue augmentation, such as silicone
rubber. Calcium is element number 20 in the peri-
odic table, and only titanium (element 22) holds a
position close to calcium yet possesses appropriate
physical properties to be fabricated into a potential
skeletal implant. It is not a coincidence, then, that
two of the most biocompatible alloplasts on a mo-
lecular level are composed of silicon and titanium.
When evaluating any new implant, its chemical
composition should first be compared to chemical
elements that are normally present in the body. If the
biomaterial is not composed of naturally occurring
elements, then the elements composing the alloplast
should be compared to calcium and carbon on the
periodic table. In general, the closer to calcium and
carbon, the better the chance for long-term biocom-
patibility.
When considering the physical form of an im-
plant, two features are important. The first is the
porosity. If pores are smaller than approximately
50 pm, it is unlikely that tissue will grow into the
implant.3.4 If the pores are larger than 1pm, it is pos-
sible for bacteria to enter those pores and to become
lodged within the implant.5 If an implant has pores
between 1 and 50 pm and becomes contaminated
with bacteria, phagocytic cells would not be able to
clear those bacteria because macrophages are too
large to pass through pores less than 50 pm. When
porosity exceeds 50 pm, tissue ingrowth and macro-
phage permeability become increasingly possible.
Therefore a decreased risk of infection is present
with implants having pore sizes larger than 50 km
or nonporous implants.6 Regardless of the porosity,
though, any implant can become a chronic source of
infection given the right local conditions.
The second feature relating to implant structure
that affects its biocompatibility is the particle size
of the implant or any fragments that may develop
over time.7.8 It is important that biomaterials be se-
lected that have minimal risk of shedding particles.
Tissue macrophages cannot phagocytize any parti-
cles larger than 60 km in diameter. Particles ranging
from 20 to 60 pm that have been phagocytized may
cause the death of the macrophage with the release
of intracellular enzymes. The release of these cyto-
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kines result in a local inflammatory response that
induces other macrophages to engulf the local de-
bris. This debris would contain alloplast particles,
and, when macrophages engulf this debris, they too
will die, giving rise to a chronic inflammatory re-
sponse. For example, Proplast (Vitek, Houston, Tx),
is a facial implant composed of polytetrafluoro-
ethylene (PTFE). Although PTFE shows excellent
biocompatibility, when Proplast was use for tempo-
romandibular joint reconstruction, particles were
produced resulting in a chronic inflammatory re-
sponse. This chronic inflammatory response led to
other problems, such as infection, bone resorption,
and chronic pain. Proplast was removed from the
United States market primarily because of this prob-
lem. In contrast, an experimental material referred to
as Bioplastique is composed of silicone particles dis-
persed in a resorbable matrix.7 This material is an
injectable viscous liquid that can be used for perma-
nent soft tissue augmentation. All of the particles in
Bioplastique are greater than 100 pm in size. Even
though this implant consists entirely of particulate
material, the specific particle size prevents the bio-
material from being phagocytized and there does
not appear to be any substantial chronic inflamma-
tory response in animal models. This material has
not yet been approved for general use by the FDA.
Following the chemical composition and physical
form of an implant, the next most important factor
is its appropriate application. Implants must be se-
lected with physical properties that are appropriate
for the location of implantation. If a skeletal alloplast
is necessary, and if that alloplast is to be stress
loaded, the implant must be sufficiently strong to
withstand those stresses. If soft tissue augmentation
is desired, and the area to be augmented is partic-
ularly mobile, then a hard implant would be inap-
propriate because its potential for extrusion would
 SYNTHETIC BIOMATERIALS-Costantino,
be high.9 Not only must the physical properties of
the implant be matched to the surrounding tissue,
but the particular site of implantation within the
head and neck are also very important. For instance,
a polymethylmethacrylate (PMMA)implant that can
be used for parietal region cranioplasty would be
inappropriate if the patient had a previous history of
infection near the calvarial defect, since approx-
imately one third of these implants would become
infected.10
POLYMERIC IMPLANTS
The vast majority of polymeric implants used in
the head and neck are composed of either carbon or
silicon chains.11We will therefore restrict this discus-
sion of polymers to those alloplasts that have a sili-
con or carbon backbone.
Silicone
One of the earliest polymeric biomaterials for fa-
cial plastic and reconstructive surgery was silicone.
Silicone appeared to be an entirely nonreactive bio-
polymer when it first gained widespread use in hu-
mans some 30 years ago, but we now know that it is
not entirely inert.12-14 The excellent biocompatibility
of silicone stems from the close proximity of silicon
to carbon on the periodic table. Furthermore, the
polymeric chains that form silicone are composed of
a silicon-oxygen backbone with methyl side groups.
The silicon-oxygenbond is particularly strong, mak-
ing the material quite resistant to degradation. De-
pending on the amount of cross-linking between the
Figure 1. Various silicone facial
implants.
Friedman, Lane
methyl side groups silicon-oxygenchains, the physi-
cal properties of the implant can be varied. With
minimal cross-linking, silicone forms a viscous gel.
It is this gel that has been used to fill breast implants
composed of a silicone rubber capsule. As the amount
of cross-linking increases between different silicone-
oxygen chains, the silicone becomes a solid. It is in
this form that silicone has been most useful in facial
plastic and reconstructive surgery. Solid silicone rub-
ber (Silastic, Dow Corning, Midland, MI) is a clear,
elastic material that can be fabricated with tactile
properties very close to that of natural tissue (Fig. 1).
Silicone implants can be steam autoclaved and carved
intraoperatively. These implants have achieved their
widest application for cheek and chin augmentation,
and as sheeting material for multiple applications in
the head and neck. When implanted as a solid, tissue
ingrowth does not occur and the material exists as a
nonreactive foreign body within a fibrous capsule.
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When silicone gel leaks from a gel-filled implant, the
inert nature of silicone is altered substantially. In
contrast to silicone rubber implants, silicone gel can
be phagocytized by tissue macrophages. The result
of this phagocytic activity is a chronic inflammatory
response if the particles are between 20 and 60 pm.13
An immune response can also be generated if the
engulfed silicone is combined with proteins, result-
ing in an antigen capable of stimulating the immune
system. Experimental evidence has demonstrated
that both antibody production and delayed hyper-
sensitivity (type IV immune response) have been
caused by silicone-protein complexes.14 It is this
mechanism that has generated the most concern
with respect to the silicone gel breast implant. Solid
silicone implants do not demonstrate any potential
for chronic inflammation or an immune response
FACIAL PLASTIC SURGERY Volume 9, Number 1 January 1993
unless implanted in particles smaller than 60 to 80
km in size.
The fact that a fibrous capsule develops around
these implants is not intrinsically bad. This capsule
tends to hold the implant in place, makes removal of
the implant easier, and usually does not alter the
tactile properties of solid silicone facial implants.
However, capsule formation can deform these im-
plants over time. In response to this problem, Da-
cron webbing has been embedded in some silicone
implants (particularly silicone sheets) to improve
their structural stability. The presence of a fibrous
capsule can become a problem if the implant be-
comes infected. The fibrous capsule tends to have a
relatively poor blood supply and, since the implant
remains slightly mobile inside the capsule, a dead
space persists between the implant surface and the
capsule. Once an infection becomes established, it
can be quite difficult to eradicate without removing
the implant entirely.
Although silicone implants have received sub-
stantial negative notoriety over the past year, a realis-
tic appraisal of this biomaterial must be maintained.
Solid silicone implants have an excellent track record
over the last three decades. If gel forms are used
appropriately, and attention-isgiven to implantation
technique, silicone-based biomaterials represent a
safe and useful adjunct in facial plastic soft tissue
augmentation.
Carbon-based Polymers
Polymethylmethacrylate Implants
When all synthetic implants are considered, PMMA
is probably implanted in humans in the largest
quantity on an annual basis of any type of alloplastic
material. This stems from the fact that PMMA serves
as the primary adhesive cement for the fixation of
orthopedic joint protheses. PMMA is a viscous ce-
ment that sets to a very hard and strong plastic
material. Because of its adhesive properties and sub-
stantial strength, it has achieved widespread appli-
cation in orthopedic surgery. Possessing these prop-
erties should not imply that PMMA is an excellent
biomaterial. It is not. In fact, it has been said that if
PMMA were currently undergoing evaluation by the
FDA for potential sale in the United States, it would
not be on the market today. It is only because PMMA
was used in humans prior to 1977, when currently
effective regulations were passed, and because there
are no other substitutes that it is still FDA approved.
The shortcomings of this material become more
evident when its actual biocompatibility, rather than
its structural properties, are considered. There are
two types of PMMA.15 One polymerizes slowly (over
approximately 24 hours) with the external applica-
tion of heat and pressure, and the other form poly-
merizes rapidly with an exothermic internal chemi-
cal reaction. Only the rapidly polymerizing form is
appropriate for intraoperative application and it is
the form used most frequently in the United States.
The rapidly polymerizing form of PMMA is made by
combining a powder and a liquid. The liquid is com-
posed of flammable methylmethacrylate monomer
and the powder primarily consists of methylmeth-
acrylate-Styrene copolymer. The mixing of this pow-
der and liquid results in a dense paste that can be
shaped for approximately 5 to 15 minutes, depend-
ing on the formulation. At this point, an exothermic
polymerization phase occurs, generating tempera-
tures as high as llO"C.16 Any tissues in contact with
the cement at this time would be susceptible to ther-
mal necrosis. According to the package insert, the
carcinogenic potential of this cement in humans is
unknown. Studies have uniformly shown that these
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implants are covered with a fibrous capsule, there is
no tissue ingrowth, and a chronic inflammatory re-
sponse with many foreign body giant cells develop
at the interface of the implant and surrounding tis-
sues. PMMA cannot be shaped after setting, and
removal of the implants can be difficult because
they tend to melt when attempts are made to cut or
burr them with power tools.
Despite these substantial shortcomings, methyl-
methacrylate represents the most commonly used
material for cranioplasty in the United States today.
It holds this position by default. There are currently
no other approved cements that can be shaped and
set intraoperatively and possess adequate structural
integrity so that the underlying brain is protected.
With the advent of new calcium phosphate ce-
ments,l7 it is possible that methylmethacrylate will
eventually be replaced in its use for cranioplasty and
craniofacial reconstruction. At this time, we do not
use methylmethacrylate for any facial plastic or re-
constructive applications. It is inappropriate to im-
plant this material in a previously infected site or in
contact with any of the paranasal sinuses.'O If in-
fected, the dense fibrous capsule that forms around
the implant is relatively avascular and usually pre-
vents resolution of the infection (Fig. 2A, B). PMMA
implants are easily traumatized, exposed, and ex-
truded, and they should not be used for craniofacial
surgery in the growing patient.18 In short, it is our
opinion that PMMA should rarely be used for non-
orthopedic applications.
PO1~tetrafluoroeth~lene Implants
PTFE is a highly biocompatible carbon-based allo-
plast that comes in various forms and is sold under
the trade names of Gor-Tex, Teflon, and Proplast.19.20
This material has a carbon backbone (ethylene) with
four fluorine molecules attached to the ethylene
 SYNTHETIC BIOMATERIALS-Costantino, Friedman, Lane

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Figure 2. A: Removal of a chron-
ically infected PMMA implant used
for frontal cranioplasty. After opening
the surrounding fibrous capsule, the
implant was easily lifted off of the
bone. B: The superficial layer of the
fibrous capsule is held in the forceps,
whereas its deep layer can be seen as
the white area covering the frontal
bone. Notice the oozing from the sur-
faceof the skull and the near total lack
of bleedingfrom the internal surfaceof
the fibrous capsule.

monomer. Although fluorine is not normally found
in the body and is a very reactive chemical element, it
forms such stable bonds with the carbon atoms that
it is essentially nondegradable. The body has no
enzyme systems to break these carbon-fluorinebonds,
unlike other halogens. Because of this, PTFE is a
very biocompatible alloplast. This material has been
used for a number of different applications, such as
vascular grafting, soft tissue augmentation, and re-
habilitation of the paralyzed vocal cord. It is capable
of a wide variety of applications because the material
can be synthesized in various forms with different
densities and porosities. It can be manufactured as
either a soft or relatively firm spongelike material,
and it is microporous, allowing fibrovascul-,r tissue
ingrowth.
Proplast was one of the first porous implants for
facial augmentation and was originally composed of
Teflon (PTFE) and graphite (element carbon), which
resulted in a spongy black implant that was not
widely applied due to its unappealing appearance.
Proplast I was replaced by Proplast 11, which was a
white material composed of Teflon and alumina
(aluminum is close to carbon on the periodic table).
Proplast I1 received much wider application and had
a minimal complication rate when used as a maxil-
lary onlay implant. All forms of Proplast are com-
pressible spongy material permeated with pores
ranging from 50 to 400 p+m in size (Fig. 3). Pores
comprise approximately 70 to 90% of the entire vol-
ume of the implant and the material has low elastic-
ity, giving it a softness similar to tissue. The pore
volume allows for fibrovascular ingrowth, which
tends to fix the material in place rather than result
FACIAL PLASTIC SURGERY Volume 9, Number 1 January 1993
was eventually replaced by
in a fibrous capsule. The Teflon-alumina combina-
tion is chemically inert and is not degraded by the
body.
Proplast I1 Proplast
hydroxyapatite, (HA). This combination retained the
spongelike consistency of Proplast while adding hy-
droxyapatite to enhance bone fixation to the implant
surface. Although Proplast I and I1 were primarily
used as onlay materials for facial augmentation, tem-
poromandibular joint reconstruction was carried out
using a high-density form of this biomaterial. The
physical properties of Proplast did not permit its
application in areas under substantial shear stress.
The shearing forces on the Proplast caused particle
formation that resulted in a chronic inflammatory
response. The resultant morbidity let to a reevalua-
tion of the material by the FDA, and all forms of
Proplast were withdrawn from the United States
market.
Teflon (Dupont, Wilmington, DE) paste is com-
posed of PTFE and is approved by the FDA as an
injectable material for true vocal cord augmentation.
It is not approved for use as a facial soft tissue im-
plant. The problems of migration, which can be seen
when used for vocal cord augmentation, are ampli-
fied when this material is injected into the facial soft
tissues. Furthermore, if this material is used as an
unencapsulated paste, it retains the potential of be-
ing broken into particles that can cause a chronic
inflammatory response. These problems of migra-
tion and particle formation indicate that Teflon should
not be used in facial plastic and reconstructive surgery.
Gor-Tex PTFE sheeting (W.L. Gore & Associates,
Flagstaff, AZ) has recently become popular for a
number of applications in facial plastic and recon-
Figure 3. Compressible sponge
microstructure of Proplast II, which
permits primarily fibrous tissue in-
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growth. ( ~ 2 0 . )
structive surgery. In our experience, it has func-
tioned well as a nasal tip and a dorsum graft and can
be used for static rehabilitation of the paralyzed face
instead of tensor fascia lata. Gore-Tex sheeting comes
in 0.4, 0.6, 1.0, and 2.0 mm thicknesses, and the
material can be either gas or steam sterilized.21 Su-
turing of this alloplast should be done with non-
resorbable monofilament sutures because resorbable
sutures can result in inadequate anchoring. This is a
spongy microporous material that, like other porous
PTFE implants, is ingrown by fibrovascular tissue
over time. It tends to resist encapsulation and is
not prone to migration.
High Density Polyethylene Implants
Medpor (Porex Medical, Fairburn, GA) is com-
posed of high-density polyethylene (HDPE)and was
designed for use in facial augmentation. Although
similar in chemical composition to PTFE, Medpor
has different physical properties. Medpor is rela-
tively noncompressible in contrast to spongy PTFE
implants, yet it can be carved and is somewhat flex-
ible. It can be applied directly onto the surface of
the facial skeleton as an onlay implant. Medpor im-
plants contain pores (Fig. 4) that are all greater than
100 pm and permit soft tissue and bone ingrowth, in
contrast to the fibrous ingrowth seen with spongy
PTFE implants.22 Medpor is somewhat osseocon-
ductive in that it allows bone to grow onto the surface
of the implant, and the 100 pm pores are large
enough to permit bone to grow into the internal
volume of the implant (Fig. 5) to some degree.23.24
This firmly fixes the implant in place and enhances
its biointegration with the surrounding tissue. Like
other polyethylene-based biomaterials, Medpor is
 SYNTHETIC BIOMATERIALS-Costantino, Friedman, Lane

Figure 4. Noncompressible po-

rous microstructure of Medpore,
which permits both fibrous and os-
seous tissue ingrowth. (Reprinted with
permission of Porex Medical, Fair-
burn, GA.) ( ~ 2 0 . )

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nonresorbable and shows a minimal foreign body re-
sponse. Although Medpor is HDPE, it is not appro-
priate for use in stress-bearing areas because it can
become particalized and cause a chronic inflamma-
tory response. Medpor should be inserted into a
subperiosteal pocket for optimal fixation to the un-
derlying bone. Prior to ingrowth by fibro-osseous or
fibrovascular tissue, these implants can become in-
fected. Impregnating them with an aqueous anti-
biotic solution prior to insertion may help to mini-
mize the potential for infection. These implants are
most useful for cheek and chin augmentation and
come in a variety of shapes and sizes for these appli-
cations (Fig. 6). The soft tissue thinning seen with all
types of polymeric cheek and chin implants is also
seen with Medpor, but underlying bone resorption
appears to be minimal.24
Polyester and Polyamide Mesh Implants
Mersilene and Supramid mesh will be considered
together because they have virtually the same uses,
although different chemical compositions. Mersi-
lene (Ethicon, Somerville, NJ) is composed of poly-
ethylene terephthalate, a carbon-based material that
can be formed into a multifilament mesh (Fig. 7).25
Supramid (Ethicon) is also a mesh, but composed of

Figure 5. Fibro-osseous ingrowth

into Medpor. (reprinted with permis-
sion of Porex Medical, Fairburn, GA.)
(X40.)
FACIAL PLASTIC SURGERY Volume 9, Number 1 January 1993
Figure 6. Various Medpor implants.
polyamide instead of polyethylene. The only sub-
stantial difference between Supramid and Mersilene
is that Supramid tends to resorb during the first 1to
2 years after implantation.26
Mersilene mesh has become quite popular for soft
tissue augmentation of the chin. The mesh can be
rolled into the desired volume and shape and is
usually inserted through a cutaneous incision. These
implants are intimately ingrown by connective tis-
sue, which fixes them firmly in place. This fixation,
in addition to their soft pliable nature, minimizes
their potential for exposure and extrusion. Mersilene
mesh does not appear to undergo any noticeable
degree of resorption, which results in a very predict-
able aesthetic result. These implants should not be
placed through intraoral incisions because small in-
terstices within the mesh can harbor bacteria result-
ing in chronic infection. Because Mersilene mesh
implants are ingrown by fibrovascular tissue over
time, they have a very good retention rate and the
risk of infection is quite low after tissue ingrowth
is complete. If these implants initially become in-
fected, fibrous tissue ingrowth usually does not oc-
cur and they are easy to remove. If fibrous ingrowth
has occurred and a revision procedure is contem-
plated, their removal can be quite difficult. Fre-
quently, a cuff of surrounding tissue must be taken
to free these implants from their fibrous bed. This is
a particular concern when these mesh alloplasts are
used for nasal augmentation.
METALLIC IMPLANTS
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When discussing metal implants, the concept of
osseointegration must be understood. All metal im-
plants fall into two broad categories, those that
osseointegrate and those that do not. Osseointe-
grated implants actually bond to the bone on a mo-
lecular level. The bone is able to grow up to and
physically attach to the implant surface without any
intervening fibrous tissue. The bone does this be-
cause it recognizes the implant as a biologically com-
patible material with elemental characteristics equiv-
alent to calcium. Implants that do not osseointegrate
are separated from the bone by a thin layer of fibrous
tissue and more prone to weak fixation, loosening
over time, and infection. Osseointegration primarily
occurs with titanium and its all0ys.27~28Other metals
used in facial plastic and reconstructive surgery,
Figure 7. Mersilene mesh.
 SYNTHETIC BIOMATERIALS-Costantino, Friedman, Lane

such as stainless steel, do not osseointegrate to the the newer systems have moved away from this tech-
same degree as titanium. Although stainless steel is nique for applications other than mandibular plat-
quite strong and can be easily machined, most of the ing. Although newer materials such as pure carbon
companies producing facial plating systems have screws and plates have been developed, they have
converted to the use of titanium over the last decade, few advantages over titanium in their malleability,
and this is certainly the trend for the foreseeable strength, and biocompatibility. It is only when a
future. With this in mind, further discussion of resorbable screw or plate system is perfected that the
metal implants will be restricted to titanium. current titanium planting systems will be replaced.
Several companies make facial plating systems Although Johnson & Johnson Orthopedics (Somer-
composed of titanium alloy. These systems have ville, New Jersey) is marketing a resorbable poly-
proven their worth in mandible reconstruction and dioxanon pin for the fixation of bone fragments in the
the treatment of facial fractures. Furthermore, their knee and hand, and many other companies are con-
lack of interference with both magnetic resonance ducting research on resorbable screw and plate sys-
imaging and computed tomography (CT) scanning tems, a number of significant problems persist.
gives them a significant advantage over other metal Their approval by the FDA is much more than 3 years
implants. The biocompatibility of titanium plates is away.
excellent and there is no evidence that titanium is
degraded over time. Eventual corrosion and stress
fractures are possible, particularly with mandibular SILICATE AND CALCIUM-BASED OSSEOUS

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reconstruction plates. It is important that only ti- ALLOPLASTS
tanium screws are used with titanium plates, be-
cause dissimilar metals (stainless steel screws and Alloplasts have been developed over the last 20
titanium plates) can cause corrosion and stress fail- years that can function as bone graft substitutes
ure of the plate. In addition, segemental mandibular rather than inert implants. Most of these materials
defects bridged by a metal plate should be recon- are composed of silicate or calcium phosphate and
structed with a bone graft to prevent eventual stress are regarded as sufficiently biocompatible that bone
failure of the plate. is able to bond to and grow over these materials. The
Many of the titanium mandible reconstruction ability of an alloplast to support bone overgrowth is
systems require a pretapped hole prior to screw referred to as osseoconduction. None of these mate-
placement. Tapping is used to increase the contact rials causes de novo bone formation when implanted
between the screw threads and the bone to improve in sites not in contact with viable bone, that is, none
osseointegration. For small microplates (Fig. 8), pre- of these materials is osteogenic. Some of these mate-
tapping holes does not appear to be necessary and rials have been in clinical use for more than 15 years
(ceramic HA), whereas others are still in animal and
clinical trials.

Silicate Implants

Bioglass (Geltech, Alachua, FL) was initially de-

Figure& Varioustitaniummicroplatesandscrews.The
longest screw measures 6 m m in length.
scribed in the late seventies and represents the first
silicate-based bone graft substitute. Bioglass is a
hard solid transparent glass composed of sodium
oxide, calcium oxide, phosphorus pentoxide, and
silicon dioxide, with silicate as the primary compo-
nent. When implanted in direct contact with bone,
an alkaline layer of calcium phosphate develops over
the implant surface, permitting bone to osseointe-
grate with this biomaterial. Bioglass is not replaced
by bone because osteoclasts are unable to resorb
silicate-based biomaterials, but a molecular bond
does form between the Bioglass surface and bone
without an intervening layer of fibrous tissue. The
use of silicate results in a stronger implant compared
with calcium phosphate-based preparations such as
ceramicHA. Numerousanimalsstudieshavebeen
carried out using Bioglass for experimental osseous
FACIAL PLASTIC SURGERY Volume 9, Number 1 January 1993
replacement in most areas of the skeleton, and it has
performed reasonably we11.29.3o It is unclear what
advantages Bioglass would have over ceramic HA or
the previously described polymeric materials that
can be shaped intraoperatively. This material is not
approved for human use in the United States, but
silicate-based bone alloplasts are now in clinical use
in Europe. It is conceivable that Bioglass could be
approved by the FDA within the next 3 years, al-
though we do not know whether FDA approval is
being sought for Bioglass.
Ionogran (Ionos Medizinishe Produkte, Seefeldl
Obb, Germany) is a porous silicate-based alloplast
currently approved for clinical use in Europe. This
granular material is composed of aluminum-calcium-
fluorosilicate, and it is osseoconductive when placed
in contact with viable bone. The granules come in 0.5
to 1.0 mm and 2.0 to 3.0 mm sizes and can be packed
into osseous defects where they serve as a nonre-
sorbable scaffold on which bone can grow. Ionogran
does not set and has no substantial structural stabil-
ity until surrounded by fibro-osseous tissue. The
implant remains as a permanent inclusion within the
fibro-osseous matrix. It is unclear what advantage
this material would have over the ceramic HA gran-
ules that have been available for clinical use in the
United States since the late 1970s. It could be ex-
pected that this material would retain the potential
for deformation and migration seen with other gran-
ular implants when used for onlay skeletal augmen-
tation.
Ionomeric cement is a self-setting cement based on
the same chemical composition as ionogran gran-
ules. It is made by the same company that produces
Ionogran and is currently in clinical trails in Ger-
many. The cement is formed by the reaction of a
calcium aluminosilicate glass powder with poly-
alkenoic acid and can be mixed intraoperatively and
sets in situ. The setting of the glass ionomer cement
involves the exchange of metal ions from the ionomer
to the acid, resulting in a gel phase that solidifies.
The material forms a dense paste that hardens in
approximately 10 minutes to form a water-insoluble
solid. The cement can be shaped up to several min-
utes prior to hardening. Until fully set, this material
can be dissolved by the ambient liquid in the wound.
Similar to other silicate-based alloplasts, bone can
bond to this material but cannot penetrate or replace
the hardened cement.
This cement has been used in several hundred
patients for calvarial reconstruction and otologic sur-
gery.31The results have been very favorable, with no
toxic reactions and a low incidence of infection. The
exception to this occurs when cranioplasty is per-
formed in contact with the paranasal sinuses using
this cement. In this application, the infection rate
approached 40%, based on a recent Swedish study
(personal communication). This material, like most
other alloplasts, must be covered with well-vascular-
ized tissue, or chronic exposure is possible. The FDA
status of this potentially useful material is unknown.
Calcium Phosphate Implants
Ceramic Hydroxyapatite
HA forms the principal mineral component of
bone and comprises 60 to 70% of the calcified skele-
ton. Its chemical composition is CaIo(PO,),(OH),
and it has been produced synthetically since the
early 1970s and used clinically for the last 20 years.32
All forms of HA have excellent biocompatibility and
when placed in contact with viable bone result in
osseoconduction and osseointegration. There is no
evidence that HA is osteogenic. HA does not cause a
chronic inflammatory response, toxic reactions, or a
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foreign body giant cell reaction.
There are two types of HA: ceramic and nonce-
ramic. Until recently all forms of HA in clinical use
were ceramic preparations. Ceramic HA is synthe-
sized in crystal form at a very low pH, then heated to
800 to 1300" to form a solid mass of HA. This heating
process, called sintering, results in a hard, strong,
functionally nonresorbable biomaterial. Ceramic HA
is available in two forms: dense or porous. The dense
form is entirely nonporous and can be fabricated into
blocks or granules. The blocks are not useful in facial
plastic and reconstructive surgery because they are
difficult to shape and do not permit fibro-osseous
tissue ingrowth. HA granules also have significant
limitations. They have no intrinsic structural integ-
rity and do not become mechanically stable until
surrounded by fibro-osseous tissue. Granules are
difficult to contain within the desired site of implan-
tation and retain the potential for migration for sev-
eral weeks to months. For these reasons, HA gran-
ules are not appropriate for use in facial skeletal
augmentation.
In an attempt to solve the problems of granule
containment and poor structural stability, HA gran-
ules have been combined with resorbable carrier
compounds. These carrier compounds bind the HA
granules into a resorbable matrix, maintaining the
histologic advantages of hydroxyapatite.33 A new
bone graft substitute called Hapset uses this tech-
nique by mixing plaster of Paris (calcium sulfate)
with HA granules to simulate an HA cement. Hap-
set is currently in FDA trials for use in orodental
defects. Plaster of Paris has been used as an implant
material for over 100 years. Its use has been limited
because it is completely resorbed by the body within
several months, resulting in an intense granuloma-
tous response in the surrounding soft tissues. This
granulomatous response can limit local bone forma-
 SYNTHETIC BIOMATERIALS-Costantino,
tion and result in lymphadenopathy until the cal-
cium sulfate is fully resorbed.34 Hapset may prove
useful in small quantities for the repair of perio-
dontal defects and may be approved for this use by
the FDA within the next 3 years. We have significant
reservations about using large volumes of this mate-
rial for facial skeletal reconstruction or augmentation
due to its potential side effects.
Porous HA, the other form of ceramic HA, has
interconnecting 200 km pores that allow bone to
grow onto the internal surface area of the implant by
osseoconduction. The porous pattern of this material
is based on marine coral. The calcium carbonate
skeleton of the coral is chemically converted to HA
while maintaining the porous structure of the coral.
This material is produced by Interpore International
(Irvine, CA) and is referred to as Interpore 200.
Porous HA is ingrown by fibro-osseous tissue and
becomes fixed to the surrounding bone within sev-
eral weeks. After tissue ingrowth is complete, the
implant consists of approximately 17% bone, 43%
soft tissue, and 40% residual HA implant. Although
these implants are very slowly resorbed (1% per
year), they can be considered functionally nonre-
sorbable. This material comes in block form but is
difficult to shape because it fractures easily. It cannot
be used for any stress-bearing applications and is
most appropriate as an onlay graft or spacer material
following facial osteotomies.35 Because it is fragile
and difficult to contour, applications have been
largely limited to dentistry. Experience with porous
HA for alveolar ridge augmentation has shown that
this material is resistant to infection after ingrowth
by fibro-osseous tissue, but can become exposed if
the overlying soft tissue is not adequate.
In summary, porous ceramic HA is a very biocom-
patible alloplast with some significant structural lim-
itations. It should be considered as a bone graft sub-
stitute only for selected applications in facial plastic
and reconstructive surgery.
Nonceramic Hydroxyapatite
HA cement is the only nonceramic alloplast that
forms a pure HA implant. It is substantially different
from the ceramic forms of HA currently approved by
the FDA. HA cement is produced by direct crystal-
lization of HA in vivo and does not require heating
for the formation of a structurally stable implant. The
dry cement is composed of tetracalcium phosphate
and dicalcium phosphate. These two reactants form
microporous HA at physiologic pH and tempera-
ture. When mixed with water, this material forms a
paste that can be molded to the desired shape intra-
operatively. The cement sets in approximately 10 to
15 minutes and converts to HA within 4 hours. After
'conversion to HA, it is no longer water soluble.
Animal testing over the last 5 years has shown that
Friedman, Lane
HA cement is appropriate for a number of applica-
tions in the craniofacial ~keleton.17~36~37 Although
it has good compressive strength in the range of 60
MPa, it has limited shear resistance and is only ap-
propriate for use in non stress-bearing applications.
The most notable feature of this material, other than
its cement form, is its slow replacement by bone over
time without a loss of volume or change in shape.
Unlike ceramic HA or silicate-based alloplasts, this
cement is slowly resorbed and replaced by new bone.
When used for cranioplasty in animals, approx-
imately 35% of the implant volume was replaced by
fibro-osseous tissue over 12 months and new bone
comprised approximately 75% of that fibro-osseous
ingrowth.
This material is currently experimental and under-
going clinical trials. It is produced only on a research
basis at the Paffenbarger Research Center of the
American Dental Association Health Foundation at
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the National Bureau of Standards and Technology,
Gaithersburg, MD. Forty-five patients have been im-
planted with this material over the last 13 months
for craniofacial reconstruction and to repair calvarial
defects. To date, there have been no toxic reactions,
no increases in serum calcium level, and no struc-
tural failures. The infection rate is currently 5% ,and
over 93% of the implants have placed in contact with
the paranasal sinuses. Thus far, the cement has been
applied to seven cerebrospinal fluid leaks and has
been successful in all cases. This cement can be
applied directly onto the dura without any adverse
effects. Three of these leaks were treated endo-
scopically by sealing the skull base with the cement
through the nose. The majority of the implants have
been used for frontal bone reconstruction (Fig. 9),
frontal sinus obliteration, and cranioplasty. Trans-
labyrinthine approaches to the cerebellopontine an-
gle and complex anterior cranial fossa defects have
also been reconstructed with this material. Approval
of this cement by the FDA for non stress-bearing
applications in the head and neck is expected within
2 years.
SUMMARY
The development of a new generation of synthetic
biomaterials is just now beginning to move from the
laboratory to large animal testing. Within the next 10
to 15 years, biomaterials may be developed that will
revolutionize the way craniofacial reconstructive sur-
gery is done. The promise of biologically active
growth proteins in combination with resorbable syn-
thetic alloplasts would allow missing tissues to be
regenerated rather than just "filled in" by permanent
implants. There will also be a steady drift away from
materials based on chemical elements other than
FACIAL PLASTIC SURGERY Volume 9, Number 1 January 1993

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Figure 9. A: Open cutaneous fis-

tula into the frontal sinus following a
failed Reidel procedure. B: Three di-
mensional CT scan showing size of
frontal bone and supraorbital rim de-
fects. C: lntraoperative photograph
(cranial to caudal view) showing the
frontal bone defect. Each arrow indi-
cates a supraorbital rim defect. (Figure
continued on next page)
 SYNTHETIC BIOMATERIALS-Costantino, Friedman, Lane

Downloaded by: University of British Columbia. Copyrighted material.

Figure 9, cont. D: Placement of the hydroxyapatite ce-

ment into the defect. E: Complete frontal bone reconstruc-
tion. F: Three-dimensional CT scan showing the inferior
surface of the orbital roofs and frontal contour from below
following reconstruction (cranial to caudate view). (Figure
continued on next page)
FACIAL PLASTIC SURGERY Volume 9, Number 1 January 1993

Downloaded by: University of British Columbia. Copyrighted material.

Figure 9, cont. G: Preoperative axial CT scan showing

the frontal bone and forehead skin defect. H: Postoperative
CT scan showing the reconstructed frontal bone at approx-
imately the same level as G. I: Postoperative appearance 4
weeks after frontal bone reconstruction and local flap clo-
sure for cutaneous forehead defect.
 SYNTHETIC BIOMATERIALS-Costantino,
carbon and calcium, thereby minimizing the risks of
carcinogenesis or immune reaction over time.
As promising as these new alloplasts appear to be,
we should learn from past experience. Implants that
initially seem biocompatible can eventually fail in
unpredictable ways when exposed to the hostile en-
vironment of the body. As surgeons responsible for
the final evaluation of these new materials before
they are used in patients, we should remember an
old Italian proverb: "The more one learns, the less
one believes."
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