Case Report

Aesthetic Facial Surgery

Complications after facial
contour augmentation with
injectable silicone. Diagnosis
and treatment. Report of a
severe case
G. E. Anastassov, S. Schulhof, H. Lumerman: Complications after facial contour
augmentation with injectable silicone. Diagnosis and treatment. Report of a severe
case. Int. J. Oral Maxillofac. Surg. 2008; 37: 955960. # 2008 International
Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights
reserved.
G. E. Anastassov
1
, S. Schulhof
1
,
H. Lumerman
2
1
Maxillofacial Surgery, Mount Sinai School of
Medicine, New York, USA;
2
Department of
Pathology, Mount Sinai School of Medicine,
New York, USA
Abstract. The purpose of this article is to increase the practitioners awareness of the
adverse effects associated with the clinical utilization of foreign bodies
(heterollers), especially silicones for contour augmentation of the face. Diagnostic
modes for such difcult cases as well as means for their treatment are discussed in
the light of a severe case of facial siliconomas. The case of a 46-year-old female
patient with severe facial irregularities and pain secondary to siliconomas 5 years
after facial augmentation with silicone is presented. The patient was treated
surgically after histological and radiographical conrmation of the diagnosis of
facial siliconomas. Extensive dissection of the siliconomas and inltrated
surrounding fascial planes was performed. The patient underwent a protracted
course of oral minocycline followed by facial lipolling with autogenous fat for
correction of residual contour irregularities. Silicone may produce unpredictable
and devastating complications, which are difcult if not impossible to treat
adequately. It is cautious not to use foreign bodies that are not approved by the FDA
as contour enhancers, especially not in large quantities.
Keywords: facial llers; silicone; heterollers;
siliconoma; granuloma; facial disgurement; fat
grafting.
Accepted for publication 24 April 2008
Available online 12 June 2008
The desire for facial and body volume
enhancement is not new. In the 18th cen-
tury and at the beginning of the 19th
century, parafn injections were used
for contour augmentation. The use of
injectable parafn became popular in the
1900s. In 1899, Gersuny used parafn to
create a testicular prosthesis in a young
individual via scrotal injections. The
patient had lost his testicles due to tuber-
culosis. In 1902, Eckstein observed par-
afn migration and soft tissue induration
and consequent mutilation
11
. Parafno-
mas, leading in some cases to malignant
transformation of the surrounding tissues
were also reported
18
. According to these
reports the parafn usually was displaced
due to the gravitational as well as dynamic
Int. J. Oral Maxillofac. Surg. 2008; 37: 955960
doi:10.1016/j.ijom.2008.04.020, available online at http://www.sciencedirect.com
0901-5027/100955 +06 $30.00/0 #2008 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
forces producing unpredictable and
unsightly outcomes. The era of modern
soft tissue augmentation dates back to
Neuber, who rst described the use of
autogenous adipose tissue for contour aug-
mentation
11
. He used fat blocks obtained
from the arms via open lipectomy to aug-
ment depressed facial defects.
Multiple synthetic formulations are on
the market today. These are based on
derivatives of polyvinylsiloxane, ePTFE
(GoreTex), homologous preserved dermis
(AlloDerm), homologous lyophilized fas-
cia lata (Fascian), derivatives of hialuronic
acid (Restiline), homologous and hetero-
logous as well as autologous collagen (e.g.
Zyderm), and others. For a material to be
an ideal tissue ller it must meet certain
criteria. It should be biologically inert,
retain its physical properties, be easy to
manipulate, be easily obtainable, inexpen-
sive, and produce consistently predictable,
good results in the short and long term
1
.
Such material currently does not exist.
Silicones are synthetic long-chain organo-
silicones. The most popular of these com-
pounds is polydimethylsiloxane. Silicone
can exist in many different forms, from
liquid, gel to solid. Silicone became pop-
ular in the 1950s, especially in the Far East
where it was used extensively for contour
enhancements. It was used mainly on the
face, breast and hips. Silicone was used as
an injectable material and as a shell and
shell ller in breast prostheses. The pro-
ponents of silicone use believe that poly-
vinylsiloxane is inert and stable once
injected subcutaneously causing no or
956 Anastassov et al.
Fig. 1. Preoperative clinical photographs.
Fig. 2. Maxillofacial CT scans. Note diffuse , extensive irregular asymmetric multiple nodular
radiodensities secondary to inltration of the midfacial region, nasolabial folds and periorbital
soft tissues.
Fig. 3. Clinical photograph during biopsy, depicting pale, indurated foreign body in the right
maxillary vestibule (arrow).
only a mild immunological response
5
.
Devastating consequences to silicone
injections have also been reported
225
.
The pathophysiology of the granuloma-
tous reaction caused by silicone is
unknown but thought to be a cross reaction
to a viral agent, the material acting as a
focus for infection, impure additives and
cross-contamination during injection
3
.
Repeated exposure to silicone gel may
induce an antigen-specic lymphocyte-
mediated response
6
. The tissue reaction
to silicone varies and depends on the form
in which it is being used. The silicone
shells (implants) produce walling-off
via a foreign-body giant-cell reaction with
possible leakage to the regional or distant
lymph nodes. When used as a gel or liquid
silicone usually produces empty, micro-
cystic spaces, which are generally small or
medium sized and depend on the amount
of silicone injected to the tissues
6
. These
side effects can present immediately after
injection or many years later. The granu-
lomas associated with silicone injections
in the soft tissues are known as silicono-
mas, a term used by Winer in 1964
27
. The
diagnosis is usually established reliably
through CT or MRI imaging and histo-
pathological investigation. The treatment
of these lesions is controversial and ranges
from intralesional injections of steroids,
systemic steroids, immunomodulators,
antibiotics, suction assisted lipectomy to
open surgical removal of the lesions. The
treatment depends on the location, the
extent of the lesion, the wishes of the
patient and the surgeons preference and
experience.
Case presentation
A 46-year-old Latin American female pre-
sented in June 2005 with complaints of
facial contour irregularities, skin tightness
and pain. The history included injections
of vitamins to her face 5 years pre-
viously. The symptoms started appearing
shortly thereafter and gradually pro-
gressed to constant nuisance. On clinical
examination (Fig. 1) the patient had multi-
ple facial irregularities and indurations in
the frontal, glabellar, periorbital, malar,
temporal, upper and lower labial, buccal
and pre-masseteric areas. The overlying
skin was slightly erythematous and the
areas were tender to palpation. There
was evidence of prior facial rhytidectomy
(pre- and post-auricular scars), which was
done prior to the injections according to
the patient. The facial motor and neuro-
sensory functions were otherwise not
altered. The preliminary diagnosis was
foreign body reaction. Facial CT imaging
and incissional biopsy were performed
(Figs. 2 and 3). The CT scan showed
multiple irregular asymmetric nodular
densities surrounding the facial muscles.
The biopsy specimen was taken from the
right buccal region via a transoral-vestib-
ular approach. The lesion biopsied had a
pale, pearly appearance and felt indurated
and rubbery in consistency. On sectioning
through the specimen, rubber-like resis-
tance was felt. The histopathology report
conrmed silicone granuloma (Fig. 4).
The patient was brought to the operating
room in July 2005 for removal of silico-
nomas. The lesions were outlined on the
skin preoperatively (Fig. 5). The access to
these granulomas was through a facial
rhytidectomy approach and pre-trichial
Complications after facial contour augmentation 957
Fig. 5. Preoperative outline of the areas involved with palpable siliconomas to be dissected out
during the surgical intervention.
Fig. 4. Histopathology of the biopsy sample (magnication x200). Note the clear spaces from
the pre-existing silicone in the soft tissues as well as in the multinucleated foreign body type
histiocytes. In addition, there is a chronic inammatory reaction (lymphocytes, plasma cells,
histiocytes).
forehead incision combined with intraoral
vestibular incisions (Fig. 6). On reection
of the skin aps, it was noted that the
lesions were inltrating the surrounding
subcutaneous plane and fasciae of the
underlying muscles. These lesions formed
almost a uniform intrafascial plane. Care
was taken to identify and protect the
branches of the facial nerve. The lesions
were painstakingly dissected. Approxi-
mately 200 mg of granulomatous tissue
was removed and submitted. The post-
operative course was uneventful. The
patient had some persistent skin irregula-
rities due to siliconomas, which could not
be safely removed without compromising
the functional integrity of the muscles of
facial expression, such as the orbicularis
oculi (Fig. 7). Some of the lesions were
intimately associated with the overlying
skin and caused skin depressions after
their removal. To reduce the residual
inammation the patient was started on
oral regimen of minocycline 100 mg twice
a day. The residual facial irregularities
were augmented with autogenous fat via
lipolling after sufcient time for resolu-
tion of the oedema had passed. The min-
ocycline improved the residual skin
irregularities. The patient was brought to
the operating room 6 months after the
initial procedure where abdominal suc-
tion-assisted lipectomy was performed,
lipoaspirate collected sterile, centrifuged
and injected in the face in the decient
areas. This improved the contour of the
face signicantly. It also improved the
quality of the overlying skin (Fig. 8). Cur-
rently the patient is free of symptoms and
satised with the outcome of the multiple
surgical procedures. The patient has com-
pleted a 12-month course of minocycline
without adverse reactions.
Discussion
The complications associated with the
injection of foreign substances to the face
and body are well recognized
8,10,15,26
. If
the injected substance comprises small
size particles, amenable for phagocytosis
by macrophages then the matter will be
eliminated or replaced by broblasts or
collagen bers within 13 months post-
injection. If it is larger, foreign-body reac-
tion and walling-off of the lesion will
occur
2,17
. The size of the silicone particles
is 170 micrometers. The phagocytic abil-
ity of the microphages is limited to 15
micrometers and hence, they are unable to
process silicone particles
15
. In vitro stu-
dies have shown signicant changes of the
cellular conguration and alteration of
broblast proliferation
16
. The complica-
tions reported in the literature related to
injection of silicone for cosmetic purposes
are numerous. They are pain, local inam-
mation, dyschromia, migration, abscess
formation
22
, indurated granulomas
27
,
severe migratory granulomatous reac-
tions
24
, connective-tissue disease
8,10,12
,
calcinosis cutis with hypercalcemia
13
,
lupus milliaris disseminatus and sicca
complex
23
and even death
3
.
For these reasons, the Food and Drug
Administration (FDA) has not approved
silicone for volume augmentation.
Recently, the FDA approved Adatosil
5000 and Silicon 1000 for the treatment
of retinal detachment in ophthalmology.
There are proponents for the use of sili-
cone as llers who have presented large,
retrospective series of patients with rela-
tively low complication rates and excel-
lent results. These authors base their
support on the premise that success
depends on training and the use of sterile,
medical grade silicone by microdroplet,
using a multistage technique and proper
patient selection
5
.
The rationale for the application of
minocycline is based on its anti-inam-
matory, immunomodulating, and anti-
granulomatous properties
2,21
. The
reported cases show that protracted use
of minocycline is safe and efcient in
alleviating the chronic inammatory
symptoms of siliconomas
2
. Side effects
such as skin depigmentation have been
reported
2
. Other chemotherapeutic agents
have been described for treatment of sili-
cone-related granulomas, such as corticos-
teroids and immunomodulators
(Imiquimod 5% cream)
3
. The case pre-
sented by these authors, however was
milder and of short duration; only six
months after the administration of silicone
injections. This may be one of the reasons
for the positive effect of this therapeutic
modality. The authors stated, of course,
placebo effect cannot be excluded as well
as spontaneous improvement of the con-
dition. The present case was severe with
the involvement of multiple regions, a
mask-like area of the face and associated
with pain. It was felt that owing to the
extent of the siliconomas the most appro-
priate treatment was surgical removal of
the lesions although, there are reports on
use of ultrasonic suction-assisted lipect-
omy (SAL) for elimination of facial and
corporal siliconomas
7
. In the present case
the siliconomas were diffusely inltrating
multiple fascial planes, muscles in close
proximity to vital structures (nerves, ves-
sels) and an open, controlled procedure
958 Anastassov et al.
Fig. 6. Intraoperative photograph showing extensive involvement of the subcutaneous tissues
with siliconomas and lack of clear plane between the lesions and the surrounding tissues.
Complications after facial contour augmentation 959
Fig. 8. Photographs taken after lipolling. Note improved facial con-
tour and skin quality.
Fig. 7. Clinical photographs taken 2 months postoperatively showing
multiple skin .
provided advantages over a closed, blind
procedure. Neither SAL nor open debride-
ment provides ideal results and additional
procedures are often required for an opti-
mal result to be achieved
12
. Autogenous fat
obtained via SAL and centrifuged, injected
atraumatically still remains the material of
choice for contour augmentation.
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Address:
George E. Anastassov
Maxillofacial Surgery Services
18 East 50th Street
5 Floor
New York
NY 10022
Tel.: +1 212 751 0001
Fax: +1 212 753 0540
E-mail: ganastassov@mfss.net
960 Anastassov et al.