ONLINE EXCLUSIVES
Granuloma formation secondary
to silicone injection for soft-tissue
augmentation in facial cosmetics:
Mechanisms and literature review
Leo L. Wang, MS; William W. Thomas, MD; Oren Friedman, MD
Abstract
The use of injectable fillers is increasingly popular as an
alternative to surgery for facial cosmetic applications. In
this regard, silicone is a versatile biomaterial filler that
has been used for these purposes, but its use warrants
further investigation, especially since it is not clinically
approved for such uses. We describe the use of silicone as
a facial injectable filler through a scholarly review of the
literature for cases of silicone granuloma formation pub-
lished from September 2007 through September 2017,
and we present various contexts in which this compli-
cation has been observed. We further review the im-
munologic etiology of granuloma formation and other
complications of silicone injections. We write this report
to caution physicians on the use of silicone fillers which,
for all their advantages, are associated with significant
long-term risks that are frequently overlooked.
Introduction
The use of injectable fillers in facial cosmetic proce-
dures has become extremely popular over the past
decade. These materials are considered an excellent
addition to the armamentarium of the cosmetic med-
ical provider, as they allow for a minimally invasive
approach to facial reconstruction and rejuvenation. In
view of the minimally invasive nature of these prod-
ucts, patients and providers alike might approach
these injections with the notion that they represent a
low-risk procedure, but they are not without potential-
ly significant drawbacks.
Our goal in presenting this article is to highlight
one of the significantly deforming complications that
From the Perelman School of Medicine, University of Penn-
sylvania, Philadelphia (Mr. Wang); and the Department of
Otorhinolaryngology–Head and Neck Surgery, Perelman School
of Medicine (Dr. Thomas and Dr. Friedman).
Corresponding author: Leo L. Wang, MS, Perelman School of Medicine,
University of Pennsylvania, 3400 Civic Center Blvd., Philadelphia,
PA 19104. Email: leowang4@gmail.com
E46 www.entjournal.com
may result from the use of certain injectable fillers. We
describe the known complications of facial cosmetic
silicone injections with a focus on granuloma forma-
tion. In addition, we cite several case reports from the
literature that have detailed various aspects of silicone
granuloma formation, based on our extensive 10-year
review of the recent literature. It is our hope to increase
awareness of the problem and thereby minimize poten-
tial harm to patients.
Silicone is a versatile material that is used frequently
in biomedical procedures. Its use dates back as early
as the 1940s, when it was first described for breast
augmentation in Japan.1,2 Its most common form is
polydimethylsiloxane, also known as dimethicone
and silicone oil, and it is available in solid, gel, and
liquid forms:
• In its solid form, silicone is an elastomer—an elastic
covalently cross-linked polymer network that is used in
implantable prosthetics and intravenous-fluid tubing.3
• As a gel, silicone exists swollen in solvent and may
be cross-linked, which allows it to exhibit properties of
both its solid and liquid forms. Silicone gels are used
primarily in breast augmentation.
• In its liquid state, silicone typically exists in
low-molecular-weight forms. While it is used primari-
ly in ophthalmology and is approved only for use in the
retina,4 liquid silicone also has been used for soft-tissue
injections in facial, gluteal, and breast cosmetic appli-
cations, although its use in these circumstances is still
off-label. In addition to being injectable, the advanta-
geous biologic qualities of liquid silicone include the
facts that it is inert, noncarcinogenic, and inexpensive.
Silicone is just one of many biomaterials used for
cosmetic facial injections, but unlike hyaluronic acid,
collagen, and calcium hydroxyapatite, silicone had not
been granted FDA approval for these applications. Some
ENT-Ear, Nose & Throat Journal January/February 2018
 GRANULOMA FORMATION SECONDARY TO SILICONE INJECTION FOR SOFT-TISSUE
AUGMENTATION IN FACIAL COSMETICS: MECHANISMS AND LITERATURE REVIEW
physicians have advocated the regulated use of silicone
in view of its ability to provide long-lasting cosmetic
corrections.5,6 The FDA has recently approved several
clinical trials to establish the safety and efficacy of
silicone under controlled conditions.7
Even though silicone is biologically inert, its injection
can result in the formation of granulomas.8 Silicone
granulomas were first described in 1964 as a rare com-
plication that was, and continues to be, a diagnostic
challenge.9 The severity and frequency of granuloma
formation, as well as other immunologic complications,
will likely increase if injections are administered by
incautious or unqualified, perhaps unlicensed, practi-
tioners using non–medical-grade silicone.
The popularity of administering liquid silicone injec-
tions as a dermal filler in facial cosmetic procedures has
fluctuated. Injectable silicone’s primary functions have
been to reduce glabellar, nasolabial, and marionette skin
lines, to camouflage scars, and to augment the lips. The
microdroplet technique allows for the administration of
liquid silicone at 1-month intervals so that clinicians
can assess gradual improvement incrementally.
Small amounts of injection have traditionally been
associated with good results.10 However, in some cases,
they have been associated with relatively minor compli-
cations, including pain, swelling, erythema, ecchymosis,
pigmentation, induration, and deformity from material
migration.11 Migration of injected silicone may occur
over the course of years, leading to an accumulation of
particles and nodular granulomas at sites far removed
from the points of injection. Over time, many of these
complications may resolve, with or without conserva-
tive treatment measures. However, because silicone is a
permanent filler, nodules and granulomas, particularly
in the lips, will not resolve without direct excision.
With larger injections, which are typically adminis-
tered to the gluteal region and chest wall, more serious
complications have been reported, including cellulitis,12
ulceration and necrosis,12 abscess,13,14 lymphadenop-
athy,15,16 pneumonitis,17 hepatitis,18 toxic shock syn-
drome,19 systemic sclerosis,20 end-organ failure,21 and
embolization leading to sudden death22 and blindness.23
Most recently, Lee et al documented a case of lym-
phoma after silicone injection.24 In that case, extranodal
marginal-zone B-cell lymphoma of MALT (mucosa-
associated lymphoid tissue) arose in a 72-year-old wom-
an who had received a silicone injection in her cheek.
This suggests that chronic inflammation secondary
to the injection might trigger adverse immunologic
reactions and tumorigenesis.
Complications of silicone injections can occur im-
mediately, within 3 weeks, within a year, or as long
as decades after treatment. Although catastrophic
complications are rare, physicians always should be
Volume 97, Number 1-2
careful not to inject silicone into vasculature and to use
appropriate injection techniques to minimize risk. Some
rare immunologic complications include pseudocyst
formation, fibrosis, and eosinophilia.13 However, the
most commonly described immunologic and histologic
finding is granuloma formation.
As mentioned, silicone granulomas, also called silicono-
mas, were first described in 1964; Winer et al reported
them as representing a dermal immunologic response to
silicone injection in 3 patients.9 Clinically, these lesions
present as a subcutaneous nodule that can be either
local or located at a distance from the site of injection.
Most granulomas form within the first 12 months after
injection; common sites are the lips, nose, and chin.25,26
The diagnosis of silicone granuloma can be made only
by pathologic confirmation, but a history of cosmetic
injections should raise a clinician’s suspicion. Ultra-
sonography, computed tomography, and/or magnetic
resonance imaging can demonstrate pertinent anatomic
boundaries. It is important to distinguish a silicone
granuloma from orofacial granulomatosis, which is a
granulomatous process that leads to persistent swelling
and enlargement of the mouth and lips.27,28
As is the case with any foreign-substance injection,
the body reacts through both an acute and chronic
inflammatory response (figure). The acute phase is
characterized by migration of neutrophils and protein
exudate, while the chronic phase involves lymphocyte
and monocyte aggregation. In particular, the monocytes
differentiate into macrophages, and they induce a gran-
ulomatous response through signaling by a constellation
of cytokines, including interferon gamma (IFN-γ) and
tumor necrosis factor alpha (TNF-α).29
In general, the granulomatous response to silicone
is variable. It usually manifests as a central region of
macrophages surrounded by a zone of lymphocytes
and a zone of fibroblasts. The presence of both epithe-
lioid macrophages and multinucleated foreign-body
giant cells with centrally arranged nuclei is a classic
histologic feature.19
Collagen deposition by fibroblasts is often a desired
side effect because it can tighten sagging skin. Vacuolated
macrophages can also mimic lipoblasts and liposarco-
mas histologically.30 Because such responses can also
be seen in liposarcoma, which can have a complicated
and extensive treatment plan, a history of cosmetic
injections, particularly long-standing or unregulated,
should be elicited.
In silicone-induced inflammation, it is unclear whether
the immune system is responding to the silicone itself or
to additives or contaminants, which have been reported
to include fumed silica, an amorphous aggregate of
silica, and platinum.31 Fumed silica has previously been
shown to be highly immunogenic in an animal model.32
www.entjournal.com E47
 Wang, Thomas, Friedman

Hu et al described a case
of delayed-onset silicone
granuloma formation in
the nose and periorbital
eye that had arisen 40
years after the patient had
received a silicone implant
in conjunction with liquid
silicone.35 The patient did
not respond to antibiot-
ics, although systemic
steroids were effective in
limiting symptoms. For
treatment, the patient
underwent rhinoplasty
using irradiated costal
cartilage and had the
silicone implant and sur-
rounding tissue removed.
This case shows that a
granulomatous reaction
Figure. Illustration depicts the foreign-body response to silicone that leads to encapsulation and can occur decades after
granuloma formation. The response involves an initial inflammatory response dominated by the initial injection and
neutrophils, which leads to a fibrous encapsulation that is initiated by responses from fibroblasts and suggests that physicians
macrophages. (FBGCs = foreign-body giant cells.) Reproduced with permission from the Nature
Publishing Group.49 need to acknowledge the
potential for this compli-
Previous studies have demonstrated that silicone can cation for the entire duration of a patient’s life.
induce an antigen-specific response in and of itself, Chen et al described a similar complication that also
perhaps as a result of hydrophobicity.33 However, they occurred 40 years after an injection.36 In this case, a
have also demonstrated that the immune response woman had received silicone for chin augmentation.
is significantly enhanced by additional antigens that She had been initially diagnosed with angioedema
are present alongside the silicone, suggesting that mimicking total facial swelling, but she was later was
contamination or additives might be responsible. This found to have silicone granulomas that had spread all
theory is supported by the fact that a small fraction of over her face. In another case in which surgical involve-
granulomas that form in response to silicone injections ment was precluded, Crocco et al reported successful
are infectious granulomas.34 treatment with systemic minocycline monotherapy.37
Despite the ability of granulomas to wall off silicone, Another highly interesting case demonstrating the
unencapsulated silicone may leak to regional or distant delayed onset of silicone granuloma formation was
lymph nodes and travel to other parts of the body, where described in 2014 by Eun et al.38 They reported the
it can cause adverse immunologic phenomena. case of a 62-year-old woman in South Korea who had
presented with a disfigured nose. The disfiguration
Literature review involved thickening and lichenification of the nasal root
We reviewed the PubMed database using the search term and the upper two-thirds of the nose, which resulted in
silicone granuloma to identify articles published from an elephant trunk-like appearance. Forty years earlier,
September 2007 through September 2017. We then se- the patient had been illegally injected with a filler by
lected all articles that involved silicone granulomas that an unlicensed practitioner to correct a flat nose bridge.
arose as a result of cosmetic injections in the face; articles After her nose had been thickened, she was subsequently
involving silicone granulomas elsewhere were excluded. administered a “dissolving” agent, which eventually
Our search identified 180 different kinds of reports culminated in her disfiguration. On histology, she
on silicone granulomas; of these, 15 involved cosmetic was found to have a granulomatous response that
silicone injections in the face.8,10,20,23,26-28,30,35-41 We also involved mononuclear cells, lipid-laden macrophages,
included a single as-yet-unpublished case that is cur- and foreign-body giant cells, with spherules of lipid
rently in press.42 What follows is a synopsis of some of consistent with sclerosing lipogranuloma, most likely
the more interesting cases: from a silicone injection. This case demonstrates the

E48 www.entjournal.com ENT-Ear, Nose & Throat Journal January/February 2018

 GRANULOMA FORMATION SECONDARY TO SILICONE INJECTION FOR SOFT-TISSUE
AUGMENTATION IN FACIAL COSMETICS: MECHANISMS AND LITERATURE REVIEW
potential for sclerosing granulomas to cause serious
disfigurement.
Similarly, Friedmann et al reported the formation
of granulomas that formed in response to either poly-
methylmethacrylate or liquid silicone in 4 patients
who had been injected between 15 months and 5 years
earlier.39 They postulated the formation of biofilms and
argued that silicone provides a surface upon which
microorganisms can adhere. They suggested the use of
polymerase chain reaction testing for biofilm detection
on silicone injectables.
Woodward et al added polyacrylamide and poly-
L-lactic acid to the list of injectables that can cause
granulomas because of their ability to serve as a nidus
for biofilm formation.40 They also suggested a novel
treatment that had been earlier proposed by Kornstein43
in which ultrasonography is used to break apart silicone
nodules to prevent granuloma formation and spread.
Rongioletti et al described the cases of 2 women in
Italy who developed diffuse facial nodular tumefaction
after silicone injections.41 One patient presented with a
leonine face after receiving an illegal injection of what
she had been told was Juvederm, a hyaluronic acid prod-
uct. A punch biopsy revealed that she had developed
a siliconoma, for which she was treated with minocy-
cline. Another patient presented with multiple painful
nodules in her periorbital and perioral areas; she had
also received silicone under the impression that it was
hyaluronic acid. She was also treated with minocycline.
The 2 cases reported by Rongioletti et al highlight the
dangers of receiving injections by unlicensed providers
and the fact that a filler purported to be hyaluronic acid
might actually be the much more dangerous silicone.
We have also seen this complication in one of our own
patients who had received such an injection by an un-
licensed provider.42
In another report illustrating the same idea, Ellis
et al described 2 cases of granuloma formation after
silicone injection.8 A 39-year-old man presented with
subcutaneous nodules in his nasolabial folds 5 weeks
after he had received injections from a nurse at a day
spa. The product was purported to be Restylane, a
hyaluronic acid product. The patient failed to respond
to numerous treatments, including a low-dose steroid,
tacrolimus, imiquimod, and pulsed-dye laser therapy.
The granulomas were finally treated successfully with
the use of high-dose intralesional steroid injections,
but the patient required ongoing cycles of treatment.
In the other case described by Ellis et al, a 57-year-old
woman developed swellings in her lips after she had
undergone lip augmentation by an unlicensed provider.8
Histology suggested silicone granuloma formation, and
the patient was treated with a combination of pulsed-dye
laser therapy, pimecrolimus cream, a calcineurin inhibitor,
Volume 97, Number 1-2
and low-dose intralesional steroid injections. This is yet
another example of how silicone injections are often mis-
represented as FDA-approved fillers and used illicitly by
unlicensed providers, resulting in great harm to patients.
Finally, Sanchis-Bielsa et al reported a series of 15 cases
of granuloma formation from cosmetic injections, one
of the largest series on granuloma formation to date.26
They treated 14 women and 1 man who had developed a
foreign-body granulomatous reaction in response to the
injection of cosmetic materials. To highlight silicone’s
prevalence as a primary factor in causing these compli-
cations, 9 of these 15 cases had been caused by silicone. In
these patients, systemic steroids rather than intralesional
steroids were used to control symptoms with great success.
Discussion
Silicone granulomas are as prevalent as they have always
been, but there is no consensus regarding their treatment.
Treatment can be difficult and in many cases unsuccess-
ful. Clinicians should try to individualize treatment for
each patient. If surgical excision is deemed necessary,
significant scarring can be expected because the silicone
itself and the granulomas can migrate throughout mul-
tiple layers of soft tissue, often necessitating the removal
of thick sections of tissue. In some patients, granulomas
will resolve spontaneously without treatment.
The more common treatments include systemic and
local steroids,3 minocycline,16,37 5-fluorouracil,44 isotreti-
noin45 and, for localized granuloma formation, surgical
resection. While success has been achieved with steroids,
relapse often occurs after a steroid taper. Consideration
should be given to whether an oral or intralesional steroid
would be more appropriate. Patients with disseminated
granulomas or with multiple lesions may need an oral
steroid. The antimetabolite 5-fluorouracil has also been
successful in conjunction with triamcinolone.44
Antibiotics, especially minocycline, have been used
successfully for their anti-inflammatory and antigran-
ulomatous properties, as well as their mycobacterial
coverage. Their use has been enhanced with the ad-
dition of celecoxib.46 Isotretinoin is also used for its
anti-inflammatory properties and dermatologic efficacy.
More specific treatment modalities that are targeted
directly to granulomas include imiquimod and etaner-
cept. Imiquimod acts by modulating IFN-γ.47 Etanercept
is a TNF-α inhibitor that directly prevents granuloma
formation.48 There have been reports of success with the
use of both in treating silicone granulomas.
Surgical resection is a good option for localized gran-
ulomas, although the resected tissue must be replaced
to fill the dead space and minimize postoperative
aesthetic deformity.
There is not enough literature detailing the causal
mechanisms of silicone granulomas, and there are
www.entjournal.com E49
 Wang, Thomas, Friedman
various explanations on how they form. Silicone formu-
lations can be highly heterogeneous, necessitating some
standardization in the way silicone is manufactured.
Finally, as we have seen, some unlicensed practitioners
are providing silicone injections as a dermal filler, often
misleading patients into believing that they are receiving
an FDA-approved hyaluronic-acid–based product such
as Juvederm or Restylane. Physicians should be aware
of these inappropriate uses.
In conclusion, the popularity of injectable fillers has
increased dramatically over the past decade. Many non-
physicians and some poorly trained physicians perform
injectable filler procedures to capitalize on the significant
financial incentives associated with this practice. Patients
are attracted to injectable fillers because of their nonin-
vasive method of administration. However, practitioners
sometime perform these procedures cavalierly, at times
ignoring the potential for serious complications.
We write this report to inform otolaryngologists of
the need to weigh the risks and benefits of injectable
fillers, especially silicone. There are significant potential
downsides to the administration of injectable fillers, and
providers and patients alike must be made aware of both
the short- and long-term risks. Granuloma formation
after liquid silicone injections should be considered in
the differential diagnosis of any patient with a history
of cosmetic injections who has developed inflammatory
masses. Granulomas form because of foreign-body
reactions to silicone that lead to fibrous encapsulation
and deposition of a dense collagenous fibrous matrix.
The three most common cell types implicated in this
process are lymphocytes, macrophages, and fibroblasts.
Silicone granulomas can be managed both medically
and surgically, but in nearly all cases, they will leave
some degree of permanent scar deformity.
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