2231

CASE REPORTS

Penile Injection with Silicone: Case Report and Review of

the Literature

Jonathan Silberstein, MD,* Tracy Downs, MD,* and Irwin Goldstein, MD†
*University of California, San Diego—Division of Urology, San Diego, CA, USA; †Alvarado Hospital—San Diego Sexual
Medicine, San Diego, CA, USA

DOI: 10.1111/j.1743-6109.2008.00911.x

ABSTRACT

Introduction. Liquid injectable silicone (LIS) has been used for soft tissue augmentation in excess of 50 years. Until
recently, all literature on penile augmentation with LIS consisted of case reports or small cases series, most involving
surgical intervention to correct the complications of LIS. New formulations of LIS and new methodologies for
injection have renewed interest in this procedure.
Aim. We reported a case of penile augmentation with LIS and reviewed the pertinent literature.
Methods. Comprehensive literature review was performed using PubMed. We performed additional searches based
on references from relevant review articles.
Results. Injection of medical grade silicone for soft tissue augmentation has a role in carefully controlled study
settings. Historically, the use of LIS for penile augmentation has had poor outcomes and required surgical inter-
vention to correct complications resulting from LIS.
Conclusions. We currently discourage the use of LIS for penile augmentation until carefully designed and evaluated
trials have been completed. Silberstein J, Downs T, and Goldstein I. Penile injection with silicone: Case report
and review of the literature. J Sex Med 2008;5:2231–2237.
Key Words. Liquid Injectable Silicone; Penile Augmentation; Silicone

Introduction lay persons. Paraffin, mineral oil, metallic mercury,

silicone, petroleum jelly, transmission fluid, subcu-

P enile augmentation has been reported in the

literature since the 19th century. Currently
accepted methods of augmentation include penile
fat grafts or suspensory ligament release. These
are invasive procedures that require surgical inter-
vention with limited success. Injectable fillers for
penile augmentation are a theoretically preferable
method for penile augmentation because of their
limited invasiveness; however, safe and effective
fillers continue to elude investigators. The first
reported instance of injected fillers into the male
genitalia occurred by Gersuny in 1899, using par-
affin into the scrotum of a boy who had undergone
bilateral orchiectomy for tuberculosis [1].
Penile augmentation with injectable materials
has been attempted by medical professionals and
taneous stone implantation, and autologous fat
implantation are some of the various materials that
have been tried [2–5]. These procedures can cause
foreign body reaction, scarring, deformity, ulcer-
ation, and sexual dysfunction [6–8]. Even worse
consequences including Fournier’s gangrene,
erectile dysfunction, perineal abscess, and pain
have been reported [9–11]. Liquid injectable sili-
cone (LIS) is unique from other fillers in that it
currently has the U.S. Food and Drug Adminis-
tration (FDA)-accepted uses for ophthalmologic
injections and is undergoing approved investiga-
tions for facial injections. LIS is also approved in
Europe for pedal injections. It is conservatively
estimated that hundreds of thousands of people
have undergone injection with silicone in the last

© 2008 International Society for Sexual Medicine J Sex Med 2008;5:2231–2237

2232 Silberstein et al.

half century, and there is a significant body of

literature on the use of LIS for tissue augmenta-
tion purposes [12]. Recently, improved purifica-
tions and increased viscosities of silicones as well as
new techniques for administration have renewed
medical interest in the use of LIS as soft tissue
filler for augmentation purposes.
We report a case of self-penile injection with
silicone for augmentation purposes and reviewed
the literature and history of silicone injections to
the phallus.

Case Report
A 61-year-old male was hospitalized for intrave-
nous antibiotic administration. The patient had
cellulitis in his right lower extremity and suspicion
of infected orthopedic hardware, which had been
placed several years prior for a tibia/fibular frac-
ture. Upon admission, a complete physical exam
was performed, revealing a grossly edematous
circumcised penis with marked firm swelling
(Figure 1). His scrotum demonstrated diffuse
enlargement with bilaterally descended testicles,
normal size and firm but smooth in texture. There
was no evidence of either erythema or cellulites or
suspicion of infection.
Discussion with the patient revealed that his
penis had had this swollen edematous appearance
since his teenage years and that this had been a
stable condition. The patient admitted to a cir-
cumcision in 1993 but adamantly denied any other
genitourinary interventions. Because of concern of
possible malignancy, testicular ultrasound (US)
and pelvic computed tomography (CT) scan were
obtained. US demonstrated testicles normal in size
and echo texture bilaterally as well as normal arte-
rial flow. CT scan revealed a diffusely enlarged
penis, with multiple rounded structures with
peripheral calcification, the largest measuring
2.3 cm, distortion of the soft tissues, and poor
visualization of the corpus cavernosum and spon-
giosum. Alpha feta-protein (AFP), lactic dehydro- Figure 1 Patient who underwent silicone injection of his
genase (LDH), and beta human chorionic penis about 15 years prior to photos.
gonadotropin (bHCG) were all within normal
limits. Finally, after the CT scan findings were
Review of the Literature
reviewed with the patient, he admitted that a
nonmedical practitioner had injected a “silicone Silicone (polydimethyl siloxilane [PDMS]) is the
mixture” several years prior (the patient could only term used to describe a large family of synthetic
approximate 10–15 years) for augmentation pur- polymers containing elemental silicon. Silicones
poses. The patient stated he was “pleased” with the are mixed inorganic–organic polymers with the
outcome of the silicone injections and declined any chemical formula [R2SiO]n, where R = organic
further intervention. groups such as methyl, ethyl, and phenyl. The

J Sex Med 2008;5:2231–2237

Penile Injection with Silicone
viscosity of these compounds is a function of the
polymerization and cross-linkage of their mol-
ecules. They can exist as solids (elastomers), gels,
and liquids. The fluids are made from linear chains
of PDMS, whereas the gels are lightly cross-linked
to give them a thicker cohesiveness [13]. LIS exists
as a colorless, odorless, nonvolatile oil. These
compounds are largely inert, atoxic, nonimmuno-
genic, heat resistant, and nonstick [14]. These
properties, along with their diversity of form,
result in a tremendous number of applications in
all types of industries, and as a result, these prod-
ucts can be found in kitchens, offices, and garages.
History
Silicone injections for soft tissue augmentation are
reported to have begun in Japan following World
War II, where injections into sex workers were
intended to produce a more “Western” appearance
for American servicemen [15]. This practice
spread to the United States, primarily in Califor-
nia, Las Vegas, Nevada, and Texas, and grew in
prominence throughout the 1960s, fueled largely
by the advent of the Dow Corning 360 Medical
Fluid (also known as MDX 4-4011). This was a
highly purified medical grade silicone introduced
in 1962. It was never intended for injection but
rather for medical use in needle coating, oral drug
delivery systems, and immersion therapy for burn
patients [15]. In 1965, the FDA approved the
investigational use of the Dow Corning 360
Medical Fluid, under the name new drug no. 2702,
for soft tissue augmentation purposes. Eight
principal investigators across the nation were per-
mitted to participate in a nonblinded, single-
treatment prospective study. However, in 1976,
the FDA suspended the investigational use of this
product, citing inadequate follow-up, lack of case
reports, and numerous patients who left the
protocol [14].
Despite the investigational nature of this drug,
its availability prompted physicians and lay persons
alike to utilize silicone for soft tissue augmentation
purposes. Tens of thousands of American patients
underwent large-volume injections, often liters of
fluid, throughout the latter half of the 1960s and
into the 1970s. Some of these patients had disas-
trous outcomes, prompting the FDA to suspend the
use of this drug in 1976, and the Nevada state
legislature to criminalize its use in 1975 [15].
Early experiences with these large-volume
injections demonstrated problems with migration.
Reformulations of silicone were made with “scar-
ring agents” or “adulterants.” These would result
2233
in significant inflammatory response and fibrosis
formation in order to prevent this migration.
Among these reformulations was, most famously,
the Sakurai formula, which included the addition
of vegetable oils (primarily olive oil). The Sakurai
formula was injected into tens of thousands of
patients, with multiple publications touting its
success [13].
In 1994, AdatoSil 5,000 was approved by the
FDA for ophthalmologic use, as was Silikon 1000
in 1997. These injectable silicone compounds have
greater purity and higher viscosity than the Dow
Corning 360 Medical Fluid. Increased viscosity is
believed to diminish the risk of migration to other
tissues, and fewer impurities are thought to
decrease granulomatous reactions that occasion-
ally accompany such injections. Currently, neither
of these fluids is indicated as a soft tissue filler;
however, Silskin, with even higher purification, is
currently being used in an FDA-approved trial for
facial lipoatrophy and in a limited investigational
study for the cosmetic improvement of nasolabial
folds, marionette lines, and midmalar depressions.
Jones et al. recently reported on the outcomes of
77 patients involved in these studies, with excellent
outcomes and no adverse events [16]. In Europe,
silicone injections to the foot have been approved
for the reduction of abnormal foot pressures and
prevention of diabetic foot ulcers.
Histology and Tissue Response
When silicone is injected, it forms optically empty
vacuoles of various sizes, encapsulated by fibro-
blasts and collagen fibers. Over long periods of
time, fibrosis becomes prominent, surrounding
the clusters of vacuoles. Biopsy specimens most
frequently reveal empty-appearing cystic spaces.
They are described as “Swiss cheese-like.” They
most frequently appear small and uniform, but
depending on the amount of material introduced,
they may become more varied in size and shape.
Inflammatory reaction varies. Macrophages often
show foamy aspect or have multivacuolated cyto-
plasm. Multinucleated giant cells may or may not
be present. In patients who present with severe
adverse reaction, the histologic findings are often
similar [11].
Allen [17] provided an excellent histologic
documentation of the natural human response to
the injection of silicone. Essentially, natural acti-
vation of the resorption process by host tissue is
activated with any foreign body injection, and sili-
cone is no exception. Neutrophils and monocytes
dominate the early response, followed by foreign-
J Sex Med 2008;5:2231–2237
2234
body giant cells formation. At about 4 weeks,
epithelioid cells and fibroblasts appear, and signi-
ficant collagen deposition begins and progresses
throughout the next 4 weeks. At 6 months, stable
giant cells are present along with dense collagen
and fibrocytes [17,18].
LIS and Penile Augmentation
LIS has been reported to augment various por-
tions of the body with varying degrees of scientific
scrutiny and success. The first reported injection
of LIS to the penis was in 1973 by Arthaud, who
reported on one patient who had had a suprapubic
injection of “silicone” from a nonprofessional
person who told him it would “drain down” [19].
Prior to this report, investigators had reported on
the injection of various oils, but this was the first
report involving silicone. The investigators con-
firmed that the substance used for the injection
was silicone by confirming the presence of silica on
X-ray spectroscopy. The patient had the silicone
mass surgically removed because it was tender and
inflamed. Since this publication, there have been
various reports of liquid silicone injections to the
penis, with varying success and failure. Wassser-
mann and Greenwald reported on a 42-year-old
man who had had silicone injected into his corpora
cavernosae 14 years prior to his presentation [8].
The patient presented with complaints of increas-
ing edema of the penis and scrotum. He had
attempted to drain his penis 8 months before pre-
sentation, but the needle had broken at the skin
and remained until presentation. The patient had
palpable siliconomas obstructing the glans and
required surgical resection. Lighterman reported
that he had seen two patients who had undergone
silicone injections 7 years prior to presentation.
One had poor results requiring surgical resection
and the other was pleased with his outcome and
wanted no intervention [20].
In the first systematic investigation into LIS
injection to the penis, Yacobi et al., in 2007,
reported on their experience with 324 patients [21].
These investigators used Siluron 1000 (Fluron
GmbH, Germany), an ultrapurified LIS. They
injected 5 mL between Buck’s fascia and the penile
skin, on the dorsal and lateral aspects of the penis at
each session. Patients had three to six sessions, with
a minimum of 30 days between sessions. These
investigators reported an increase in penile girth of
27%, with 21 men reporting improved erectile
function, and no men reporting complications in
the relatively short period before follow-up (mean
20 months, range 1–36 months). These investiga-
J Sex Med 2008;5:2231–2237
Silberstein et al.
tors noted their drastically different findings from
all previous reports, pointing out that prior case
reports were anecdotal and described complica-
tions only. Furthermore, they attributed their suc-
cessful outcomes to advances in the purity and the
quality of the LIS, as well as their adherence to the
microdroplet injection technique.
Adverse Reactions and Complications of
Silicone Injection
LIS has been used for tissue augmentation for
more than half a century, often with very good
outcomes [22]. Advocates will point out that while
the literature is replete with reports of adverse
outcomes of silicone injections, these are anec-
dotal, the quality and the purity of the silicone are
rarely known, the methods of injection have varied
greatly, the injectors themselves rarely were quali-
fied medical practitioners, and the site of injection
may play a critical role in determining outcomes.
While all of these are fine considerations, there
have been serious side effects of LIS that deserve
consideration.
Short-term reactions include the immediate
impact of injecting any foreign material and
include pain, ecchymosis, pigment change, or
most catastrophic, embolism or pneumonitis if the
LIS is injected directly into the vascular system
[23,24]. With regard specifically to penile injec-
tions, direct injection into the cavernosum could
result in embolic events, priapism, or impotence.
Only Wassermann and Greenwald [8] have
reported on one patient who had a direct injection
of silicone into his corpora cavernosum with no
impact on his sexual function and no immediate
adverse outcome.
Most adverse reactions occur within months to
years after the augmentation procedure. Rapaport
et al. published a series of 54 complications follow-
ing the injection of “medical grade” LIS, the
majority of which occurred 5–25 years postinjec-
tion [25]. Furthermore, complications have been
reported to occur as long as 36 years after treat-
ment, and LIS is referred to by this author as a
“time bomb” because of the frequency of delayed
adverse reactions [26].
Silicone migration has been reported to occur
with LIS injections to the breast, face, and other
parts of the body [27]. In fact, several of the case
reports of LIS injection to the penis have noted
migration as well [19,20]. Silicone migration is
thought to be the result of large-volume, low-
viscosity injections, which do not allow encapsula-
tion of the material. Advocates argue that increased
Penile Injection with Silicone 2235

viscosity and use of the microdroplet technique has

with implantation of penile

and granulomatous tissue
Surgical excision of silicone
Surgical removal of silicone

Surgical removal of silicone

Surgical removal of silicone

largely obviated this complication. The microdrop-
let technique employs 0.005–0.01 mL microdrop-
lets of LIS injected into the subdermal plane at 2- to

Surgical excision
No intervention

Patient refused
10-mm intervals. This technique is believed to

prosthesis
Intervention
allow the silicone to remain stationary long enough
for a fibrous capsule to surround the foreign body

No f/u

None
and prevent migration [13]. Large volumes are able
to migrate before such collagenous anchoring can
occur. Some investigators have suggested that the

Increasing edema, palpable siliconomas obstructing

massive size preventing penetration. Multiple firm
Satisfactory for 12 years. Then, gradual increase in
less than 0.5 cm, increase in penile girth by 20%

nodular 1.5-cm masses circumferentially around

size with impotence, decreased sensation, and
Patient pleased, occasional granulomatous mass
great discrepancies in reports of silicone migration

Stony hard lobulated suprapubic mass, silicone

Three years after injection, patient experienced

migration of silicone, preventing penetration
from one part of the body vs. another may be
because of the properties of the tissues injected,

Increase in penile girth 27% (mean); no

with some areas being able to “hold” the silicone
better than others [14].
Silicone has been reported to migrate along
facial planes as well as through the reticuloendot-

Results and complications

Diffusely enlarged penis

helial system and has been noted to be present in
all organs, on postmortem examination, of patients

Firm penile edema

the entire shaft.
with localized silicone injection [28]. Additionally,

complications
silicone has been noted in regional lymph nodes,

the glans
migration
the liver, and spleen, without clear systemic impli-

No f/u
cations [25,28,29].
Silicone granulomas were reported in the
majority of case reports of LIS injection to the
“Nonprofessional

penis (Table 1). Noninflammatory granulomas

practitioner in

practitioner

practitioner
“Unidentified

California”
consist of small nodules that often occur in a

Nonmedical
Naturopath

Naturopath

Naturopath
person”

Unknown

Unknown
delayed fashion following injection. Histologically,

Medical
Injector

these lesions reveal no evidence of inflammation

but do demonstrate foreign body reaction. Inflam-
matory granulomas are similar but demonstrate

Mean 16 months

(1–36 months)
Case reports regarding liquid injectable silicone into the penis

significant inflammatory infiltrate. These lesions

10–15 years
are not believed to result from bacterial infection
Time since

20 months
14 years

14 years
because of repeatedly negative culture swabs,
injection
4 years

7 years

7 years

No f/u

rather they are suspected to result from allergic or

autoimmune reaction. These lesions have been
treated with varying degrees of success with oral
22–42
19–65

and intralesional corticosteroids [12]. Of note, sili-

Age
51

38

49

42

42

61

cone granulomas of the penis have been either

observed or treated with surgical excision; to our
Number of

knowledge there are no reports of corticosteroid

patients

use for these lesions.

1

18
1

5
324

1
publication

Conclusions
Year of

1973

1976

1976

1976
1982

1995

2006
2007

2008

LIS has been used for soft tissue augmentation,

with varying success, for more than a half century.
The use of this product is highly controversial.
Christ and Askew [10]

and Greenwald [8]

Cavalcanti et al. [30]

Most of the literature reporting on this subject

Yacobi et al. [21]

(present case)

comprises case reports or case series in which the

Silberstein et al.
Lighterman [20]

Lighterman [20]

Lighterman [20]

Wassermann

authors report on their experience with patients

f/u = follow-up.
Arthaud [19]

who presented with complications secondary

Table 1

Authors

to injection of foreign material that nonlicensed

practitioners had told them was silicone. Great

J Sex Med 2008;5:2231–2237

2236
discrepancy has been noted as to the purity and
viscosity of the LIS, the volume of injection, the
anatomic location of injection, and the technique of
injection. While more rigorous investigations have
been and are being conducted, definitive evidence
as to the safety of LIS is currently unknown.
Whereas FDA-approved trials of LIS for soft tissue
augmentation are currently being conducted in the
United States, the use of any silicone substance
outside of a protocol setting is currently “off-label”
use and discouraged by the authors of this report.
There are few case reports regarding LIS injec-
tion to the penis (Table 1). The majority of these
concern patients presenting with complications
resulting from LIS and requesting intervention.
To our knowledge, Yacobi et al. are the only
medical practitioners intentionally injecting pa-
tients with LIS in a systematic fashion and rig-
orously reporting their results [21]. While their
results are encouraging, the complications of LIS
may not be evident for many years; it is thus con-
cerning that they have already reported on inject-
ing more than 300 patients, undoubtedly with
more to come.
We reported this case to instruct practitioners
to be aware of this unusual presentation and con-
dition. Furthermore, we reviewed the literature of
LIS augmentation of the penis with the hopes of
presenting a fair and balanced review of this con-
troversial topic. Finally, until there is more rigor-
ous investigation into LIS and its use for penile
augmentation, we strongly discourage practitio-
ners from using this product in a non-FDA
approved protocol setting.
Corresponding Author: Jonathan Silberstein, MD,
University of California, San Diego—Division of
Urology, San Diego, CA 92103-8897, USA. Tel: (315)
345-1023; Fax: (619) 543-6573; E-mail: jsilberstein@
ucsd.edu
Conflict of Interest: None declared.
Statement of Authorship
Category 1
(a) Conception and Design
Jonathan Silberstein
(b) Acquisition of Data
Jonathan Silberstein
(c) Analysis and Interpretation of Data
Jonathan Silberstein
Category 2
(a) Drafting the Article
Jonathan Silberstein
J Sex Med 2008;5:2231–2237
Silberstein et al.
(b) Revising It for Intellectual Content
Jonathan Silberstein; Tracy Downs; Irwin
Goldstein
Category 3
(a) Final Approval of the Completed Article
Irwin Goldstein; Tracy Downs
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