FILLERS

Current Concepts in the Use of Bellafill

John H. Joseph, MD
Laura L. Eaton, RN, BSN
Steven R. Cohen, MD
Beverly Hills, Huntington Beach, and
San Diego, Calif.

Summary: As demonstrated by American Society of Plastic Surgeons statistics

(2013), patients seeking nonsurgical facial rejuvenation are increasing. A variety of temporary and semipermanent soft-tissue fillers, such as hyaluronic acid,
poly-l-lactic acid, and calcium hydroxylapatite, are readily available; however,
they have not been proven effective in treating facial acne scarring. Patient
tolerance for the inconvenience and repeat cost of short-term, temporary fillers is waning as newer generation fillers with longer durations are coming on
the market. Permanent injectable fillers, such a Bellafill (Suneva Medical Inc.,
San Diego, Calif.), represent a desirable solution for patients who want a longterm result. With the recent Food and Drug Administration approval for the
treatment of moderate-to-severe, atrophic, distensible facial acne scars on the
cheek(s) in patients over the age of 21 years, Bellafill (polymethylmethacrylate
collagen) represents an effective solution for the treatment of facial acne scarring of the face while maintaining an excellent safety profile. (Plast. Reconstr.
Surg. 136: 171S, 2015.)

oderate-to-severe acne affects around 20%

of young people and may persist into the
20s and 30s in around 64% and 43% of individuals, respectively.1 Unfortunately, atrophic acne
scarring is a common complication of acne vulgaris,
which may be associated with significant psychological distress.2 The incidence of acne scarring is not
well studied, but it may occur to some degree in up
to 95% of people with acne vulgaris.3 Until recently,
no injectable fillers were approved and on the market by the US Food and Drug Administration (FDA)
for treatment of acne scarring; however, soft-tissue
fillers, ranging from temporary to permanent (eg,
hyaluronic acid, collagen, and liquid injectable silicone), have been used off-label to treat patients
with acne scarring for many years. These soft-tissue
fillers have proven to be effective in treating patients
with shallow, rolling acne scars.2,49 Many dermatologists and plastic surgeons are comfortable using dermal fillers for other cosmetic purposes; therefore,
the transition to treatment of acne scars with these
same agents is natural.2
Bellafill (previously named ArteFill) has been
marketed and sold in the United States since 2007
as a permanent dermal filler for the correction of
From the John H. Joseph Medical Corporation; UltaMed
Corporation; and Division of Plastic Surgery, University of
California.
Received for publication March 2, 2015; accepted August 5,
2015.
Copyright 2015 by the American Society of Plastic Surgeons
DOI: 10.1097/PRS.0000000000001839

nasolabial folds (NLFs). After meeting predefined

clinical endpoints in the US Acne Scar pivotal
study, Bellafill received an expanded FDA labeling
indication in December 2014 for the correction
of moderate-to-severe, atrophic, distensible facial
acne scars on the cheeks of patients over the age
of 21 years. With this new FDA approval, Bellafill
is now the only on-label dermal filler approved
Disclosure: Dr. Joseph contributed conceptually
and intellectually to this work. He was a treating
investigator in the US Acne Scar Pivotal Trial and
Post Market Approval Safety Study. He has been a
paid investigator and consultant for Suneva Medical and is a minor shareholder of Suneva Medical.
Ms. Eaton contributed conceptually and intellectually to this work. She is an aesthetic nurse and an independent clinical research consultant. She has been a
paid consultant for Suneva Medical. Dr. Cohen contributed conceptually and intellectually to this work.
He was a treating investigator in the US Acne Scar
Pivotal Trial. He has been a paid investigator, consultant, and minor shareholder of Suneva Medical.
Supplemental digital content is available for
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Plastic and Reconstructive Surgery November Supplement 2015

in the United States for the treatment of acne
scarring.

BELLAFILL PRODUCT OVERVIEW

Bellafill (ArteFill) is a long-lasting polymethylmethacrylate (PMMA) injectable filler.9 It is
nonbiodegradable and composed of 3050 m
smooth and round PMMA microspheres (20% by
volume) suspended in a water-based gel containing 3.5% bovine collagen gel (80% by volume)
and 0.3% lidocaine.10 While the collagen carrier is
absorbed 13 months after injection, the PMMA
microspheres remain as a scaffold for the development of autologous tissue.9 The bovine collagen
carrier is replaced by the patients own connective
tissue over an estimated period of 3 months.10

US ACNE SCAR PIVOTAL STUDY

The Bellafill (ArteFill) US Acne Scar pivotal
study was a prospective, randomized, placebo-controlled, double-blinded, multicenter clinical trial
of subjects over the age of 18 years who desired
correction of moderate-to-severe, atrophic, distensible facial acne scarring on the cheek(s). Prior to
screening and enrollment, subjects provided written informed consent. The study was conducted
with institutional review board approvals in accordance with Good Clinical Practices and registered
with ClinicalTrials.gov (NCT01559922). The study
treated 147 subjects at 10 centers. Subjects who
met all inclusion criteria and no exclusion criteria
were randomized in a 2:1 fashion to either Bellafill (ArteFill) or sterile normal saline solution
for injection (control group). Randomization was
stratified by study site for gender and Fitzpatrick
skin phototype. The study included 57male subjects (39%) and 35 subjects (24%) with darker skin
types (Fitzpatrick V and VI). Prior to treatment,
subjects received a skin test to determine possible
sensitivity to bovine collagen. At 6 months, all control subjects were eligible to receive open-label
treatment with Bellafill.
US Acne Scar Study Clinical Endpoints
The primary effectiveness endpoint was the success rate at 6 months based on the blinded evaluating investigators (EI) assessment using the validated
4-point Acne Scar Rating Scale (ASRS) (Table 1)
with success defined as at least a 2-point improvement on the ASRS for at least 50% of treated scars.
The primary safety objective was to identify the
incidence of all treatment-related adverse events
(TRAEs). This included subject AE outcomes

recorded during the first 14days after each treatment in a patient diary and the treating investigators safety assessments that were collected during
a telephone call at 72 hours postinjection and
follow-up visits at weeks 2, 4, 6, and 8 and months
3, 6, 9, and 12. Subjects in the control group who
received Bellafill injections in the open-label phase
of the study were followed in a similar manner for
12 months.
US Acne Scar Study Inclusion Criteria
Key study inclusion criteria included men and
women, 18 years old or older, who presented with at
least 4 moderate-to-severe atrophic acne scars, per
the ASRS, on the cheek(s) which were sufficiently
distant from one another to allow for individual
treatment and grading. Treatment scars had to
be depressed rolling scars with rounded borders,
distensible, and not significantly hypopigmented
or hyperpigmented, with no underlying papules
or nodules. Icepick, boxcar, or bound-down acne
scars could not be included as treatable scars, but
could be present in the treatment area.
US Acne Scar Study Exclusion Criteria
Subjects were excluded from the pivotal study
if they had previously undergone treatment of
acne scarring with any of the prohibited treatments or procedures, including the use of softtissue fillers in the face during the study, as well
as concurrent administration of other aesthetic
treatments in the face during the study (eg, lasers,
implants, peels, and microdermabrasion). Female
subjects who were pregnant (positive urine pregnancy test), breast-feeding, or were of childbearing potential and not practicing a reliable method
of birth control were excluded. Subjects were also
excluded if they presented with any skin pathology or condition that could interfere with evaluation of the treatment areas or worsen due to the
proposed treatment. Subjects with a recent or current history of inflammatory skin disease, infection, cancerous/precancerous lesions, unhealed
wounds, or clinically significant acne were also
excluded. Clinically significant acne was defined
as greater than 3 active inflammatory lesions in
either the left or right treatment area. Additional
study exclusion criteria included a history of systemic granulomatous diseases, connective tissue
disorders, hypertrophic acne scarring, keloid
scarring, predominantly icepick scarring or sinus
tract scars and a known hypersensitivity or previous allergic reaction to any of the components
Bellafill, including lidocaine and bovine collagen.

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Volume 136, Number 5S Current Concepts in the Use of Bellafill

Table 1. Acne Scar Rating Scale
Acne Scar Rating
Scale Score
1
2
3
4

Description
Minimal: depth up to 0.5 mm
Visibility = perceptible with tangential
lighting
Mild: depth >0.5mm to <1.5 mm
Visibility = moderately detectable with
tangential lighting
Moderate: depth 1.5mm to <2.5 mm
Visibility = easily seen with tangential
lighting
Severe: depth 2.5 mm
Visibility = substantial shadowing with
tangential lighting

US Acne Scar Study Follow-Up Visit Schedule

Subject follow-up included telephone contact
at 72 hours after each treatment and clinic visits
at weeks 2, 4 (with touch-up if needed), 6, and 8
weeks after treatment, as well as at months 3, 6, 9,
and 12. Subjects initially randomized to control
could elect to receive open-label Bellafill injections at the 6-month visit with subsequent followups that exactly mirrored the treatment group.
Endpoints measured after treatment included
the following: (1) the blinded EIs determination
of acne scar appearance via the 4-point-validated
ASRS; (2) assessment of safety outcomes at each
visit; (3) the blinded EIs assessment of subject
appearance improvement using the Physician
Global Aesthetic Improvement Scale (PGAIS);
(4) the subjects completion of a 14-day treatment
diary; (5) the subjects evaluation of appearance
using the Subject Global Aesthetic Improvement
Scale (SGAIS); and (6) the subjects assessment of
scar correction (SASC).

US Acne Scar Study Population

The Bellafill and control groups were well
balanced with regard to demographics and baseline characteristics with no significant differences
between groups. The mean age was 44.6 years in
the Bellafill group and 45.3 years in the control
group. The study enrolled a substantial portion of
men, which included 38.1% in the Bellafill group
and 40.0% in the control group, and subjects with
Fitzpatrick skin phototypes V and VI, with 25.7%
in the Bellafill group and 20.0% in the control
group. The number of qualified/treated scars was
8.9 in the Bellafill group and 8.5 scars in the control. The mean severity score of scars was 3.3 in
the Bellafill and 3.3 in the control group, per the
ASRS.
US Acne Scar Study Injection Volumes
The average initial injection volume of Bellafill in randomized subjects was 0.11mL per scar,
and the average initial volume injected per subject was 0.93mL. The average injection volume at
touch-up was 0.10mL per scar and 0.69 mL per
subject. The majority of subjects received a touchup injection with 82.5% in the Bellafill group and
82.0% in the control group.
US Acne Scar Study Primary Effectiveness
Results
The primary effectiveness endpoint was a
responder rate analysis in which the criterion
for success was defined as >50% of treated scars
per subject improving by 2 or more points on the
4-point ASRS at the 6-month visit, as evaluated by
a live blinded EI. The primary effectiveness endpoint was achieved with 64.4% responders in the

Fig. 1. Subject A, (left) baseline (pretreatment with Bellafill for acne scar treatment); (right)
6 months after Bellafill acne scar treatment.

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Plastic and Reconstructive Surgery November Supplement 2015

Fig. 2. Subject B, (left) baseline (pretreatment with Bellafill for acne scar treatment); (right)
6 months after Bellafill acne scar treatment.

Bellafill group and 32.6% responders in the control group (P = 0.0005) at 6 months.11 Refer to Figures1 through 5 for comparison of baseline and
6-month (primary endpoint) clinical outcome
photographs of subjects who received acne scar
treatment with Bellafill.
US Acne Scar Study Safety Results
There were no deaths, treatment-related serious AEs, infections, or vascular occlusions reported
in this pivotal study. Subjects were asked to keep
a 14-day diary after each treatment to record any
signs and symptoms of injection site response,
such as erythema, swelling, bruising, pain, itching, lumps/bumps, and skin discoloration. Eightynine percent (89%) of Bellafill subjects reported
at least 1 sign or symptom; however, the majority
of events was mild to moderate in intensity and

resolved within 17 days. Similar rates of injection

site response were noted in patient diaries following touch-up treatments.
The investigator-reported TRAEs included
implant site mass, injection site pain, injection
site reaction (eg, lumpiness and papule formation), swelling, and 1 case of acne. These events
occurred in 8 of 97 subjects who were randomized
to receive Bellafill. Five of these events resolved
and 3 cases of injection site reaction (lumpiness
and papule formation directly after injection) persisted throughout the study. All 3 of these events
occurred within the first month after injection
and were thought to be due to superficially placed
product that became palpable. Two of these events
were deemed by the investigator to be mild, and
1 event of papule formation was deemed to be of
moderate severity.

Fig. 3. Subject C, (left) baseline (pretreatment with Bellafill for acne scar treatment); (right)
6 months after Bellafill acne scar treatment.

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Volume 136, Number 5S Current Concepts in the Use of Bellafill

Fig. 4. Subject D, (left) baseline (pretreatment with Bellafill for acne scar treatment). Note: each
subject needed to have 4 scars in total (with any distribution across both cheeks) to be eligible for
the Acne Scar clinical study. (Right) 6 Months after Bellafill acne scar treatment.

The FDA identified AEs of special interest

prior to initiation of the investigation, which were
followed separately. AEs of special interest to the
agency included hyperpigmentation and hypopigmentation, hypertrophic scarring or keloid formation, and the appearance of granulomas. None
of these AEs were reported in this 12-month acne
scar pivotal study.
Global Aesthetic Improvement and Subject
Satisfaction
Subject satisfaction was assessed using the
6-point SASC scale. Greater than 83% of Bellafill
subjects judged themselves to be at least somewhat to very satisfied with the appearance of their
treated scars at all time points. Global aesthetic
improvement was evaluated by both the EI and

the subjects. Greater than 77% of Bellafill subjects

indicated that their appearance was improved or
much improved on the SGAIS assessment from
3 months onward. The proportion of blinded
EIs indicating improvement as per the PGAIS
assessment was greater than 83% from 3 months
onward.
US Acne Scar Study Discussion
The 6-month primary effectiveness endpoint
was met and results demonstrated statistically
significant effectiveness in the treatment of atrophic acne scarring of the face while maintaining
an excellent safety profile.11 Based on the results
of the PGAIS, SGAIS, and SASC, the majority of
subjects and physicians saw an improvement in
the appearance of acne scars when treated with

Fig. 5. Subject E, (left) baseline (pretreatment with Bellafill for acne scar treatment); (right)
6 months after Bellafill acne scar treatment.

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Plastic and Reconstructive Surgery November Supplement 2015

Bellafill versus a saline control injection at the
6-month primary endpoint. Unblinded evaluation out to 12 months confirmed a consistent level
of effectiveness. Based on these results, acne scar
treatment with Bellafill was shown to occur relatively quickly, was sustained, and was effective in
all races, genders, and adults of all ages.11

5-YEAR NLF POSTAPPROVAL STUDY

skin ulceration, or any other symptom that could

be the result of an inflammatory or granulomatous process. Subjects reporting any of these
symptoms were scheduled for an in-office evaluation. The protocol for this study required that all
late lesions (those occurring 90 days post injection) that could represent a granuloma be biopsied, sent to a central laboratory, and analyzed by
3 independent dermatopathologists.

Introduction and Overview

A concern for use of dermal fillers, and Bellafill in particular, is the potential for development
of granulomas. Some practitioners have avoided
the use of PMMA collagen due to concerns of
potentially higher granuloma rates over other
dermal fillers. The information that practitioners
have used to base decisions surrounding PMMA
has primarily come from small single-center studies or case reports in which the precise material
administered was not clearly identified or even
FDA approved.12 Therefore, as a condition of FDA
approval for the correction of NLFs, the agency
required the manufacturer of Bellafill (Suneva
Medical Inc., San Diego, Calif.) to conduct a
large-scale, 5-year postapproval study on the incidence of granuloma formation and satisfaction of
long-term treatment. As required, a prospective,
multicenter, open-label postapproval study was
conducted at 23 centers across the United States.
Prior to screening and enrollment, subjects provided written informed consent. The study was
conducted with institutional review board approvals using Good Clinical Practices and was registered at ClinicalTrials.gov (NCT 00778531). One
thousand two hundred seventeen subjects were
screened and 1008 were enrolled. Compliance
with follow-up was outstanding, with an 87% completion rate (871/1008) at 5 years.
For this study, subjects received treatment
with Bellafill only for the approved indication of
correcting NLFs. Clinic visits were conducted at
3 months, 60 months, and as needed for safety
follow-up. Subjects completed mail-in questionnaires at 6, 12, 18, 24, 36, and 48 months following
their final injections. A granuloma was defined as
a cutaneous lesion typically appearing 3 months
or more after treatment, frequently associated
with change and histologic evidence of granulomatous inflammation as diagnosed by a team of
independent dermatopathologists.
Granuloma surveillance included subject
reporting of enlargement of the implant, pain,
tenderness, increased sensitivity, redness, swelling, itching, burning, skin discoloration, scabbing,

NLF Post-approval Study Safety Results

A total of 177 treatment-related AEs were
reported in 118 of the 1008 Bellafill-treated subjects. The majority (74%) of TRAEs was mild in
severity and resolved within 180 days. The most
commonly reported TRAEs were lumpiness at the
injection site (29%) and redness (10%).
Seventeen subjects presented with lesions that
were classified, per protocol, and confirmed by
biopsy as granulomas, for an overall incidence
rate of 1.7%. The majority of confirmed granulomas were mild to moderate in severity. Of the
17 subjects with granuloma, 8 had complete resolution, 8 were improving with ongoing treatment
at the end of the study, and 1 granuloma initially
improved and then remained stable for the last
2 visits of the study. The average time of onset
for granuloma was 31 months, and of the lesions
that resolved, the average duration was 10 months
(range, 2.521 months).
Investigators were allowed to treat subjects
with granulomas based on their medical judgment. The most commonly used treatment was
intralesional corticosteroid injections with and
without 5-fluorouracil. No implants were excised
or removed. Additionally, there were no reports of
migration, no scarring in the subjects who developed granulomas, and no symptoms of vascular
compromise (including infarction and blindness)
in this 5-year study of over 1000 patients.
The 5-year NLF Postapproval Study provides
strong supporting evidence of the long-term safety
and expected long-term effectiveness profile that
may be experienced by acne scar patients treated
with Bellafill. The method of use of Bellafill in
this study was very similar to that used for acne
scar treatment in that the implantation technique
is largely the same. From an anatomic and histologic perspective, there are no significant differences between the NLF and the cheek. Therefore,
the authors believe that the 5-year postapproval
study of 1008 subjects provides strong evidence
of the long-term safety of Bellafill and reasonable
assurance regarding the long-term effectiveness
for acne scar indication.

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Volume 136, Number 5S Current Concepts in the Use of Bellafill

5-Year NLF Postapproval Study Discussion
This 5-year NLF Postapproval Study represents the largest and longest follow-up study of
a US-approved dermal filler product to date and
found an overall incidence rate of 1.7% granuloma formation over 5 years with Bellafill. The
number of subjects affected by a granuloma was
small, and the events were typically mild to moderate in severity and treatable with medical therapy.
Although the short-term safety of Bellafill was
already well known, this larger study further confirms the overall mild and transient nature of AEs
that can occur with PMMA collagen.

in the volar aspect of the forearm, and the patient

should be provided with the skin test card to take
home and complete. A positive skin test response
includes symptoms of erythema, induration, and/
or swelling appearing within 24 hours and lasting
greater than 24 hours after injection, or appearing greater than 24 hours after injection, for any
period of time. An equivocal response includes no
local signs or symptoms of skin reaction; however,
systemic signs and symptoms of arthralgias or
myalgias are present. A patient with a positive or
2 equivocal responses should not be treated with
Bellafill.14,15

BEST PRACTICES FOR CORRECTION

OF ATROPHIC ACNE SCARRING
WITH BELLAFILL

Pre- and Postacne Scar Treatment Photography

Pre- and posttreatment photographs are
highly recommended, as this is the best tool for
demonstrating results of acne scar treatment.
With acne scar patients, it is recommended to
take photographs using optimal angles, including frontal view and photographs from 45 and
90 degrees.16 Lighting makes all the difference
in the effectiveness of your before and after
acne scar photos. The appearance of acne scars
changes with the angles of light and is less apparent in flat light.16 When photographing acne
scars, use a focused (point) light source that
casts a narrow beam of light, rather than a soft,
diffuse source and minimize daylight and ambient lighting.16 Turn off fluorescent or overhead
lighting and insure that the flash on your camera is turned off. It is also important to position
the light source tangential to the surface of the
area of skin to be photographed. This will create
shallow contours and produce long shadows that
highlight scars.16

Acne scars selected for treatment should be

atrophic distensible scars. The best results with
Bellafill are achieved in defects requiring deep
dermal implant placement with full correction
being achieved gradually over time. The rate
and degree of correction in the implanted area
varies with the patient, treatment site, and plane
of injection. The key to success with Bellafill is
a conservative approach with avoidance of overcorrection.13 Final correction should be limited
to no more than 100% of the skin defect during treatment. One or 2 touch-up treatments
at intervals of at least 2 weeks may be required
to achieve the desired effect. Refer to Figures1
through 5 for baseline and 6-month posttreatment photographs of acne scar treatment with
Bellafill.
Acne Scar Treatment Patient Consultation
Using a hand-held mirror during the initial
patient consultation visit, you should have the
patient point out the scars that bother him or her
most. Review the degree of acne scar correction
that can be achieved with Bellafill and explain that
it may take a series of injections of to obtain optimal correction. Examine the skin of the cheek(s)
to insure that the patient has distensible acne
scars (scars that smooth out when stretched), as
these rolling, broad-based scars respond best to
treatment.
Skin Testing
Four weeks prior to treatment with Bellafill, a
skin test should be conducted to screen for preexisting allergies to bovine collagen and lidocaine.
The skin test dose of 0.1 mL should be injected

Acne Scar Treatment Injection Procedure

Prior to injection, the patient should be fully
informed of the indications, contraindications,
warnings, precautions, treatment responses,
adverse reactions, and method of administration
of Bellafill. Confirm the negative skin test. The
treatment area should be thoroughly washed with
soap and water, and the area should be cleaned
with an antiseptic. The Bellafill syringe must be
brought to room temperature before injection.
Each Bellafill syringe comes supplied with a
26-gauge needle that is 5/8 long.14
Acne Scar Treatment Injection Technique
Before injecting the patient, prime the syringe
by depressing the plunger until the product is
visible at the tip of the needle. Enter the skin at

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Plastic and Reconstructive Surgery November Supplement 2015

approximately a 30-degree angle proximal to the
edge of the scar. Advance the needle under the
base of the scar and explore for any fibrotic tissue.
If scar fibrosis exists, then pass the needle back
and forth a few times to open up a pocket for
injecting the product. You can use either a linear
threading or serial puncture technique directly
underneath the scar, in both cases injecting in a
retrograde manner. You may need to replace the
needle if it becomes occluded or dull during the
treatment session. After injection, palpate and
massage the injected acne scar with your fingertips to confirm uniform deposition of Bellafill.
The area and the borders of Bellafill injection
should be recorded on an illustration of a face for
later comparison. Instruct the patient to promptly
report any evidence of adverse texture change
in the surrounding treatment site and any other
problems possibly associated with the use of Bellafill. Refer to Video, Supplemental Digital Content 1, which demonstrates an acne scar injection
procedure by Dr. John Joseph, available in the
Related Videos section of the full-text article on
PRSJournal.com or, for Ovid users, at http://links.
lww.com/PRS/B441,) for more detailed information on treatment of acne scarring with Bellafill.

CONCLUSIONS
Historically, first- and second-generation
PMMA fillers, such as Arteplast and Artecoll, had
a greater number of smaller microspheres of
PMMA (<20 m in diameter), which are proposed
to engender a greater foreign body response and
higher rates of granuloma formation.10,17 In those

Video. Supplemental Digital Content 1, which demonstrates an

acne scar injection procedure by Dr. John Joseph, is available in
the Related Videos section of the full-text article on PRSJournal.com or, for Ovid users, at http://links.lww.com/PRS/B441.

cases, host cellular reaction was histologically

attributed to PMMA impurities and PMMA particles smaller than 20 m in diameter which could
be phagocytized.18 Bellafill is a third-generation
PMMA, with smooth surface morphology PMMA
developed to minimize inflammatory response as
a result of more uniform PMMA microsphere size
and shape.10
Bellafill has been proven to be safe and well
tolerated with excellent posttreatment outcomes,
despite the additional step of skin testing. There
were no events of granuloma present in the US
Acne Scar pivotal trial, and only a 1.7% incidence
of granuloma formation (0.9% unresolved but
improving at study conclusion) seen in a long-term,
5-year NLF Postapproval study of over 1000 patients
treated with Bellafill for correction of NLFs.
John H. Joseph, MD
Clinical Testing Center of Beverly Hills
9400 Brighton Way, Suite 203
Beverly Hills, CA 90210
drjohnjoseph@sbcglobal.net

patient consent

The patient provided written consent for the use of

his image.
REFERENCES
1. Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J
Dermatol. 2013;168:474485.
2. Fife D. Practical evaluation and management of atrophic
acne scars: tips for the general dermatologist. J Clin Aesthet
Dermatol. 2011;4:5057.
3. Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol.
1994;19:303308.
4. Beer K. A single-center, open-label study on the use of injectable poly-L-lactic acid for the treatment of moderate to severe
scarring from acne or varicella. Dermatol Surg. 2007;33(Suppl
2):S159S167.
5. Epstein RE, Spencer JM. Correction of atrophic scars
with artefill: an open-label pilot study. J Drugs Dermatol.
2010;9:10621064.
6. Goldberg DJ, Amin S, Hussain M. Acne scar correction using
calcium hydroxylapatite in a carrier-based gel. J Cosmet Laser
Ther. 2006;8:134136.
7. Sadove R. Injectable poly-L-lactic acid: a novel sculpting
agent for the treatment of dermal fat atrophy after severe
acne. Aesthetic Plast Surg. 2009;33:113116.
8. Sadick NS, Palmisano L. Case study involving use of injectable poly-L-lactic acid (PLLA) for acne scars. J Dermatolog
Treat. 2009;20:302307.
9. Rose AE. Therapeutic update on acne scarring. J Drugs
Dermatol. 2014;13:651654.
10. Lemperle G, Knapp TR, Sadick NS, et al. ArteFill permanent injectable for soft tissue augmentation: I. Mechanism
of action and injection techniques. Aesthetic Plast Surg.
2010;34:264272.

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Volume 136, Number 5S Current Concepts in the Use of Bellafill

11. Karnik J, Baumann L, Bruce S, et al. A double-blind, randomized, multicenter, controlled trial of suspended polymethylmethacrylate microspheres for the correction of atrophic
facial acne scars. J Am Acad Dermatol. 2014;71:7783.
12. Piacquadio D, Smith S, Anderson R. A comparison of commercially available polymethylmethacrylate-based soft tissue
fillers. Dermatol Surg. 2008;34(Suppl 1):S48S52.
13. Hilinski JM, Cohen SR. Soft tissue augmentation with
ArteFill. Facial Plast Surg. 2009;25:114119.
14. Suneva. Bellafill Instructions for Use. San Diego, Calif.: Suneva;
2014.

15. Suneva. Bellafill Skin Test Instructions for Use. San Diego, Calif.:
Suneva; 2014.
16. Suneva. Suneva Before and After Photo Taking Guide. San Diego,
Calif.: Suneva; 2014.
17. Lemperle G, Gauthier-Hazan N, Wolters M, et al. Foreign
body granulomas after all injectable dermal fillers: part 1.
Possible causes. Plast Reconstr Surg. 2009;123:18421863.
18. Lemperle G, Morhenn VB, Pestonjamasp V, et al.
Migration studies and histology of injectable microspheres
of different sizes in mice. Plast Reconstr Surg. 2004;113:
13801390.

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