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July 2013

Copyright 2013

764
ORIGINAL ARTICLE

VOLUME 12 ISSUE 7
Journal of Drugs in Dermatology

Small Gel Particle Hyaluronic Acid Injection


Technique for Lip Augmentation
Stacy R. Smith MD,a Xiaoming Lin MS RN,b and Ava Shamban MDc
a

Private Practice, Cardiff, CA


Formerly of Medicis Aesthetics, a Division of Valeant Pharmaceuticals
c
AVA MD, Santa Monica, CA
b

ABSTRACT
Optimizing the aesthetic outcome of lip augmentation with dermal fillers, such as small gel particle
hyaluronic acid (SGP-HA), requires skillful application of a suitable injection technique. Moreover,
achieving aesthetic goals with minimal risk for adverse events requires knowledge of lip anatomy and
function, clinical experience in the use of various injection techniques, and an individualized treatment
approach. Clinician-patient discussion of the initial assessment of lip presentation and global appearance
of lip shape and proportion is important in setting treatment expectations and establishing a basis for
follow-up assessment of the effectiveness of treatment. The effectiveness and safety of SGP-HA for lip
augmentation was demonstrated in a recent randomized controlled trial. This review discusses factors
influencing the choice of one or a combination of techniques for injection of SGP-HA for aesthetic lip
augmentation.

J Drugs Dermatol. 2013;12(7):764-769.

INTRODUCTION
Dermal fillers are commonly used for aesthetic lip augmentation procedures performed to increase lip
fullness, define lips, and restore volume loss that may occur with aging.1 Fillers and implants that have been
commonly used in clinical practice include autologous implants (eg, fat transfer), collagens (eg, bovine,
human), biosynthetic implants (eg, polymethylmethacrylate microspheres in a carrier gel, expanded
tetrafluoroethylene), and cross-linked hyaluronic acid gels, such as small gel particle hyaluronic acid (SGPHA; Restylane, Medicis Aesthetics, a Division of Valeant Pharmaceuticals).2,3 SGP-HA is derived from a
nonanimal source, does not elicit an immunogenic or inflammatory response, and is composed of small gel
particles (~300 m in diameter) stabilized with a low degree of cross-linking that provides durability of tissue
support and ease of injection through small-diameter needles. 4-6 Moreover, the viscous and elastic
properties of SGP-HA impart pliability and moldability to the gel, providing the desired lift and definition to the
lips, which may be important for achieving an optimal aesthetic outcome with lip augmentation.7
The effectiveness of SGP-HA for lip augmentation was suggested by several case series 8-10 and an openlabel pilot study11 and subsequently confirmed in a randomized controlled clinical trial.12 In the randomized
controlled trial, the majority of patients injected with SGP-HA demonstrated aesthetically meaningful
improvements based on the blinded evaluator score on the Medicis Lip Fullness Scale (MLFS), a validated lip
assessment scale.13 Initially approved by the U.S. Food and Drug Administration (FDA) for the correction of
facial wrinkles (eg, nasolabial folds), SGP-HA was recently approved for lip augmentation in patients older
than 21 years.4

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The techniques for injection of SGP-HA for lip augmentation have included serial puncture and linear
threading, which may be antegrade or retrograde. The choice of one technique over another or a combination
of techniques may be influenced by aesthetic goals and patient factors.2,10 Achieving the aesthetic goals of
lip augmentation with optimal tolerability and minimal risk for adverse events (AEs) requires knowledge of lip
functional anatomy and skillful application of a suitable technique (or combination of techniques) to achieve
accurate placement of appropriate injection volumes. This review discusses techniques for injection of SGPHA relative to the effectiveness and safety of this dermal filler for lip augmentation that was demonstrated in a
recent pivotal randomized controlled clinical trial.12

Effectiveness of Injection Techniques


A randomized, evaluator-blinded study was performed to evaluate the effectiveness and safety of dermal filler
injection techniques in patients with very thin or thin (MLFS score of 1 or 2) upper and lower lips. Details on
patient demographics, inclusion and exclusion criteria, study design, and written informed consent were
previously described.12
Live assessments of lip fullness were made by blinded evaluators using the 5-point MLFS12 in which a
response was defined as an improvement of at least 1 point from baseline in lip fullness for the upper or
lower lip. A typical outcome is illustrated in Figure 1.
Although every injection technique has the potential to achieve effective results, an analysis of the injection
techniques used in this study found differences in the likelihood of achieving a positive response. In this
study, most patients (54%) received more

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than 1 injection technique. The combinations of techniques were categorized by exclusion of one technique.
Thus, 40% of patients were treated with a combination of techniques that included linear antegrade threading
(ie, did not exclude linear antegrade threading); 66% were treated with a combination of techniques that
included linear retrograde threading, and 17% were treated with a combination of techniques that included
serial puncture. These percentages add to >100% because most patients were treated with more than 1
technique. However, regardless of injection technique, treatment with SGP-HA compared with no treatment
was statistically significantly predictive of a positive response in the upper and lower lips (Table 1). In the
upper lip, the predictive value for a positive response was greatest with techniques that did not exclude linear
retrograde threading (odds ratio [OR] = 34.23), intermediate with techniques that did not exclude linear
antegrade threading (OR=11.84), and least with techniques that did not exclude serial puncture (OR=5.83).
Even though all techniques have the potential to provide effective results, selection of the most appropriate
technique or combination of techniques is based on the individual needs of the patient. Thus, the observed
differences in predictive value associated with different techniques may reflect the technical challenge of
achieving the desired aesthetic outcome based on individual patient characteristics rather than limitations of
the technique itself. In the lower lip, the predictive value for a positive response was slightly greater with
techniques that did not exclude serial puncture and slightly less with techniques that did not exclude linear
antegrade or linear retrograde threading. The reasons that predictive values differed more between
techniques in the upper lip compared with the lower lip are unclear. Although similar numbers of patients
overall received injections in the upper (n=134) and lower lips (n=122), there was wide variation in the
percentage of patients who received different combinations of injection techniques (discussed above) and
wide variation in the
estimates of the response to treatment that may have contributed to differences in predictive values between
the upper and lower lips. Moreover, these differences also may reflect an upper lip emphasis on lip contour
and vermilion border accentuation in contrast with a lower lip emphasis on volume augmentation.

Safety of Injection Techniques


Overall Safety of Injection Techniques
A previous retrospective clinical review documented that injection of SGP-HA for lip augmentation was
associated with transient injection site reactions and occasional bruising and that other AEs were uncommon
and easily managed.8 A more recent study found that the majority of patients (67%, 204/306) who received
1 injection of SGP-HA by 1 of several injection techniques experienced at least 1 treatment-emergent AE
(TEAE).12 These safety analyses found that for the first treatment, techniques using only linear injection
compared with techniques that incorporated serial puncture were associated with a higher frequency of tissue
mass (0%5% vs 0%, respectively), pain (15%17% vs 0%2%), swelling (37%42% vs 0%15%), and
bruising (15%41% vs 4%12%).12 Thus, there appears to be an association between AEs and injection
technique; however, sample sizes differed and no formal statistical analyses were performed. These data
may indicate that, despite the necessity of multiple injections, serial puncture may cause less tissue trauma
than the submucosal tunneling of the lip that occurs with linear techniques. Not surprisingly, the frequency of
all TEAEs was lower when the treatment was repeated after 6 months compared with the first treatment,
regardless of technique.12

Considerations for Optimally Aesthetic Lip Augmentation


Injection of SGP-HA for lip augmentation can be used to enhance lip fullness, define lip margins, reduce the
appearance of perioral rhytides, correct asymmetry, and better define the shape of the lips.10 Achieving these
goals can be challenging, requiring detailed knowledge and expertise in the clinical assessment of lip
anatomy and function as well as practical experience in the use of dermal filler injection techniques.
In our opinion, optimal aesthetic outcomes are obtained when the treatment goals are based on accentuation
of the patients natural lip contours (with correction of asymmetry and abnormalities) rather than attempting to
conform to an arbitrary ideal. Consequently, initial assessment should document the patients natural lip
shape to guide treatment planning in concert with the patients desired outcome. Since all injection
techniques can be effective, physician preference for a given technique should not influence the outcome of
treatment.

Pretreatment Patient Evaluation


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Assessment of the intrinsic properties of the lips and discussion of treatment goals with the patient should be
performed so that the clinician and patient have a clear understanding of the limitations of dermal filler
injections and realistic expectations for optimal aesthetic improvement. Approaches to clinical evaluation of
the lips in patients seeking lip augmentation vary and may include live assessments alone or in combination
with photonumeric rating scales or lip function scales such as the MLFS.13-15 As a starting point for setting
realistic expectations, it may be useful to globally categorize patients into 3 groups: patients with attractive lip
shape, size, and definition who are seeking limited augmentation; patients with inadequate lip fullness who
desire overall lip augmentation; and patients with poorly defined lips and/or the presence of vertical lip
lines.14 Assessment of needs and expectations and formulation of a treatment plan for lip augmentation
require asking the patient to provide responses to viewing their lips in a mirror.10 However, treatment
expectations vary from patient to patient and should be guided by consideration of the proper proportioning of
lip height and length (ie, intercommissure width) and the need to recreate a distinct upper lip white roll in a
given patient.16 Patient perceptions of lip presentation at the initial clinic visit will likely influence treatment
expectations. Thus, it may be useful to discuss the potential zones for lip augmentation (Figure 2) with the
patient to set realistic expectations and document the appearance of lip zones and subunits at baseline to
provide an objective basis for assessment of treatment effectiveness (Table 2).10

Overview of Injection Techniques


Selection of injection technique may depend on the size and location of the area to be corrected, the skill and
experience of the injector, and individual patient needs. The serial puncture technique (Figure 3A) is well
suited for delivery of multiple

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small amounts of dermal filler to discrete lip zones such as the vermilion at the apex of Cupids bow and the
commissural zone and for correcting asymmetry. Alternatively, linear threading techniques (Figure 3B) may
best be used when correcting the appearance of the philtral zone or the vermilioncutaneous junction (Figure
2). Also, injection techniques may be used in combination at the discretion of the treating clinician to achieve
an optimal aesthetic outcome. In the recent pivotal randomized clinical trial, treating investigators followed a
protocol that allowed the injection of SGP-HA for correction of lip shape and fullness but not perioral rhytides
and oral commissures.12 However, injection techniques and the effectiveness of SGP-HA for correction of
aesthetic defects in these specific lip zones have been reviewed elsewhere.17,18

Pain Management
Injection procedures for the delivery of hyaluronic acid for lip augmentation may be associated with local
discomfort. In the pivotal study of SGP-HA for lip augmentation, most patients (96%) received a topical or
regional anesthetic at the time of initial injection of hyaluronic acid.12 Regional anesthesia in the form of
infraorbital and mental nerve blocks can effectively manage procedural pain, but instillation of the blocks is
also painful and produces prolonged dysesthesia. Consequently, patients may prefer to tolerate the
procedure with topical anesthetic alone. Although not available when the pivotal study took place, a
formulation of SGP-HA mixed with lidocaine recently received FDA approval for aesthetic correction of
nasolabial folds, oral commissures, marionette lines, and perioral rhytides.19 The authors suggest using this
revised formulation by injecting a small amount of implant material in all of the areas initially designated for
augmentation. This allows the lidocaine to take effect before proceeding to the detailed and complete
injection process.

Volume of SGP-HA for Lip Augmentation


Prescribing information indicates that SGP-HA be administered using sterile 1.0-mL syringes provided with a
(supplied) sterile 30-gauge 0.5-inch needle.4 The treating clinician should inject the amount of dermal filler
necessary to achieve an optimally aesthetic outcome in a given patient, based on the patients goals and the
clinicians assessment. However, the pivotal study of SGP-HA for lip augmentation recommended using 3
mL of hyaluronic acid (ie,1.5 mL per lip) for a given treatment, a volume that had little effect on the incidence
of AEs. 12 Patients naive to lip injections may benefit from a more conservative approach to initial
administration of dermal filler and a 2-week follow-up to administer additional hyaluronic acid if needed. It is
extremely common for patients to have a fear of excessive augmentation with a resulting appearance that
they may find undesirable. This fear usually abates several days after the patient becomes familiar with their
new appearance and often culminates in a desire for additional augmentation at later visits.
Tracking of injection volume during treatment is important to ensure a symmetrical enhancement. However,
one should not strictly adhere to only injecting precisely the same volume into the left and right sides. Any
given lip will have minimal to significant lateral asymmetry before injection and may require slightly different
injection volumes to achieve a best outcome. Additionally, the ideal ratio of upper to lower lip fullness is not
1: 1, and patients can have considerable variation in the comparative sizes of their upper versus lower lips.3
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Thus, the volumes injected into upper versus lower lips need not be compared.
In this study, the injection time needed for the initial treatment of both lips exceeded that for touch-up visits
(mean, 14.1 vs 7.6 minutes). However, the recorded treatment times represent the total time required to
perform the procedure, including positioning the patient, identifying the injection site, performing the injection,
and applying pressure to stop bleeding. Previous studies suggested that a faster rate of injection (ie, 120 vs
135 seconds) and administration of a higher mean volume (ie, 1.04 vs 0.8 mL) of hyaluronic acid gel were
correlated with the presence of AEs in patients undergoing aesthetic correction of nasolabial folds. 20
Additionally, rapid tissue expansion is associated with increased perception of pain.21 Thus, careful attention
to the volume and rate of injection may be important factors in minimizing pain and AEs when using
hyaluronic acid for correction of lip shape and fullness.

Techniques for Injection of Dermal Filler


Small gel particle hyaluronic acid is administered by submucosal injection at a depth deemed appropriate for
a given patient by the clinician. Whatever the injection technique, care should be taken to inject an amount of
filler in a given location sufficient to achieve lip correction without distorting the natural anatomy orientation of
the lips. Lip anatomic zones are well vascularized, and there have been few reports of arterial embolization
resulting from injection of hyaluronic acid. 22,23 However, most reports of embolization or vascular
compromise from soft tissue augmentation arise from treatment in the nasolabial fold or glabellar areas.24
Importantly, there were no reports of arterial embolization of hyaluronic acid in patients enrolled in the pivotal
randomized clinical trial of SGP-HA for lip augmentation.12
In the serial puncture technique, the intended injection site should be grasped between the index finger and
thumb of the noninjecting hand and the needle inserted to the appropriate depth. Ideally, the plunger should
be withdrawn before injecting material to ensure extravascular placement of the needle tip. After delivery of a
small amount of filler, the needle should be removed and reinserted a short distance farther along the
planned line of treatment (based on anatomic landmarks, measurements, and pretreatment assessment) and
another small amount of SGP-HA delivered. This process can be repeated until the desired correction is
achieved. Care should be taken to plan injection points such that the deposited implant extends to each
injection point, avoiding any skip areas.
In the linear retrograde threading technique, the lip is held in place by applying gentle downward or posterior
force to oppose the soft tissues against the teeth. This must be done gently because excessive pressure can
induce significant pain. At the same time, gentle traction should be applied to the lip to make needle insertion
a rapid, comfortable action. The needle is inserted to the appropriate depth and tunneled under the anatomic
defect, typically from lateral to medial. SGP-HA is then injected as the needle is slowly withdrawn to implant a
continuous linear depot of filler; injection of filler should be stopped just before the needle is removed from
the skin to prevent superficial deposition of filler. This technique is particularly useful for enhancing the
aesthetic appearance of the vermilion of the lip. When using the linear antegrade injection technique, SGPHA is delivered as the needle is tunneled forward along the intended path, implanting a continuous linear
depot of filler as the needle advances.
Regardless of the injection technique, the treating clinician should repeatedly assess the degree and
uniformity of lip correction. Any areas omitted can be detected by palpation and treated with additional dermal
filler or may be corrected by gently massaging the lips until the implanted material is uniformly palpable. If an
excessive volume of hyaluronic acid has been injected, this can be dissipated into the surrounding tissues by
firm massage between the fingers or against adjacent bone or teeth.4
The small individual depots of SGP-HA injected by serial puncture can be massaged or manipulated to
confluence to achieve an effect similar to the continuous depot implanted with linear techniques. Serial
puncture alone and in combination with linear techniques was used by treating investigators in the pivotal
study that confirmed the effectiveness (eg, 94%-95% MLFS responders at week 8; significantly improved
[P<0.001] the Global Aesthetic Improvement Scale scores at all visits) of SGP-HA for lip augmentation.12
However, the question of whether one technique or another is more effective in achieving optimal aesthetic
outcomes when performed by skilled and experienced injectors needs to be further investigated on the basis
of validated clinical efficacy analyses.
Serial puncture allows precise placement of the filler but produces multiple puncture wounds. However, the
question of whether more tissue trauma results from precisely placed multiple punctures or from tunneling the
full needle length through lip tissue with linear antegrade or retrograde techniques needs to be investigated
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further on the basis of clinical safety analyses. Massage is a key part of dermal filler administration and is
especially important when treating the lips. However, massage itself may lead to increased bruising or
tenderness after treatment and should be used judiciously.
SUMMARY
Achieving an optimal aesthetic outcome for lip augmentation with dermal fillers such as SGP-HA requires
knowledge of lip anatomy and function, clinical experience in the use of different injection techniques, and an
individualized approach to treatment. Devising an individualized treatment plan will depend on a thorough assessment of lip presentation at
the time of the initial clinic visit in addition to the global appearance of lip shape and proportion. Importantly,
clinician-patient discussion of the assessment is a critical step in the setting of realistic treatment
expectations and should provide a basis for evaluation of treatment effectiveness. Effective administration of
SGP-HA requires that treating clinicians develop an understanding of injection techniques, including the
appropriate volume and injection sites, to achieve optimal aesthetic outcomes that are pleasing to the patient
and minimize the risk for AEs.
DISCLOSURE
Editorial support for this manuscript has been provided by Craig D. Albright PhD, and Robert Gatley MD, of
Complete Healthcare Communications, Inc., Chadds Ford, PA, with funding from Medicis Aesthetics, a
Division of Valeant Pharmaceuticals.
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ssmith@stacyrsmithmd.com.

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AUTHOR CORRESPONDENCE
Stacy R. Smith MD
E-mail: ssmith@stacyrsmithmd.com

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of any portion of the contents of these materials may be made without the express written consent of the Jddonline. Licensed to
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