COSMETIC

Injectable Poly-L-Lactic Acid (Sculptra):Technical Considerations inSoft-Tissue Contouring

Samuel M. Lam, M.D.Babak Azizzadeh, M.D.

Miles Graivier, M.D.

Plano, Texas; Beverly Hills, Calif.;and Roswell, Ga.

Background: Poly-L-lactic acid gained U.S. Food and Drug Administration ap-proval for use in human immunodeficiency virus–related facial lipoatrophy inAugust of 2004. Since that time, it has become available for use in the United Statesfor human immunodeficiency virus facial lipoatrophy patients and for off-label usesin other areas for soft-tissue contouring. This article is intended to enumeratereconstitution, injection techniques, management, and avoidance of complications.Methods: The authors have pooled their experiences to arrive at a consensus opinionfor recommendations on treatment protocols for injectable poly-L-lactic acid use.Results: This article prescribes techniques to achieve safer, consistent results whileminimizing risks of complications with injectable poly-L-lactic acid. Although theproduct has been used widely in Europe since 1999, physicians in the United Stateshave only recently begun to explore the uses of Sculptra as a volumizing agent inthe face and the body. U.S. physicians have benefited from the European experi-ence with this product, including early problems secondary to overaggressive use,low-volume reconstitution, higher volume injection of product at one session, andinadequate time between injection sessions.Conclusions: The authors therefore have opted for a more conservative ap-proach in their treatment recommendations. Higher volume dilution (8 to12 cc), fewer vials used at each session, injections placed in the subcutaneousplane without any product being placed in the dermis, adequate time be-tween injection sessions (at least 6 weeks), and postinjection patient massageshould decrease the risks and avoid the potential complications associatedwith poly-L-lactic acid soft-tissue augmentation. (Plast. Reconstr. Surg. 118(Suppl.): 55S, 2006.)

The past decade has brought on a funda-mental change with regard to our perspec-tive on facial aging. Gravitational descent

was implicated in the past as the principal mech-anism by which facial aging occurred. Therefore,lifting procedures (e.g., face lift, brow lift, mid-face lift) served as the primary methods withwhich to address this process. Today, volumetricdeficiency has also come to be increasingly rec-ognized as a major component of the aging pro-cess, which can be addressed through a variety oftechniques. Facial fat grafting and alloplastic

implants have served as the principal surgicalmodalities for correcting the volume loss associ-ated with facial aging.1,2

Poly-L-lactic acid can be thought of as an ap-proximate nonsurgical equivalent to facial fatgrafting. Serving in a rejuvenative capacity, poly-L-lactic acid is injected into the subcutaneousplane to gradually cause volumetric expansionover time. Unlike other dermal “fillers” that areintended to correct discrete facial deficiencies(e.g., lines, folds, and attenuated lips), poly-L-lactic acid is designed to provide volumetric ex-

From the Lam Facial Plastic Surgery Center and Hair Res-toration Institute; Audrey-Skirball Kenis Center for Plasticand Reconstructive Surgery, Cedars-Sinai Medical Center;Division of Head and Neck Surgery, David Geffen School ofMedicine at UCLA; and North Atlanta Plastic Surgery.Received for publication March 21, 2006; accepted May 26, 2006.Copyright ©2006 by the American Society of Plastic Surgeons

DOI: 10.1097/01.prs.0000234612.20611.5a

Poly-L-lactic acid is approved by the FDA forrestoration and/or correction of the signs offacial fat loss (lipoatrophy) in people withhuman immunodeficiency virus; other usesare “off-label.”

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pansion of volume-deficient areas. Approved forhuman immunodeficiency virus–related lipoat-rophy by the U.S. Food and Drug Administra-tion, poly-L-lactic acid can act to reverse thestigmata of malar and submalar soft-tissue de-pression in these patients, the improvement ofwhich can be sustained in some reports for up-ward of 2 years.3 Poly-L-lactic acid has also beenused extensively in an off-label capacity tocorrect non–human immunodeficiency virus–related facial volume loss.

Originally developed and marketed in Europeas New-Fill, poly-L-lactic acid has been success-fully recruited for aesthetic indications since1999 in over 150,000 clinical cases and in over 30countries to date. The experience in the UnitedStates has been more cursory and dates back toAugust of 2004, when the product was first ap-proved by the U.S. Food and Drug Administra-tion for human immunodeficiency virus–relatedfacial atrophy and marketed as Sculptra (DermikLaboratories, Bridgewater, N.J.). Despite this rel-atively short period, the U.S. experience has con-tributed to an improved understanding of theexpanded clinical indications of the product andthe potential complications that can arise. Thisarticle is intended to summarize the current useof poly-L-lactic acid in the United States andenumerate the pearls and pitfalls that have in-formed the clinical practices of the authors. Wewill focus on the techniques (i.e., reconstitution,injection, and postoperative care) that may re-duce the occurrence of adverse events, such assubcutaneous papules, and management of com-plications associated with poly-L-lactic acid.

PRODUCT INFORMATIONInjectable poly-L-lactic acid is a biocompat-

ible, biodegradable, synthetic polymer from thealpha-hydroxy-acid family. Injectable poly-L-lacticacid, marketed as Sculptra, is composed of crys-talline, irregularly sized microparticles of poly-L-lactic acid. Poly-L-lactic acid has been used fornumerous years in dissolvable suture material andother medical devices, including absorbable seal-ants, flow restrictors, fixation systems, and fixationscrews, and in tissue regeneration.4,5

Sculptra is packaged as a sterile, freeze-driedpreparation in a clear glass vial and is stable for 72hours after reconstitution. The freeze-dried prod-uct can be stored at room temperature for up to2 years and does not require refrigeration. Sculp-tra also contains sodium carboxymethylcelluloseas a suspending agent to maintain even distribu-tion of poly-L-lactic acid particles after reconsti-

tution and nonpyrogenic mannitol that enhancesthe lyophilization process. Poly-L-lactic acid poly-mers degrade through nonenzymatic hydrolysis tolactic acid monomers, which are in turn metabo-lized into carbon dioxide or incorporated intoglucose.

The mechanism by which injectable poly-L-lactic acid engenders volumetric facial expansionis related to a foreign body giant cell reaction thatoccurs several weeks to months later. In addition,collagen production that occurs as the productdegrades produces the observed volume changesand aesthetic benefit.

CLINICAL STUDIESTwo major clinical studies have been con-

ducted into injectable poly-L-lactic acid in Europe:the VEGA study and the Chelsea and Westminsterstudy. The VEGA study was a prospective, open-label, single-center evaluation that included 47patients with human immunodeficiency virus–re-lated facial lipoatrophy who were studied over aperiod of 2 years and who attended up to sixinjection sessions, with one vial per cheek persession. Injection sessions were undertaken every2 weeks, with the majority of patients (86 percent)completing four to five injections. Ultrasoundmeasurements of mean skin thickness demon-strated a statistically significant three-fold increasein skin thickness, with results that were sustainedover the 2-year evaluation.2 Treatment-related ad-verse events that occurred included subcutaneouspapules that arose on average 7 months (range,0.3 to 25 months) after treatment initiation, withspontaneous resolution in 24 percent during thestudy.

The Chelsea and Westminister study was a24-week, open-label, single-center, randomizedevaluation that compared immediate versus de-layed treatment in patients with human immu-nodeficiency virus–related facial lipoatrophy.All patients underwent three treatment sessionswith one vial of poly-L-lactic acid per cheek. Onearm of the study received treatment at 0, 2, and4 weeks; the other arm, at 12, 14, and 16 weeks.In the immediate treatment group, significantchanges in skin thickness were observed at week12 when compared with the delayed treatmentgroup, which had not been treated at that point.These changes were sustained for the durationof the 24-week study. In the delayed group, sig-nificant changes were not observed until week24 and were equal to those of the immediatetreatment group at that point. Data regarding

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the occurrence of subcutaneous papules werenot discussed in this study.6

MATERIALS AND METHODSTechnique

To date, the only U.S. Food and Drug Admin-istration–approved indication in the United Statesfor injectable poly-L-lactic acid is treatment of hu-man immunodeficiency virus–related lipoatro-phy. This article discusses treatment protocols thatcan be used for human immunodeficiency virus–and non–human immunodeficiency virus–relatedfacial volume loss and other regions of the bodythat warrant similar volume enhancement. Sub-cutaneous papules is the main complication thatcan arise after treatment with poly-L-lactic acid.Consequently, the techniques presented in thissection have been developed to limit the inci-dence of subcutaneous papules and also obtainsatisfactory results. These recommendations arederived from the clinical experiences of the au-thors and may differ from the guidelines pre-sented in the literature that accompanies the man-ufactured product. These recommendations arenot meant to be absolute or definitive but areculled from personal experience and should befollowed with that caution and advisement inmind.

ReconstitutionProper reconstitution of the freeze-dried

product is a critical step in the avoidance of po-tential subcutaneous nodules. In the past, with theoriginal studies presented, the product was recon-stituted with 2 cc of sterile water. The authors haveincreasingly recognized the need for a much morecopious amount of dilution to minimize the risk ofnodule formation, with anywhere from 5 to 10 ccof sterile water per vial. As recommended, thesterile water is added the night before injection topermit sufficient time for the product to be en-tirely reconstituted. Although more abbreviatedtimes have been used for reconstitution, the au-thors strongly recommend a minimum of 12 hoursfor reconstitution. An evenly distributed poly-L-lactic acid hydrogel should diminish the incidenceof clumping of the particulate poly-L-lactic acid. Ifthe product is reconstituted only shortly beforethe time of injection, the risk of nodule formationmay be accentuated.

Immediately before injection, additional localanesthetic (e.g., 1% lidocaine with 1:100,000 epi-nephrine) is recommended to be added to the vialto provide additional anesthesia and hemostasis.

Placement of 1 to 2 cc of local anesthesia willtypically suffice to meet those objectives. With epi-nephrine in the mix, it is preferred that the lido-caine be added only shortly before the time ofinjection to ensure that its efficacy is not compro-mised. At this point, immediately before drawingup syringes for injection, the physician or assistantcan swirl the vial more thoroughly to ensure aneven suspension and reconstitution.

InjectionFor patient comfort, it is advisable to apply a

topical anesthetic with occlusive dressing over allof the treatment areas intended for enhancement.A dental block may improve patient comfort buthas been found to be of little added benefit, giventhe wider arc of treatment that lies outside of theterritory covered by a regional nerve block. Thelidocaine with epinephrine that is recommendedduring the process of reconstitution can furtheroptimize anesthesia.

With the patient in an upright position, thetopical anesthesia is removed with a moist 4 � 4gauze and the patient more carefully inspected forareas that would benefit from volumetric enhance-ment. A wide-nibbed permanent marker is thepreferred method of marking the patient in anupright position. The physician should avoid in-jecting directly through a skin mark to avoid therisk of a permanent traumatic tattoo.

At this point, the physician should calculatehow best to distribute the poly-L-lactic acid acrossthe areas of the face. Analyzing the face during theinitial consultation is the most important aspect ofobtaining the ideal results with poly-L-lactic acid.We typically use one vial per face, whereas previ-ous studies from Europe have relied on two vialsper face. If one vial of poly-L-lactic acid is to beused for the entire face and the vial is reconsti-tuted with a total of 8.5 cc of diluent (e.g., a mix-ture of 6.5 cc of sterile water and 2 cc of lidocaine),the calculation can be based on this dilution (Fig.1). It is best to eliminate 0.5 cc from the calcula-tion, as there is almost always some degree ofspillage or waste in the syringe hub. With any extraamount left behind, the physician can easily dis-tribute the remainder evenly between the twosides. The contrary is also true: if the physician wasplanning to place 4 cc on one side and 4 cc on theother side and ends up with only 3 cc on theremaining side, he is left with the potential for anasymmetric allocation. Thus, 1-cc Luer-Lok sy-ringes are preferred for injection control andmaintenance of accurate counts during injection.

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One-inch, 25-gauge Terumo (Somerset, N.J.) nee-dles have been found to provide ease of injectionand limited clogging. As the particulate nature ofthe suspension may occasionally lead to cloggingin the needle, the physician should always with-draw the needle from the injection site to clear anyobstruction before continuing.

Generally speaking, no more than two vials ofreconstituted poly-L-lactic acid are recommendedduring any single treatment session to minimizethe risk of overdelivery of product until additionalexperience is acquired. For the more mature pa-tient or severely volume-depleted patient, eventwo to three vials of poly-L-lactic acid can be usedduring a single treatment session. However, usingthese high quantities in one treatment sessionrisks nodularity, which can arise from placementof an excessive amount of product in a limitedspace (e.g., the perioral region). For the acolyte,starting with a single bottle for a single treatmentsession is recommended. As a good rule, theedema and volumetric fullness that accompany an8-cc dilution of a single vial of poly-L-lactic acid isroughly equivalent to the way a patient will ulti-mately appear several months following a total of

three vials. This estimation can prove to be effec-tive in communicating with a patient about thenumber of treatment sessions that will be neededto achieve the desired aesthetic endpoint. For ex-ample, if the patient feels that he or she appearsovercorrected, only one to two treatment sessionsmay be necessary. In contrast, if the patient be-lieves that the volume gained immediately afterinjection still appears deficient, more than threetreatment sessions may be required.

When calculating the areas for augmentation,it is advisable to divide each treatment area in halfso that half of the treated area receives injectionin one direction and the remaining half in theperpendicular cross-hatched fashion. Perpendic-ular cross-hatching facilitates a more even distri-bution ultimately than a unidirectional pass canafford. The depth of injection is one of the mostimportant modifications in the authors’ tech-nique since the earlier recommendations. In thepast, intradermal injection was advocated, but do-ing so may have led to a higher incidence of nodu-larity. The authors have found that the subcuta-neous plane is the desired plane of distribution tominimize risk of this complication. No more than

Fig. 1. Preinjection markings and planning (8-cc dilution). Temporal hollows (depot technique), 0.1 cc/injection site� 3; tear trough and periorbital area (depot technique), 0.1 cc/injection site � 5; nasolabial fold (linear threading �

cross-hatching), 1.2 cc; labiomental crease, perimental hollow, prejowl, and marionette line (linear threading andcross-hatching), 2.0 cc.

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0.1 cc of reconstituted poly-L-lactic acid per passof the syringe should be injected, to minimizedeposition of excess product into a discrete locusthat might translate into nodule formation. Also,before each injection, the syringe should be gentlyflashed back to ensure that intravascular penetra-tion has not been committed.

The malar and submalar regions are the eas-iest to correct and can show the greatest improve-ment, with minimal morbidity, using the afore-mentioned tunneling/cross-hatching method.Effacement of lines and folds is also possible withinjectable poly-L-lactic acid (Fig. 2) but should becarried out with greater caution for two reasons.

Fig. 2. (Left) Before injections. (Right) Four weeks after one vial of Sculptra (4 cc in the nasolabial fold plus 1 cc in thecheek). (Courtesy of Jeff Kenkel, M.D.)

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First, placement of too much volume in a discretearea to manage a line or fold can lead to thepotential for overcorrection and nodularity. Sec-ond, if the patient is truly desirous only of lineeffacement or modulation, the physician shouldopt for a true dermal filler that can provide atargeted solution to the problem with instanta-neous results. The reader is reminded that withinjectable poly-L-lactic acid, there is no visual end-point: the physician simply places more product inan area with the prospect that over the ensuingweeks to months that area will manifest greatervolume expansion.

The areas that should be avoided in the facefor modification with poly-L-lactic acid are the lipsand nose. Lip enhancement with poly-L-lactic acidis unpredictable. Although an estimate can bemade with clinical experience of how much col-lagen growth will occur after a single treatmentsession, no certainty of a result can be firmly es-tablished. Accordingly, nasal augmentation isfraught with risk because the difference betweenan improvement and a deformity is within a mil-limeter or two of tolerance. It has also been ob-served that placement of poly-L-lactic acid into theneck can also lead to undesirable side effects offrequent nodularity and should be avoided.

The periorbital and temporal areas are alsosensitive, albeit treatable, areas. Unlike the re-mainder of the face, these two zones should beaddressed with conservative amounts in a depotrather than tunneling fashion. Periorbital en-hancement should be reserved for more experi-enced surgeons who are familiar with treatmentoutcomes. We generally like to use an 11-cc dilu-tion for this area. Generally speaking, to amelio-rate the appearance of a hollow inferior orbitalrim contour, two to three deep (supraperiosteal)depot (direct transcutaneous) injections are madeacross each bony rim with approximately 0.1 cc ofaliquot per depot site evenly distributed across therim. The injection sites are then immediately dig-itally massaged against the bone to enhance aneven distribution. The area should be undercor-rected, unlike the other regions of the face.

To manage temporal hollowing, the medialextent of the temporal hollow (i.e., the transitionzone between a hollow temple and a fuller centralforehead) is obscured with several depot depositsof 0.1 cc per site using approximately two to threeevenly distributed injections, again deeply placedand massaged immediately thereafter. To reiter-ate, the temporal fossa is not augmented; rather,the transition zone between the temporal fossaand the medial forehead in the region of the con-

joined tendon is muted. With these conservativerecommendations, the physician can advance tomore liberal guidelines with experience.

Other limited areas of the body can be ad-dressed with Sculptra. These areas have in-cluded the hands and neck; decollete and atro-phic scars; and congenital, traumatic, andpostsurgical depressions. The volumes andnumber of treatments necessary to correct thedeficits vary, depending on individualized eval-uation and response to treatment (Fig. 3).

RESULTS

Posttreatment Care and Management ofExpectations

Posttreatment care is centered on vigorousmassage for several days to a week to distribute theproduct evenly and to limit the potential for un-toward nodule formation. Immediately after treat-ment, massage should be undertaken using amoisturizer to facilitate ease of manipulation,which should be carried out in a deep, circularmotion for approximately 5 minutes. A simple ruleof thumb that the patient can easily recall forself-administered massage at home is the “3-3-3rule” (i.e., 3 minutes of deep, circular massagewith lubricant in the treated areas three times perday for 3 days).

The patient must understand clearly that theapparent volume at the end of the treatment ses-sion represents only edema and administered ster-ile water, all of which will dissipate in several days’time. The delayed effect of volumetric enhance-ment will not be observed for several weeks to evenmonths after treatment. As an easy guide, patientscan be counseled that after a single treatment, theperceived benefit is minimal and may not even beperceptible to the majority of patients. The ruleproposed earlier should be recalled that the visualendpoint observed immediately at the conclusionof the treatment session approximates the aes-thetic appearance after a total of three treatmentsessions. Careful and standardized photographicdocumentation is indispensable for patient dia-logue and maintenance of patient rapport. Thepatient must be counseled about the delayed plea-sure of witnessing the aesthetic transformation, incontrast to the instant gratification that is attainedwith other types of fillers. In the past, the intervalbetween sessions was only approximately 2 weeks.There is no definitive guideline as to the timebetween sessions, but we recommend it to be atleast 4 to 6 weeks, to minimize the occurrence ofnodularity and to evaluate the volumetric and tex-

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tural changes from the injection. With additionaltreatment sessions, the physician should attemptto distribute the poly-L-lactic acid into a slightlydeeper plane below the immediate subcutaneousplane where the first treatment session was con-ducted. Volume expansion can be seen severalmonths after the initial injections; therefore,the interval between the third and subsequentsessions should be extended beyond the 6-weekperiod, again to evaluate the necessity of fur-ther treatment.

ComplicationsThe technical details outlined above are in-

tended to direct the reader away from poten-tially harmful injection techniques and to nav-igate a safe course of therapy. Nevertheless,complications can and will most likely arise be-cause of either technical error or an exposure toan increased number of patients over time. Thissection aims to classify the types of nodules thatcan arise and thereby outline a treatment strat-egy based on that classification scheme.

The major distinction of a palpable and/orvisible lump after injectable poly-L-lactic acid isdivided between a nodule and a granuloma. Anodule can be visible or nonvisible and may ariseas a result of technical error, uneven distribu-tion of the poly-L-lactic acid in the suspension,or uneven dispersal in the injected areas. It isdistinguished by its indurated nature and sep-aration from the surrounding soft tissue. Ittends to remain the same size until it is ab-sorbed, treated, or removed. Vleggaar, in thissupplement, notes a nonvisible nodule rate of3.2 percent and a visible nodule rate 1.2 percent,which resolved spontaneously in 26.9 percentand 7.7 percent, respectively.7 Histologically,the nodule consists of fluid droplets or micro-particles surrounded by a normal foreign bodyreaction. They typically arise only several weeksafter injection. Conversely, granulomas may be-come apparent after many months to years, andthey arise throughout the bed of implantationrather than at a few discrete loci. Their reportedincidence ranges from 0.28 to 12 percent.9 Using

Fig. 3. Correction of left lateral abdominal depression 9 months after the second treatment with one-half vial ofSculptra (8-cc dilution) per treatment.

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a higher dilution of 5 cc for reconstitutionrather than the earlier reconstitution volume of3 cc, Vleggaar’s six granulomas in 3000 patients(0.2 percent) is probably the most accurate. Un-like nodules, the borders of a granuloma areseldom well defined. Without treatment, theymay grow over time, persist, and at times spon-taneously resolve. They are characterized by er-ythema, edema, and a violaceous hue because ofthe abundance of congested capillaries. Al-though the cause remains unknown, at times astimulus (e.g., systemic infection, trauma, oper-ation) may trigger the immune memory of mac-rophages to induce a foreign body reaction.Treatment of nodules and granulomas is dis-similar and requires in-depth review.

Nodules can be further subclassified intoearly and late nodules. Early nodules that ap-pear within several weeks of treatment representclustering of poly-L-lactic acid. The coalescenceof these microparticles can be disrupted bymeans of several techniques: needle fragmen-tation of the nodule and injection of the nodulewith saline to hydrate and redistribute the par-ticles followed by aggressive massage. A Luer-Lok syringe with 1 to 3 cc of sterile water and a25-gauge needle is the preferred method. Thesetechniques may need to be repeated on a weeklybasis until improvement or full resolution. Ifthese lesions do not resolve over time, they canbe locally excised. Late nodules that appear sev-eral months after injection may be treated withan intralesional steroid (triamcinolone, 10 mg/cc) and massage. Again, failure to respond tothese treatments may mandate local excision ofthe offending lesion. Since August of 2004, theauthors have performed 325 injections on 144patients. In only one patient has there been apostinjection nodule present (0.7 percent). Nogranulomas in this group have been seen thusfar.

Granulomas are distinct entities that requirea divergent treatment protocol. Local excisionfails to address these entities which, when theyarise, do so more pervasively and lack distinctborders, which makes excision untenable. Fur-thermore, surgical excision of a granuloma maylead to fistulas, abscesses, and scars. Steroidtherapy (i.e., intralesional, intramuscular, andoral) with or without immune-modulating med-ications is the mainstay of intervention. Aggres-sive intralesional steroids with triamcinoloneacetonide, 40 mg/cc, can be used every 3 weeksuntil resolution and may require one to 10 in-jections over 3 to 6 months for management.

Oral and intramuscular steroid therapy can befurther supportive, as necessary. Also, 5-flurou-racil (50 mg/cc) alone or in combination withKenalog (1 mg/cc) or betamethasone (7 mg/cc) can be beneficial and decrease the rate ofsteroid-induced skin atrophy.10,11 Although wehave not as yet had to treat any granulomas inour series, effective combinations have includeda mixture of one-third 5-flurouracil (1.6 ml),one-third betamethasone (3.5 mg), and one-third lidocaine.12 Vleggaar also reports success-ful treatment of granulomas with an intrale-sional injection of 0.4 cc of 5-flurouracil with 0.6cc of Kenalog (10 mg/ml) weekly for up to 4weeks and oral steroids and doxycycline (100mg) for at least 8 weeks.7 Intense pulsed lightcan play an adjunctive role in the treatment ofengorged capillaries. At times, granulomas mayresolve spontaneously. When treated and re-solved, they rarely recur.

DISCUSSIONAs with any aesthetic product, recommenda-

tions and guidelines are in a state of perpetualevolution and refinement. This article is intendedto reflect current thinking regarding the tech-niques that can lead to potentially safer injectionof poly-L-lactic acid. As stated, these recommen-dations are not meant in any way to be absolute butinstead reflect personal experience.

In recent years, there has been a virtual pleth-ora of new fillers and injectable agents developedfor aesthetic purposes. Injectable poly-L-lactic acidremains in a distinct category, as aesthetic resultsare delayed and the principal objective is to re-store volume and not to treat specific lines andfolds per se. Unlike other dermal fillers, treatmentis not undertaken until a visual endpoint isachieved. Instead, the product is distributed in thevolume-deficient areas to await an empiric changeover time.

As injectable poly-L-lactic acid is only specifi-cally U.S. Food and Drug Administration–ap-proved for human immunodeficiency virus–re-lated lipodystrophy, published reports regardingits off-label indication have been sparse.13 Further-more, early manufacturer recommendations forpoly-L-lactic acid use may have led to an unnec-essary incidence of nodules. Specifically, intrader-mal injection, low-volume reconstitution, and ag-gressive use of the product may have contributedto a higher likelihood of untoward events. Al-though patient and injection numbers and lengthof follow-up are relatively low, it would appear that

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a more conservative approach as described is thusfar yielding a lower complication rate.

CONCLUSIONSThis article describes techniques for achieving

safer results (i.e., subcutaneous injection, highervolume reconstitution, and a moderate timetablefor therapy). In addition, a classification schemehas been proposed for types of complications thatmay arise and a treatment algorithm tailored ac-cordingly. As ongoing clinical experience with in-jectable poly-L-lactic acid mounts in the UnitedStates, further refinements in on-label and off-label usage will continue to surface. The authorshope that this article will help the novice andexperienced practitioner with safe and effectiveimplementation of injectable poly-L-lactic acid.

Miles H. Graivier, M.D.1295 Hembree, Suite 100B

Roswell, Ga. 30076mgraiviermd@mindspring.com

DISCLOSURESMiles Graivier, M.D., and Babak Azzizadeh, M.D.,

are on the physicians’ advisory panel for Dermik Labo-ratories. Samuel M. Lam, M.D., has no financial in-terest in any of the products, devices, or drugs mentionedin this article.

REFERENCES1. Lam, S. M., Glasgold, M. J., and Glasgold, R. A. Complementary

Fat Grafting. Philadelphia: Lippincott Williams & Wilkins, 2006.2. Binder, W. J. Submalar augmentation: An alternative to face-

lift surgery. Arch. Otolaryngol. Head Neck Surg. 115: 797, 1989.3. Valantin, M., Aubron-Olivier, C., Ghosn, J., et al. Polylactic acid

implants (New-Fill) to correct facial lipoatrophy in HIV-infectedpatients: Results of the open-label study VEGA. AIDS 17: 2471,2003.

4. Kulkani, R. K., Pani, K. C., Neuman, B. S., and Leonard, F.Polylactic acid for surgical implants. Arch. Surg. 93: 839, 1966.

5. Kronenthal, R. L. Biodegradable polymers in medicine andsurgery. Polym. Sci. Technol. 8: 119, 1975.

6. Moyle, G. J., Lysakova, L., Brown, S., et al. A randomizedopen-label study of immediate versus delayed polylactic acidinjections for the cosmetic management of facial lipoatrophyin persons with HIV infection. HIV Med. 5: 82, 2004.

7. Vleggaar, D. Soft tissue augmentation and the roll of poly-L-lactic acid. Plast. Reconstr. Surg. 118 (Suppl.): , 2006.

8. Vleggaar, D. Personal communication, 2006.9. Salyan, Z. Facial fillers and their complications. Aesthet. Surg.

J. 23: 221, 2003.10. Fitzpatrick, R. E., and Manuskiatti, W. Laser, steroid, and

5-FU therapy appear comparable for keloid scar. Arch. Der-matol. 138: 1149, 2002.

11. Narins, R. S., Brandt, F., Leyden, J., et al. Randomized, dou-ble blind, multicenter comparison of the efficacy and toler-ability of Restylane versus Zyplast for the correction of na-solabial folds. Dermatol. Surg. 29: 588, 2003.

12. Apikian, M., and Goodman, G. Intralesional 5-fluorouracil in thetreatment of keloid scars. Australas. J. Dermatol. 45: 140, 2004.

13. Vleggaar, D. Facial volumetric correction with injectablepoly-L-lactic acid. Dermatol. Surg. 31: 1511, 2005.

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