Hyaluronic Acid Fillers - clinicachociai.com.br · Hyaluronic acid Soft tissue fillers Juvederm...

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Hyaluronic Acid Fillers Science and Clinical Uses Karol A. Gutowski, MD* INTRODUCTION Facial aging may manifest as skin texture and color changes, formation of fine lines and deeper creases, more pronounced active wrinkles, and overall facial soft tissue decent. Decreased skin tone, fat loss, and underlying bony changes contribute to the loss of facial fullness. Each of these components of facial aging can be addressed by specific treatments such as medical grade skin care and resurfacing, neuromodulators, and soft tissue fillers. Although not a substitute for surgi- cal rejuvenation, nonsurgical options are more accepted by patients owing to convenience, lower initial cost, less downtime, and fears of “going under the knife.” In this environment, hyaluronic acid (HA) fillers have become in leading tool in not only maintaining a youthful facial appearance, but also for enhancing facial features in younger patients. HYALURONIC ACID FILLER COMPOSITION Although HA fillers may seem to be similar, they actually each have different physical properties that differentiate them, making proper product choice important when used for facial rejuvena- tion. Factors such as HA concentration, amount of cross-linking, particle size, extrusion force, and elastic modulus (G 0 ) influence product selec- tion and indications. Therefore, there is no univer- sal HA filler. Although there is some overlap in their clinical uses, they should not be considered inter- changeable in all situations. This section highlights of a more detailed anal- ysis of HA fillers by Kabik and colleagues. 1 HA is found in human tissue but the injectable products are obtained from animal or bacterial sources. The HA molecule itself is a glycosaminoglycan disac- charide composed of alternately repeating units of D-glucuronic acid and N-acetyl-D-glucosamine. At physiologic pH, HA binds water extensively, providing “fullness” in the tissue. HA may be modi- fied by chemical cross-linking between HA strands, which increases product firmness, mak- ing it more resistant to stress, and also making it more resistant to in vivo enzymatic degradation resulting in a longer duration of filler effect. Although each product has a listed HA filler concentration, there may be variation in the amount of soluble versus insoluble HA. Because the soluble HA is metabolized rapidly, it does not contribute to clinical effectiveness. Therefore, listed HA concentrations may not truly reflect product performance. Conflicts of Interest: None. Disclosures: The author is an instructor for Bellafill (Suneva Medical), a non-hyaluronic based fillers mentioned in this article. Division of Plastic Surgery, University of Illinois, Chicago, IL 60611, USA * 820 South Wood Street, Suite 515 CSN, Chicago, IL 60612-7316. E-mail address: [email protected] KEYWORDS Hyaluronic acid Soft tissue fillers Juvederm Restylane Voluma Belotero KEY POINTS Hyaluronic acid (HA) injections are an integral part of facial aesthetics. HA products are similar but not interchangeable. Individual patient assessment and an understanding of facial aging is necessary for optimal results with HA injections. Clin Plastic Surg 43 (2016) 489–496 http://dx.doi.org/10.1016/j.cps.2016.03.016 0094-1298/16/$ – see front matter Ó 2016 Elsevier Inc. All rights reserved. plasticsurgery.theclinics.com

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Hyaluronic Acid Fil lersScience and Clinical Uses

Karol A. Gutowski, MD*

KEYWORDS

� Hyaluronic acid � Soft tissue fillers � Juvederm � Restylane � Voluma � Belotero

KEY POINTS

� Hyaluronic acid (HA) injections are an integral part of facial aesthetics.

� HA products are similar but not interchangeable.

� Individual patient assessment and an understanding of facial aging is necessary for optimal resultswith HA injections.

INTRODUCTION

Facial aging may manifest as skin texture andcolor changes, formation of fine lines and deepercreases, more pronounced active wrinkles, andoverall facial soft tissue decent. Decreased skintone, fat loss, and underlying bony changescontribute to the lossof facial fullness.Eachof thesecomponents of facial aging can be addressed byspecific treatments such as medical grade skincare and resurfacing, neuromodulators, andsoft tissue fillers. Although not a substitute for surgi-cal rejuvenation, nonsurgical options are moreaccepted by patients owing to convenience, lowerinitial cost, lessdowntime, and fearsof “goingunderthe knife.” In this environment, hyaluronic acid (HA)fillers have become in leading tool in not onlymaintaining a youthful facial appearance, but alsofor enhancing facial features in younger patients.

om

HYALURONIC ACID FILLER COMPOSITION

Although HA fillers may seem to be similar, theyactually each have different physical propertiesthat differentiate them, making proper productchoice important when used for facial rejuvena-tion. Factors such as HA concentration, amount

Conflicts of Interest: None.Disclosures: The author is an instructor for Bellafill (Sunevin this article.Division of Plastic Surgery, University of Illinois, Chicago,* 820 South Wood Street, Suite 515 CSN, Chicago, IL 60E-mail address: [email protected]

Clin Plastic Surg 43 (2016) 489–496http://dx.doi.org/10.1016/j.cps.2016.03.0160094-1298/16/$ – see front matter � 2016 Elsevier Inc. All

of cross-linking, particle size, extrusion force,and elastic modulus (G0) influence product selec-tion and indications. Therefore, there is no univer-sal HA filler. Although there is some overlap in theirclinical uses, they should not be considered inter-changeable in all situations.

This section highlights of a more detailed anal-ysis of HA fillers by Kabik and colleagues.1 HA isfound in human tissue but the injectable productsare obtained from animal or bacterial sources. TheHA molecule itself is a glycosaminoglycan disac-charide composed of alternately repeating unitsof D-glucuronic acid and N-acetyl-D-glucosamine.At physiologic pH, HA binds water extensively,providing “fullness” in the tissue. HAmay be modi-fied by chemical cross-linking between HAstrands, which increases product firmness, mak-ing it more resistant to stress, and also making itmore resistant to in vivo enzymatic degradationresulting in a longer duration of filler effect.

Although each product has a listed HA fillerconcentration, there may be variation in theamount of soluble versus insoluble HA. Becausethe soluble HA is metabolized rapidly, it does notcontribute to clinical effectiveness. Therefore,listed HA concentrations may not truly reflectproduct performance.

a Medical), a non-hyaluronic based fillers mentioned

IL 60611, USA612-7316.

rights reserved. plasticsurgery.th

eclinics.c

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The rheology of HA fillers is complex and labora-tory measurement differences may not translate toclinical differences. However, a products’ G0 maybe used to describe its firmness or ability to “lift”tissue. A high G0 product will require more appliedstress to deform it, whereas a low G0 product willdeform with little applied stress.In clinical terms, lowG0 HA products may be bet-

ter for fine lines and wrinkles and where firmness isnot desired, for example in the lips. High G0 prod-ucts may be better suited for deeper tissue eleva-tion such as moderate to severe nasolabial foldsand malar enhancement. Reported G0 measure-ments in Pascal units are listed in ascending order2:

Belotero Balance 128

Juvederm Ultra XC 207

Juvederm Ultra Plus XC 263

Voluma 398

Restylane-L 864

Restylane Lift-L 977

Finally, because HAs bind water, they may resultin tissue swelling after injection. This is partiallydependent on HA molecule modifications andthe amount of cross-linking.

PATIENT ASSESSMENT

Proper patient assessment includes not only thearea of their present concern, but an overall facialassessment and plans for future treatments. Inmiddle-aged and older patients, HAs typically arecombined with neuromodulators and medicalgrade skin treatments to achieve proper facialrejuvenation. Despite patient hopes, not all facialaging can be improved with fillers. A discussionof why more invasive treatments are appropriatemay be needed. Likewise, expectations that 1 or2 syringes of a product will give dramatic resultswill also need to be addressed. Lip enhancementsmay only need 1 or 2 mL of an HA, but moderatefacial aging may require 1 to 2 mL in each temple,malar region, nasolabial fold, and perioral area.Eight to 10 mL of HA (or more) may be used insome patients to achieve a “liquid facelift.” Ifhigh filler volumes are being considered, otherlonger acting products such as L-poly-lactic acid(Sculptra) and polymethyl methacrylate (Bellafill)should be discussed. Calcium hydroxylapatite(Radiesse) is another option for deeper injectionsto achieve tissue elevation, such as in the malaror temple regions.A written informed consent should be obtained

before the first injection session. Standard photodocumentation of the area being treated and the

entire face should be done before any treatment.Because many of the changes from filler injectionsare subtle, consistent before and after images areimportant in measuring outcomes and educatingpatients.

ETHNIC AND GENDER CONSIDERATIONS

Not all ethnic groups have similar needs and thisshould be taken into account. For example,whereas Caucasian patients may seek injectionsto address age-related changes, Asian patientsmay be younger and be seeking changes in facialshape. The “T zone” (forehead, nose, cheeks, andchin) can be projected in such cases to reshapethe face.3 Ethnic groups with darker skin types,such as African Americans,4 may have fewer finelines and wrinkles and will focus more on volumeloss. Latino patients may have unique cultural con-siderations that can influence treatment.5 Men aremore likely to focus on regaining stronger malefeatures, such as in the chin, and also present fornasolabial fold and tear trough correction.6

INJECTION PREPARATION AND TECHNIQUE

Depending on the injection site and size of needleused, analgesic modalities include topical anes-thetics, ice packs, distraction techniques, localanesthetic injections, and nerve blocks. SomeHA products are available with lidocaine mixed inthe syringe, which decreases injection discomfort.The injection site should be cleaned in a wide

area with appropriate skin disinfectant. Dryiodine-based solutions can be wiped off with analcohol pad to allow assessment of skin color forsigns of blanching or intravascular injection. Tech-nique should be as aseptic as possible becauselate infections and biofilm formation can occur.For intradermal injections, short 29-G needles

work well. When using amore viscous HA product,30-G and 31-G needles can be used. For subder-mal injections, longer 27-G or 29-G needles areuseful. More recently, disposable blunt-tipped in-jection cannulas have been favored for subdermaland deeper injections because they may causeless bruising and are less likely to result in an intra-vascular injection.Specific injection technique depends on the in-

jection site, tissue plane, and clinical problem be-ing treated. Small bolus injections (0.05–0.1 mL)are appropriate for deep and supraperiosteal in-jections such as for malar elevation or filling inthe prejowl sulcus. Fine lines and wrinkles arebest treated with smaller volume linear injectionsof product into the dermis, parallel to the line beinginjected. Elevation of more superficial tissue, such

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as the lip corners or cheek hollows, can be donewith a cross-hatching technique of linear perpen-dicular injections. A fanning technique from a sin-gle injection point is useful to highlight or elevatean area. Low injection pressure and small volumeinjections will prevent overcorrection. If tissueswelling makes it difficult to assess the results,the injection can be stopped and repeated in 1 to2 weeks.

After the injection, the area should be palpatedto check for any lumps or unevenness, whichcan me massaged until smooth. Cool gel packsare useful immediately after injection to reduceswelling and bruising. Patients can resume regularactivities, but should be instructed not to massageor otherwise manipulate the treatment area.

Follow-up evaluation is suggested at 2 weeks todetermine if additional injections are needed. If anynodules are seen, they may still be able to bemanipulated and made smooth. If an area is obvi-ously overcorrected, or the patient is not satisfiedwith the results, HA fillers (unlike non-HA fillers)can be reversed with hyaluronidase. A human re-combinant hyaluronidase (Hylenex, HalozymeTherapeutics) is preferable to animal derived hyal-uronidase. Small amounts of HA may be dissolvedwith 15 to 30 units of hyaluronidase, althoughmoremay be needed (50–100 units) for larger amountsor in products with high HA cross-linking.

HA products are not intended to be stored foruse after opening the syringe. However, if used un-der sterile conditions, they may be stored for atleast 2 months without any bacterial growth.7

PRODUCT COMPOSITION AND AVAILABLEPRODUCTS

Worldwide, there are many HA injectable productswith indications for both facial aesthetic and otheruses. The products mentioned below will belimited only to HA fillers approved by the USFood and Drug Administration (FDA) for facial aes-thetics as of January 2016.

Juvederm Ultra, Juvederm Ultra Plus, andVoluma

The Juvederm and Voluma groups of products aremade by Allergan Inc. (Irvine, CA).

Juvederm Ultra has the lowest G0 (207 Pa) andJuvederm Ultra Plus has a slightly higher G0

(263 Pa). Both are made with proprietary Hyla-cross technology, which allows high water uptakeby the HA gel after injection. This may cause more“swelling” and the appearance of overcorrection.Voluma has the highest G0 in the Allergan HA prod-uct group (398 Pa) and is approved for malaraugmentation. Volift (G0 340 Pa) and Volbella (G0

271) are similar to Voluma, but are not currentlyFDA approved. These last 3 products use proprie-tary Vycross technology and absorb less waterthan Juvederm Ultra or Juvederm Ultra Plus.8

Restylane, Restylane Silk, and Restylane Lyft

The Restylane group of products is made by Gal-derma (Uppsala, Sweden) and each product alsohas specific properties. Restylane Silk is a low G0

small particle HA that is FDA approved for lipaugmentation and treatment of perioral lines. It isalso useful for fine lines in other areas, teartroughs, and in places where less filler “lift” isneeded.9 Restylane has a high G0 (864 Pa),whereas Restylane Lyft (formerly called Perlane)has the highest G0 (977 Pa) of the FDA-approvedHA products.

Belotero Balance

Belotero Balance is approved for mid to deepdermal injections for correction of moderate to se-vere facial wrinkles and folds and is considered asuperficial to midlevel volumizer. It has a low G0

(128 Pa), which makes it appropriate for treatingfine lines and wrinkles.10 Other Belotero productsnot yet FDA approved include Belotero Volume(a deep volumizer), Belotero Intense (a midlevelvolumizer), and Belotero Soft (a superficialvolumizer).

Unlike Voluma, Juvederm, and Retylane prod-ucts, Belotero Balance available in the UnitedStates does not contain lidocaine for injectioncomfort. However, it may be mixed with 0.15 mLof 1% lidocaine per 1 mL of product for a morecomfortable injection. The formulation of Beloteromay produce less Tyndall effect (a visible bluishdiscoloration of the HA when injected in the super-ficial dermis), making it useful for fine lines, areasof thin skin, and superficial injections.

DURATION OF EFFECT

Studies to determine the duration of clinicalimprovement after HA injections frequently usestandardized assessment scales with patient andphysician reported scores. A 1- or 2-pointimprovement on a 5-point scale is consideredeffective. These same studies may allow for touchup injections and corrections during the studyphase. For Juvederm products, Restylane prod-ucts, and Belotero Balance, duration is frequentlyat least 6 months, with some patients seeing re-sults up to 1 year. Voluma has a reported durationof 1 to 2 years.

Clinical experience shows that there is widervariability in the time needed before retreatment.

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This may be based on injection technique, injec-tion site, and individual patient HA metabolism orjust owing to initial treatment undercorrection,which becomes evident after swelling resolves.Therefore, patients should be advised that, insome cases, the duration of results may be shorterthan expected and retreatment, or a differentproduct, may be needed.

FACIAL TREATMENT STRATEGIES

Each patient will have unique goals and expecta-tions as well as underlying anatomic variabilityand stages of aging that need to be consideredwhen planning treatment. A full facial analysis bythe injector, combined with patient educationand agreement with the treatment plan, will helpto achieve a favorable outcome. In many cases,a neuromodulator may be used to prevent linesand wrinkles that form with movement (activelines) and HAs can be used for lines that are pre-sent at rest (static lines).11 The following facial re-gions can be improved with HA fillers; most ofthese are not FDA-approved indications andshould be considered “off-label” uses.

Forehead Lines

Mild to moderate static lines in the foreheadshould first be addressed with a neuromodulatorinjection to the frontalis muscle to treat the under-lying cause. In most cases, these line will improveafter a few months. If needed, deep dermal low tomoderate G0 HA injections can be used to fill in anyresidual static lines.

Temples

Temple hollowness is a sign of aging usually notnoticed by patients and needs to be brought totheir attention. Once addressed, the results canbe dramatic.12 Deep injection in the supraperios-teal plane, starting from the depression superiorlateral to the orbital rim and tapering to the hairlinewith a high G0 HA can lift and revolumize thehollowness.

Superior Orbital Rim

Although not a common injection area, the supe-rior orbital rim can be enhanced for a more mascu-line appearance, or to provide the appearance ofslight brow elevation by using a high G0 HA in thesubdermal or supraperiosteal plane.

Glabella

Vertical glabellar lines, sometime called the “11’s”are a common initial complaint of patients seekingfacial enhancement. As with forehead lines, the

first step is to treat the underlying corrugator mus-cle contractions with a neuromodulator. Then, ifneed after a few months, a low to moderate G0

HA intradermal or subdermal injection can beused to fill in residual static lines. Care should betaken because this area may be more prone tofiller-associated skin necrosis.

Crow’s Feet

As in the forehead and glabella, active lines arefirst treated with neuromodulator injections to theorbicularis oculi muscle. Although rarely needed,low to moderate G0 HA intradermal injections canbe used for static lines.

Upper Eyelid

Upper orbital hollowness, including sequelae of fatpad removal, has been improved with HA injec-tions.13 This should be done very carefully andonly by experienced injectors who are familiarwith the anatomy in this region.

Tear Troughs and Lower Eyelid Bags

For patients with tear troughs and mild to moder-ate lower orbital fat pads, a moderate G0 HA injec-tion in the supraperiosteal plane can fill in thetrough (Fig. 1) and make the lower lid fullnessless noticeable.14 This area is less forgiving thanother facial regions, because the thin skin maymake the HA product more visible and palpable.Therefore, undercorrection followed with a touchup 2 weeks later if needed is a reasonableapproach. Prolonged swelling and late edemaare also common and HA products have lastedup to 5 years in this facial zone.15 In some moder-ate cases, and most severe cases of lower orbitalfullness, a blepharoplasty is more appropriate.

Earlobes

Deflated earlobes and creases can be improvedwith small injections of HA fillers.

Malar

High cheek bones are frequently desired byyounger women, and loss of malar volume is com-mon in older women and men, as well as in pa-tients with malar hypoplasia. High G0 HA fillerscan be injected in the supraperiosteal plane ofthe malar prominence and low to moderate G0

HA can be used more superficially for refinedenhancement (Fig. 2). In some cases, adding vol-ume to the malar area can soften nasolabial folds,but overfilling should be avoided to prevent an un-natural appearance when smiling and so as not tomake cheek hollowness more obvious.

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Fig. 1. Before and after low G0 hyaluronic acid injection for tear trough improvement (Juvederm Ultra, 0.5 mL perside).

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Submalar and Cheek Hollowness

Cheek hollowness in the submalar area iscommonly associated with advanced aging,weight loss, or in very physically active patientswith a low body mass index. Revolumization withsubcutaneous HA fillers can restore a more youth-ful appearance and improve cheek wrinkles owingto facial deflation (Fig. 3).

Nose

Minor nasal imperfections and deformities can beimproved with HA fillers.16 Small dorsal humpscan be “reduced” by adding supraperiosteal vol-ume above and below the hump to crease astraight dorsum. Likewise, some dorsal deviationscan be camouflaged with fine supraperiosteal in-jections on the concave side. Minor tip changescan bemade with careful subcutaneous injections.Higher G0 HA fillers may be better to provide morestructural support as the nasal skin tends to betight and can deform low G0 products.

Lips

Perhaps owing to popular cultural influences, lipenhancement in younger patients and correctionof lip volume loss in older patients is frequentlyrequested. Low and moderate G0 HA products

Fig. 2. Before and after high G0 hyaluronic acid injection

are used commonly (Fig. 4). Proper assessmentand aesthetic judgement are critical because over-done lips are easy to produce. In older patientswith a thin lip and long vertical upper lip, a surgicallip lift may be a better option. During and after HAinjection, swelling is common and it is wise to limitinjection volumes to 1 mL, then reevaluate andretreat in 1 to 2 weeks.

Peri Oral, Lip Lines, and Downturned LipCorners

Vertical upper and lower lip lines should first bemanaged with low-dose neuromodulator injec-tions to control the underlying orbicularis oris mus-cle contributions. Fine lines can be injected withlow G0 prime intradermal injections17 and thedownturned lip corners may need higher G0 HAsfor improvement. If the depressor anguli oris mus-cle is contributing to the downturned lip, a neuro-modulator injection may be added.

Nasolabial Folds

Most early indications and studies were done onHA injections to improve nasolabial folds. More su-perficial lines respond well to intradermal injec-tions of low to moderate G0 products. Deeperfolds respond better to higher G0 HAs in the subcu-taneous tissue (Fig. 5).

for malar elevation (Restylane Lyft, 1.5 mL per side).

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Fig. 3. Before and after moderate G0 hyaluronic acid cheek revolumization (Voluma, 1 mL per side).

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Marionette Lines

Similar to nasolabial folds, marionette linesrespond well to HA injections (Fig. 6). In the lowerface, conservative amounts should be usedbecause too much volume may make the lowerface too full and unattractive.

Jaw Line, Prejowl Sulcus, and Chin

The appearance of mild jowls can be minimized byfilling in the sulcus between the jowl and chin witha supraperiosteal high G0 HA injection (Fig 7).Overcorrection or attempts to improve a largerjowl may make the jaw look to large and “heavy.”Posterior to the jowl, and at the mandibular angle,injections can refine the jawline or give a moremasculine jaw appearance. Likewise, modestchin augmentation can be achieved withinjections.

SAFETY OF HYALURONIC ACID FILLERS

Although generally considered safe when used byappropriately trained injectors, there are associ-ated risks and potentially serious complications.Mild swelling and bruising can be expected; rarely,

Fig. 4. Before and after low G0 hyaluronic acid lip enhanceand lower lip).

persistent swelling may occur, especially in thelower orbital area. Palpable lumps, nodules, andgranulomas are not common when proper injec-tion technique is used. More serious complica-tions usually involve an intravascular injection,which can cause significant tissue necrosis andblindness. A recent FDA warning calls attentionto these events.18

All those who inject fillers should know thespecific anatomy of the area they are treating soas to minimize the risk of intravascular injection.Suggested techniques for safe injections include:

� Avoiding injections in an area with large bloodvessels;

� Use of a blunt cannula instead of a sharpneedle (where appropriate);

� Pulling back the syringe plunger beforeinjection; and

� Slow injection with observation for tissueblanching.

In the event of an intraarterial injection, whichtypically presents with immediate skin blanchingand occasionally pain, immediate treatment ismandatory. Skin and soft tissue necrosis mayresult even if preventative actions are taken.

ment (Juvederm Ultra Plus, 1 mL split between upper

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Fig. 5. Before and after high G0 hyaluronic acid injection for nasolabial fold improvement (Restylane, 1 mL perside).

Fig. 6. Before and after moderate G0 hyaluronic acid marionette line correction (Voluma, 0.5 mL per side).

Fig. 7. Before and after high G0 hyaluronic acid injection in the prejowl sulcus (Restylane, 0.4 mL per side).

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Likewise, any vision changes during or immedi-ately after an injection need to be considered asan intravascular injection and treated as an emer-gency. Intravenous injections may present hoursor days later with blue or purple skin discolorationand tissue slough.As soon as an intravascular injection is

recognized, a preplanned protocol should beactivated19:

1. Stop the injection.2. Inject hyaluronidase under the dermis of the

affected area; 100 units or more may berequired.

3. Administer 1 aspirin orally.4. Massage the area to break up any residual

HA.5. Apply warm compress.6. Consider sildenafil (Viagra) for vasodilation.7. Consider applying nitropaste to affected area.8. Reassess every 1 hour and inject more

hyaluronidase if needed.9. Consider hyperbaric oxygen referral if there is

a risk of tissue loss.10. Antibiotics or steroids are not indicated.

If a vision change occurs, an ophthalmologistshould be notified immediately and a retrobulbarhyaluronidase injection should be done with1 hour.

SUMMARY

HA fillers have expanded treatment option forfacial aging and are often combined with othernonsurgical modalities such as neuromodulatorsand skin treatments. They are accepted by thepublic and should be offered by all plasticsurgeons who perform facial rejuvenation.

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