Radiesse - Advanced Techniques and Applications for a Unique and Versatile Implant

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Radiesse, first launched in the United Statesas Radiance, is a long-lasting syntheticinjectable implant. Although first approved

for its reconstructive and surgical applications, ithas gained popularity with facial rejuvenationbecause of its elasticity, longevity, excellent bio-compatibility, and low incidence of allergenic-ity.1 As the first volumizing filler, it was originallyapproved for treatment of HIV-related facial lipo-dystrophy.2 Much of our understanding and earlyknowledge of nonsurgical reshaping and lifting was learned in this patient cohort.

The original Food and Drug Administration(FDA) studies for aesthetic approval looked atcorrection of the nasolabial fold by direct injec-tion of Radiesse and graded improvement basedon a global standardized aesthetic scale.3,4 It wasonly in subsequent years that studies of the agingface began to unveil the remarkable and complexchanges of the bone, fat compartments and otheranatomic markers. The advent of newly avail-able volumizing agents supplanted fat injection,allowed for a more nuanced approach to facialrejuvenation that helped move us away from onlyfilling folds or cutting and lifting soft tissue andskin for natural appearing and long-lasting resultsthat are both effective for full face rejuvenation.5–7

Disclosure: Dr. Eviatar is a physician trainer, con- sultant, lecturer, and member of the advisory board for Allergan, Merz, Galderma, ThermiAesthetics, andKythera. Dr. Lo and Dr. Kirszrot have no financial in- terest to declare in relation to the content of this article.Copyright © 2015 by the American Society of Plastic Surgeons

DOI: 10.1097/PRS.0000000000001825

Joseph Eviatar, MD, FACSChristopher Lo, MD James Kirszrot, MD

New York, N.Y.

Background: Radiesse is a well-tolerated facial injectable with unique fillingand lifting capabilities. Although initially approved for facial volumizing inHIV-related lipodystrophy patients, it quickly gained wide acceptance foraesthetic facial rejuvenation. In the USA, the Food and Drug Administrationhas approved several new indications for its use. This synopsis presents theexperience and injection techniques currently favored by the primary authorafter many years of use in thousands of patients.Methods: The anecdotal practice of an experienced injector is presentedalong with the current Food and Drug Administration–approved standards ofRadiesse injection.Results: Radiesse has many on- and off-label applications that can be thought-

fully incorporated into clinical practice. Its unique chemical compositionallows for immediate lifting and filling with long-term collagen stimulation.The product can be reconstituted to increase its versatility and minimize adverse events. Injections can be performed in the supraperiosteal space andthe subcutaneous layer and are best administered in small, calculated doses toprevent nodules or vascular occlusion. Various techniques for Radiesse injec-tion in specific areas are discussed in detail.Conclusions: Radiesse is a versatile injectable implant and a valuable tool forshort- and long-term cosmetic and reconstructive treatments. In addition to various off-label uses, this injectable is often used in conjunction with bo-tox, other injectables, collagen stimulators and tightening devices. A custom-ized reconstitution of product increases its versatility for natural appearingand long lasting results that are both economical and effective for full facial

rejuvenation. (Plast. Reconstr. Surg. 136: 164S, 2015.)

From the Department of Aesthetic Medicine and Surgery,Chelsea Eye and Cosmetic Surgery Associates; Departmentof Ophthalmology, New York University; and Department ofOphthalmic Plastic and Reconstructive Surgery, Metropoli- tan Hospital Center.Received for publication April 30, 2015; accepted August5, 2015.

Radiesse: Advanced Techniques and Applications for a Unique and Versatile Implant

FILLERS




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

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RADIESSERadiesse is an admixture of calcium hydroxyl-

apatite microspheres suspended in a gel structurethat is composed of sterile water, glycerin, and car-boxymethylcellulose. This unique chemical com-

position initially allows for direct filling and liftingdue to its cohesive, space occupying properties.The product is considered a semipermanent toolin facial rejuvenation because as the carboxymeth- ylcellulose is resorbed, it creates a foreign bodyreaction that stimulates elastin and type 1 collagenreplacement in the injected soft tissue to maintainlong-term correction.8–11 Although the gel carrieris absorbed during the first few weeks, the subse-quent secondary biostimulatory tissue swelling cre-ates a net neutral filling effect.

Radiesse’s characteristically high G-prime, a

measure of elasticity, makes it suitable for lifting softtissue and contouring.12 Its high density, viscosity,and cohesiveness make it an ideal agent for deepsupraperiosteal injections along the malar emi-nence and zygomatic arch to replenish bone resorp-tion in an aged face. These properties also make itan excellent filler to replenish fat loss in the deepfat compartments of the midface or submental area.These same qualities require that it be used with cau-tion and in small amounts, generally with retrogradeinjection technique of 0.1-cc aliquots, when injectedinto deep dermis or the subcutaneous plane, in

patients with thin skin, or in locations such as thetemples and periorbital region where the benefits ofcollagen stimulation and activation of fibroblasts arefelt to outweigh the possibility of a nodule.

Unlike with hyaluronic acid fillers, which can bequickly dissolved with hyaluronidase when neededto treat a nodule, overcorrection, or other adverseevent, there is no “reversing agent” for Radiesse.Smaller nodules that are generally nonvisiblerespond well to conservative treatment with digitalmassage. Large nodules, which are rare in expe-rienced hands, can be treated by breaking up the

overaccumulation of product with an injection ofnormal saline and lidocaine. Up to 0.3 cc of 5-fluo-rouracil can be mixed with an equal amount of lido-caine or lidocaine with epinephrine and injecteddirectly into the nodule to reduce fibroblastic activ-ity in these sites while breaking up the nodule. Thistechnique mechanically disrupts the nodule andprevents further volume creation by inhibiting itsbiostimulatory properties. Injection of steroid intothese noninflammatory nodules has been largelyabandoned due to its potential for permanent skinthinning and depigmentation, which may result in

a potentially more visible contour problem for the

patient. Finally, the most rare but feared adverseevent with injectable fillers is arterial vascularocclusion, leading to tissue necrosis or blindness. Although exceedingly rare with all products, thiscomplication becomes a larger treatment chal-lenge without the ability to immediately dissolve theimplanted product. For occlusion, the same proto-cols are advised as with other agents (including theuse of hyaluronidase) to release the occlusion.

Another important consideration in the “real world” is the cost of the treatment. Radiesse is anideal agent for pan-facial volumization becauseit is available in a large 1.5-cc syringe with a basecost that is competitive with products distributed insmaller volumes per syringe. When one looks at theideal full correction achieved in FDA trials, multiplesyringes are required for panfacial treatment com-pared with the amount required in nasolabial foldcorrection. There are various ways to address thisissue in patients who are financial unable to achievethe “full” or ideal correction. A provider couldchoose to treat a single area to full correction to theneglect of other areas, which would result in an oddor unbalanced appearance. Alternatively, the provider could undertreat the entire face, which wouldresult in a dissatisfied patient. Radiesse often allowsfor more complete facial volumization for patients whom caost is an issue. In addition, by adding 0.4,0.6 or 0.8 cc of lidocaine to customize the Radiessesyringes (to the needs of the patient), they benefitfrom the collaborative efforts of immediate spaceoccupying correction with long-term collagen stim-ulatory properties of the product.

ALTERNATE VOLUMIZERSIn addition to Radiesse, we now have other

volumizing fillers, each with distinct properties,to formulate an optimal treatment plan for eachpatient. Properties that differentiate these productsand their usage in the clinical setting include par-ticle size and shape, cohesiveness and the degree of

cross-linking, G-prime, flow characteristics, varyingthickness, and the ability to lift rather than spread.13

Injectable grade silicone, approved in theUnited States for intraocular injection during reti-nal detachment repair, was historically used off-label to create volume in the area of injection bya similar biostimulatory process. Nonpermanenthyaluronic acid fillers are the most widely usedand marketed for facial implantation. Finally,L-polylactic acid (Sculptra) is a unique injectablethat also has a biostimulatory mode of action. Thistreatment is FDA approved for both aesthetic treat-

ments and HIV-associated facial lipodystrophy as




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Plastic and Reconstructive Surgery • November Supplement 2015

is Radiesse and both companies offer compassion-ate-use pricing for eligible patients.

PREPARATIONHistorically, when “dermal fillers” such as col-

lagen and then Restylane were injected into thedermis, topical anesthetic was applied prior toinjection. Nerve blocks were used for especiallysensitive areas, such as the lips. When injectingRadiesse during the HIV lipodystrophy trial, itbecame obvious that the injections couldn’t anes-thetize the entire face, were, uncomfortable for thepatient, and there was also lasting discomfort formore than 30 minutes post treatment. Despite dis-comfort, these young disfigured patients were verymotivated to correct what exposed their illness.

With advances in knowledge of facial aging and

the use of products for off-label aesthetic corrections,experienced injectors have found that supraperios-teal injections created a more physiologic correctionthat resulted in a more natural appearance. Subse-quently, Lidocaine was also added to the product via a sterile connector for more comfortable injec-tions without the need for nerve blocks. Subsequentstudies established that the slightly reduced viscos-ity allowed for use of a 27-gauge 1¼-inch needle(rather than a 25-gauge needle) without diminish-ing the aesthetic result or longevity of the product. Although this connector is now “on-label” and pro-

vided with the product, some advanced injectors willadd more lidocaine or normal saline to lower theG-prime when needed to allow the product to beused in areas such as the temples, the hands, peri-orbital area, and dermis. With this diluted formula-tion, small 0.1-cc aliquots can now be injected in alayered fashion subdermally or in the deep dermisto add volume by skin thickening, improving tone,texture, and reducing rhytids.

Both needles and cannulas can be used in theinjection of Radiesse. Although there are no con-trolled studies comparing needles and cannulas,

one may claim that the blunt tip of cannulas preventstrauma to the tissue. However, if an artery is entered,the cannula with a larger diameter potentially couldinject larger volumes of product with more devas-tating complications. Needles are a popular choicebecause of the ease of treating various tissue com-partments through the same puncture site.

TECHNIQUEIn-depth knowledge regarding facial anat-

omy is imperative to safely achieving an optimal

aesthetic outcome. Facial asymmetry at varying

degrees is the norm and needs to be recognized,documented, and communicated with the patientas is facial balance and harmony. Digital photogra-phy and assessment of facial photographs with thepatient should be performed during each sessionto highlight subtle changes and clarify the goals of

each treatment session. Symmetry can be achievedbetween the 2 sides of the face by injecting varyingamounts in different locations and the patients’gender, ethnicity, age and degree of skin laxityand sun damage all play a role in setting expecta-tions and establishing a long term treatment plan.

Injections in the subdermal or supraperios-teal plane with volumes kept below 0.2 cc underlow pressure and always injected in a retrogradefashion significantly minimizes any risk of arterialocclusion should an artery be pierced. The infra-orbital foramen is palpated and identified prior

to tear trough injections. If a patient complains ofincreased or radiating pain, the needle should beimmediately repositioned.

There have been studies looking at the tech-nique of midface, chin, and cheek volumizationthrough an intraoral approach. Although thistechnique has the advantage of less bruising dueto implant placement directly over the perios-teum instead of through muscle, the theoreticalincreased risk of late onset biofilm infection andthe inability to fully sterilize the injection points inthe mucosa have greatly reduced this, otherwise

well accepted, technique by many injectors. Pre-treatment with hydrogen peroxide is one option when using this technique.

Advanced injectors treat structural deficits with deep volumetric correction in small aliquotsusing a retrograde fanning or linear threadingtechnique. This is followed by a customized lowerG-prime product injected with the same 27-gaugeneedle in the subdermal plane or in areas such astemples where more spread and less lift is desired.

Lidocaine 2% with epinephrine 1:100,000 canbe used during product reconstitution if an injec-

tor’s technique involves injecting segmentally inthe face from side-to-side and returning to the previous area of injection for refinement. Studies thatlook at the effectiveness of adding lidocaine withepinephrine to fillers with varying techniques arestill lacking. However, anecdotally, less bruisingand discomfort are noted in areas well anesthe-tized by previous product injection as this author'stechnique involves partial treatment of one side ofthe face and then returning to refine the correc-tion after treating the contralateral face.

A combination of injectable products can be

used in a staged fashion to evaluate the patients’





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physical and mental response to treatment andminimize soft-tissue swelling and the short-termappearance of overcorrection. Gradual improve-ments over several treatment sessions are believedto result in better tissue integration, collagen stim-ulation, and longer-lasting results.

Patients are advised that although the producthas been shown to last histologically in the body for years, this duration varies based on the targeted loca-tion of injections.14 Furthermore, the longevity of theproduct is different from the duration of correction.In managing the patient’s expectation, treatmentevery 6–12 months of a small volume is generallyrecommended, depending on the patients’ goals,metabolism of the product, and lifestyle.

What follows is a brief outline of general prin-ciples of Radiesse use in commonly injected facialregions.

PERIORBITAL REJUVENATIONLoss of volume in the periorbital region due

to a combination of bone remodeling, deep fatpad, and subcutaneous fat loss can result in theappearance of “bags” and “dark circles” due toexposed contours of underlying structures. Theuse of injectable fillers in this region can pro-duce natural and long-lasting results in patients where the underlying pathophysiology lends itselfto volumetric correction.15 Experienced injectors

often use Radiesse in this area in a more dilutereconstitution. Due to the complex anatomy ofthe region, careful slow injections in the deepsupraperiosteal plane are advised. Inexperiencedinjectors are recommended to choose more for-giving reversible hyaluronic acid–based productsin this region.

Temples/Lateral Brow

As with many other aesthetic procedures, thereare different approaches with the goal of achiev-ing similar results. A layered approach with deep

supraperiosteal injections can be useful for cor-recting large volumetric deficiencies, while subtlercontour and skin changes can be targeted withinjections in the subcutaneous plane. Neurotoxinis often used during the same or in prior treat-ment sessions to contour the brows. Hyaluronicacid products can be used in a more superficialplane or other segments of the face, such as sub-galeal injections, to improve the forehead contourand support the brows when there is bony contourdeficiency. Radiesse can be injected with a thinnerreconstitution of 0.9 cc of 2% lidocaine with epi-

nephrine, up to and beyond the hair line to lift the

lateral brow and lateral canthus if descent is felt tobe secondary to volume loss and soft-tissue laxity.

Zygomatic Arch/Cheek

Age-related descent of the cheek associated

with aging or lipodystrophy can create a visibledefect at the lid and cheek junction as a promi-nent tear trough and accentuate the nasolabialfold. Radiesse injections can restore volume to

Fig. 1. A 55-year-old woman with periorbital volume loss and

shadowing from the resultant contour causing prominent skin

discoloration. Patient also has lower face soft-tissue and bony

loss and a hyperactive mentalis.

Fig. 2. After treatment, the patient had improved overall facial

symmetry and increased midface and lower face volumization 6

months after 2 treatments with 2 Radiesse syringes in each ses-

sion (6 cc), with emphasis placed on volumization of the perior-

bital region to reduce the appearance of “bags” and “dark circles.”

Each syringe was reconstituted with 0.9 cc of 2% lidocaine with

epinephrine 1:100,000. The patient also received Botox to the

chin. Further possible nonsurgical treatments include Botox or

filler to the superolateral aspect of the brow to create a lateral

brow lift and improve facial contour.




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this region, minimizing tear trough deformity and

a deep nasolabial fold. Volumetric or structuralcontouring is performed first to lift and shapethe area of correction. Improvement of nasolabialfolds or marionette lines is usually left for the endof the session to refine the final appearance withan injection in the deep dermal or subdermalplane. Care is taken to identify and avoid the neu-romuscular bundles hen product is injected in aretrograde fashion (Figs. 1 and 2).

Lower Face Rejuvenation

After treatment of the upper face, attentionshould then be directed at the lower facial struc-tures and jowling. Radiesse is currently the onlyFDA-approved filler with a jawline indication.Radiesse is a preferred injection for the jawlinebecause it can define and correct volume throughperiosteal and subcutaneous injections. Revolu-mization of the chin can be accomplished in alayered fashion with deeper volume restoring injec-tions in the supraperiosteal plane using the slowretrograde linear threading technique with care toavoid the neurovascular structures in this sensitive

region. The parotid gland and vasculature preventdeep implantation in this area by most injectors.Depending on the patient’s skin quality and

amount of correction necessary, the product canbe customized with 0.3 cc or more for a full cor-rection. After volume of the chin is corrected, therest of the jaw line is defined in a subcutaneousfashion. Gender considerations and the under-lying facial architecture are essential for Jawlineimprovement. In general, women require smalleramounts of product in this region, whereas themale jaw aesthetically favors larger volume injec-

tions (Figs. 3 and 4).

Other Commonly Injected Areas

Although treatment of the nose, glabella,horizontal forehead lines, and crow’s-feet arecommonly performed with fillers, extra caution isadvised when using Radiesse in these areas due

to its high viscosity and the challenging nature oftreating adverse events, such as nodules or vascu-lar occlusion. Diluted small aliquots and meticu-lous, slow retrograde injection technique must beused for these areas if Radiesse is used in otherregions of the face. If these areas are targeted inisolation, a hyaluronic acid substitute would bethe preferred first-line injection.

Neck rejuvenation can be performed inselected patients with narrow, thin necks and skinlaxity with 1.5 cc of Radiesse reconstituted with2 cc of normal saline and 0.3 cc of 2% lidocainein a fanning technique. The effect can be aug-mented by soft-tissue tightening treatment suchas Ulthera or ThermiSmooth 250. Further stud-ies are needed to evaluate the synergistic effect ofcombination therapy and the dilution of Radiessebeyond the current FDA recommendation, whichlimits dilution to less than 2.5 cc of lidocaine ornormal saline.

Radiesse has been shown to be unpredictablefor lip filling or contouring and is consideredto be contraindicated for use in this region16,17

(Figs. 5 and 6).

Fig. 3. Pretreatment view of a 47-year-old woman with weak

architecture of the chin and jawline area that creates unbal-

anced facial proportions.

Fig. 4. After treatment, the patient had improved lower face

and chin contouring 1 month after injection of 5 Radiesse

syringes (7.5 cc), with each syringe reconstituted with 0.9 cc

of 2% lidocaine with epinephrine 1:100,000. Radiesse was first

administered to the supraperiosteal region and then to the sub-cutaneous tissue. Botox was also administered to the depressor

anguli oris and the mentalis. Future correction should be per-

formed in a staged fashion to improve the longevity of the jaw-

line volume.





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Hands

Although hand rejuvenation has just nowbeen approved with the standard FDA-reconsti-tuted product, many injectors have an extensiveexperience using a less viscous admixture withgood patient satisfaction and minimal adverseevents. An ideal candidate may include an indi- vidual with loss of volume in the subcutaneousdorsum of the hand with prominent veins andtendons. This author uses a 1.5 cc of Radiesse is

mixed with 1.0 cc of 2% lidocaine with epineph-erine. The skin on the dorsum of the hand ispinched for ease of injection into the immediatesubcutaneous plane. Injections are performedin a linear threading fashion of up to 0.4 cc withmassage to the site after each injection. Injectionsare strategically placed in the deepest troughsto smoothen the transitions between tendonsand veins. This author limits treatment to 1.5cc syringes per hand and prefers to repeat thetreatment 2-4 weeks later to achieve full correc-tion if needed. Intense pulsed light (IPL) or

V-beam (Vascular) laser are excellent adjunctivetreatment.

HIV-RELATED LIPODYSTROPHY Treatment of this condition is different from

aesthetic facial rejuvenation because these, often young, patients have significant volume loss with-out the bony, structural changes of their oldercounterparts. Less attention is needed to cor-rect deep volumetric changes attributed to boneremodeling and deep fat pad atrophy. Moreover,

there is often an intact dermal “envelope” within

which to fill. A less viscous reconstitution canbe used for the superficial subdermal injectionsrequired in the midface. A severely fat depletedpatient would be treated over 2 or more ses-sions to allow collagen stimulation to contrib-ute to a more natural appearing result. Just 6–9cc of total product is not unusual to sufficiently

achieve full correction in a patient with grade 4lipodystrophy over a 3- to 6-month period. Main-tenance with 1–2 additional vials is generally nec-essary at 3- to 6-month intervals to maintain thisfull correction.

POSTENUCLEATION/EVISCERATIONSOCKET SYNDROME

Postoperative volume insufficiency is a com-mon issue after enucleation or evisceration of aneye with intraoperative placement of an orbital

implant and subsequent fabrication of an ocu-lar prosthesis. This can lead to enophthalmos, adeep superior sulcus, blepharoptosis, and lowerlid laxity. Enlarging the prosthesis and altering itsshape can often mitigate some of these problems;however, the increased weight of the prosthesiscan lead to excess lower lid laxity, ectropion, andpoor overall fit of the prosthetic device. Surgi-cal options for augmentation of orbital volumeinclude implant exchange, autologous tissueplacement, or tissue expanders. Each of theseprocedures carries the potential risk of anesthesia

and operative complications.

Fig. 5. A 50-year-old woman presented for facial rejuvenation.

She had pan-facial volume loss with good underlying bone

structure and skin representing predominant soft-tissue loss.

Fig. 6. After treatment, the patient had improved periorbital,

midface, and lower face volume 1 month after injection with 2

Radiesse syringes (3 cc). Each syringe was reconstituted with 0.6

cc of 2% lidocaine with epinephrine 1:100,000. Additional futuretreatments could include Restylane injection to the upper lid

and nonsurgical brow lift with Radiesse or Botox.



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As a nonsurgical, off-label option for orbitalaugmentation, Radiesse has been used with goodresults and minimal adverse events and other fillersare being similarly used for such indications.18 Theproduct is mixed with 0.2 cc of 2% lidocaine, withor without epinephrine, and delivered via 27-gauge

needle in a bolus retrobulbar injection techniquealong the orbital floor in an extraconal, preperi-osteal position. It is critical to pass the needle pos-terior to the orbital implant before injection tocreate an anterior displacement of the implant.If needed, balancing injections can also be madealong the lateral and/or medial orbital walls, againin the extraconal preperiosteal position. Immedi-ate reduction in enophthalmos and sulcus defor-mity is usually seen, and the amount of injectedfiller can be titrated to reach the desired symmetry.

Complications of anophthalmic injection of

Radiesse may include hemorrhage, orbital pain/discomfort, and anterior migration of the calciumhydroxylapatite into the lower lid. Migration ofinjected product may be due to prior postsurgi-cal scarring leading to tracks for injected materialthrough anterior paths of less resistance. Eyelidmassage or nodule injection can often lead toresolution, although surgical removal of the dis-placed product also remains an option.

CONCLUSIONS

Radiesse is a useful and versatile tool for facialrejuvenation due to its high G-prime, robust fill-ing, and lifting capabilities. Although there arenow more and more FDA-approved applications,there remain are many effective off-label uses forRadiesse. The collagen-stimulating properties ofRadiesse allow for potential long-term benefitsthat could be coupled with other injectables andminimally invasive skin and soft-tissue tighteningdevices. Optimal treatment is often achieved byconsidering each product and device as a uniquetool to be used toward the creation of a desired

result. The combination of treatments with fill-ers, toxins, and devices is the norm, rather thansingle-product treatment for most patients. Fur-ther studies are required to truly determine thesynergistic value or potential negative effects ofusing these products in combination with tis-sue tightening devices (i.e. Ulthera, Thermage,ThermiTight, etc).

Joseph Eviatar, MD, FACS Chelsea Eye & Cosmetic Surgery Associates

157 W 19th Street New York, NY 10011 [email protected]

PATIENT CONSENT

Patients provided written consent for the use of theirimages.

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13. Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite(Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol . 2010;9:446–450.

14. Ridenour B, Kontis TC. Injectable calcium hydroxylapatite

microspheres (Radiesse). Facial Plast Surg . 2009;25:100–105. 15. Bernardini FP, Cetinkaya A, Devoto MH, et al. Calciumhydroxyl-apatite (Radiesse) for the correction of periorbitalhollows, dark circles, and lower eyelid bags. Ophthal PlastReconstr Surg . 2014;30:34–39.

16. Sankar V, McGuff HS. Foreign body reaction to calciumhydroxylapatite after lip augmentation. J Am Dent Assoc .2007;138:1093–1096.

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Radiesse - Advanced Techniques and Applications for a Unique and Versatile Implant