Non-surgical Facial Rejuventation with Fillers

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Chapter 3 Non-surgical Facial Rejuventation with Fillers

Brian M. Kinney, David J. Rowe, David Stepnick

The rising interest in cosmetic surgery among the general population is so widespread that cosmetic procedures, surgical, and non-invasive, have essentially entered the popular lexicon. With the purification of bovine collagen and its subsequent clearance for marketing by the US Food and Drug Administration (FDA), soft-tissue filling first became practical in the 1980s. As minimally invasive cosmetic procedures grew from an occasional medical novelty, the purview of the rich and famous, their use became widespread in the 1990s, eventually to a commonly sought means of cosmetic enhancement for millions of people. In 1992 the American Society of Plastic Surgeons reported 41 623 collagen injections, the only type of exogenous filler generally available in the USA. In 2006, 388 316 injections were reported by its members and their use had been accepted in mainstream culture. If data on botulinum toxin is included, the numbers go beyond 1 million per year.

Summary

1. Facial aging is multi-factorial, and often due to a combination of ptosis, loss of skin tone, elasticity, perfusion, hydration, muscle function, and subcutaneous tissue volume.
2. Soft-tissue fillers are rapidly increasing in use and sophistication, but do not address all lost tissues.
3. Very few patients’ conditions are correctable by injection alone; a thorough understanding of combination therapy, including surgery, is essential.
4. Natural fillers are safer and generally preferred to synthetic, but do not last permanently.
5. Permanent fillers are synthetic, have more serious complications and require extremely careful injection techniques.
6. As more fillers become available, more understanding is required by the surgeon and more confusion is likely by the patients.
7. While minimally invasive in nature, injections must be guided by an accurate understanding of the surgical anatomy.
8. Complications are rare, but excellent results are more elusive than generally appreciated.
9. The nasolabial folds and the marionette lines are generally easier to manage than other regions.
10. Injections in the hands and on the trunk are less common, well-studied and efficacious than in the face.

Introduction

The rising interest in cosmetic surgery among the general population is so widespread that cosmetic procedures, surgical, and non-invasive, have essentially entered the popular lexicon. With the purification of bovine collagen and its subsequent clearance for marketing by the US Food and Drug Administration (FDA), soft-tissue filling first became practical in the 1980s. As minimally invasive cosmetic procedures grew from an occasional medical novelty, the purview of the rich and famous, their use became widespread in the 1990s, eventually to a commonly sought means of cosmetic enhancement for millions of people. In 1992 the American Society of Plastic Surgeons reported 41 623 collagen injections, the only type of exogenous filler generally available in the USA. In 2006, 388 316 injections were reported by its members and their use had been accepted in mainstream culture. If data on botulinum toxin is included, the numbers go beyond 1 million per year.

The choice of the appropriate filler, however, has become increasingly difficult. With the ever-expanding number of fillers and filler types, the surgeon must, not only maintain an adequate knowledge of the physiochemical properties of the filler types, but also must understand the differences in injection levels and techniques for each of the fillers. A thorough aesthetic evaluation of the patient as well as a complete discussion of the patient’s aesthetic goals and treatment preferences must be performed in order to achieve a treatment plan that is safe and realistic.

Soft Tissue Loss in the Aging Patient

Some of the features that a youthful face exhibits include smooth contours, few wrinkles, except in dynamic expression, and full subcutaneous tissues with minimal or no soft-tissue atrophy (Fig. 3.1). Nasolabial, glabellar and crow’s feet skin folds are almost uniformly absent at rest, and minimally noticeable, even with muscular contraction. During aging of the normal, healthy adult, there is loss of soft-tissue fullness in the face, often beginning in the nasolabial folds and progressing inferiorly along the marionette lines. Lines in the upper face may show years earlier during dynamic expression than at rest. Lipoatrophy can distress the aging patient with resultant low self-image and self-esteem, depression and social isolation.1,2 With the severe rise in obesity in recent years, loss of facial fat due to aging may be partially offset due to fatty accumulation after weight gain.

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Fig. 3.1 Location of rhytids in the aging face.

In the normal aging face there is gravitational pull on sagging skin, flattening of the youthful contours, accompanied by solar degeneration, variation in pigmentation, an increase in rhytids, capillary break-down, loss of muscle tonicity and progressive thinning of the skin and subcutaneous tissues (Figs 3.2 and 3.3). One of the hallmarks of aging skin – and one for which we have essentially no topical or minimally invasive corrective solution – is poor elasticity, breakdown of elastic fibers and excess skin envelope. In essence, with an imbalance of soft tissue volume to skin envelope, there are three basic approaches: 1) fill up the lost tissue volume, 2) chemically peel, laser, or mechanical dermabrade or excise the excess skin, or 3) live with the difference. Because few patients have one isolated contributing factor, the ideal approach would often include volume restoration and treating the skin. However, many patients do not desire more aggressive treatment. Chemical peels and lasers chemically denude the superficial layers of the skin, but do not reduce the surface area of the skin sufficiently to balance the loss of soft tissue volume in any but the mildest conditions in the youngest patients. While they tighten the skin, in essence by cross-linking collagen and other proteins, they do not restore the elasticity of youth.

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Fig. 3.2 The aging face: presence of rhytids and soft tissue descent.

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Fig. 3.3 Architecture of rhytids.

Soft Tissue Loss in Disease Conditions

While less common, certain disease conditions cause premature loss of soft-tissue volume; some are genetic and some acquired. Congenital generalized lipodystrophy (autosomally recessive) results in lack of adipose tissue from birth. Familial partial lipodystrophy (autosomally dominant) causes progressive peripheral fat loss beginning at puberty and, typically, the facial fatty tissue will stay the same, or rarely gain fat, while the body atrophies. Mandibulosacral dysplasia (autosomally recessive) shows two forms: type A demonstrates peripheral fat loss with normal or excess facial fat, while type B shows generalized fat loss. Partial lipodystrophy (autoimmune mediated) presents during childhood or adolescence and the upper body, including the face, presents with fat loss. Excess fat is found in the legs and hips. Generalized lipodystrophy (immune mediated) presents during childhood or adolescence and shows generalized fat loss, including the face.

Acquired lipodystrophies arise from multiple mechanisms, but more commonly small localized areas of fat loss may occur from drug injections, local trauma or crush injuries, immune-mediated mechanisms, cancer or HIV, the most prevalent form. Highly active antiretroviral therapy (HAART) is associated with the condition, but its actual mechanism is unknown. There appears to be some interaction with protease inhibitors and nucleoside reverse transcriptase inhibitors. The HIV patient shows rapid loss of peripheral fat and fat in the face, occurring within 1 year of treatment.3 Fat paradoxically accumulates in the abdomen, breast and dorsocervical spine. In the face, the buccal and temporal fat pads are most locally affected; however, there is loss of fat diffusely in the face. Fat loss may be rapid and progressive and is often permanent, refractory to steroid administration and dietary intervention. The prevalence has been reported as variable (18-83%) due to differing definitions.4 Lipoatrophy in HIV patients can lead to compliance issues, reducing the effect of HAART and accelerating disease progression, fear of stigmatization and recognition.5,6

Indications

Indications

1. Nasolabial fold prominence
2. Marionette lines and secondary smile lines
3. Perioral lines
4. Paramental soft tissue atrophy
5. Tear trough atrophy
6. Temporal and buccal fat loss
7. Generalized cheek atrophy
8. Crow’s feet
9. Glabellar lines
10. Combination therapy with laser, chemical peel or facelift.

Skin lines, wrinkles and folds

By far the most frequently injected area, the nasolabial fold (NL), may be best evaluated by the standardized Lemperle scale of severity (Fig. 3.4). Natural folds in the face are created by attachment of the facial muscles to the undersurface of the skin. No comparable scale is widely used in the marionette lines, the crow’s feet and/or other skin folds of the face. However, an appropriate approach would be to use the commonly accepted Lemperle scale. The NL fold may begin to appear in the early 20s and progresses with aging. While this scale is primarily focused on skin wrinkling, soft tissue loss is a contributing factor as well.

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Fig. 3.4 Lemperle scale of nasolabial fold severity. A, Grade 0 contains no wrinkles or lines, but may show some minimal contour depression. B, Grade 1 shows just perceptible wrinkles. C, Grade 2 shows shallow wrinkles. D, Grade 3 shows moderately deep wrinkles. E, Grade 4 shows deep wrinkles with well-defined edges. F, Grade 5 shows very deep wrinkles with a redundant fold.

Facial lipoatrophy scale

A four-point grading system is commonly used to measure facial lipoatrophy (Fig. 3.5). Grade 1 is characterized by small localized areas of fat loss, especially in the nasolabial folds. Grade 2 includes mentolabial folds (marionette lines) and may include concavity of the lips. Grade 3 progresses to malar fat atrophy, preauricular hollowing and shadowing of the cheeks and mandibular ridge, while Grade 4 demonstrates malar fat ptosis, temporal hollowing and protruding musculature and bones.

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Fig. 3.5 Facial lipoatrophy scale. A, Grade 1 facial lipoatrophy. B, Grade 2 facial lipoatrophy. C, Grade 3 facial lipoatrophy. D, Grade 4 facial lipoatrophy.

(Photos courtesy of Ute Bauer, MD, 2004.)

Contraindications

Contraindications

1. Positive skin allergy test (in injections containing collagen).
2. Known sensitivity to injectate (e.g. collagen, hyaluronic acid, calcium hydroxlyapatite, etc.).
3. Severe skin disease e.g. psoriasis, eczema.
4. Severe systemic disease.
5. Active acne in the region of injection.
6. History of connective tissue disease.
7. Recent chemical peel or ablative laser treatment.
8. Recent use of aspirin, non-steroidal anti-inflammatories or other blood-thinning medications.
9. Previous lumps or nodules in the area of injection.
10. Dense scar tissue.

While there are many contraindications to surgical interventions, there are very few for injectables. This, along with their relatively low incidence of complications, is the factor contributing to their wide popularity. They are very easy to inject, but much more difficult to inject well. Careful attention to topical and deep anatomic detail is essential to avoid distortion of facial anatomy, lumps and nodules. In addition, even in patients with an undesirable outcome, effects rarely last longer than the prospective duration of the injection. This ranges from about 3 months with collagen to about 2 years for calcium hydroxyapatite, but may be permanent with polymethylmethacrylate synthetics. Patients with mild connective tissue diseases may be eligible for injection after a careful history and physical exam, but should be considered a relative contraindication. Active acne, psoriasis or eczema warrant withholding the procedure. A patient who has an apparent large softtissue volume loss may be corrected partially, but almost never should be fully corrected, as a significant portion of the defect may also be due to ptosis of soft tissues. To the extent the soft tissues have fallen they should be lifted; to the extent the soft tissues have atrophied, the volume should be restored.

Preoperative History and Considerations

Pre-procedure analysis

Paramount in the decision-making process as to the choice and location of injectable fillers are the patient’s physical characteristics and aesthetic goals. A complete pre-procedure assessment includes pre-procedure history and a site-directed physical/aesthetic examination, as well as patient education and informed consent. First, an accurate understanding of the patient’s aesthetic goals must be ascertained. Perhaps the most important consideration in the busy cosmetic clinic is an unreasonable expectation by the patient, e.g. viewing an injection as a facelift in a syringe. Part of this misperception is due to unreasonable promotion by some physicians and the titanic interest in the procedure by the fashion, beauty industries and the public at large in a youth-oriented culture.

It is therefore the surgeon’s obligation to include discussion of possibly relevant surgical as well as non-surgical procedures that may be needed to meet the patient’s expectations. If the patient is best suited for a surgical procedure and opts for a filler-type correction, one must carefully point out what will and what will not be corrected with the filler.

Age is an important factor, as approximately 80% of all injections are performed between the ages of 35 and 64.7 Increasing age leads to the tendency of decreased immunogenicity, so, presumably, there would be less of an inflammatory response to a permanent or semi-permanent filler. However, thinner skin and dermal atrophy make superficial injection techniques risky, as lumpiness and color deformity may occur more readily. Avoidance of aspirin, NSAIDs, gingko biloba, St. John’s Wort, and high-dose vitamin E for 1-3 weeks prior to the injection is encouraged.

Injectable Fillers

We have truly entered the ‘filler revolution’ and the number of new fillers on the market is constantly increasing.8 The first injectable filler that was approved by the FDA was bovine collagen (Zyderm/Zyplast; Inamed Aesthetics, Santa Barbara, CA). The need for skin testing and its lack of longevity were key issues hindering its widespread use.9 Since this time, many classes of fillers have been approved by the FDA, with more likely in the future. Listed in this section is a brief description of each of the major injectable fillers currently being utilized in the USA.

Hyaluronic acid

Of the 9.2 million non-surgical cosmetic procedures performed in 2004, almost 900 000 included augmentation using injectable hyaluronic acid (HA) fillers.10 Hyaluronic acid is a glycosaminoglycan that is a naturally occurring polysaccharide. Hyaluronic acid is an essential component of the extracellular matrix, essentially ubiquitous throughout all animal species. Therefore, it has no species or tissue specificity, making HA ideal from an immunologic standpoint. In its native form, catabolism of HA is rapid (hours to days), therefore stabilization via crosslinking is essential for utility as an injectable filler. HA is hydrophilic and able to retain 95% of volume with water.11 Unique to HA is its ability to follow isovolemic degradation, a process by which the remaining molecules of HA are able to bind an increasing amount of water thus maintaining volume until the majority of product is degraded.

Currently, there are several HA derivative products approved by the FDA. All products are approved for mid-to-deep dermal implantation for correction of moderate-to-severe facial wrinkles and folds:12–14 Restylane (Medicis, Scottsdale, AZ), Perlane (Medicis, Scottsdale, AZ), Juvederm (Allergan, Irvine CA), Captique (Allergan, Irvine, CA), and Hyalform (Allergan, Irvine, CA). Restylane was the first of the HA fillers to be FDA approved (12/2003); in initial studies by Narins et al it showed superiority to Zyplast with a smaller concentration of product.15 Restylane has a HA concentration of 20 mg/ml, a gel particle size of 400 μm, and a 1% degree of crosslinking.16 It is distributed in 0.4 ml and 1.0 ml disposable syringes. Wang et al17 recently reported that, in addition to the physiochemical properties of Restylane, it may augment dermal filling by stretching fibroblasts and thereby stimulating de novo collagen formation.

Other HA fillers are similar to Restylane but differ in several key categories: concentration, particle size, and degree of crosslinking. Juvederm was FDA approved in June 2006 and has a slightly higher concentration of HA (24 mg/ml), a higher percentage of crosslinking, and has randomly shaped particles. In addition to Juvederm, two other formulations of Juvederm have been FDA approved. Juvederm Ultra is a thinner version of Juvederm. Juvederm Ultra Plus has a greater particle size and a larger degree of crosslinking, marketed to be utilized as a volumizer injected deeper than its predecessor. Perlane is similar in crosslinking to Restylane; however, like Juvederm Ultra Plus, it has a larger particle size intended to be placed deeper in the dermis and/or subdermis. Restylane, Juvederm, Juvederm Ultra, Juvederm Ultra Plus, and Perlane are all derived from non-animal stabilized HA (NASHA). NASHAs, coupled with the ubiquity of HA, render these injectables as having a low potential for immunogenic reaction. In contrast, Hylaform is derived from rooster combs and does confer immunogenicity. Puragen recently renamed as Prevelle Shape, has been approved in the EU for two years and is double cross-linked with the aim to better resist degradation (Figs 3.6, 3.7 and 3.8).

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Fig. 3.6 Patient in her 50s 14 months after double cross-linked hyaluronic acid in the nasolabial folds.

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Fig. 3.7 A, Patient in his 50 s 9½ months after injection of double cross-linked hyaluronic acid. B, At 12 months the left nasolabial fold has partially returned.

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Fig. 3.8 A 57-year-old patient with double cross-linked hyaluronic acid. Almost full correction at 10½ months.

Table 3.1 Comparison of hyaluronic acid fillers chemistry and impact on clinical outcomes

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Calcium hydroxylapatite

Synthetic calcium hydroxylapatite (CaHA) is a biocompatible substance with a similar mineral component to bones and teeth. TheCaHA scaffold theoretically allows for tissue ingrowth with no immunogenic or inflammatory response as well as no migration. Radiese(BioForm Medical, San Mateo, CA) is a suspension of 30% CaHAmicrospheres of 25-45 μm in diameter in a gel consisting of 1.3%carboxymethyl cellulose, 6.4% glycerin, and 36.6% sterile water.Radiesse was approved by the FDA in December 2006 for the correctionof soft-tissue wrinkles and folds; however, it was previously approvedfor laryngeal augmentation, soft-tissue marking, and filling/augmenta-tion of dental intraosseous defects and oral/maxillofacial defects.18 It is also now approved for correction of HIV facial lipoatrophy.19

Histologically, by 3 months, there is some residual phagocytosis ofthe gel substrate and a fine fibrous stroma between the CaHA microspheres (Fig. 3.9). By 9 months, there is irregularity of the shape ofthe CaHA microspheres, presumably from enzymatic degradation. Noforeign body granulomatous reactions have been identified (Fig. 3.10).20–23 Radiesse has been reported to persist histologically from 2 to 7 years.24

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Fig. 3.9 Microspheres individually surrounded by delicate fibrous encapsulation 12 months after implantation.

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Fig. 3.10 Six months after injection of upper and lower lips, nasolabial folds and the oral commissure.

(Photo courtesy of Miles Graivier, MD.)

Poly-L-lactic acid

Poly-L-lactic acid (PLA) is a synthetically polymerized lactic acid material first synthesized from vegetable sources in 1954 and used in multiple surgical devices, including suture materials (DEXON (Davis & Geck, Manati, Puerto Rico), VICRYL (Ethicon, Inc., Somerville, N.J.), and in resorbable plates and screws, as well as a vehicle for sustained drug release. Sculptra (New-Fill in Europe) is manufactured in Italy and distributed in the USA by Dermik Laboratories (Berwyn, PA – Sanofi-Aventis, Bridgewater, NJ). Sculptra is formulated into PLA microspheres (40-63 μm) suspended in a sodium carboxymethylcellulose carrier and reconstituted with sterile water. Sculptra was FDA approved in 2004 for correction of facial lipoatrophy in HIV patients (Figs 3.11 and 3.12).

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Fig. 3.11 A, Patient in her early 40s with facial atrophy after more than 6 months of seizure medications. B, Nine months after three injection sessions 4-6 weeks apart with poly-L-lactic acid injections in the temple and cheek. Her weight did not change appreciably.

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Fig. 3.12 A, Septuagenarian patient prior to poly-L-lactic acid (PLA) injections in the hands. B, Eight months after three injections of PLA about 6 weeks apart in the dorsal hand, first through fourth web spaces. There is palpably increased soft tissue in the hands.

Following solubilization, the lactic acid degrades via the lactate/ pyruvate route, and is then eliminated as CO2 through the respiratory system.25 Histologically, no polymer is detected after 9 months.21 Tissue filling is ultimately achieved by ingrowth of type I collagen (neocollagenosis).26 Thus, the filling persists despite resorption of polylactic acid microparticles. Investigations in HIV lipoatrophy have revealed increased dermal thickness by threefold, as well as increasing the quality of life in this group of patients.27,28

Polymethylmethracylate beads coated in collagen

Polymethylmethracylate (PMMA) microspheres are insoluble, synthetic and chemically related to Plexiglas. PMMA is commonly used in orthopedics for permanent fixation and support of bony tissues. ArteFill (San Diego, CA) is composed of a 20% solution of PMMA microspheres 30-42 μm in diameter and suspended in a solution of partly denatured bovine collagen and 0.3% lidocaine. ArteFill received FDA approval in January 2007 for correction of facial wrinkles, thus making it the first permanent injectable wrinkle filler in the USA.29 Patients must be skin tested for allergy to bovine collagen and possibly tested for reactivity to collagen.30

Artecoll, the identical product with previous marketing nomenclature, has been implemented throughout the world since 1994. Reportedly 400 000 patients have been treated to date.31,32 The PMMA microspheres are non-biodegradeable and are unable to be phagocytosed by macrophages, due to their size and lack of electrical charge. Thus, soft-tissue augmentation is thought to be permanent. By 1 month post-injection, each individual microsphere is encapsulated by collagen, macrophages, and fibroblasts. Resorption of the bovine collagen and replacement with native collagen occurs within 1-3 months. The size of the Artecoll microspheres is unchanged by 9 months.21,33

Injected in small amounts and corrected less than 1 : 1 in volume, excellent results can be extremely pleasing clinically, as good as or better than any others. The injectate is permanent and may not show at all, or potentially after the normal soft-tissue atrophy of aging occurs years later. Experience has not ranged over sufficient years since introduction about 10 years ago to be sure of the clinical significance of this possibility.34 If there is a complication, the results may respond to triamcinolone injection, or may require excision, because the body cannot resorb this synthetic polymer.

Polyacrylamide gel

Aquamid (manufactured by Ferrosan, Copenhagen, Denmark; distributed by Contura International, Soeberg, Denmark) consists of 2.5% crosslinked polyacrylamide and 97.5% water. Polyacrylamide injected into the subcutaneous tissues elicits a fibrous capsule that surrounds the gel by 6-9 months.21 This material is currently not approved by the FDA; however, it is in use throughout Europe, South America, and the Middle East.

Other injectables

Silicone has a very small group of supporters, but it is not cleared by the FDA and has a past history of an extremely high incidence of complications, including severe scarring, distortion of anatomy and the need for surgical excision of skin, fibrosis and even muscle. Autogenous fat, a highly successful technique, is not within the scope of this chapter, but should always be considered when choosing a method of soft-tissue restoration.

Operative Approach

Anesthesia

While many patients are able to tolerate neurotoxin injections without the use of anesthesia, most patients require an anesthetic to ensure maximal comfort for the injection of fillers such as the HAs. Especially in extremely sensitive areas such as the lips, an otherwise good experience can leave lasting memories of anxiety and pain, which may curb a patient’s desire to have repetitive treatments. Areas such as the region under the eyes may require a much lower level of anesthesia, and, as such, choice of an anesthetic must be tailored to the patient, the material being injected, and the area of treatment.

Applying ice to the area to be injected is probably the lowest cost and easiest technique for decreasing the apparent pain. Many patients prefer this technique rather than either waiting for the topicals to take effect or experiencing the anesthesia which can be achieved with regional blocks.

Topical anesthetics include EMLA cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%), L-M-X (lidocaine 4%), and Tetracaine cream. Compounding pharmacies may create other products utilizing these and various other available topical anesthetic agents. When a topical anesthetic is used, maximal effect is achieved if the product remains in place for 30-60 minutes after application. Rare serious side effects, such as methemoglobinemia with EMLA, may occur. The senior author (BK) has found that in over 90% of patients with triple anesthetic cream and slow, low-pressure injection technique, there is no need for local injection or regional block. Pain Ease®, topical dichlortetrafluoroethane and ethyl chloride (Gerbauer Company, Cleveland, OH), and similar products are topical refrigerants which can be applied to the skin just prior to needle insertion. The product is useful for the nasolabial folds and cheeks, and should not be used on the oral mucosa.

Nerve blocks provide the most effective and profound anesthesia. Local infiltration of an anesthetic agent is to be discouraged, since the volume of anesthetic changes the apparent volume of the area to be corrected with the filler material. Very small volumes of an anesthetic agent – 0.3-0.5 cc – properly deposited in the area where the nerves exit their foramina provide anesthesia without altering the tissue volume. Various choices are available, but lidocaine is the most commonly used agent.

Anatomical considerations

Superficial layers

Low crosslink density, small particle size hyaluronic acids are best close to the surface where the likelihood of lumpiness or nodularity is low. Collagen preparations may be injected here with low risk. The greater the crosslink density and the larger the particle size, the deeper the injection should be placed.

Deeper layers

CaHA and PMMA should be injected in deeper layers, not close to the surface due to their long duration and firmness. PLA, a volume restorer, should be injected in deeper layers. These injections are in large volumes and should not be placed close to the skin or targeted at rhytids.

Nasolabial folds

Threading, fanning, and serial droplet techniques can be employed. Of these, the threading technique provides good results and is an optimal choice for the nasolabial crease. An eyeliner pencil is easily visualized yet can be effortlessly removed. Patients then may lean back and receive the injections in a relaxed, semi-recumbent position. The needle is inserted to its hub in the deep dermal or immediate subdermal plane. HAs are injected into the deep dermis; CaHA is injected just below the dermis. Inspection and feel guide proper needle placement: dimpling of the skin with downward pressure on the needle signifies that the needle is, indeed, in the deep dermis. If the needle can be visualized through the skin, it is too superficial. If there is little resistance to the needle and the product, it is likely in the subcutaneous tissue.

Approximately three threads of product are placed, taking care to deposit the material in the valley beneath the nasolabial crease. The triangular area bounded by the nasal alar crease and the nasolabial fold should be filled. If the cheek above the crease is injected, the nasolabial fold will be accentuated rather than blunted. A key part of the procedure is firmly massaging the deposited material, molding it to fill the hollow, achieving a natural appearance without visible lumpiness.

Following injection, the patient is given ice to hold on the areas for 15 minutes to help minimize swelling and bruising. Results improve over 1 week or 2 as inflammation subsides. Especially with calcium hydroxyapatite, which is much denser than the surrounding soft tissue, the material is palpable for weeks to 2-3 months, at which point the carrier vehicle absorbs and degrades, and the tissue consistency resembles normal tissue. Patients should be so advised.

To achieve optimal results and longevity, the nasolabial folds must be maximally corrected. Less than maximal correction often contributes to patient dissatisfaction. Studies examining longevity treated patients to maximal correction and, as such, patients not receiving maximal correction cannot be expected to have as long-lasting a result. Indeed, complete correction and placement of the materials in the proper plane appear to be key factors for success.17

HAs placed too superficially appear as a visible, raised blue line along the fold. Calcium hydroxyapatite appears white. For the HAs, the product can often be expressed by digital pressure or by nicking the dermis with an 18 gauge needle and expressing it with applied pressure. Hyaluronidase injections will break down the product if needed. Patients with deep, hyperdynamic creases or those with heavy cheeks may have a suboptimal result.

Marionette lines

The fanning technique is particularly useful in this region. Fanning involves introducing the needle at a 30 ° angle to the level of the deep dermis. The needle is passed back and forth medially and laterally to the fold by about 2 mm in each direction. Unlike the linear threading technique, the material is deposited both upon insertion and withdrawal of the needle, and bevel position is irrelevant. As with the nasolabial crease, if too much material is deposited superior/lateral to the fold, it may be accentuated instead of being reduced.

Paramental crease

As with other areas of the face, the paramental crease and prejowl sulcus results from a combination of descent of tissues, due to gravity and loss of elasticity, together with deflation and loss of volume in particular areas of the face. While surgical correction is the only way to lift and tighten the jowls themselves, fillers can be used in the pre-jowl sulcus to camouflage the appearance of the jowls. As this is not a discrete crease like the nasolabial creases and the marionette lines previously discussed, the material deposited needs to be more diffuse and slightly deeper. Subcutaneous placement is desired, whereas deep dermal placement may produce a lumpy appearance.

Glabellar lines

In general, glabellar rhytids are best and most frequently treated with botulinum toxin. However, for patients with particularly deep lines, the neurotoxin may not provide sufficient improvement to appropriately eliminate these creases. In such patients, a synergistic effect can be obtained by using a filler in combination with the neurotoxin.33 Others have reported that concurrent injection of Restylane® and botulinum toxin increases the longevity of the former.35 The serial puncture technique is used, staying in the mid-dermis. Injection occurs as the needle is being withdrawn. It may be useful to compress the supratrochlear vessels to minimize likelihood of intravascular injection.

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Fig. 3.13 Techniques of injection. A, Serial puncture technique: multiple injections are placed sequentially along the length of the wrinkle or fold. Adjacent areas should join together into a continuous, smooth line without spaces. B, Linear threading technique: the full length of the needle is inserted into the middle of the fold and material is injected while gently withdrawing the needle longitudinally. Each thread should be as long as the needle inserted to the hub. C, Fan technique: the needle is inserted in the area as when using the linear threading technique, and after injecting in one line, the needle is kept under the skin and reinserted in a new line, repeated in a fan-shaped pattern. D, Cross-hatching technique or Lake technique: commonly used for poly-L-lactic acid and may be used for filling the cheeks with hyaluronic acid.

Bruising is not uncommon in this region. Multiple cases of skin necrosis and scarring have been reported in the literature, particularly in this region.36,37 Immediate care of prolonged skin blanch after injection involves massage to stimulate blood flow into the region. If this is not effective topical 2% nitroglycerine ointment can be applied.

Lower eyelids (nasojugal groove and tear trough regions)

One of the more difficult areas to treat successfully is that area of the lower eyelids. However, a good result is equated with high degrees of patient satisfaction.38 Significant hollowing occurs as a result of pseudoherniation of orbital fat combined with descent of the buccal fat. This may also result as a result of cosmetic lower blepharoplasty. The thin, delicate nature of the skin makes this area a challenge. The area bruises very easily, especially in patients with clotting abnormalities, those prone to bleeding, or in whom pharmaceuticals are used that interfere with normal clotting. Fillers injected just beneath the surface of the very thin skin can be visible, and are to be avoided. For this reason, many clinicians are reluctant to inject the tear trough region. Surgeons who have an excellent understanding of the orbital and lid anatomy form having operated upon it in the past are well-prepared to inject in an entirely different plane than discussed with the other subsited thus far. The filler should be injected beneath the orbicularis muscle, overlying the periosteum, serially along the orbital rim. Surface irregularities can in this way be minimized. Undercor-rection is preferred to overcorrection. As the HAs are hydrophilic and attract water in the first few weeks after the filler is placed, complete correction can actually become overcorrection, and the eyes may take on a puffy appearance. More than any other area, bruising can occur and so patients need to account for this to ensure that whatever bruising does occur does not interfere with their lifestyle.

Lips

Fillers can be useful when patients complain of lipstick ‘bleeding’ onto the cutaneous lip, enhancing the lip border lessens or eliminates this problem. Similarly, in smokers, the fillers can re-inflate the fine lines that develop around the lips as a result of smoking. The lips are an extremely sensitive area and nerve blocks are virtually a necessity. Linear threading is essentially always used in place of serial puncture. The risk of hematoma (in the labial artery) is quite high compared to other areas of injection and careful observation is necessary. Immediate application of firm pressure is required, should it occur. In the midst of injection it is possible to monitor the flow of injection. Some prefer convexity of the mucosa surface and some prefer definition in the vermillion border; needle placement should be adjusted accordingly. The filler is injected carefully, as any irregular deposition will be obvious as the swelling diminishes. Ice should be used to minimize swelling, but even with ice, swelling may hide any lumpiness or irregularity. As such, the lips should be carefully palpated, and massaged to properly contour the lips. For patients with thin lips, the needle is reinserted and a second bead of filler is placed 1-2 mm inferior to the vermillion border, parallel to the first injection. This produces a favorable upwards roll to the lip.

Increased volume and lip body are achieved by injecting directly into the lip. The body of the lip is injected in a manner similar to the vermillion, in the area of the lip between the vermillion and the wet lip. The wet lip should not be injected, because at this depth, the labial artery is at risk of occlusion by the material and the theoretic risk of ischemia of the lip needs to be considered. Typical volumes needed to enhance the volume of the lip are 0.25-0.5 cc per lip. It is unusual to use more than 1.0 cc per lip. Deep vertical rhytids can be individually and directly injected, but should not be overcorrected.

Generally, HA, having supplanted the use of collagen in the last 3-4 years, is the injectate of choice in the lip (Fig. 3.14). CaHA, PMMA and PLA are generally not indicated in the lips and should be used with great caution except in the hands of the experienced injector and the experienced patient who know the doctor well.

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Fig. 3.14 Injection of double cross-linked hyaluronic acid (HA) for lip augmentation. A, Double cross-linked HA pre injection. B, Double cross-linked injection at 4 months. Lower lip eversion and decreased vertical upper lip lines are still improved. Volume loss has begun to occur.

Patients with a history of cold sores should receive antiviral prophylaxis, as injections can stimulate reactivation of latent herpes infection. These patients should receive Valtrex 500 mg bid on the day of treatment and for a total of 10 days of therapy.

Other important details

The patient should be in a position that best demonstrates the defect – usually in a near upright position. The head should be stabilized against a headrest. We like to have the patient examine closely the areas of treatment in a handheld mirror while we highlight the method of treatment prior to its start. After each injection the patient has an opportunity to view the partial result within an individual area and compare left to right.

Optimizing outcomes

• Correction must be optimized based on product hydration and swelling expected.
• Overcorrection and swelling is permissible immediately after underhydrated HA products.
• Permanent fillers should never be used to overcorrect volume.
• Slow, gentle injection without excess pressure is essential.
• During rapid, high-pressure injection the injectate will dissect along the path of least resistance, which may even be perpendicular to the long axis of the needle.
• Intra-injection monitoring of tissues is required for optimal contouring and volume restoration.
• Calcium hydroxlyapatite must be injected deep and in several sessions to avoid palpable or visible nodules.
• Adequate local anesthesia prevents facial muscle contraction and distortion during injection.
• Compounding pharmacies make available a triple anesthetic cream with 20% benzocaine, 8% lidocaine and 4% tetracaine, which works within just a few minutes, much faster than the standard topical anesthetics that may take up to 30-45 minutes to anesthetize adequately.

Complications and Side Effects

1. Pain
2. Erythema
3. Swelling
4. Bruising
5. Inflammation
6. Asymmetry
7. Hematoma
8. Allergy
9. Early resorption
10. Nodularity and purulence.

The first five on the list are relative common adverse events, are almost always transitory and responsive to palliative treatment. Asymmetry is almost always present, but those cases leading to dissatisfaction are relative uncommon. Hematoma, while relatively more uncommon, is also short-lived and generally easy to treat. Allergy implies exposure to protein, and in HA preparations it is residual from the production process of bacterial fermentation. Protein loads in HA preparations is in the order of 1 part per million. This is generally not a problem with CaHA and PLA, but PMMA has an outer coating of collagen and carries the risk of allergy, just as traditional collagen injection does. However, hypersensitivity reactions may occur many months after treatment. In a study of 709 patients injected with Hylaform or Resylane followed-up for 12 months or more, six developed delayed skin reactions 8 weeks after injections.39 In a 1999 study, localized hypersensitivity reactions occurred in approximately 1 in 1400 patients, and adverse events were reported in one in 650 patients (0.15%). In 2000, when the amount of protein in the raw product decreased, those numbers fell to one in 5000 for hypersensitivity reactions and one in 1800 for adverse events (0.06%). Andre performed a retrospective study evaluating the incidence of adverse reactions after non-animal stabilized hyaluronic acid injections and found an overall 0.8% global risk of hypersensitivity reactions, of which 50% were immediate and resolved in under 3 weeks.40

The incidence of purulence and nodularity amongst HA injections is not known, but may be between 1 : 1000 and 1 : 5000. This can be a devastating complication and can lead to scarring, and permanent contour alteration. Treatment includes various combinations of antihistamines, oral or parenteral antibiotics, hyaluronidase injection and triamcinolone injection depending on the clinical presentation.

Clinical examples

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Fig. 3.15 Hyaluronic acid injection with expected immediate post-injection edema and erythema. Cold compresses immediately after injection and over the counter analgesics are all that are required.

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Fig. 3.16 Asymmetry 14 months after double-cross-linked hyaluronic acid (Puragen) due to irregular resorption and underlying anatomical differences. This case is not a complication per se. Retreatment at the patient’s or physician’s discretion is permitted. A greater than 40% correction remains in a 120 kg male, almost 2 meters tall, not a typical patient. Early asymmetry may be due to missed diagnosis, incomplete correction or other causes.

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Fig. 3.17 Nodularity without purulence. Late nodule formation with photos 9 months and 9 months and 1 day after injection. Nodularity resolved within a few days. The patient had reported several episodes between 3 and 9 months of temporary (1-2 day) appearance and spontaneous resolution of inflamed nodularity. Improvement was likely due to rapid resorption of hyaluronic acid (HA) after episodic breakdown of the long-standing normal connective tissue capsule. Connective tissue inflammation may be treated with triamcinolone injection and HA sequestrum may be treated with hyaluronidase enzyme injection.

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Fig. 3.18 Early resorption at 4 months in a 1½ pack per day cigarette smoker who has used indoor tanning booths twice a week for many years. No other findings were seen.

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Fig. 3.19 Hyaluronic acid injection in the nasolabial fold with nodule formation and inflammatory response. Multimodal treatment may include triamcinolone injection, hyaluronidase injection, oral antibiotics and antihistamines. Ultrasound treatments or hypodermic epidermoclysis may break down the connective tissue capsule.

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Fig. 3.20 A, Nodularity following polymethylmethracylate (PMMA) injection. B, Biopsy of four sites after injection of PMMA microspheres.

(Photo courtesy of Claudio DeLorenzi, MD.)

Postoperative Care

Immediate post-injection treatment is minimal, but varies with each material. Generally, the patient is kept in the office for 5-10 minutes with cold compresses applied to monitor for hematoma, nodularity, palpability or other problems. No dressings are required and makeup may be applied before leaving the office. Much discussion has occurred about having patients refrain from vigorous physical activity for several days, but this has no scientifically validated foundation. It is left to the preference of the individual doctor and patient.

A 2-week appointment is essential to effectively evaluate theresults. Often patients will call with questions, and to answer most anexamination is required. With long-acting materials like CaHA andPMMA excessive injection at the first visit is likely to increase nodu-larity, palpability and overcorrection. It is much safer to assess thefinal endpoint of injection at 2 weeks rather than at the first injection.With increasing experience on the part of the doctor and the patient,the repeat visits may be canceled at the patients’ discretion. Pre- andpost-procedure photography is standard care in plastic surgery and isessential for the precise recognition of contour changes.

Long-term care is minimal, but follow-up is essential. Appoint-ments at 3, 6 and 9 months allow for the opportunity to performtouch-up procedures, monitor for the inevitable asymmetric resorbtionand consider complimentary procedures. The rare late complicationcan be discovered on these visits.

Conclusion

Soft-tissue injectables are among the safest and most satisfying procedures in plastic surgery. They go a long way to ameliorating the earlyeffects of aging; infectious, post-traumatic or acne scars; and soft-tissueatrophy of many etiologies. Many patients who are not clinically readyfor more advanced or invasive procedures, are not willing to undergosurgery, cannot afford the time or financial impact, or are just new toaesthetic procedures are ideal for this approach to rejuvenation. In anASPS survey 47% of patients who had a positive experience with injections would consider having surgery with the doctor with whom theyunderwent injection procedures.

It is important to understand the different chemistry and variationsin technique among the various materials available. While it is easyto perform injections, it is not easy to perform them excellently. Pres-ervation of the tissues, careful attention to topical, subcutaneous andmuscular anatomy, precise correction and meticulous injection technique is required. The ideal approach would be to ‘tissue engineer’ cutaneous and subcutaneous tissues. In the future, our choices willincorporate more advanced materials, with chemistry more closely analogous to our natural tissues.

References

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