Non-hyaluronic acid fillers for facial augmentation

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CHAPTER 75 Non-hyaluronic acid fillers for facial augmentation

Douglas S. Steinbrech, Oren M. Tepper

History

The concept of soft tissue fillers dates back to as early as the 19th century with Nueber’s description of the use of autologous fat for tissue augmentation. Soon thereafter, permanent synthetic fillers were applied for cosmetic purposes. Paraffin, for example, was injected into the face at the start of the 20th century, but had only limited success due to the risk of granuloma formation. Other permanent injectables such as silicone have been used “off-label” for improved cosmesis, but have experienced a variable and controversial clinical course.

Given the risk of irreversible complications with permanent injectable substances, the medical community sought to develop non-permanent soft tissue filling agents. The first temporary soft tissue filler to be introduced to the market was collagen in 1977, but numerous other substances have since been developed. Today, soft tissue augmentation with temporary fillers represents one of the most popular procedures performed in medicine.

Soft tissue fillers can help achieve a more youthful appearance by addressing the effects of tissue atrophy, or by augmenting areas that help define an attractive face. Soft tissue fillers are generally used to treat nasolabial folds, glabellar wrinkles, marionette lines, perioral wrinkles, and the lips. Other age-related changes of the face such as ptosis or inferior skin quality, however, cannot be successfully treated with soft tissue fillers. As patients continue to seek minimally-invasive procedures to address these age-related changes, it can be expected that soft tissue fillers will continue to play an important role in physician practices for many years to come.

Classification of fillers

Various types of injectable substances are currently available to restore a youthful appearance. Compounds manufactured from natural tissue may be thought of as biologic, and can be classified based on their origin from either a human (allogeneic) or animal source (xenogeneic). Synthetic, or alloplastic, materials represent man-made compounds used to augment the face for facial rejuvenation. Lastly, autologous tissue that is harvested from elsewhere in the body and used for tissue augmentation may be classified as syngeneic products. An overview of this classification scheme can be found in Table 75.1. The following chapter highlights xenogeneic, allogeneic, and alloplastic soft tissue fillers (Table 75.2).

Table 75.1 Dermal filler classification

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Table 75.2 Side effects associated with soft tissue fillers

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Xenogeneic

Bovine and porcine collagen

The use of collagen adhesive can be traced back as far as the Egyptians 4000 years ago. The word collagen is derived from the Greek word for glue, kolla. Collagen, or “glue producer”, refers to the early process of boiling skin and tendons of animals to obtain glue. Injectable bovine collagen was introduced to the market in 1981 and became the first commercially available filler to be approved by the FDA for soft tissue augmentation. Today, collagen has become one of the most commonly utilized injectable agents, with an estimated use of over 200,000 injections per year.

Zyderm represents the first form of bovine collagen to be developed. Newer generation bovine products have been established which include Zyplast and Zyderm II (Inamed, Santa Barbara, CA). Zyplast consists of cross-linked fibers, while Zyderm II consists of a more viscous form of Zyderm. Zyderm is primarily injected into the superficial dermis, and is recommended for correction of fine wrinkles at the crow’s feet, lip, and marionette lines. In comparison, Zyplast is injected at mid-dermal layer, and thus should be used to correct deformities such as deep nasolabial folds. Porcine collagen products include Permacol (Tissue Science Labs, UK), Fibroquel (Aspid, Mexico), and Evolence (ColBar LifeScience, Israel).

Because an estimated 3–5% of the population has a pre-existing allergy to collagen, it is essential to perform a skin test 4 and 2 weeks prior to use. In patients with a history of an uncomplicated collagen injection of more than 1 year prior, a single test dose is also recommended.

Allogeneic

Human collagen

As animal-based collagen products continued to gain popularity, scientists aimed to develop human-based collagen products in order to alleviate concerns of allergenicity. The first of the human collagens to be introduced to the market included Dermolagen (Collagen Matrix Technologies, Boca Raton, FL) and Autologen (Autogenesis Technologies, Acton, MA). The production of Autologen involves harvest of autologous skin and subsequent extraction of collagen from decellularized human dermis. In comparison, Dermolagen provided an advantage of processing collagen from cadaveric skin.

In 2003, the family of Cosmoderm products (Inamed, Santa Barbara, CA) were introduced to the market and approved by the FDA. Cosmoderm I (collagen concentration of 3.5%) and Cosmoderm II (collagen concentration of 6.5%) are currently used to treat fine-to-moderate wrinkles. Cosmoplast is a more robust formulation for deeper lines and folds. These human-based products provide the advantage of not requiring a test dose for skin sensitivity. Other human collagen products that are available for use include cadaver-based products: Fascian (Fascia Biosystems, Beverly Hills, CA) from cadaveric fascia and Cymetra (LifeCell Corp, Branchburg, NJ) which is a particulate form of alloderm.

Cross species

More on this topic may be found in Chapter 74 on hyaluronic acid fillers.

Alloplastic

Hydroxylapatite (Radiesse)

A unique form of soft tissue fillers that was recently introduced to the market is synthetic calcium hydroxylapatite. The most well known product is Radiesse, formally known as Radiance FN (Bioform Medical, San Mateo, CA), which consists of calcium hydroxylapatite (30%) and an aqueous carrier gel (70%). At present, Radiesse was initially approved by the FDA for filling of oromaxillofacial defects, soft tissue marking, and laryngeal augmentation. In 2006, FDA approval for Radiesse was extended to the treatment of nasolabial folds and lipoatrophy.

Many clinicians believe that Radiesse may offer exhibit greater longevity relative to other temporary fillers, lasting 12–18 months. One potential explanation for this observation may be its mechanism of action. Following injection of Radiesse, the carrier gel is gradually absorbed and new collagen formation occurs around the calcium hydroxylapatite microspheres. Studies to date demonstrate calcium hydroxylapatite to be biocompatible and non-antigenic, and thus sensitivity testing is not necessary prior to delivery.

Poly-L-lactic acid (Sculptra)

Sculptra (Sanofi-Aventis, Bridgewater, NJ) consists of poly-L-lactic acid (PLLA) and was approved by the FDA in 2004 for the treatment of facial lipoatrophy secondary to HIV-associated medications. Worldwide, Sculptra is utilized for aesthetic indications as well. Sculptra is primarily used to fill deep folds or areas of significant atrophy, and therefore should be delivered in the deep dermis or subcutaneous space. Side effects of Sculptra include delayed appearance of subdermal bumps, but some believe that this risk is significantly decreased by the delivery of Sculptra in a more dilute form.

Artecoll

Artecoll (Artes Medical, San Diego, CA) is an injectable made up of polymethylmethacrylate (PMMA) microspheres coated with bovine collagen at a ratio of 1 : 3. Artecoll has been used for a number of years in Europe to treat deep folds and depressions in the glabellar, nasolabial, and perioral region. From a histophysiologic perspective, the collagen within Artecoll is absorbed within approximately 4 weeks, while the PMMA beads persist and stimulate adjacent connective tissue growth. Thus, Artecoll may be best categorized as a semi-permanent soft tissue filler. In 2006, the FDA approved Artecoll for the treatment of nasolabial folds. Artecoll should primarily be delivered in the deep dermis or subcutaneous layer, particularly given its association with granuloma formation. In addition, skin testing is recommended prior to delivery because it consists partly of bovine collagen.

Silicone

Historically, the use of injectable liquid silicone has been surrounded by a great deal of controversy. Serious side effects such as granulomas, nodules, skin necrosis, and pneumonitis, led many physicians to oppose the use of this permanent injectable. On the other hand, advocates of silicone believe that is an excellent and safe filler for glabellar, nasolabial, and marionette folds, as well as for acne scars. Liquid silicone is currently available as either AdatoSil or Silicon 1000, which differ in viscosity. Both substances are currently approved by the FDA for retinal detachment, but their use for cosmetic applications in the face remains entirely off-label at present. Given the controversial and irreversible nature of silicone, it is recommended that physicians exhibit extreme caution with this product.

Syngeneic

Recently, autologous fat has generated a great deal of excitement for its potential applications as a soft tissue filler. Other syngeneic products are available to plastic surgeons to treat facial atrophy. Isolagen (Isolagen Technologies, Houston, TX) is collagen derived from the patient’s own fibroblasts, but is limited by the time required for culture/expansion. Autologen is an injectable form of collagen that comes from the patient’s own skin, but similarly requires a donor site for harvest and time required for manufacturing. Nevertheless, these products may be appealing to patients who already plan to undergo a procedure that involves skin resection for other surgical procedures.

Physical evaluation

Patient characteristics

Similar to other cosmetic procedures, a thorough preoperative evaluation is essential in order to generate a successful treatment plan and minimize potential complications. It is important to obtain a detailed medical/surgical history in all prospective patients. Key issues to address include history of facial fillers, facial surgery, cold sores, autoimmune disorder, allergies, and pregnancy or nursing status. In addition, one should obtain a complete list of medications, including homeopathic substances. Medications that may inhibit platelet function or increase the risk of bleeding should be avoided prior to treatment. Also of note is the importance of examining patients in the absence of makeup.

Surgeons should assess the patient’s chief complaints, and determine which anatomic areas soft tissue augmentation may be indicated. Regions of the face that are commonly treated with soft-tissue fillers include forehead wrinkles, glabellar folds, crow’s feet, tear trough, nasolabial fold, perioral rhytids, and lip augmentation (Fig. 75.1).

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Fig. 75.1 Common anatomic areas of injectable augmentation.

Technical factors

Patient comfort during a filler-procedure is of critical importance. A thorough understanding of the local anesthetic techniques can greatly facilitate patient satisfaction and overall treatment success. Nerve blocks are recommended for injection of soft tissue fillers, and generally can be delivered away from the site of treatment without significantly distorting anatomy. Eight different nerve blocks to anesthetize various regions of the face have been well-described (Fig. 75.2).

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Fig. 75.2 Common facial nerve blocks.

Adapted from Zide BM, Swift R. How to block and tackle the face. Plast Reconstr Surg 1998;101:840–851.

Injection technique is essential to the overall success of soft tissue augmentation with fillers. Important factors to consider with injectable agents include delivery depth (intradermal, subdermal) and technique (serial puncture, threading, fanning, and cross hatching). Physicians should be familiar with the various delivery methods. Serial puncture involves serial injections along a rhytid in order to raise/lift the fold. Serial threading works well for fine wrinkles, as well as glabellar or philtral column enhancement. Linear threading entails insertion of the needle directly to the middle of the wrinkle and delivery of the substance along the whole length of the space. Injection of the filler by linear threading can be done while either advancing or withdrawing the needle. Fanning represents multiple linear injections in a clockwise (or counterclockwise) pattern and is typically applied to deep folds. Cross hatching involves a series of linear injections as a grid, and is advantageous for relatively large treatments areas such as the perioral region (Fig. 75.3).

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Fig. 75.3 Injection techniques.

Technical steps

1. The patient is counseled as to the types of available fillers and which one would be most appropriate for the desired aesthetic result.

2. Risks, benefits, and alternatives of the minimally-invasive procedure are discussed at length including but not limited to those in the section on complications. Risks also may be tailored to emphasize the particular anatomic area involved.

3. Informed consent is obtained.

4. All makeup is removed and treatment areas are wiped with alcohol swabs.

5. While the patient is in an upright position, regions of interest are marked using a delible marking pen. This should be done prior to delivery of anesthetic in order to prevent distortion of the tissue.

6. The patient is placed in a relaxed semi-fowler beach-chair position.

7. Topical anesthetic cream or a facial cooling system can be applied for approximately 15–30 minutes prior to the nerve block or injection

8. An anatomically-specific local nerve block is delivered.

9. The product is injected into the area using the anatomically-appropriate technique: droplet or threading depending on the area and defect.

10. Be mindful of the hydrophilic quality of the product to allow estimation of how much to over- or under-correct.

11. The area is cleansed of all ink marks.

12. The patient is placed in an upright position for a final evaluation.

13. Any small areas necessitating final adjustment are corrected.

14. The physician or assistant performs a final massage and cleans the area while the patient remains seated.

15. Ice is applied to the injected area to minimize echymosis and swelling.

16. Patient is assessed for ambulatory stability.

17. Makeup may then be applied in an adjacent post-procedure area.

Postoperative care

Patients can return to their routine activities following soft tissue augmentation with fillers. Make-up may be applied as normal, but patients should be careful to not aggressively manipulate the treated area. Patients should be made aware that there is a degree of over-correction which will be lost as edema resolves. Swelling and bruising typically last for 2–3 days, but both may persist longer. Patients rarely experience significant discomfort, and should avoid taking non-steroidal anti-inflammatory agents in the initial post-treatment period. Patients should be seen with the first 1–2 weeks following injection.

Complications

It is imperative that physicians performing injection of soft tissue fillers are aware of potential adverse effects and also discuss them with their patients. Although certain adverse events may be associated with particular fillers, there are a number of side effects that may occur with all types of soft tissue fillers. A summary of early and late side-effects are provided in Table 75.3.

Table 75.3 Xenogeneic, allogeneic, and alloplastic soft tissue fillers

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During the early time period following treatment (i.e. 1–7 days), patients may exhibit a localized inflammatory reaction characterized by pain, erythema, and edema. The degree of inflammation one exhibits depends on a number of factors, including the amount of filler delivered, anatomic location, skin quality, and co-morbidities. Herpes simplex virus may be activated in patients undergoing injection of soft tissue fillers. Accordingly, it is recommended that patients with a known history of oral herpes simplex infections be pre-treated with valcyclovir (Valtrex) or acyclovir (Zovirax).

Other complications may be the result of technical errors and are therefore important to consider. Delivery of a substance in a layer too superficial can lead to visible or palpable lumps in the skin. Blindness is a dreaded complication that has been described with all types of injectables. Although rare, this complication occurs due to intravascular injection into the supratrochlear artery. Constant movement during injection presumably reduces the risk of this occurrence by preventing intravascular injection through a resting needle. Others recommend compression of the supratrochlear vessels while delivering the filler. Skin necrosis may occur secondary to blockage of the subdermal plexus, but similarly is largely prevented by constant motion of the needle.

The incidence of pre-existing allergy to bovine collagen is approximately 3–5%, and thus warrants skin testing prior to their use. Although acute allergic reactions are less common with other injectables, they have been described for other substances such as hyaluronic acids (0.1%). An allergic reaction in the face manifests as swelling, heat, redness (typically within 30 minutes), and should be treated with systemic steroids.

Other complications may occur/persist during the late post-injection period. Hypertrophic scars may result following superficial injections, and thus are an important pre-treatment consideration in patients with a history of hypertrophic scarring. Granulomas may form 6–24 months following delivery of dermal fillers, and are generally responsive to intralesional steroid delivery. Lipoatrophy of the surrounding tissue has been described as a side-effect of soft tissue fillers, yet the etiology of this rare occurrence is unknown.

Pearls & pitfalls

Pearls

• Ice up the Botox areas, then place the appropriate nerve block for the filler. Use the time that nerve block is taking effect to inject Botox to the desired areas.

• Train with experienced injectors before “experimenting” with the products on your patients.

• “Layering” of products with differing molecular size and cohesiveness may allow a more effective and sometimes longer lasting result.

• Pre- and post-treatment photographs are imperative for comparison, and can often help patients appreciate changes they may otherwise not recognize.

• Use a topical intra-oral cream, (Benzo-gel) before intra-oral V2 and V3 approach.

Pitfalls

• Use a local anesthetic with a vasoconstrictor when working around the periorbital areas to diminish chance of arteriole emboli. Also recommended is compression of the supratrochlear vessels while delivering a filler in order to prevent intravascular injection.

• Always withdraw prior to injection to help prevent embolizing product intra-arterially.

• Thicker fillers (i.e. Zyplast, Cosmoplast) have been associated with vascular compromise and skin sloughing in the glabellar region.

• Injections should be limited to <0.1 mL in order to prevent bumps from forming.

• Inadvertent lumps and bumps that result from injection should be massaged.

Summary of steps

1. The patient is counseled as to the types of available fillers.

2. Risks, benefits and alternatives of procedure are discussed.

3. Informed consent is obtained.

4. Makeup is removed and treatment areas wiped with alcohol swabs.

5. Regions of interest are marked using a delible marking pen.

6. Topical anesthetic cream or a facial cooling system can be applied, and anatomically-specific local nerve block is delivered.

7. The product is injected into the area.

8. The area is cleansed of all ink marks.

9. Any small areas necessitating final adjustment are corrected.

10. Final massage and cleansing.

11. Ice is applied to the injected area.

12. Makeup may then be applied in adjacent post-procedure area.

Further reading

Born TM, Airan LE, McGrath MH, Hughes CE, Nahai F. Soft tissue fillers in aesthetic facial surgery. The art of aesthetic surgery – principles and techniques. St Louis, MO: Quality Medical Publishing; 2005.

Broder KW, Cohen SR. An overview of permanent and semipermanent fillers. Plast Reconstr Surg. 2006;118(3 Suppl):7S–14S.

Fagien S, Klein AW. A brief overview and history of temporary fillers: evolution, advantages, and limitations. Plast Reconstr Surg. 2007;120(6 Suppl):8S–16S.

Klein AW. Filler materials. Grabb and Smith plastic surgery, 6th edn. Philadelphia: Lippincott; 2007.

Lemperle G, Rullan PP, et al. Avoiding and treating dermal filler complications. Plast Reconstr Surg. 2006;118(3 Suppl):92S–107S.

Rohrich RJ, Rios JL, et al. Role of new fillers in facial rejuvenation: a cautious outlook. Plast Reconstr Surg. 2003;112(7):1899–1902.

Zide BM, Swift R. How to block and tackle the face. Plast Reconstr Surg. 1998;101(3):840–851.

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