Non-biodegradable Dermal Fillers

Several non-biodegradable fillers are available (Table 1.2). As well as being expensive, frequent injections can be quite tiresome for both the patient and the physician, and so the application of a non-biodegradable or permanent filler holds a certain attraction. Conversely, there are certain disadvantages that should be taken into account. First, patients of all ages can be treated in aesthetic medicine. It may therefore be quite uncertain how a permanent depot will appear after 3 or even 4 decades, by which time age and solar- induced elastosis has reduced the dermal and epidermal layers. Second, there is always a possibility of adverse reactions to fillers. The most common subacute or late reaction to permanent fillers is the development of a granuloma. Treatment of an adverse reaction to a filler material is much more difficult when the filler is non-biodegradable because it will provide a permanent stimulus for the surrounding tissue.

Silicone Dermal Filler

Injectable silicone filler is one of the oldest injectable filler materials used. Medical-grade silicon is a clear, oily, colorless liquid composed of long chains of polymerized dimethylsiloxane. There are several methods of injection for this product. One of the recommended techniques is the microdroplet technique (Orentreich 2000; Webster et al. 1986). Fluid silicone is injected into the dermis as 0.01 ml microdroplets. Each mircodroplet is separated by 1 mm. Undercorrection is recommended as the main side effect is a foreign body ( fibrotic) reaction. In fact, as a result of severe adverse reactions, the FDA declared the use of injectable silicone illegal in 1991. Nevertheless, silicone oil is still widely used in other countries.

Polyacrylamide Aquamid

Polyacrylamide (trade name Aquamid) is composed of 97.5 % water and 2.5% cross-linked poly- acrylamide. It is recommended for folds, skin sculpturing, and facial atrophy. It is not effective for new wrinkles. Aquamid should be injected deeply using the subcutaneous tunneling tech- nique (Breiting et al. 2004; De Cassia Novaes and Berg 2003).

Combination of Non-biodegradable and Biodegradable Fillers

Some fillers are a combination of non-biodegradable (permanent) and biodegradable (temporary) materials. The purpose of the biodegradable material is to act as a carrier and to ensure an immediate effect until the fibrotic foreign body reaction induced by the non-biodegradable filler leads to visible effects.

Polymethylmethacrylate PMMA and Collagen – Bellafill / ArteFill

The combination of polymethylmethacrylate (PMMA) and collagen (Artefill / Bellafill) was introduced at the end of the 1980s and is the oldest available combination preparation. PMMA beads are suspended in a solution of 3.5% bovine collagen (as a carrier) and 0.3 % lidocaine (for pain relief). While the collagen resorbs over a period of 2–3 months, the PMMA spheres become en- capsulated by fibrotic material. Bellafill PMMA has been used for a variety of aesthetic indications.

Artecoll / Artefill / Bellafill PMMA should be injected into the lower third of the dermis with a 26- to 27-gauge needle using the tunneling technique. The material should not be injected too supercially; the needle should never be visible through the skin. Careful massage with a fingertip after application helps to distribute the material more evenly. Overcorrection is not advisable; however, a second implantation may be necessary after 3 months (Lemperle et al. 2003). Although the preparation contains collagen, in Europe a skin test is not mandatory (personal communication Ro l Medical International).

Hydroxyethylmethacrylate and Hyaluronic Acid – DermaLive

Hydroxyethylmethacrylate (HEMA) and ethylmethacrylate microspheres suspended in hyaluronic acid have been available in Europe as DermaLive since the end of the 1990s. This product consists of 40% bacterial hyaluronic acid and 60% acrylic hydrogel particles (diameter of 45–65 μm). A similar formulation with larger- sized particles (about 85–110 μm) and a somewhat higher hyaluronic acid content is marketed as DermaDeep and is intended to be injected deeper.

DermaLive should only be injected with a 27.5-gauge needle into the deeper layers of the dermis, at the junction between the dermis and the hypodermis, with the tunneling technique, while DermaDeep is supposed to be injected with a slightly bigger needle (26.5-gauge) deeper into the subperiosteal layer or the hypodermis. Overcorrection must be avoided. In addition, it is recommended that a period of at least 3 months should be le between two injection sessions (Bergeret-Galley et al. 2001).

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Calcium hydroxylapatite (CHP / CAHA) is another comparatively new product that is made from synthetically formed calcium phosphate pearls, a procedure that is classified as bioceramics and involves the ionic bonding of calcium and phosphate ions. When injected they form a foundation within a matrix that allows the local cellular infiltration of fibroblasts. e complex is available as a gel to allow easier application.

Again, as for the majority of injectable llers, there are 40 clinical trials that show equivalence or even superiority to standard products (Comite et al. 2004; Sklar and White 2004; Tzikas 2004). Based on information from the manufacturer, the e ects of this product should last longer than for other biodegradable products.

In contrast to the other fillers, CHP is visible on x-rays; patients should be informed of this so that they can tell their doctors should they re- quire an x-ray of the face.

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Hyaluronic Acid Dermal Fillers

After the bovine collagens, the emergence of different hyaluronic acid preparations has revolutionized the injectable filler market because they require no prior skin test. Hyaluronic acid, which belongs to the family of glycosaminoglycans, consists of repeated disaccharide units. e hydrophilic properties of hyaluronic acid attract water into the extracellular matrix and therefore increase the skin turgor. Hyaluronic acid is gradually degraded. In order to increase the durability of the various hyaluronic acid preparations, stabilization is usually obtained by cross linking with several substances, such as 1.4-butanediol diglycidyl ether, which is found in Restylane.

Hyaluronic acids can be derived from avian or bacterial sources; each product has its own, specific characteristics. Several preparations adapted for different injection depths are available for most products, which di er based on the concentration of hyaluronic acid and the degree of cross-linking, and thus the rate of degradation.

Hyaluronic Acid of Avian Origin

Cross-linked hyaluronic acid of avian origin became the first non collagen filler to be widely used. e Hylaform product family is based on hyaluronic acid derived from processed rooster combs. Several products with different viscosities allow the treatment of different dermal levels. e Hylaform product family, with an average content of hyaluronic acid of 5.5 mg/ml, is easy to inject due to its superior rheological proper- ties and is less palpable than some products of bacterial origin (Manna et al. 1999).

In 2003, data from a clinical trial comparing Hylaform with Zyplast for the treatment of nasolabial folds was presented to the FDA. A total of 480 patients were included in this study which, to our knowledge, has not yet been published. Based on the data that are available from the FDA, no difference between the products could be established. A er 12 weeks the mean (±standard deviation) wrinkle severity score, which ranged from 0 to 5, was 3.3±1.11 for Hylaform and 2.2±1.12 for Zyplast (

Hyaluronic Acid of Bacterial Origin

Typical examples for bacterial hyaluronic acid products are the Restylane and Juvederm / HydraFill families. e hyaluronic acid used for these products has a lower molecular weight, but is used at a higher concentration than the avian products: 20 mg/ml for Restylane and 24 mg/ml for Juvederm / HydraFill.

e rheology of these products is less than that of avian hyaluronic acid, and therefore in- creased pressure has to be applied while inject- ing the material into the dermis. Furthermore, a er injection the product is much more palpable. For example, when treating nasolabial folds the product remains palpable as a threadlike structure for days or even months. e material dissolves more gradually, however, and so over- correction is not necessary.

In contrast to other hyaluronic-acid-based products, clinical trials focusing on safety and durability exist for Hyalform and Restylane. A randomized controlled clinical trial was conducted to compare the e cacy and safety of Restylane and Zyplast. A total of 137 patients were included in the intention-to-treat analysis. A er 6 months the authors concluded that Restylane was superior to Zyplast (based on the assessment of the Winkle Severity Rating Scale). e superi- ority of Restylane (i. e., where the investigator felt that Restylane was more effective) was observed in 56.9 % of their patients, compared to 9.5 % pa- tients in whom the investigator felt that Zyplast was superior (p<0.0001). ose patients in whom there was no difference between these products (33.6 %) were not included in the simple univariate statistics (Narins et al. 2003). Although the authors concluded that Restylane was superior to Zyplast, it was later determined by the FDA that these data were not su cient to claim the superiority of Restylane compared to Zyplast at the de ned study endpoint of 6 months. No such data exist at the moment for any of the other bac- terial hyaluronic acid products. However, clini- cal trials for Juvederm/HydraFill in the United States are underway and are expected to be com- pleted soon.

Combination of Hyaluronic Acid and Dextranes

Combination of hyaluronic acid, hydrox- proylmethylcelluose and dextranes, marketed as Matridex, is thought to be more durable than other products. However, there is as yet no good clinical data on its e cacy and safety.

Polylactic Acid

Polylactid acid (PLA) is a synthetic biodegrad- able material. It is basically the same substance as that used in suture material. When injected into the deep dermis it gradually stimulates collagen formation. is takes some time and the manu- facturer recommends three initial treatment ses- sions, each approximately 6–8 weeks apart. A er the three initial treatments the result are sup- posed to last for up to 2 years. erefore, PLA cannot be compared with a standard ller like hyaluronic acid where the e ects can be seen im- mediately and where the results gradually abate a er each injection.

is product has to be diluted with sterile wa- ter at least 2 h before injection. Although initially the recommended dilution for PLA was 3 ml, the current recommendation is to dilute it in a vol- ume of 5 ml. Some of our colleagues add 1 ml of a local anesthetic to decrease the pain associated with the injection. Only retrograde injection is recommended. Even when administered using the correct injection technique and the higher dilution, in some cases the needle will block dur- ing the injection, at which point the needle has to be changed.

us far, studies on the e cacy and safety of PLA are based mainly on the treatment of HIV patients with drug-induced lipoatrophy (Moyle et al. 2004; Perry 2004; Valantin et al. 2003). Only case reports and case series exist for the use of PLA for aesthetic indications (Rzany et al. 2004; Woerle et al. 2004). According to the manufacturer, a clinical trial covering aesthetic indications is under way in the United States.

Overview of Injectable Fillers – Collagen

Biodegradable Fillers

Biodegradable llers are de ned as having a limited life span usually ranging from a couple to several months, or even to a couple of years. ey usually consist of puri ed dermal compo- nents from human, animal, or bacterial sources and can be divided into the following categories: xenogra s (donor and recipient are from di er- ent species), autogra s (donor and recipient are from the same individual), homogra s (donor and recipient are from the same species), and synthetic materials.

Collagens from various sources and with speci c characteristics exist. erefore, it is important to discuss the di erent products separately.

Collagen of Bovine Origin

Prior to the introduction of the hyaluronic acids, collagen was the most widely used ller and was considered the gold standard with which other dermal llers were compared. e classical bo- vine enzyme-digested collagen (95 % type I, 5 % type III) is available in several preparations, which can be distinguished by the collagen con- tent and the addition of glutaraldehyde for sta- bilization (Homicz and Watson 2004). Glutar- aldehyde crosslinks lysine residues within the collagen structure, thereby increasing the stabil- ity of the product and its ability to resist in vivo enzymatic degradation.

Depending on the collagen content and the degree of crosslinking, di erent products should be used for di erent levels of the dermis. For ex-

ample, Zyderm 1 and Zyderm 2, which are llers with noncrosslinked collagen, should be injected super cially into the papillary level of the der- mis. Zyplast, a crosslinked form, should be in- jected more deeply into the reticular layer. All of these products are easy to inject. Furthermore, overcorrection is recommended for Zyderm 1 and Zyderm 2, as these collagen preparations will loose volume over time.

Zyderm Collagen was cleared for market- ing in 1981 by the Food and Drug Administra- tion (FDA) a er reviewing clinical data based on a large case series of 9,427 tested and 5,109 treated patients (Cooperman et al. 1985; Matti and Nicolle 1990). In addition to this case series, which focused mainly on safety issues, a recent clinical trial showed that it was e ective for at least several months (Cooperman et al. 1985; Matti and Nicolle 1990)

As collagen may elicit hypersensitivity reac- tions, pretesting is so far mandatory. Pretesting consists of an intradermal injection of Zyderm 1 collagen into the volar aspect of the forearm. A minimum of one skin test should be admin- istered and evaluated a er 28 days.

Collagen of Porcine Origin

A few porcine collagen-based llers have been described in the literature (Saray 2003). How- ever, they have not been widely used. A novel porcine collagen ller, Evolence, was introduced into the European market in 2004. In contrast to other collagens, this product is crosslinked by mimicking the process of collagen glycation using d-ribose as the crosslinking agent. A ran- domized clinical trial is currently under way with the objective of presenting the superior ef- cacy of Evolence to bacterial hyaluronic acid for the treatment of nasolabial folds. Data on the e cacy of the implant have not yet been pub- lished. e company that produces this collagen ller states a product durability of at least 1 year. In the recent Conformité Européenne (CE) cer- ti cation of Evolence, pretesting was not consid- ered a prerequisite.

Collagen of Human Origin

Collagen of human origin can be of allogenous or autologous nature.

Collagen of Allogenous Nature (from Cadaver)

In addition to bovine or porcine sources, colla- gen can be derived from human cadavers. Data is available for two products: Dermalogon and Cymetra. Both products derive from pooled hu- man cadaverous tissue from accredited tissue banks. Overcorrection is recommended by the manufacturer. Here again the available data on the e cacy and safety of the product are limited. Cymetra was tested against Zyplast in a random- ized controlled trial. A total of 47 patients were treated: 20 received Cymetra and 27 received Zyplast. Various photometric outcome measures

Collagen of Allogenous Nature (from Culture)

Later-generation noncadaverous collagen prod- ucts are CosmoDerm and CosmoPlast. ey are made from natural human collagen grown un- der controlled laboratory conditions. ere is no need for a pretreatment skin test for these ster- ile devices, which are composed of highly puri- ed human-based collagen that is dispersed in phosphate-bu ered physiological saline contain- ing 0.3% lidocaine. CosmoDerm is a noncross- linked formulation that is used in the treatment of super cial lines, whereas CosmoPlast is cross- linked and is used primarily in the treatment of more pronounced wrinkles. ese products are not available in countries outside of the United States; regulations surrounding products of hu- man origin vary on a country-by-country basis (Bauman 2004). No clinical trials are available because the FDA concluded that since Cos- moDerm and CosmoPlast represent a material source change to Zyderm and Zyplast (from bo- vine- to human-based collagen), they did not re- quire new clinical e cacy studies to be carried out.

Collagen of Autologous Nature

e commercial preparation Autologon consists of dermal extracellular matrix, primarily col- lagen (types I, III, and VI), that has been har- vested from the patient‘s own skin. It requires the excision of the patient‘s skin and is therefore mostly suitable for those undergoing surgical procedures. Here again, overcorrection is rec- ommended by the manufacturer. e available data on the e cacy and safety of the product are limited (Sclafani et al. 2000).

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What makes people want to buy Juvederm? Aside from creating instant results, it also is 100% safe, made of natural animal products, and very cost effective. You can buy 5 3ml syringe refills for only $885.48. That’s only $65 per ml of product. (The best part is that shipping is included in this price.) While most other fullers are either inexpensive or not the quality you are looking for, with Juvederm, you get a high quality product without having to compromise on price, in this case you are getting much more then you pay for. Another great thing is the product can be returned at any point for a full refund.

Now, you may be wondering where Juvederm can be used on the face. It would be easier to ask where is couldn’t be used. When you buy Juvederm, take it to your practitioner and they will be able to treat many areas of the face. Juvederm have been used to stop preliminary signs of aging, such as fines lines, it is used to correct smile lines, for sunken eyes and lip correction. As long as you make exactly what you want clear to your practitioner, the area of our face that has been a source of self-consciousness can be fixed after one treatment   and for 8-12 months you won’t have to worry about people noticing it.

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