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have been reported, but are less likely if the new injection guidelines are followed55,56 Sculptra injection technique is very different than that of HA fillers and the learning curve is higher In addition, there is lack of reversibility as with HA fillers Specialized training is required by the manufacturers of Sculptra before they will sell the product to a physician
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Although the current momentum in the cosmetic market is toward the less invasive procedures, which are safer, permanent fillers are very popular outside the US because of the lower cost Many of these products are used by unskilled practitioners and lead to disfiguring results If practitioners are to use a permanent filler, they should be skilled in the technique and certain of the patient s expectations In the primary author s opinion, it is best to use a temporary filler first, to make sure that a patient is pleased, before proceeding to a permanent or semipermanent option Newer fillers (eg, Artefill) as well as older fillers (eg, silicone) are being used for this purpose These nonbiodegradable fillers stay enclosed by the skin for an indeterminate and lasting period of time However, these fillers are not to be used for and by the lighthearted They are associated with rare, significant side effects such as granulomas, migration, and asymmetry and are best implanted into a patient experienced with prior soft tissue augmentations and by a proficient physician Remember, as with anything enduring, if one is not pleased with the results, one has to live with long-term consequences ARTEFILL Overview In October 2006, the FDA approved the novel permanent filler Artefill (Artes Medical, Inc, San Diego, CA) for the correction of nasolabial folds57 Artefill is constituted with 20% homogenous polymethylmethacrylate (PMMA) suspended in equilibrium with partly denatured 35% bovine collagen (from enclosed US cattle herds) and 03% lidocaine As opposed to the original European product, Artecoll, which contained different size microspheres of PMMA that potentially contributed to a higher risk of granulomas, Artefill is composed of uniform size PMMA microspheres (30 50 m) that are less likely to result in the formation of granulomas Small size, uniformity, and smoothness are refined characteristics of Artefill that promote biocompatibility
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and resistance to phagocytic degradation and migration as well as ensure encapsulation by patients collagen leading to lasting nonimmunogenic results Artefill is packaged in a kit of three 08-mL and two 04-mL syringes that are injected through a 26-gauge needle into subdermal and subcutaneous space via a tunneling technique without overcorrection33 After injection, gentle massage is recommended to evenly distribute material in the skin and prevent clumping Artefill must be stored via refrigeration (2 C 10 C) and warmed before use In order to achieve optimal correction of rhytides, two to three treatment sessions, a few months apart, are suggested51 Like Sculptra, specific injection training for Artefill is required Bene ts Artefill offers the dual action of immediate wrinkle correction from collagen (lasting about 1 3 months) and permanent deep-fold ablation from PMMA (lasting for more than 5 years)51 The long-term efficacy is believed to be because of the stimulatory influence of PMMA on the surrounding skin, causing fibroblast and collagen proliferation around the material starting at 1 month33 Although approved only for nasolabial folds, PMMA has also been successfully used in other deeper defects (eg, the cheek and malar regions) Lidocaine content eliminates the necessity for alternative anesthesia and alleviates intrainjection discomfort As compared to the standard of bovine collagen, PMMA filler has been found to be superior in efficacy with a comparable safety profile51 Widely used in implantable medical devices for more than 50 years, PMMA has a long safety record32 Drawbacks Artefill contains bovine collagen; therefore, skin testing prior to injections is strongly advised to reduce the incidence of hypersensitivity This means that patients cannot be treated on the initial office visit Furthermore, because of Artefill s higher viscosity, more administration pressure is required by the clinician, and the product is more difficult to inject than collagen and HA fillers Although the majority of side effects caused by Artefill are mild and transient (eg, swelling, redness, hypersensitivity, and temporary lumpiness, which is amenable to massage), rare moderate-to-severe effects have been reported (eg, granuloma and inflamed nodule formation, manageable with intralesional steroids or excision)51 Because of the reported lumpiness with
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this product, it is currently discouraged for lip augmentation or any superficial wrinkle correction Having to inject through a larger bore needle may induce more posttreatment edema and ecchymoses, which require slightly longer downtime The disadvantage of implanting permanent fillers such as Artefill is the inability to foretell the long-term appearance of the patient; since the skin changes with age, the natural look may be altered Time will tell the exact risk-to-benefit ratio of this filler SILICONE Overview Silicone is composed of dimethylsiloxane chains linked by oxygen with varied viscosity based on the length of the polymer Used in patients since the 1940s, the liquid form of this product is one of the oldest soft tissue augmentation materials58 The use of this injectable filler is fraught with controversy because the initial unpurified product was associated with long-term disfiguring side effects, including migration and granuloma formation It was illegal to perform silicone injections in the US in some states until recently However, because of the purification of liquid silicone and honing of the injection technique, this soft tissue filler has returned and is very popular in Brazil At the turn of the 21st century, the FDA approved two forms of medical-grade silicone oils: ADATO (or Sil-ol 5000, Bausch & Lomb Surgical, Inc, San Dimas, CA) with 5000 centistoke (cs) viscosity and Silikon 1000 (Alcon Laboratories, Inc, Fort Worth, TX) with 1000 cs viscosity These are both indicated for the ophthalmologic uses of retinal temponade and detachment32,33 Although neither of these products have been approved by the FDA as skin injectables, they are used off-label Furthermore, there are ongoing studies in the US assessing the safety and efficacy of SilSkin (a 1000 cs, highly purified polydimethylsiloxane, OFASTherapeutic Silicone Technologies, Inc, New York, NY) for the correction of nasolabial folds and HIV-associated lipoatrophy Pilot studies in patients with HIV-lipoatrophy have revealed satisfactory results with minimal side effects59 Similar to PMMA and PLLA, silicone oil biostimulates the surrounding skin to slowly generate a focal fibro-granulomatous reaction that leads to a permanent volumizing Zappi et al analyzed the microscopic biologic behavior of liquid silicone and concluded that it was an effective, durable (up to 23 years), and immunologically compatible filler60
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