The popularity of dermal fillers has grown rapidly in recent years because they offer the rejuvenative and enhancing aesthetic improvements previously only achievable with surgery, but at lower cost and with limited-to-no recovery time. According to data from the American Society for Aesthetic Plastic Surgery (ASAPS), more than 1.6 million dermal filler treatments were performed in 2011, making them the second most popular nonsurgical cosmetic procedure performed in the USA after neuromodulators; the latter procedure is frequently performed in concert with dermal filler injections.
As public awareness and acceptance of dermal fillers grows, so does the size of the market, with an estimated 160 products currently available worldwide from more than 50 companies. Their main indications are the filling of rhytides and folds, and correction of soft tissue loss due to disease or age. Increasingly, fillers are used for volume replacement and enhancement procedures, including cheek and chin augmentation, tear trough correction, nose reshaping, midfacial volumization, lip enhancement, hand rejuvenation, and the correction of facial asymmetry. As the indications and the number of procedures performed increase, the number of complications will likely also increase.
Understanding the different characteristics, capabilities, injection techniques, risks, and limitations of available fillers is essential for injectors to reduce the risk of complications, improve patient outcomes, and care for patients who have experienced adverse events. This requires expert familiarity with the properties and potential complications of a wide range of products, including those that are not available in the injector’s country of practice, as patients may present with adverse reactions to fillers that were injected abroad. Particularly important is how the incidence of local adverse events following treatment is related to the injection technique versus the chemical composition of the dermal filler. This review will provide physicians with a background to the etiology of filler-related complications, and structured and clear guidance on their treatment and avoidance.
In this article, we mainly focus on ArteFill or ArteColl and Sculptra. ArteFill or ArteColl consists of 80% bovine dermal collagen plus 20% 32-40um PMMA microspheres. The collagen vehicle is degraded within 1–3 months, leaving the microspheres encapsulated by a fine fibrous capsule. Sculptra aesthetic is an injectable implant containing microparticles of poly-L-lactic acid (PLLA), carboxymethylcellulose (USP), non-pyrogenic mannitol (USP) and sterile water for injection (USP).
Pic.1: Characteristics of Sculptra and ArteFill
1. ArteFill or ArteColl
Cost: about $700 per syringe, but can vary widely
Allergy test required: Required because of the bovine collagen component of the injection
Durability: 1 year but maybe permanent
Function / Purpose:
Treatment of medium-to-deep wrinkles, folds and furrows, particularly nasolabial folds; also may be suitable for pitted scars, lip augmentation, etc.
Polymethylmethacrylate (PMMA) is nonbiodegradable, relatively nontoxic and chemically inert dermal filler used under the brand of ArteFill (a.k.a. ArteColl). It consists of PMMA microspheres suspended in bovine collagen solution. Due to the presence of bovine collagen, it requires an allergy test.
Polymethylmethacrylate (PMMA) is a synthetic polymer with a long history of use in medical implants. It has been used in bone cement, dentures, pacemaker covers and so forth. It is considered nonbiodegradable, relatively nontoxic and chemically inert. As a dermal filler, it is being used under the brand of ArteFill (a.k.a. ArteColl), which, in essence, is PMMA microspheres (microscopic particles of spherical shape about 30-40 microns in diameter) suspended in bovine collagen solution. The anesthetic lidocaine 0.3% is included in the injection to reduce discomfort.
The role of collagen solution in ArteFill is to provide a smoother suspension and possibly aid in skin matrix integration. After the injection of ArteFill, the bovine collagen is degraded over about 2-3 month. At the same time, PMMA gets encased in the patient’s own collagen produced in response to foreign material and bovine collagen. This results in good integration of the filler and produces highly durable results with low risk of filler migration. There have been reports of cases when the injections area became hardened or bumpy, possibly due to excessive formation of the scar tissue. Whether this was primarily to the reaction of PMMA or bovine collagen remains unclear. This complication may respond to a steroid injection.
ArteFill (ArteColl) has been in cosmetic use since late eighties – longer than most cosmetic synthetic filler on the market. The incidence of long-term side-effects appears to have been relatively low. ArteFill requires prior allergy test due to bovine collagen component.
Cost: about $600 per syringe, but can vary widely
Allergy test required: Not required
Target User: SCULPTRA Aesthetic is indicated for use in immune-competent people as a single regimen forcorrection of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate. SCULPTRA Aesthetic should not be used in any person who has hypersensitivity to any of the components of SCULPTRA Aesthetic
Durability: Lasts 1–2 years, effects develop gradually
Function / Purpose: According to documents from the US Food and Drug Administration, the FDA initially approved the drug on the basis of small studies conducted on HIV patients, specifically “for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV).
Sculptra is a proprietary formulation of poly-L-lactic acid (PLLA) that is an FDA-approved dermal filler manufactured by Dermik Laboratories, which conducts the North American business of Aventis Dermatology, the global dermatology unit of Aventis (of Sanofi-Aventis).
PLLA was approved by the FDA on August 3, 2004, for the treatment of facial fat loss (also called facial lipoatrophy). According to documents from the US Food and Drug Administration, the FDA initially approved the drug on the basis of small studies conducted on HIV patients, specifically “for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV). Facial lipoatrophy is a condition in which people lose fat in their faces, especially in their cheeks and around their eyes and temples. People with HIV who take anti-HIV drugs may develop lipoatrophy. Sculptra was subsequently approved by the FDA for use with non-HIV patients with wrinkles, despite substantial complications reported to the FDA.
PLLA is injected into the skin in areas where fat has been lost. It causes the skin to thicken via collagen neo-synthesis, improves appearance of folds and sunken areas, and hides the fat loss. For most people who participated in PLLA clinical studies, the effects of treatment lasted for two years.
Side effects of Sculptra injections included the delayed appearance of small bumps under the skin in the treated area. Other side effects included bleeding, tenderness or discomfort, redness, bruising, or swelling