Dermal fillers vary from biologic to synthetic materials, and from absorbable to nonabsorbable compounds. In general, dermal fillers are volume-producing agents that are approved for injection into the dermal layers for the correction of moderate-to-severe wrinkles, contour deficiencies, folds, depressions, and to increase volume in the hands.
Dermal fillers include human fat and medical device implants approved for medical use by the Food and Drug Administration (FDA). Autologous fat transfer is the removal of fat from one part of the body and transferring it somewhere else on the body. The FDA has approved a multitude of injectable dermal fillers and volume-producing agents for treatment localized to the face in order to create a smoother appearance. The agents include, but are not limited to, autologous cellular product (azficel-T, laVív), human collagen (CosmoDerm, CosmoPlast), hyaluronic acid (Restylane, Restylane L, Juvederm, Captique, Belotero Balance, Prevelle Silk, Hydrelle), bovine collagen (Zyplast, Zyderm), human collagen from human tissue (Cymetra), microscopic plastic beads and polymethyl methacrylate [PMMA] microsphere-enhanced bovine collagen (Artefill), calcium hydroxylapatite [CaHA] (Radiesse®), and Poly-L-Lactic Acid (PLLA) (Sculptra Aesthetic). In addition, Restylane and Restylane L Injectable Gels are approved for lip augmentation in those over the age of 21 years.
The FDA has also granted approval to two dermal fillers, Sculptra® and Radiesse®, to address facial lipoatrophy, which is a component of lipodystrophy syndrome (LDS) in individuals with human immunodeficiency virus (HIV). LDS is associated with a triad of complications, including lipoatrophy (localized loss of subcutaneous fat); lipodystrophy (regionalized fat accumulation); and metabolic abnormalities (insulin resistance, hypercholesterolemia, and hypertriglyceridemia). Facial LDS is often characterized by a localized loss of fat from the face, resulting in facial abnormalities such as excessively sunken cheeks. Facial LDS may occur as a side effect of medicinal (antiretroviral) therapies that individuals receive as part of an HIV infection treatment regimen. Facial LDS may occur by itself and should not be confused with HIV wasting, which may also occur in the face. HIV wasting affects muscle rather than subcutaneous fat and is not a part of LDS. Individuals with facial LDS may experience adverse psychological conditions, such as depression, and stop their HIV treatments in an attempt to halt or reverse this complication.
Sculptra® (injectable poly-L-lactic acid) is a biodegradable, biocompatible synthetic polymer that is injected below the surface of the skin in individuals with HIV and facial LDS. It works by inducing the synthesis and deposition of the body's own collagen to create a smoother, fuller appearance of underlying dermal tissues. Injections are administered in a series that may last for a year or more, and they do not correct the underlying cause of the facial fat loss. There is no literature providing evidence that Sculptra® improves the physiological functioning of the eyes, nose, mouth, or chin.
Radiesse® (injectable calcium hydroxylapatite [CaHA]) is a semi-solid, cohesive implant, whose principle component is synthetic CaHA suspended in a gel for injection below the skin in individuals with HIV and facial LDS. Small particles of CaHA act as a scaffold for collagen growth, which promotes volume replacement to folds and sunken facial areas. In a clinical study, the treatment lasted for one year after the first treatment session in all individuals. As with Sculptra®, there is no literature providing evidence that Radiesse® improves the physiological functioning of the eyes, nose, mouth, or chin.
Repetitive injections with both Sculptra®, and Radiesse® may be necessary to maintain the therapeutic treatment effect in individuals with HIV and facial LDS.
The use of injectable dermal fillers has aesthetic applications. For example, these products provide volume for wrinkles around the eyes, cheeks, lips, and neck, thereby improving appearance. Cosmetic services are those provided to improve an individual's physical appearance, from which no significant improvement in physiological function can be expected. Emotional and/or psychological improvement alone does not constitute improvement in physiological function.
