Dermal fillers, injectable implants, or soft tissue fillers are gelatin-like products intended to be injected under the outer layers of the skin to improve the appearance of wrinkles, depressions, and defects such as scarred tissue, or correct loss of volume on different body parts, allowing a smoother and fuller appearance. These products are considered medical devices by the US FDA.

According to its composition and capacity to be absorbed by the human body, there are temporary (absorbable) and permanent (non-absorbable) dermal fillers.

Absorbable products include hyaluronic acid (HA), hydroxyapatite, and poly-L-lactic acid (PLLA).

The US FDA approved only one non-absorbable product made from polymetylmathacrilate pearls embedded in a collagen solution.

Dermal fillers are approved by the US FDA for the following specific purposes:

• Filling skin folds around the nose and mouth.
• Increasing fullness of lips, cheeks, chin, mandible, and back of the hand.
• Correcting lipoatrophy
• Correcting wrinkles and acne scars

• Bruising
• Redness
• Swelling
• Pain
• Rash
• Itching
• Necrosis of the skin, is a serious complication associated with accidental injection into blood vessels.

No dermal fillers have been approved by the FDA for:

• Breast augmentation
• Buttocks contouring
• Correcting or filling the area between the eyebrows (glabella), nose, perioral, forehead, or neck.
• Spaces between muscles

Injectable silicone remains permanently in the body, hence it is not considered a dermal filler. The US FDA has not approved injectable silicone to be used in aesthetic procedures. Its utilization may be associated with grave and permanent side effects such as infection, disfigurement, and even death.

The FDA has approved a number of botulinum toxin derivatives (e.g. Botox) for the treatment of facial lines and wrinkles. These products are not dermal fillers and are considered injectable drugs. The safety of the combination of dermal fillers and botulinum toxin products has not been scientifically proven.

Source: FDA

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