Approved Uses of Dermal Fillers

The FDA has approved dermal fillers for use in adults 22 years of age or older (over the age of 21) for specific uses:

• Absorbable (temporary) fillers are approved for moderate to severe facial wrinkles and skin folds, such as nasolabial folds (lines extending from the sides of the nose to the edges of the mouth) and perioral lines (small wrinkles in the skin around the mouth and lips).
• Augmentation (increased volume) of lips, cheeks, chin, and back of the hand.
• Non-absorbable (permanent) fillers are approved for only nasolabial folds and cheek acne scars.
• The restoration and correction of signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV).
• Correction of contour deficiencies, such as wrinkles and acne scars.

Unapproved Uses of Dermal Fillers

The FDA recommends against using dermal fillers or any injectable filler for body contouring and enhancement to:

• Increase breast size (breast augmentation)
• Increase size of the buttocks
• Increase fullness of the feet
• Implant into bone, tendon, ligament, or muscle
• Inject the glabella (area between eyebrows), nose, periorbital area (around the eyes), forehead, or neck

These uses for dermal fillers are not approved by the FDA.

Risks of Using Dermal Fillers

As with any medical procedure, there are risks involved with the use of dermal fillers. It is important to understand their limits and probable risks.

Any dermal filler can cause temporary side effects, permanent side effects, or both. Most side effects associated with dermal fillers occur shortly after injection and many resolve in a few weeks. Swelling and pain after hand treatment may last a month or longer. In some cases, side effects from a dermal filler injection may appear weeks, months, or years after injection.

Unintended injection into blood vessels:

The most concerning risk associated with the use of dermal fillers is unintentional injection into a blood vessel, leading to blocked blood vessels and poor blood supply to tissues. While the chances of this happening are low, if it does happen, the resulting complications can be serious and may be permanent. Complications reported include necrosis (death of tissue), vision abnormalities including blindness, and stroke.

Patients should be tested for allergies before using fillers made with certain materials, especially animal-derived materials (for example, cow (bovine) or rooster comb).

The following risks accompany FDA-approved uses of dermal fillers. The risks associated with unapproved uses of dermal fillers, or with the use of unapproved products are not known.

Common risks include:

• Bruising
• Redness
• Swelling
• Pain
• Tenderness
• Itching
• Rash
• Difficulty in performing activities (only observed when injected into the back of the hand)