Your Skin Changes Over Time
Over time, your skin can lose elasticity and moisture. This normal process, plus environmental factors like sun exposure, can cause different facial lines to form, including moderate to severe wrinkles and folds.
Dermal fillers, also known as injectable implants, soft tissue fillers, or wrinkle fillers are medical device implants approved by the Food and Drug Administration (FDA) for use in helping to create a smoother and/or fuller appearance in the face, including nasolabial folds, cheeks and lips and for increasing the volume of the back of the hand.
The FDA has approved dermal fillers made from absorbable or temporary material for the correction of moderate to severe facial wrinkles and skin folds, such as nasolabial folds, which are the wrinkles on the sides of your mouth that extend towards the nose often referred to as “smile lines” or “marionette lines.”
The FDA approved a dermal filler made from non-absorbable (permanent) material ONLY for the correction of nasolabial folds and cheek acne scars in patients over the age of 21 years.
The FDA has approved some dermal fillers for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV).
The FDA has approved several absorbable dermal fillers for uses such as lip and cheek augmentation in patients over the age of 21, and the correction of contour deficiencies, such as wrinkles and acne scars.
The FDA has also approved one filler for hand augmentation, which increases the volume of the back of the hands.
Patients may need more than one injection to get the desirable smoothing/filling effect. Successful results will depend on the health of the skin, the skill of the doctor, and amount and type of filler used. The time that the effect lasts depends on the filler material used and the area where it is injected.
As in any medical procedure, there are risks involved with the use of dermal fillers. That is why it is important for you to understand their limits and possible risks.
Any dermal filler can cause short- or long-term side effects, permanent side effects, or a combination. However, most side effects associated with dermal fillers occur shortly after injection and most go away in less than two weeks. Swelling and pain after hand treatment may last a month or more. In some cases, side effects may appear weeks, months or years after injection. Patients should be tested for allergies before using fillers made with certain materials, especially animal materials (e.g., cow 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 Side Effects Include:
• Itching, Rash
• Difficulty in performing activities (only observes when
injected into the back of the hand)
Less Common Side Effects Include:
|• Raised bumps in or under the skin (nodules or
granulomas) that may need to be surgically removed
• Open or draining wounds
• A sore at the injection site
• Allergic reaction
• Necrosis (tissue death)
The following rare side effects have also been reported to the FDA:
|• Severe allergic reaction (anaphylactic shock) that
requires immediate emergency medical assistance
• Migration/ movement of filler material from the site of
• Leakage or rupture of the filler material at the injection
site or through the skin (which may result from tissue
reaction or infection)
• The formation of permanent hard nodules in the face
• Vision abnormalities, including blindness
• Injury to the blood supply
• Damage to the skin or the tips
If you choose to have permanent fillers removed or reduced through surgery, you may experience the same adverse events typically associated with surgery. You should be aware that it may be difficult to remove the filler material.