In the quest for youth-or at least a more youthful appearance-women and men are seeking treatments to minimize laugh lines, crow's feet, and forehead furrows. A popular treatment involves injecting cosmetic wrinkle fillers into the face.
Injectable cosmetic wrinkle fillers are soft tissue fillers approved as medical devices by the Food and Drug Administration (FDA). These devices are injected into the skin to help fill in facial wrinkles, restoring a smoother appearance. Most of these wrinkle fillers are temporary because they are eventually absorbed by the body.
Dianne Murphy, M.D., is director of FDA’s Office of Pediatric Therapeutics. Dr. Murphy graduated from the Medical College of Virginia and completed her residency in pediatrics at the University of Virginia in Charlottesville. She has been with FDA since 1998.
Q: How does FDA define “children”?
A: For drugs, a child is defined as a person up to 17 years of age. For devices, 21 years of age is the upper limit.
Q: Are medications that are intended for children clinically tested on children?
Some people may need more than one injection to achieve the wrinkle-smoothing effect. The effect lasts for about six months or longer.
Successful results depend on
health of the skin
skill of the doctor
type of filler used
FDA has approved absorbable injectable cosmetic wrinkle fillers for correcting soft tissue contour defects, such as moderate and severe wrinkles and folds. Some absorbable fillers are approved for restoring or correcting the signs of facial fat loss in people with human immunodeficiency virus (HIV).
The only non-absorbable FDA-approved injectable cosmetic wrinkle filler is for correcting facial tissue around the mouth.
FDA-approved cosmetic wrinkle fillers should not be used for
plumping the lips (lip augmentation)
increasing breast size (breast augmentation)
implanting into bone, tendon, ligament, or muscle
implanting into blood vessels
Wrinkle fillers are made of various types of materials, and some include a combination of products. Some products also contain lidocaine, which numbs the skin at the injection site.
The materials used in injectable cosmetic wrinkle fillers include
Temporary (absorbable) fillers
Collagen injections are made of highly purified cow or human collagen. Collagen is a natural protein that is a major component of skin and other tissues in the body.
Hyaluronic acid gel is a protective lubricating gel, produced naturally by the body, that binds with water to plump the skin.
Calcium hydroxylapatite is a mineral that is a major component of bone. Calcium hydroxylapatite is a well-matched (biocompatible) material that dissolves in the body (biodegradable) and is implanted in the form of a gel.
Poly-L-lactic acid (PLLA) is a biodegradable, biocompatible, synthetic material from the alpha-hydroxy-acid family that has been widely used for many years in dissolvable stitches and bone screws.
Permanent (non-absorbable) filler
Polymethylmethacrylate beads (PMMA microspheres) are tiny round, smooth plastic particles that have been tested to be biocompatible. They are not absorbed by the body.
Getting injected with cosmetic wrinkle fillers is an elective procedure. As with any medical procedure, it poses risks.
Possible side effects include
itching and rash
raised bumps of skin (nodules or granulomas) that may need to be surgically removed
death of skin, which may cause disfiguration, if the cosmetic wrinkle filler is injected and blocks a blood vessel
sore (abscess) at the injection site
wrinkle filler that breaks through the skin
open or draining wounds
blurred vision and flu-like symptoms
increased allergic reaction that may lead to a severe allergic reaction (anaphylactic shock) that requires emergency medical help. (Your doctor may request a pre-treatment allergy test to determine if you are allergic to the filler.)