Injectable Cosmetic Wrinkle Fillers
November 11, 2011 zhion@zhion.com    
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. Some people may need more than
one wrinkle filler 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 and type of wrinkle filler used.

Uses
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.

Wrinkle Filler Materials
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) wrinkle 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) wrinkle 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.

Risks
Getting injected with cosmetic wrinkle fillers is an elective procedure. As with any medical procedure, it poses risks.
Possible side effects include infection bruising redness swelling pain tenderness 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 and increased allergic reaction that may
lead to a severe allergic reaction (anaphylactic shock) that requires emergency medical help.

Most side effects of wrinkle fillers occur shortly after injection and go away within seven days. In some cases, side effects
may emerge weeks, months, or years later.

A non-absorbable wrinkle filler may cause long-term side effects. You should not use cosmetic wrinkle fillers if any of the
following applies to you: severe allergies marked by a history of anaphylactic shock, allergy to cow collagen or eggs,
allergy to lidocaine, inflamed or infected skin, prone to form excessive scarring (keloid) or thick scarring (hypertrophic
scars), bleeding disorder and active inflammatory condition (cysts, pimples, rashes or hives) or infection; you should
postpone treatment until the condition is controlled.
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Botox
Botox Cosmetic is an injectable drug, but it is not a wrinkle filler. Instead of filling the wrinkle, it keeps muscles from
tightening so the wrinkles don’t show as much. FDA has approved Botox Cosmetic only to treat wrinkles between the
eyebrows.
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FDA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and
effective use of the wrinkle fillers when injected into the nasolabial folds.
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contact information on the label.

There are always new information. Please, send me an email (
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care has been taken in preparing this document and the information provided herein is believed to be accurate. The
information is not intended to be a substitute for professional medical advice. It is important to seek the advice of a
physician about any medical condition or symptom or the benefits and side effects of a supplement or a drug product.
Finally, please, do not transfer the article to other website. Thank you. ALL RIGHTS RESERVED.
Reference: Wrinkle Relief: Injectable Cosmetic Fillers. FDA C o n s ume r He a l t h In f o rma t i o n / U. S . F o o d a n d Dr u g Admin i s t r
a t i o n JUNE 2008
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Trade Name
Material
Applicant         
PMA Number
Decision
Date
ARTEFILL
Polymethylmethacrylate Beads,
Collagen and Lidocaine.
Suneva Medical,
Inc.
P020012
10/27/2006
RESTYLANE INJECTABLE
GEL
Hyaluronic Acid
Q-med Ab
P020023
12/12/2003
HYLAFORM (HYLAN B GEL)
Modified hylauronic acid derived
from a bird (avian) source
Genzyme
Biosurgery
P030032
4/22/2004
CAPTIQUE INJECTABLE GEL
Hyaluraonic Acid
Genzyme
Biosurgery
P030032 S002
11/12/2004
PREVELLE SILK
Hyaluraonic Acid with Lidocaine
Genzyme
Biosurgery
P030032 S007
2/26/2008
SCULPTRA
Poly-L-Lactic Acid (PLLA)
Sanofi Aventis U.S.
P030050
8/3/2004
SCULPTRA AESTHETIC
Poly-L-Lactic Acid (PLLA)
Sanofi Aventis U.S.
P030050 S002
7/28/2009
RESTYLANE INJECTABLE
GEL
Hyaluraonic Acid
Medicis Aesthetics
H
P040024
3/25/2005
ELEVESS
Hyaluraonic Acid with Lidocaine
Anika Therapeutics
P050033
12/20/2006
RADIESSE 1.3CC AND 0.3CC
Hydroxylapatite
Bioform Medical, Inc
P050037
12/22/2006
JUVEDERM 24HV,
JUVEDERM 3
Hyaluraonic Acid
Allergan
P050047
6/2/2006
RADIESSE 1.3CC AND 0.3CC
Hydroxylapatite
Bioform Medical, Inc
P050052
12/22/2006
EVOLENCE COLLAGEN
FILLER
Collagen
Colbar Lifescience l
P070013
6/27/2008
ZYDERM COLLAGEN
IMPLANT
Collagen
Allergan
P800022
7/22/1981
ZYPLAST(R
Collagen
Collagen Corp.
P800022 S011
6/24/1985
COSMODERM 1
HUMAN-BASED C
Collagen
Inamed Corporation
P800022 S050
3/11/2003
COSMODERM AND
COSMOPLAST
Collagen
Inamed Corporation
P800022
S052         
5/11/2004
FIBREL
Collagen
Serono
Laboratories
P850053 S001
7/18/1988