For centuries, physicians and patients have sought non-surgical
therapies to remove or reduce the appearance of facial wrinkles and
aging. Many materials have been tried; some with good results,
others with disastrous results and others have proven ineffective.
The products mentioned below represent a partial listing of
injectables receiving ongoing attention.
As the largest plastic
surgery organization in the world and the foremost authority on
cosmetic and reconstructive plastic surgery, the American Society
of Plastic Surgeons welcomes the introduction of new and
exciting therapies and products. The society however, cautions that
without meaningful scientific evaluation, physicians may be
unwilling to use products until there is convincing evidence of
their safety and efficacy.
Collagen (Bovine based)
Since the 1980s, injectable collagen has been used as a
soft-tissue filler. Collagen is a naturally occurring protein that
supports various parts of the body including skin and joints.
Commonly used injectable collagen is made from purified cow skin to
fill wrinkles, lines and scars on the face. The primary risk of
injectable collagen is allergic reaction. Injectable collagen
absorbs into the body. Nearly 450,000 people had collagen injections
in 2002, according to the (ASPS)
|
Injectable |
Description |
Purpose |
Possible Side Effects/Risks |
Results |
Regulatory Status |
|
Collagen injection made from
purified cow skin. |
Fills wrinkles, lines and scars on
face and around lips. |
Allergic reaction. Requires skin
test prior to procedure. |
Immediate, lasts up to 6 months. |
FDA Approved |
Human Tissue Derived Collagen
A group of human-derived collagen products are currently
available in the United States. The tissue, harvested from donors or
grown in a laboratory, is sterilized and processed to form an
injectable human collagen matrix.
|
Injectable
|
Description |
Purpose |
Possible Side Effects/
Risks |
Results |
Regulatory
Status |
| Cymetra
(Micronized Alloderm)
|
Injectable human tissue collagen
matrix derived from cadaver tissue, screened for contamina-tion. |
Filler for lips, nasolabial folds,
deep wrinkles and lines. |
Bruising |
Multiple treatments needed. Lasts 2
months |
FDA Approved |
| CosmoDerm/ CosmoPlast |
Derived from human tissue that has
been purified and grown in a laboratory |
Approved for frown lines, crow’s
feet, forehead lines, smile lines, vertical lip lines,
marionette lines, lip border and for certain scars. Cosmoderm is
used for superficial lines, while Cosmoplast is used for more
pronounced wrinkles. |
Bruising |
Immediate. Results last up to six
months depending on the area treated |
FDA Approved |
| Fascian |
Injectable derived from
donor-fascia (connective tissue made of collagen) of the thigh
muscle. |
Stimulates collagen formation |
Bruising |
Lasts up to 6 months |
FDA Approved |
| Autologen |
Injectable collagen
prepared from the patient’s skin. Small pieces of skin are
harvested for the patient, processed and prepared for injection
or frozen for later use. |
An alternative to
traditional collagen injections. |
Bruising |
2 or 3 treatments over
a 6 to 8 week period to produce collagen. Not permanent |
Not required |
Human Derived Product
|
Injectable |
Description |
Purpose |
Possible Side Effects/ Risks |
Results |
Regulatory Status |
| Plasmagel |
Plasma emulsion
(protein) made of patient’s blood and Vitamin C complex |
Soft tissue filler to
add volume |
Bruising |
Lasts up to 3 months |
Not required |
Fat
Fat injections have been used for years to add volume,
fill wrinkles, lines and enhance the lips. Fat injections involve
taking fat from one part of the patient’s body (abdomen, thighs or
buttocks) and reinjecting it beneath the facial skin. Unlike
collagen, allergic reaction is not a factor as the fat is harvested
from the patient’s own body. Results are variable, but can be
permanent. More than, 54,000 individuals had fat injections in 2002,
according to the ASPS.
Botulinum toxins
Botulinum toxins have been used for neck spasms, cranial nerve
disorders and eye spasms. With the recent FDA approval of Botox for
cosmetic use in the glabellar region, the drug is used to smooth
wrinkles. When injected into facial muscles botulinum toxins block
nerve impulses, temporarily paralyzing muscles and smoothing
wrinkles. Currently Botox® is the only form of
botulinum toxin approved by the FDA for cosmetic purposes in the
glabellar region, but two others, MyoblocTM and
Dysport® are under FDA review for cosmetic use.
More than 1.1 million people had Botox® injections in
2002, according to ASPS, representing 15 percent of non-surgical
cosmetic plastic surgery procedures. Fifty-four percent of all Botox®
procedures were performed on people between the ages of 35 –50.
|
Injectable |
Description |
Purpose |
Possible Side Effects/
Risks |
Results |
Regulatory
Status |
| Botox |
Botulinum toxin type A |
Smoothes wrinkles |
Bruising, numbness, droopy eyelids,
body may become immune |
Can begin to take effect 5-7 days,
maximum effect in two weeks |
FDA Approved for use in the
glabellar region |
| Myobloc |
Botulinum toxin type B; Requires
larger dose than Botox but takes effect more quickly. Myobloc
has a longer shelf life than Botox. May serve as alternative to
patients resistant to botulinum toxin type A. |
Smoothes wrinkles |
Bruising, numbness, droopy eyelids,
body may become immune |
Can takes effect in 4-6 hours,
maximum effect in 2 weeks |
In use outside U.S. FDA approved
only for cervical dystonias. Off-label use is permitted. |
| Dysport |
Botulinum toxin type
A; Requires larger dose than Botox but manufacturer claims
injections are stronger and last longer with patients returning
twice a year rather than four treatments with Botox. |
Smoothes wrinkles |
Bruising, numbness,
droopy eyelids, body may become immune |
Can begin to take
effect 5-7 days, maximum effect in two weeks |
In use outside the
U.S. FDA decision pending. |
Hyaluronic Acid
Hyaluronic acid exists naturally in all living organisms and is a
natural component of connective tissues, including the skin.
Hyaluronic acid has been used to treat joint pain. Restylane
is a soft tissue filler made of synthetic hyaluronic acid, which
adds volume to minimize wrinkles and lines. As the substance
naturally occurs in humans, allergic reactions are rare. Restylane
is being used in Canada and Europe. Hylaform is another
tissue filler composed of hyaluronic acid extracted from rooster
combs. It is currently used in Canada and Europe.
|
Injectable |
Description |
Purpose |
Possible Side Effects/Risks |
Results |
Regulatory
Status |
Restylane/
Perlane |
Non-animal based derived hyaluronic
acid. Perlane is reserved for deep facial lines |
Soft tissue filler that adds volume |
Rare allergic reaction |
Immediate lasting up to 1 year |
In use outside the U.S. FDA
decision pending. |
| Hylaform |
Hyaluronic acid extracted from
rooster combs |
Soft tissue filler to add volume |
Redness, swelling, higher rate of
allergic reaction-animal based product |
Vary, usually 3 – 6 months |
In use outside the U.S. FDA
decision pending. |
Semi-permanent Fillers
Two additional soft tissue fillers being studied for their
wrinkle reducing and volume-adding qualities are: Artecoll®
and Radiance TM. Artecoll is a permanent
"micro-implant" to fill facial wrinkles and lines, which is
currently used in Europe, Canada and Mexico. Radiance is composed of
calcium hydroxylapatite, which has been used in the body for
multiple applications including cheek and chin implants. Radiance is
injected into the face adding volume through microspheres that are
suspended in polysaccharide carriers until encapsulation occurs.
|
Injectable |
Description |
Purpose |
Possible Side Effects/
Risks |
Results |
Regulatory Status |
| Artecoll |
75% percent collagen and 25%
polymethyl-methacrylate microspheres (non-silicone, carbon
–based polymers) |
Artecoll’s manufacturer claims the
injectable is permanent, as the micro-spheres do not absorb into
the body. The body forms collagen around the micro-spheres. |
Lumping, granulomas (localized skin
reactions to foreign bodies, which can appear as hardness or a
rash), micro-spheres can possibly move to other areas of the
body |
Immediate |
In use outside the U.S. FDA
decision pending. FDA advisory panel recom-mended approval with
conditions 2/03. |
| Radiance (Bioform) |
Calcium hydro-xylapatite
(a substance found in bone and teeth, made into an injectable
paste) |
Reported to last 2-5
years. Little risk of allergic reaction The body forms collagen
around the microspheres. |
Clumping, lumping,
granulo-mas, micro-spheres may move to other areas of the body |
Immediate according to
manu-facturer |
FDA approved only for
vocal cord paralysis and urinary incontin-ence. Off label use
permitted. |
Silicone
Injectable Silicone is not approved for cosmetic use in
the United States. In 1991 the FDA banned its use for the treatment
of wrinkles and facial defects. Injectable silicone tends to harden,
migrate and cause inflammation and skin necrosis.
ASPS, founded in 1931, is the largest plastic surgery
organization in the world and the foremost authority on cosmetic and
reconstructive plastic surgery. ASPS represents physicians certified
by The American Board of Plastic Surgery (ABPS) or The Royal College
of Physicians and Surgeons of Canada. For referrals to ABPS-certified
plastic surgeons in your area and to learn more about cosmetic and
reconstructive plastic surgery, call the ASPS at (888) 4-PLASTIC
(888-475-2784) or visit www.plasticsurgery.org.