Restylane and Other Injectables At-A-Glance

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
Zyderm/ Zyplast	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 begin to take effect 5-7 days, maximum effect in two 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.

Reprinted with permission from the American Society of Plastic Surgeons Web site.

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