Parkwest Plastic Surgery, PLLC

For Immediate Release: September 17, 2003

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, tendons and ligaments. 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. More than 576,000 people had collagen injections in 2003, 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 using sterile techniques from donors or grown in a laboratory, are 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. Doesn't require a skin test.	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, adds bulk.	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, time consuming and expensive	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 bovine 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 61,000 individuals had fat injections in 2003, 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, Myobloc^TM and Dysport^® are under FDA review for cosmetic use.

More than 3.1 million people had Botox^® injections in 2006, according to ASPS. Botox injections were the most popular cosmetic minimally invasive procedure in 2006. Fifty-seven 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, hyperhydrosis	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 hyaluronic acid manufactured by recombinent technology, which adds volume to minimize wrinkles and lines. As the substance naturally occurs in humans and all animals, allergic reactions are rare. According to ASPS, more than 44,000 people had Restylane injections in 2003. 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

Non-animal based derived hyaluronic acid.

Soft tissue filler that adds volume

Redness, swelling, rare allergic reaction

Immediate lasting up to 1 year

FDA approved for filling moderate to severe wrinkles around the nose and mouth.

Hylaform

Hyaluronic acid extracted from rooster combs

Soft tissue filler to add volume

Redness, swelling. People with sensitivities to avian products may have an allergic reastion.

Vary, up to 6 months

FDA approved

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.

Another semi-permanent filler, Sculptra, a synthetic polylactic acid, has been approved to restore volume in HIV patients who are suffering from facial lipoatrophy. Sculptra has been marketed under the trade name, New Fill in Europe.

Injectable	Description	Purpose	Possible Side Effects/ Risks	Results	Regulatory Status
Artecoll	75% percent bovine collagen and 25% polymethyl-methacrylate microspheres (non-silicone, carbon –based polymers)	Artecoll’s manufacturer claims the injectable is permanent, as the microspheres do not absorb into the body. The body forms collagen around the micro-spheres that adds bulk	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 that adds bulk.	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.
Sculptra	Synthetic polylactic acid contained in microspheres	Restores lost facial volume in people with HIV. The body forms collagen around the microspheres	Redness, bruising, lumping and granulomas	Immediate according to manu-facturer	Recommended by FDA panel with conditions to reconstruct HIV patients suffering from facial lipoatrophy. In use outside the U.S. as New Fill, to fill wrinkles.

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.