Injectable Fillers

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In the quest to eradicate the signs of aging, cosmetic plastic surgery patients continue to demand better results with less recovery time. Recent advances in technology aim to meet those demands, giving plastic surgeons and patients many options for facial augmentation. 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 ASPS 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) Injectable Fillers

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 265,000 collagen injection procedures were performed in 2006, 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 Injectable Fillers

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 contami-nation.	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 need 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, lasting 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 from 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 Fillers

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 Injectable Fillers

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 52,000 fat injection procedures were performed in 2006, according to the ASPS.

Botulinum Toxins Injectable Fillers

First used to treat eye disorders, botulinum toxins have been used for neck spasms, cranial nerve disorders and eye spasms. For cosmetic purposes, the bacteria is used for the temporary improvement of moderate to severe wrinkles in the glabellar region. 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 4 million Botox® injections were performed in 2006, according to ASPS. Botox injections were the most popular minimally-invasive cosmetic procedure in 2006. Sixty-five percent of all Botox® procedures were performed on people between the ages of 30 –55.

Injectable	Description	Purpose	Possible Side Effects / Risks	Results	Regulatory Status
Botox	Botulinum toxin type A	Smoothes wrinkles, reduces 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. All other use considered off label.
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 take effect in 4-6 hours, maximum effect in 2 weeks	In use outside U.S. FDA approved only for cervical dystonias. All other use considered off label.
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 Injectable Fillers

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 the ASPS, more than 770,000 hyaluronic acid injection procedures were performed in 2006. Captique™ is another soft tissue filler made of hyaluronic acid which received FDA approval in 2004. Hylaform® and Hylaform Plus® are soft tissue fillers composed of hyaluronic acid extracted from rooster combs - both received FDA approval in 2004. Two additional tissue fillers composed of hyaluronic acid, Perlane® and Restylane® Fine Line, are used outside the United States but are not approved by the FDA.

Injectable	Description	Purpose	Possible Side Effects/ Risks	Results	Regulatory Status
Juvederm (24HV, 30, 30HV)	Hyaluronic acid gel	Temporarily corrects moderate to severe facial wrinkles and folds	Temporary redness, pain/tenderness, firmness, swelling, and bruising at injection site; should not be used in patients with severe allergies, particularly allergies to bacterial proteins	Immediate; corrects facial wrinkles of folds for up to six months or longer	FDA approved
Restylane	Non-animal derived hyaluronic acid.	Soft tissue filler that adds volume to wrinkles around the nose and mouth.	Redness, bruising, tenderness, swelling, pain, itching	Immediate, lasts six months to one year	FDA approved for filling moderate to severe wrinkles around the nose and mouth. All other use considered off label.
Restylane Fine-lines	Non-animal derived hyaluronic acid.	Soft tissue filler that adds volume.	Redness, swelling, tenderness, especially at sight of injection; acne-like formations are rare	Immediate, may last up to 1 year	In use outside U.S. Not FDA approved for any use in the U.S.
Perlane	Non-animal derived hyaluronic acid.	Soft tissue filler that adds volume to wrinkles and folds in deep layers of skin.	Pain, redness, swelling, itching, discoloration, and tenderness at the point of injection	Immediate; lasts six months to one year; subsequent injections may require less Perlane	FDA approved for the correction of moderate to severe facial folds and wrinkles.
Captique	Non-animal derived hyaluronic acid.	Soft tissue filler that adds volume.	Bruising, swelling, rare allergic reaction	Immediate, may last up to 1 year	FDA approved for filling moderate to sever facial wrinkles and folds around the nose and mouth
Hylaform	Hyaluronic acid extracted from rooster combs.	Soft tissue filler that adds volume.	Redness, swelling, people with sensitivities to avian products may have an allergic reaction	Vary, may last up to 6 months	FDA approved for filling moderate to severe wrinkles around the nose and mouth. All other use considered off label.
Hylaform Plus	Hyaluronic acid extracted from rooster combs. Contains large hyaluronic gel acid particles.	Soft tissue filler that adds volume.	Redness, swelling, people with sensitivities to avian products may have an allergic reaction	Vary, may last longer than 4-6 months	FDA approved for filling moderate to severe wrinkles around the nose and mouth.

Semi-permanent Injectable Fillers

Two additional soft tissue fillers being used for their wrinkle reducing and volume-adding qualities are Sculptra® and Radiesse® (formerly Radiance^TM). Radiesse® - received FDA approval for cosmetic applications in December 2006 - is composed of calcium hydroxylapatite, which has been used in the body for multiple applications including cheek and chin implants. Radiesse® is injected into the face adding volume through microspheres that are suspended in polysaccharide carriers until encapsulation occurs. Sculptra®, which is made of synthetic polylactic acid contained in microspheres, is approved by the FDA for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Any other use is considered off-label.

Injectable	Description	Purpose	Possible Side Effects/ Risks	Results	Regulatory Status
Radiesse (Bioform)	Microspheres of calcium hydro-xylapatite suspended in an aqueous gel carrier.	Reported to last 1-2 years. The body forms collagen around the micro-spheres that adds bulk.	According to manufacturer, clumping, lumping, and nodules can appear when injected into the lips. Little risk of allergic reaction.	Immediate, according to the manufacturer.	FDA approved for correction of moderate to severe wrinkles and folds.
Sculptra	Synthetic polylactic acid contained in micro-spheres.	Restores lost facial volume in people with HIV. The body forms collagen around the micro-spheres.	Redness, bruising, lumping and granulomas	Immediate, and typically last two years according to manufacturer.	Approved by FDA for restoration and/or correction of lipoatrophy in HIV patients. In use outside the U.S. as New Fill, to fill wrinkles.

Non-resorbable/"Permanent" Injectable Fillers

Unlike other dermal fillers that eventually become absorbed by the body, ArteFill® is the first injectable to provide a permanent support solution to fill wrinkles and prevent further wrinkling.

Injectable	Description	Purpose	Possible Side Effects/ Risks	Results	Regulatory Status
ArteFill	Contains 20% tiny, round, non resorbable, smooth particles (polymethyl methacrylate microspheres) and 80% purified bovine collagen gel with 0.3% lidocaine. Microspheres not absorbed by the body; provide support for wrinkle correction	Indicated for the correction of nasolabial folds (a.k.a. smile lines)	Skin test required Lumpiness, granulomas, persistent swelling or redness, increased sensitivity at injection site, rash, itching Contraindications: -lip augmentation -patients with known lidocaine hypersensitivity -patients with bovine allergies Not for patients with known susceptibility to keloid formation	Immediate results One or two touch up injections at intervals of at least two weeks may be required to achieve desired results	FDA approved as non resorbable aesthetic injectable implant for correction of nasolabial folds

For referrals to ABPS-certified plastic surgeons 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.

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