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Injectables At-A-Glance

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.

CHART UPDATED - May 2009

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 179,000 collagen injection procedures were performed in 2008, according to the ASPS.

InjectableDescriptionPurposePossible Side Effects/RisksResults 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
Evolence Filler made from purified porcine collagen Correction of moderate to deep facial wrinkles and folds such as nasolabial folds Allergic reaction, inflammation, swelling, redness, tenderness Lasts up to six 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.

InjectableDescriptionPurposePossible Side Effects/ RisksResults 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

InjectableDescriptionPurposePossible Side Effects/ RisksResults 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 46,000 fat injection procedures were performed in 2008, according to the ASPS.

Botulinum toxins

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. Until now, Botox® was the only neurotoxin approved by the FDA for cosmetic purposes. Dysport® recently became the second neurotoxin to receive FDA approval for cosmetic use. Myobloc® is indicated for the treatment of cervical dystonia.

More than 5 million Botox® injections were performed in 2008, according to ASPS. Botox injections were the most popular minimally-invasive cosmetic procedure in 2008.

InjectableDescriptionPurposePossible Side Effects / RisksResults 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 Treats cervical dystonia Bruising, numbness, droopy eyelids, body may become immune Can take effect in 4-6 hours, maximum effect in 2 weeks

FDA approved for treatment of cervical dystonia.

Dysport Botulinum toxin type A Smoothes wrinkles Bruising, numbness, droopy eyelids, body may become immune Can begin to take effect 2-5 days, maximum effect in two weeks FDA approved for treatment of glabellar lines and cervical dystonia.

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 the ASPS, more than 1.1 million hyaluronic acid injection procedures were performed in 2008. Captique™ is another soft tissue filler made of hyaluronic acid. 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.

InjectableDescriptionPurposePossible Side Effects/ RisksResults 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

Semi-permanent Fillers

Two additional soft tissue fillers being used for their wrinkle reducing and volume-adding qualities are Sculptra® and Radiesse® (formerly RadianceTM). Radiesse® 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.

InjectableDescriptionPurposePossible Side Effects/ RisksResults 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 manu-facturer, clumping, lumping, and nodules can appear when injected into the lips. Little risk of allergic reaction. Immediate, according to the manu-facturer. 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 manu-facturer. 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" Filler

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.

InjectableDescriptionPurposePossible Side Effects/ RisksResults 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