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It’s hard to watch fine lines become deep creases and sit idly by as your formerly pert cheeks slide into your jowls. Most of us are considering facial plastic surgery. But the idea of trusting a total stranger with a knife in his hands might strike you as a little drastic. Thankfully, new cosmetic treatments have arrived to bridge the gap between skin cream and scalpel. These anti-aging programs could make plastic surgery – once thought of as the wave of the future – a thing of the past.
It is used by doctors to plump up fine lines, wrinkles, some scarring, and augment the lips by restoring volume and definition. In other words “rejuvenate” the skin.
Dermal fillers are made from a variety of materials. Any fillers placed on the market is classified as medical devices and must meet the requirements of the Medical Devices Directive (MDD) in Europe and FDA approval in the US.
The doctor injects the filler in a series of small injections and the area gently massaged. You can expect to be a little swollen and tender for a short while afterwards. Some treatments require the application of a local anaesthetic cream, or may be performed using nerve block anaesthesia. The treatment time can vary between 30 minutes to an hour. The area may be a little swollen and tender for 24 hours and during that time you should avoid coffee, alcohol, hot drinks and the sun.
There are dermal fillers derived from collagen, some which come from a bovine source and some from a porcine source. Other fillers are synthetically produced in laboratory and are derived from hyaluronic acid. Fillers derived from both collagen and hyaluronic acid are temporary biodegradeable products, meaning the cosmetic results will last 3-12 months depending on the product and the amount used. Fillers made using collagen normally require a skin test for allergy whereas fillers made from hyaluronic acid may not. Some of the brand names of temporary fillers include Restylane®, Hydrafill®, Juvederm® and and Radiesse®.
In the past it was the only dermal filler in town, collagen injections steadily declined in attractiveness over the past decade as better alternatives introduced to the market. With the new collagen filler, Evolence, a new FDA-approved version that lasts twice as long, collagen may make a comeback. Unlike its predecessors, which are made of cow and bioengineered human collagen, Evolence comes from pigs. It's more similar to human collagen than the bovine version, so it doesn't require allergy testing and it’s free from “Mad cow disease”.
How it works. Collagen makes up about 80 percent of skin's foundation layer, the dermis. As these fibers break down over time, wrinkles develop and skin becomes looser and sags. Collagen injections replace the lost volume by integrating with your tissue to strengthen skin structure and smooth out lines.
Best uses. Whereas the old version of collagen was used mainly on fine lines, Evolence is effective at restoring lost volume to just about any medium-depth wrinkle like folds around the nose and mouth. And if Evolence Breeze is approved this year as anticipated, this less-viscous version will provide a viable option for superficial wrinkles like crow's feet.
Potential pitfalls. Lumps and bumps are a risk, but soft collagen can be massaged down at the doctor's office if the bumps are immediately apparent, or your doctor may be able to dissolve them within two weeks by injecting the enzyme collagenase.
How long it lasts. Six to twelve months for Evolence; three months for older collagen products like CosmoDerm and Zyderm.
Cost. $500 and up per treated area.
According to FDA: Evolence Porcine Collagen Dermal Filler manufactured by Colbar Life Science was approved in 2008 for: Evolence Collagen Filler is an injectable product indicated for the correction of moderate to deep facial wrinkles and folds such as nasolabial folds.
Device Description: Evolence Collagen Filler is a sterile, non-pyrogenic device stable at physiological pH that is yellowish, homogeneous, opaque gel, prepackaged in a syringe. It is composed of a 35 mg/ml (± 5 mg/ml) biodegradable Type I fibrillar porcine collagen crosslinked using D-ribose suspended in phosphate buffered saline (PBS). Various antigenic portions of the collagen molecule have been removed.
The most widely used forms of the sugar-derived gel, hyaluronic acid (HA), currently include Restylane, Juvéderm, and Perlane.
How it works. Doctors inject HA to add contour, plump up sagging skin, lips augmentation and smooth wrinkles.
Best uses. HA fillers are approved for the treatment of medium to deep facial wrinkles, like the nasolabial folds that run from the nose to the corners of the mouth. But its various viscosities enable doctors to use HA off-label for filling superficial lip and forehead lines, as well as for contouring the jaw line. Some doctors may also fill hollowed under-eye areas to compensate for fat loss.
Potential pitfalls. Swelling and bruising are common side effects, usually lasting less than a week. Injecting HA unevenly or too superficially can cause bumps; using too much may leave you looking inflated or puffed up.
How long it lasts. HA fillers are all fairly similar — except in terms of longevity. One shot of Juvéderm lasts up to a year, while the FDA recently OK'd a claim by Restylane makers that it persists for up to 18 months. You do need a second injection after six months or so, because the filler will dissipate slightly, but it's typically half the amount of your first shot.
Cost. Anywhere from $600 to $1,000 per treated area.
According to FDA: Restylane Injectable Gel and Perlane Injectable Gel manufactured by Medicis Aesthetics Holdings, Inc. was approved in 2005 for: Restylane is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Perlane is indicated for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds.
Device Description: Restylane consists of stabilized, hyaluronic acid (HA) generated by streptococcal bacteria and formulated to a concentration of 20 mg/ml, suspended in a physiological buffer pH 7. Restylane is a transparent, viscous and sterile gel, supplied in a disposable glass syringe. The syringe is packed in a blister together with a sterile 30 G needle. The HA has a molecular weight of about 1 million and is stabilized by adding a minimum amount of BDDE (1,4-butanediol diglycidyl ether) to allow formation of a 3-dimensional HA molecular network (gel). Perlane is a sterile gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically cross-linked with BDDE, stabilized and suspended in phosphate buffered saline at pH = 7 and concentration of 20 mg/ml. The largest fraction of gel particles size is between 940 and 1090 microns.
Juvederm Gel Implants (Juvederm 30, Juvederm 24HV, Juvederm 30HV) manufactured by Allergan was approved in 2006 for: Juvederm 30, Juvederm 24HV, and Juvederm 30HV are injectable gels indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Device Description: JUVEDERM injectable gel is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogenized gel implant. JUVEDERM consists of crosslinked hyaluronic acid (HA) formulated to a concentration of 22-26 mg/mL, suspended in a physiological buffer. The HA in JUVEDERM is produced by Streptococcus equi bacteria. The HA used in JUVEDERM has a molecular weight of approximately 2.5 million Daltons and is crosslinked by adding a minimum amount of BDDE to form a 3-dimensional HA gel.
JUVEDERM is available in three formulations (30, 24HV and 30HV) and is supplied in prefilled disposable syringes. Juvederm 30 HV is a more highly crosslinked robust formulation, injected using a 27G needle for volumizing and correction of deeper folds and wrinkles.
Juvederm 24HV is a highly crosslinked formulation that can be injected using a 30 G needle for more versatility in contouring and volumizing of facial wrinkles and folds. Juvederm 30 is a highly crosslinked formulation, injected using a 27G needle, for subtle correction of facial wrinkles and folds.
These collagen boosters include Sculptra and Radiesse.
How they work. Both prompt your body to make its own collagen over time. Radiesse, made of calcium-based microspheres suspended in gel, provides instant plumping; Sculptra (poly-L-lactic acid) takes a few months to produce results because it depends solely on your body's producing more collagen.
Best uses. They're both most effective for filling in deep wrinkles around the mouth or for bolstering severely hollowed cheeks.
Potential pitfalls. Because you don't see results right away with Sculptra, the less-is-more rule definitely applies to each doctor visit. There is also a tiny risk of hardened nodules, particularly if Radiesse is injected too superficially; for this reason, avoid both fillers around thin-skinned areas like the eyes.
How long they last. A year or more for Radiesse; up to two for Sculptra.
Cost. About $800 for Radiesse, $1,000 for Sculptra, per treated area.
According to FDA: Sculptra manufactured by Sanofi Aventis Pharmaceuticals, Inc. was approved in 2004 for: Sculptra is intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with or receiving treatment for human immunodeficiency virus.
Device Description: Sculptra is an injectable poly-L-lactic acid implant in the form of a sterile lyophilized cake. Sculptra contains microparticles of poly-L-lactic acid, a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. Sculptra is reconstituted prior to use by the addition of Sterile Water for Injections, USP (SWFI) to form a sterile nonpyrogenic suspension.
Radiesse manufactured by Bioform Medical, Inc. was approved in 2006 for: Radiesse is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Device Description: Radiesse is a sterile, non-pyrogenic, semi-solid, cohesive implant, whose principle component is synthetic calcium hydroxylapatite (CaHA) suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. Radiesse (1.3 cc and 0.3 cc) has a CaHA particle size range of 25-45 microns and should be injected with a 25-27 gauge needle.
Not all is smooth in the world of injectable wrinkle fillers: An FDA panel reviewing the shots' safety recently called for warning labels and more testing of all cosmetic fillers after nearly 1,000 adverse reactions were reported between 2003 and 2008 (ranging from severe swelling to permanent scarring). Most of the problems were the result of off-label use (injections in areas not specifically FDA-approved).
FDA General Contraindications for Use
All dermal fillers are contraindicated for patients with
- known sensitivities to the filler material; and
- history of severe allergy or anaphylaxis; and
- bleeding disorders.
FDA Warnings and Precautions
In general, the following warnings and precautions are applicable to all dermal fillers. There are additional warnings that may be device specific, such as those related to device material composition.
- Avoid injection into blood vessels as vascular occlusion (and possible subsequent tissue necrosis) may occur
- Injection should be deferred until infection or inflammation has been controlled or resolved
- The safety and effectiveness of device injection for lip augmentation had not been established
- Injection into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes
- The safety in patients susceptible to keloid formation, hyperpigmentation and hypertrophic scarring has not been established
- Long term safety and effectiveness of the device beyond duration of clinical study have not been investigated
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