What are Dermal Fillers and what statistics are available for them?
It is well known that time affects facial aging by producing both cellular and anatomical changes that result in the loss of soft tissue volume. The advent of new technology has provided physicians with the opportunity to address these changes with the utilization of dermal fillers.
In 2007, nearly 11.7 million surgical and non-surgical aesthetic procedures were performed in the United States, with 82% of these being non-surgical procedures. Since 1997, The American Society for Aesthetic Plastic Surgery (ASAPS) reports that there has been a 754% increase in non-surgical procedures. Of these procedures, non-permanent Hyaluronic Acid (HA) dermal fillers were rated as number two of the top-five non-surgical procedures in 2007, equating to 1,448,716 procedures.
Hyaluronic acid offers the patient an effective, non-invasive, non-surgical alternative for the correction of contour problems of the face due to its ability to bind to water and the ease of implantation by injection. The medical community speculates that these numbers will increase dramatically as more dermal fillers become approved by the Food and Drug Administration (FDA). Currently, the trend in the development of dermal fillers is the production of products that either contain lidocaine or have lidocaine mixed into the product by the practitioner prior to injection.
It is important that patients have an understanding of the different characteristics, capabilities, risks and limitations of the available dermal and subdermal fillers that are available to obtain maximum results and reduce the risk of complications.
What types of Dermal Fillers are currently available?
Dermal fillers may be classified in a number of ways. For example, they may be classified as autologous (tissue from yourself), biological (HA) or synthetic (non-absorbable). Based on the duration of cosmetic benefit they may be short considered short term (less than 3 months), medium term(3-12 months), long term (12-24 months) or very long term (greater than 24 months). Using reversibility as a criterion, dermal fillers may be classified as very rapidly reversible, slowly biodegradable but not reversible, or non-biodegradable.
A brief table included within the FDA Executive Summary of Dermal Filler Devices outlines the description of all approved dermal fillers. The table shows that there is only one approved non-absorbable implant dermal filler called ArteFill, made by Artes Medical, which contains Poly(methylmethacrylate) or PMMA. ArteFill is approved for the correction of nasolabial folds.
There are two synthetic absorbable FDA approved dermal fillers. One is called Radiesse, made by Bioform Medical, which contains Hydroxylapatite. Radiesse is a semi-solid implant approved for subdermal implantation for the correction of severe facial wrinkles and folds such as nasolabial folds in individuals with human immunodeficiency virus. The other is Sculptra, made by Sanofi Aventis Pharmaceutical, which contains Poly(L-lactic acid). Sculptra is approved for the restoration and correction of facial fat loss (lipoatrophy) in people with or receiving treatment for human immunodeficiency virus.
The FDA reports that there are five approved natural dermal fillers, two of which contain collagen and two that contain hyaluronic acid. The first containing collagen is the single component of both Zyderm and Zyplast, made by Allergan. Zyderm is a bovine collagen approved for the correction of contour deformities of the dermis in non-weight bearing areas. While Zyplast, is approved for the correction of contour deficiencies in soft tissue.
The other is Cosmoderm and Cosmosplast, also made by Allergan. Cosmoderm 1 and Cosmoderm 2 are made of human-based collagen that is approved for injection into the papillary (upper level) dermis for the correction of soft tissue contour deficiencies such as wrinkles and acne scars. Cosmoplast is human-based collagen that is approved for injection into the mid-to-deep dermis for correction of soft tissue contour deficiencies such as wrinkles and acne scars.
The last is Evolence, made by Colbar Lifesciences, and is approved as an injection-based product indicated for the correction of moderate-to-deep facial wrinkles and folds such as nasolabial folds.
There are nine dermal fillers containing hyaluronic acid; one group is Restylane and Perlane, made by Medicis Aesthetics Holdings, and is approved for the mid-to-deep dermal implantation for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Perlane is approved for implantation into the deep dermis to superficial subcutis for the correction of moderate-to-severe facial folds and wrinkles, such as nasolabial folds.
Another group is Hylaform, Hylaform Plus, and Captique, made by Genzyme Biosurgery. Hylaform, Hylaform Plus and Captique are approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.
The third group is that of Juvederm 30, Juvederm 30HV, and Juvederm 24HV, made by Allergan. Each of these products are injection-based gels that are approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds.
The final filler is Elevess, made by Anika Therapeutics, which is categorized as a Cosmetic Tissue Augmentation Product (CTA) and is approved for injection into the mid-to-deep dermis for the correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds.
The FDA has also approved a new advancement in dermal fillers called Prevelle Silk, made by the Mentor Corporation. Prevelle Silk is the first hyaluronic dermal filler that contains lidocaine (anesthetic) and is approved for injection into the mid-to-deep dermis to reduce moderate-to-severe facial lines, folds and wrinkles.
What are the advantages of hyaluronic acid Dermal Fillers?
The major and unique advantage of hyaluronic acid dermal fillers is that they can be quickly and easily reversed by the injection of hyaluronidase into the areas in which the elimination of the filler is desired. A patient or physician may choose to reverse the application, either because there is an excess of HA in the area or to accelerate the resolution of an adverse reaction to treatment or to the product.
Are Dermal Fillers containing hyaluronic acid safe?
Individuals who should not use hyaluronic acid are individuals with severe allergies marked by a history of anaphylaxis or the presence of multiple severe allergies and individuals who have a history of Gram-positive bacterial proteins.
Additionally, patients who are using any medications that are known to be blood thinners such as aspirin or ibuprofen may experience increased bruising or bleeding at the injection site. Also, individuals who are undergoing immunosuppressive therapy or therapy to decrease the body’s immune system as there may be an increased risk of infection.
In general, there is a lower incidence of complications reported with HA fillers compared with the semi-permanent and permanent fillers. The implantation of non-reversible fillers requires a greater expertise on the part of the physician than does the injection of HA fillers and may produce results and complications that are difficult or impossible to manage even by the use of corrective surgery.
Most physicians use HA fillers as the foundation of their filler practices because it has been found that HA fillers produce excellent aesthetic outcomes with higher patient satisfaction, and a low incidence and severity of complications.
What is the recovery period with Dermal Fillers?
Downtime after treatment with dermal fillers is typically rare with the appropriate use of the filler and is much shorter when compared to the downtime experienced by patients post invasive surgery or energy-based treatments.
Who are candidates for Dermal Filler treatment?
Ideal candidates for treatment must be determined by the physician who takes into account the patient’s social schedule, budget, aesthetic preferences, expectations, risk tolerance, skin thickness and texture, the location to be treated, age of the patient and ethnicity.
Who is qualified to perform Dermal Filler treatments?
Only board certified dermatologists or physicians are qualified to perform dermal filling treatment. Board certified physicians are medical doctors who have acquired at least two years in additional training to perform plastic and cosmetic surgical procedures.
What is the cost of Dermal Filler treatments?
The cost of dermal filler treatments varies and is determined by geographic location, skill of the surgeon and the number of areas and treatments that are required for optimum results. Furthermore, the American Society of Plastic Surgeons has issued a recent public warning that consumers looking to cut costs during the current economic downturn cannot afford to cut corners on quality of care and that searching for bottom-basement pricing may impact safety. The directive states that patients should proceed carefully prior to putting their health and physical bodies in the hands of anyone who is not qualified to perform surgery.
Disclaimer: This information is intended only as an introduction to this procedure. This information should not be used to determine whether you will have the procedure performed nor does it guarantee results of your elective surgery. Further details regarding surgical standards and procedures should be discussed with your physician.
By Anti-Aging.org Staff
Updated: January 14, 2009