An Overview of Dermal Fillers

By Lisa Williams De Silva, NP

The number of U.S. women who underwent nonsurgical cosmetic procedures jumped 51% from 2003 to 2004.1 The most sought after nonsurgical cosmetic procedure is the injection of botulinum toxin (Botox, Myobloc), and 2.8 million people received this treatment in 2004.¹ Following in popularity are laser hair removal (1.4 million), chemical peels (1.1 million), microdermabrasion (1 million) and the injection of hyaluronic acid (Hylaform, Restylane; 882,469), which is known as a dermal filler.¹

Cosmetic dermal fillers such as the FDA-approved Restylane and Hylaform provide immediate and long lasting correction in the folds and wrinkles of the face.² I use Restylane in my medical aesthetics practice, and this article focuses on the characteristics and use of Restylane for wrinkle treatment.

Introduction to Restylane

Restylane was the first cosmetic dermal filler created using hyaluronic acid, a substance that occurs naturally in the body. Dermal fillers introduced earlier for wrinkle treatment are collagen-based (CosmoDerm, CosmoPlast). Restylane is completely biocompatible with human hyaluronic acid and therefore causes fewer allergic reactions than collagen.

The hyaluronic acid in Restylane is biodegradable. When the injected gel breaks down, it turns into water and carbon dioxide and disappears unnoticed from the body. Since it is not animal-based, there is no risk of allergic reaction or animal-based transmission. No skin or allergy testing is required.³

Restylane is a sterile gel consisting of stabilized viscous hyaluronic acid and a hydrating complex sugar. When injected into the dermal region, Restylane provides immediate improvement in elasticity loss secondary to connective tissue degeneration caused by aging.⁴

Restylane injection is a noninvasive, almost painless procedure that requires tiny injections into the dermal region of the skin. The clear gel is easy to inject, and the procedure itself takes approximately 5 minutes. The results are dramatic, generating a healthier, more rested and youthful appearance.

Restylane has an FDA-approved indication for the correction of facial wrinkles in the nasolabial area and the fold between the cheek, nose and upper lip. The effects of Restylane usually last more than 6 months, and in some cases can be evident for a full year.²

Research into the safety and effectiveness of Restylane on facial areas other than the nasolabial folds has produced encouraging results, but no additional FDA indication has been approved. The most common sites for this off-label use are the lips, the nasal brow area and the stubborn creases just under the eyes.

Use With Botox

For more than a decade, Botox administration for cosmetic purposes has been the gold standard treatment for nasal brow wrinkling (in between the brows). But many patients report that Botox administered alone is ineffective on deep creases in the nasal brow area. Researchers have concluded that injecting Botox in combination with Restylane provides a better outcome than injection of this area with Botox alone.⁴ Botox works by shutting off the acetylcholine that makes a muscle contract. This shutoff helps alleviate the permanent wrinkle that has formed. Restylane fills in the groove, making the line less apparent.

Patient Selection Issues

Because Restylane is not derived from an animal source, there is less likelihood of contamination with antigenic proteins during manufacture, reducing the risk of hypersensitivity reactions.²

Restylane is favored over collagen-based dermal fillers because it delivers longer-lasting effects and presents no risk of animal-based disease transmission or allergic reaction.³ The bovine collagen used in earlier dermal fillers is derived from cows and requires allergy testing before treatment. Because Restylane is not animal-based, it can be administered without pretesting and requires no waiting period.

Even without an allergy risk, a few precautions are necessary before treating a patient with Restylane. To reduce the risk of bruising or bleeding at the injection site, patients should avoid using aspirin, nonsteroidal anti-inflammatory medications, St. John's wort, ginkgo biloba or high doses of vitamin E supplements prior to treatment. Patients who have been affected by cold sores in the past should be notified that Restylane injections may contribute to a recurrence, particularly if the injection is around the lips. And because the safety of Restylane during pregnancy or breastfeeding has not been established, it is not recommended for these women.

Anesthesia

To minimize discomfort associated with the injection itself, a preprocedure anesthetic technique can be helpful. For example, the Zimmer cooling machine can be used in combination with laser therapy to apply cool air over the site before injection. The cryoeffects of the technique reduce the discomfort associated with the injection.

Local or topical anesthesia may be necessary for some patients. Most patients find lip injections painful and require an injection of lidocaine prior to the procedure (as long as no allergy exists). Most patients find the Restylane injection quite tolerable on any other part of the face. Some may prefer a topical anesthetic administered for approximately 15 minutes to 30 minutes.

Side Effects

Temporary swelling, tenderness, redness and possible distortion may occur after Restylane injection. These effects typically last 12 to 72 hours. When the lips are injected, swelling tends to last a day or two longer than on other areas of the face. Some patients experience lip swelling for about a week, and the lips can look somewhat uneven during this time. Thus, the visible results immediately after the treatment do not constitute the final results.

Tiny bumps and lumps around the treated area are normal for a few days following an injection. Gentle 1-minute massages of the treated area with clean fingers three times a day will help these disappear.

Patients who receive an injection of Restylane should avoid touching the treated area for about 6 hours postprocedure. Light makeup may be applied over the treated area immediately after an injection. After 6 hours, the makeup should be washed off with hypoallergenic soap and water.

Patients should not expose a treated area to intense sunlight or extreme cold for 24 hours, since these conditions can irritate the injected area and prolong healing. For the same reasons, they should also avoid straws and hot beverages for approximately 6 hours after injections around the lips. Cold compresses or ice packs can be used to reduce any swelling or discomfort and to minimize bruising.

Adverse reactions are rare with Restylane, but patients should return to the office if one occurs. Informed consent must be obtained in writing prior to treatment, after all possible adverse events have been discussed. The patient should sign a statement that she understands the explanation of the risks, benefits and alternatives and has had the opportunity to ask questions. The consent form should state that specific results are not guaranteed, and that the actual degree of improvement cannot be predicted. The form should also state that additional treatments may be necessary to achieve the effects sought by the patient.

Patients may complain of discomfort the evening or day following Restylane injection. Acetaminophen dosed every 4 to 6 hours can help manage this pain. I also recommend ice application every 4 to 6 hours for the first 24 hours after treatment.

Associated Costs and Charges

The cost of Restylane treatment varies from patient to patient because some require multiple syringes of the substance. In general, the cost of Restylane is comparable to the cost of other dermal fillers. In most areas of the country, NPs can purchase Restylane at a wholesale cost of around $230 for a 1-cc syringe and $140 for a 0.4-cc syringe. The typical treatment charge to the patient is between $375 and $500 per 1-cc syringe. The average patient requires about 1 cc of Restylane to achieve the desired results, but up to 4 cc can be injected in a single session, using four syringes. The smaller syringe amount can be used to address correction of small areas such as vertical lip lines. Dermal filler injections can provide a profit margin of about 40%.

Hylaform is sold as a gel derived from rooster combs of domestic fowl. It typically is sold at a lower price than Restylane. However, Restylane contains a higher concentration of hyaluronic acid (20 mg/mL) than Hylaform (5.5 mg/mL). Because Restylane is longer-lasting, it proves to be more economical over the long term.

When you are initially setting fees and payment options, you might help position your niche in the cosmetic dermatology arena by offering Restylane treatments at a lower charge than what is typical for plastic surgeons and dermatologists in your area.

Putting It Into Practice

Autonomous, entrepreneurial practice is more feasible than ever for NPs. More than 26 states now allow NPs to practice independently. Furthermore, several boards of nursing have issued advisory opinions specifying that nurse practitioners can be direct providers of dermatologic care including nonsurgical cosmetic procedures.^5,6 This practice niche is an ideal professional opportunity that offers reduced stress and higher revenue streams. Patients pay out of pocket, removing problematic insurance and reimbursement barriers. Restylane injection is a safe, effective and lucrative clinical offering for NPs who are interested in entering the specialty of medical aesthetics.

References

1. American Society for Aesthetic Plastic Surgery. 11.9 million cosmetic procedures in 2004. Press release posted on the ASAPS Web site. Available at: http://www.surgery.org/press/news-print.php?iid=395§ion=. Accessed Nov. 11, 2005.

2. Narins RS, Brandt F, Leyden J, et al. A randomized, double-blind multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg. 2003;29:588-595.

3. Andre P. Evaluation of the safety of a non-animal stabilized hyaluronic acid (NASHA-Q Medical, Sweden) in European countries: a retrospective study from 1997 to 2001. European Academy of Dermatology and Venereology. 2004;18:422-425.

4. Carruthers A, Carruthers J. A prospective, randomized, parallel group study analyzing the effect of BTX-A (Botox) and nonanimal sourced hyaluronic acid (NASHA, Restylane) in combination compared with NASHA (Restylane) alone in severe glabellar rhytides with a hyaluronic acid derivative compared with the derivative and BTX-A. In: Klein AW, ed. Dermatol Surg. 2003;29:802-809.

5. Nurse Practitioner Description of Role and Function. Advisory opinion issued by the Arizona State Board of Nursing, 2003.

6. Dermatological Procedures Performed by Registered Nurses. Advisory Opinion issued by the Arizona State Board of Nursing, 2005.

Lisa Williams De Silva is the owner of Ultra Smooth Skin Inc., a cosmetic dermatology practice in Scottsdale, Ariz., that is based in a spa and salon. She also trains NPs, RNs and physicians in how to provide nonsurgical cosmetic procedures.