Cosmetic Injectables
A Treatment Option Overview

by Alexander Z. Rivkin, M.D.

Every study, fact and statistic reveals consumers are spending significant amounts of money on the non-invasive cosmetic treatments medical spas provide, particularly injectable procedures such as Botox®, Restylane® collagen and Radiesse™. The public realizes these non-surgical treatments provide excellent results, and demand has increased quickly. In addition to being beneficial for clients, these procedures are also very profitable for spas.

The popularity of plastic surgery has transformed cosmetic procedures from an indulgence exclusive to the ultra-rich into a luxury widely available to the average person. People still are relatively unwilling, however, to undergo the inconvenience, risk and expense of plastic surgery. This is why non-invasive and non-ablative cosmetic techniques are emerging with astonishing rapidity. One of the most effective non-surgical techniques has been the use of injectable fillers to augment lost skin volume and add definition to facial structures.

Cosmetic patients have high expectations. They want outstanding results, delivered instantly with minimal risk, pain, swelling or bruising. Therefore, anyone who plans to open a medical spa or offer injectable fillers in an existing practice owes it to their patients and clientele to know as much as possible about these products and their proper administration.

For starters, regulations state that dermal fillers can be injected only by physicians, physician’s assistants (PAs), nurse practitioners and specially trained nurses; the treatment cannot be performed by licensed vocational nurses, medical assistants or any other allied medical staff. The physician/owner of a medical spa should be very hesitant to delegate dermal-filler injection responsibilities to nurses or PAs. Most patients see these procedures as doctor-level aesthetic interventions that require skill and training. They will not be happy if their first injection experience at a particular medical spa is with someone who is not a medical doctor.

Then And Now

Injectable fillers first were introduced in the 1950s. Silicone oil became very popular very quickly, but safety concerns were raised; it fell out of vogue and was replaced by collagen in the late 1970s. Inamed Aesthetics’ collagen products, Zyderm® and Zyplast®, went relatively unchallenged for about 15 years. These products produced results that felt and looked natural, and were easy to inject. Unfortunately, they lasted for a maximum of three months and required allergy testing, since they were manufactured from bovine collagen.

The public demanded longer-lasting results, but physicians responded with techniques that proved inconsistent and technically difficult. For example, Gore-Tex® strips and solutions were used for lip enhancement and nasolabial fold injection. Patients looked unnatural, and infection risk was high. On the other hand, cadaver dermal matrix was, and continues to be, used as an injectable filler called Cymetra®. This material is safe and has been one of the only longer-lasting collagen alternatives for a while. Recently, however, several other fillers have come on the market that last as long or longer and are not human tissue-based.

Top: Non-surgical facelift; a combination of Restylane and Radiesse“ . Bottom: Restylane injections under the eyes to combat dark circles.

Today’s Dermal Fillers

The most prominent of the new dermal fillers is the non-animal-based Restylane, which is comprised of cross-linked hyaluronic acid. Restylane had been in use in Europe for several years before it was approved in the United States in December 2003. It has since become the dominant dermal filler in this country.

Restylane can be used safely and effectively in lips, nasolabial folds, marionette lines and, with caution, on glabellar lines and around the eyes. Unlike the collagen fillers, Restylane does not contain lidocaine, so the injections are more painful. Topical anesthetic and ice application usually are sufficient to control the pain, except during lip augmentation injections. I have found that a dental block along with ice application to prevent excessive bleeding and bruising are absolutely mandatory when injecting the lips with Restylane. The injection technique with Restylane is very precise. If the physician has not had specific training in Restylane injection during residency, he or she should undertake such training via courses and seminars.

I personally use Restylane to augment lips and to fill in vertical lip lines (in combination with Botox). I occasionally will use it to fill in small lines around the face. But, I have moved to a different product, Radiesse, for filling in nasolabial folds, marionette lines and facial sculpting.

Radiesse, produced by BioForm Medical, Inc., is a non-animal-based calcium hydroxylapatite filler that is becoming more popular. Yet, the company has not yet obtained Food and Drug Administration (FDA) approval for the use of Radiesse as a cosmetic filler, which has prevented the company from marketing it as such. However, Radiesse is approved for other indications and is thus being used “off label” for cosmetic procedures. In my experience, the material has delivered outstanding cosmetic results and longevity, so I use it as my principal filling agent for facial sculpting, nasolabial folds and marionette lines. The material lasts one and a half to two years, depending on the area injected and requires no allergy testing.

As is the case with other injections, Radiesse results are quite technique-sensitive, and a poor injection can mean many months of unhappiness for the patient. Physicians should start with Restylane and collagen, switching to Radiesse after they have mastered those shorter-duration fillers. Here again, delegating Radiesse injections to less-qualified personnel is not desirable, since a poor result is a major risk for the overseeing physician and the medical spa.

Two other hyaluronic acid fillers, both from Inamed Corp., have been FDA-approved. Use of Hyalform®, which is manufactured from rooster combs, requires allergy testing and lasts about three months. Captique™, the approval of which drew much publicity, is non-animal-based and is reported to cause less bruising and swelling than does Restylane. The duration of Captique’s effects is unclear—the company claims one year, but practitioners have reported only four to six months.

Collagen Stimulators

Another interesting filler material is Sculptra®, which is more accurately described as a collagen stimulator than as a dermal filler. It is composed of poly-L-lactic acid in a powder form that must be reconstituted with preserved saline or bacteriostatic water the night before a procedure.

Sculptra is FDA-approved for treatment of HIV facial lipoatrophy only, but it commonly is used “off label” for cosmetic procedures. The advantage of Sculptra is that it is a fairly economic way to fill large areas of the face (such as the cheeks or temples) with natural-looking results. The disadvantages are that most areas require two to three injection sessions about one month apart, and the cost to the physician is rather steep. Another drawback is that between the first and second injection session, the patient’s face goes back to its pre-injection appearance. It is not until after the second or third session that the collagen stimulation is evident and the final benefit is seen.

In The Pipeline

There are quite a few dermal fillers being widely used in Europe that have yet to gain FDA approval in the United States. One of the most talked about is Artecoll, a semi-permanent to permanent filler composed of polymethylmethacrylate beads suspended in collagen and lidocaine. After injection, the collagen is absorbed within three months, during which time a scar tissue capsule forms around each bead, preserving the filling effect for many years, if not forever.

When, and if, this material comes on the American market, practitioners will have to take great care with injection technique. There already have been several reports of patients developing post-injection lumps that have required surgical excision.

Other fillers awaiting FDA approval include Juvéderm®, Isolagen, Reviderm Intra and several more. Coming full circle, some physicians are again injecting silicone oil with a refined technique that shows some promise.

Treatment Options

With the right training and skills, injectable fillers can be an extremely valuable tool for the aesthetic practitioner. In skilled hands, dermal fillers produce outstanding results and are even more effective when combined with Botox. The most popular applications for injectable fillers are:

• Nasolabial fold correction
• Marionette line correction
• Lip enhancement
• Vertical lip line correction
• Cheek and cheek bone enhancement
• Glabellar frown line correction
• Acne scar correction
• Correction of lines around the eyes

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