Injectables are taking center stage in aesthetic practices in new and emerging ways, and the rate of satisfaction among patients is consistently high. Once upon a time, fillers were just for filling in lines and scars. The realities of modern practice have transformed this category from being thought of as simple, fluffy beauty treatments to effective and complex techniques that warrant skill and expertise to administer well.
Injectables are useful alternatives, as well as adjuncts, to surgical procedures. They are widely considered a mainstay in aesthetic practices. They can be used to prevent wrinkles in younger patients, reduce fine lines and the appearance of scars in patients in their 30s, and reverse deeper wrinkles in patients in their 40s and up.
In addition, fillers are valuable tools for reshaping the face, adding fullness, enhancing contours, correcting asymmetries, smoothing out bony irregularities, and solving some issues of facial aging that surgery does not address effectively. They also may come in handy to correct minor defects, postsurgery.
“Today’s injectable patient will be tomorrow’s surgical candidate. It is not the needle versus the knife; it is the needle and the knife,” says Foad Nahai, MD, FACS, president of the International Society of Aesthetic Plastic Surgeons. “Injectables and surgical procedures complement each other. Injectables buy time until the patient is physically, mentally, and financially ready for a surgical procedure.”
At the American Society of Plastic Surgeons (ASPS) annual meeting in Chicago in October 2008, a course titled “New Tips and Tricks with Injectables and Dermal Fillers—Optimizing Patient Results” included 4 hours of lectures and live patient demonstrations, and that session was filled to capacity.
Looking around the room, there were some unexpected attendees, included senior surgeons with well-established aesthetic practices, and prominent facelift surgeons alongside residents and physician extenders.
Many physicians are seeking out nonsurgical treatments to free themselves from the red tape of third-party payors, while others use the growing popularity of nonsurgical work to be creative and develop relationships with patients. Even for die-hard aesthetic surgeons, injectables have new relevance in today’s world.
Whether your motivation is professional or strictly financial, now is a good time to take a fresh look at how this modality is literally shaping aesthetic medicine.
Far from a “one size fits all” type of treatment, fillers require skill, expertise, and patience to create an optimal result. Advanced nonsurgical techniques for facial rejuvenation involve looking at the face in a three-dimensional way and utilizing a combination of facial-shaping agents and injectable products.
Experienced injectors tend to graduate to using more volume to address multiple areas of the face in one session, which has elevated the use of filler treatments to unprecedented levels.
NEW KIDS ON THE BLOCK
New advancements in technology have led to gradual replacement of some of the older formulations on the market with longer-lasting variations.
Physicians are giving up on the idea of simply filling up lines and wrinkles in favor of pan-facial, volumetric techniques that can restore the youthful plumpness that diminishes with each decade.
The FDA classifies dermal fillers according to their temporary (resorbable) and permanent (nonresorbable) qualities, as well as divides them into four main groups based on their primary composition.
Temporary (resorbable) fillers include the following1:
- Collagen injections, which are made of highly purified cow or human collagen. Collagen is a natural protein and a major component of skin and other tissues in the body.
Collagens include the products Evolence® (OrthoNeutrogena, Skillman, NJ) and Cosmoderm® (Allergan Inc, Irvine, Calif).
- Hyaluronic acid gel is a protective lubricating gel produced naturally by the body. It binds with water to plump the skin.
Products in this category include Restylane® and Perlane® (Medicis Pharmaceutical Corp, Scottsdale, Ariz), Juvederm® (Allergan), Prevelle® Silk (Mentor Corp, Santa Barbara, Calif), and Elevess® (Anika Therapeutics Inc, Woburn, Mass).
- The mineral calcium hydroxylapatite (CaHA) is a major component of bones. CaHA is a well-matched (biocompatible) material that dissolves in the body (biodegradable) and is implanted in the form of a gel.
Radiesse (BioForm Medical Inc, San Mateo, Calif) is a CaHA-based filler.
- poly(l-lactic) acid (PLLA) is a biodegradable, biocompatible, synthetic material from the alpha-hydroxy-acid family that has been widely used for many years in dissolvable stitches and bone screws.
poly(l-lactic) acid-based products include Sculptra™ (Sanofi-Aventis, Bridgewater, NJ).
THE LATEST ADDITIONS
Evolence, a porcine collagen-based product, and Prevelle Silk, a hyaluronic acid gel containing lidocaine, have a distinct point of difference.
Additional fillers containing lidocaine will be available in the United States in the near future to address the fear of discomfort, especially among first-time filler patients.
Longer-lasting substances and so-called wash-and-wear fillers that offer instant results with minimal downtime may have a leg up during a credit crisis.
“I would say the likelihood of bruising with Evolence is less than some of the other fillers,” said Gerald Bernstein, MD, of Bernstein Cosmetic Surgery in Seattle. “Patients can walk right out of the office.”
Many practitioners have grown wary about using a permanent filler product due to concerns about complications, granuloma formation, infection, extrusion, and the overriding concern that the patient may not like the long-term results.
What’s On the Horizon?
New filler substances will give physicians and patients more choices.
- Tri-Calcium Phosphates—Atlean™
- Hyaluronic Acids—Belotero®
- Hyaluronic Acids with Lidocaine—Prevelle® SHAPE, Prevelle® Volume, Juvederm® Ultra
- Collagens—Evolence® Breeze
In Europe, there has been a decreasing tolerance of risks and side effects more commonly associated with permanent fillers, especially as more products have entered the market that are biocompatible, nonimmunogenic, and nonmigratory.
Although patients claim to want longer-lasting fillers, the US market has not seen a huge uptick in the use of permanent injectables, as evidenced by the recent demise of ArteFill®, the only FDA-approved permanent filler.
Veteran injectors have become extremely skilled at facial assessment and have developed a greater understanding of how facial anatomy changes with age, which impacts what agents work best in each facial zone.
The middle ground between permanent and temporary fillers is “semipermanent,” resorbable fillers that may contain a biodegradable carrier plus particles of another substance that bond with the soft tissues, producing a more long-lasting effect. One such example is Radiesse, which contains CaHA microspheres.
Another emerging area is a range of products that stimulate the production of new collagen, thereby increasing volume and correction over time.
Unlike hyaluronic acid gels, which offer immediate results, these new substances are designed to gradually cause a foreign-body reaction to achieve long-lasting effects. Sculptra is a prime example. The newcomer Atlean™, comprised of tricalcium phosphate particles suspended in a hyaluronic acid gel, is marketed in Europe by Stiefel.
To provide an instant effect for patients, some injectors are layering a hyaluronic acid gel filler on top of Sculptra to enhance contours while the poly(l-lactic) acid goes to work.
As new products continue to gain FDA approval, the big question on the minds of cosmetic physicians is, how many fillers do you really need?
Although there is no definitive answer for all practices, the best policy is to master the technique for injecting a bare minimum of two, and perhaps a maximum of six, different filler products. All injectors tend to have their favorite “go-to” products on the shelf, but not all fillers can address every area and patient, so having a wide range of tools has become important.
THE FILLER FRONTIER
In the United States, dermal fillers are frequently used in an off-label manner. Although most common off-label uses are not considered illegal, the FDA recently expressed concern that some filler products are routinely being used outside of approved indications, such as lip injections.
The rise in dermal filler use under the eyes was singled out as a particular source of potential complications. The tear trough region just below the lower eyelid is usually considered a very unforgiving area for injectors due to thin skin. Overfilling can create irregularities, lumps and bumps, and discoloration; and the Tyndall effect has occurred with some hyaluronic acid products.
Injecting new areas requires a different technique and in some cases a lighter touch. Aging hands that are wrinkled, bony, or prominently veined have become a promising new arena for rejuvenation treatments.
“It takes a lot more experience and expertise, because you have to inject it deep and you have to be careful to avoid the veins,” says Rod Rohrich, MD, FACS, and chairman of the Department of Plastic Surgery at UT Southwestern Medical Center in Dallas.
According to a recent FDA report2 on fillers, side effects have been linked to injectable wrinkle fillers, and some injectable treatments have resulted in side effects that may have been performed by untrained people or in settings other than physician’s offices.
The complaints date back to 2003 and document problems including swelling, allergic reactions, and infections without specifying which products were involved. Side effects were reported to be relatively rare; however, they can be permanent and do not always occur immediately after treatment.
The FDA is now considering amending labeling requirements and changing the way the products are safety-tested.
Coming at a time when consumer confusion and uncertainty are on the rise, the FDA ruling may be interpreted by some consumers as sending a message that paints all dermal fillers, as well as all their injectors, with the same black brush.
Although it may not deter satisfied patients from continuing to receive treatments, it raises more questions about safety and risks in the mind of the large group consumers who have yet to indulge due to fear, costs, discomfort, and concern about being unhappy with the outcome.
“Cosmetic fillers have a proven safety record when injected by a properly qualified and trained physician in an appropriate medical setting,” said Donn R. Chatham, MD, president of the American Academy of Facial Plastic and Reconstructive Surgery. “While injecting dermal fillers is not surgery, it is still a medical procedure that requires the experience of a physician trained in cosmetic procedures of the face. Patient safety must be paramount.”
Although complications can occur with any filler substance, sticking with FDA-approved products and good clinical instruction helps to minimize potential side effects.
ECONOMIC IMPACT ON DERMAL FILLERS
The demand for quick, minimally invasive treatments will surely continue with the emphasis on long-lasting, safe dermal filler products from companies with strong brands.
Consumers are more likely to shop around for steals and deals in an economic slump, and discounts will be available in every market. Offering patients more for their money—or lavishing loyal patients with extra perks—can go a long way to keep them coming back to your practice. In an effort to generate new revenue streams to counter cautious consumer spending, many practices are augmenting their menu of services to offer a wider range of treatments at varying price points.
There is less money to go around, it is harder to get credit and loans for big-ticket procedures, and fewer patients are scheduling procedures. The entrance of new patients into the market is leveling off, which keeps penetration at a relatively low volume.
All of these factors add up to a “perfect storm” of decreasing demand in the face of increased competition. In general economic terms, that usually spells product price wars.
In light of the recent Johnson & Johnson acquisition of Mentor Corp, physicians and patients will be wooed by two mega-powers (Allergan and Johnson & Johnson) competing across all three key verticals—dermal fillers, neurotoxins, and breast implants—plus several other well-established big players competing in the facial aesthetics category.
According to Bryan G. Forley, MD, a plastic surgeon in New York City, “We have found that the level of minimally invasive procedures, such as dermal fillers, neurotoxins, and lasers, has been stable [and] even increased in recent months, whereas the numbers of surgical bookings have been falling off compared to a year ago.”
See also “Fillers and Injectables,” by Wendy Lewis, in the June 2008 issue of PSP.
The luxury category in every sector is showing signs of stalling. The market for beachfront homes, diamonds, furs, cars, boats, hotel suites, and five-star dining is also tapering off.
Aesthetic practitioners can take solace in the fact that America’s obsession with a youthful appearance is unlikely to subside anytime soon. Less invasive procedures are positioned to achieve the greatest growth in the near future.
As topical creams, injectables, and energy-based devices can only get you so far, we can expect there will always be a desire for aesthetic surgery.
“The ongoing interest in some surgical procedures will continue to be strong. For example, breast implants and rhinoplasty, where there are really no alternatives available that suit the majority of patients,” Forley says.
Wendy Lewis is president of Wendy Lewis & Co Ltd, a global aesthetics consulting firm, and the author of 10 books. She can be reached at www.wlbeauty.com.
- Wrinkle relief: Injectable cosmetic fillers. Food and Drug Administration Web site. www.fda.gov/consumer/updates/wrinklefillers062608.html. Note that this information was posted on June 26, 2008, prior to FDA approval for Evolence®; therefore, porcine collagen is not included here. Accessed December 15, 2008.
- FDA General and Plastic Surgery Devices Panel. Dermal Filler Devices, November 18, 2008. Food and Drug Administration Web site. www.fda.gov/OHRMS/DOCKETS/ac/08/briefing/2008-4391b1-01%20-%20FDA%20Executive%20Summary%20Dermal%20Fillers.pdf. Accessed December 15, 2008.