By Jonah Shacknai
The aesthetic landscape has changed extraordinarily since Jonah Shacknai brought Restylane to market in 2003 — and that is a benefit to physicians and consumers alike.
It seems difficult to imagine in today’s filler-filled day and age that there was ever a time when you couldn’t have your lips plumped or your marionette lines smoothed at your dermatologist or plastic surgeon’s office or even local med spa. (Note: You should always see a licensed practitioner.) But if you were to visit your doctor in the 1980s, 90s, or very early aughts requesting more fullness in your lips or face, the only dermal filler option available would have been one made from bovine collagen, which was problematic for several reasons. Firstly, many people are allergic to the ingredient, which meant that a skin test and the four weeks required to see if you had an adverse-reaction were prerequisites to injection. Bovine collagen is also animal-derived, which many people object to for religious or ethical reasons, not to mention that its results tend to disappear rather quickly.
It thus should come as no surprise that when the FDA approved Restylane (the first-to-market hyaluronic acid filler) in 2003, Rod J. Rohrich, M.D., F.A.C.S., clinical professor of plastic surgery at Baylor University and then-president of the American Society of Plastic Surgeons, said, “The arrival of Restylane to the U.S. has been long-awaited by physicians and consumers alike given its worldwide safety record and reputation as the ideal solution to eliminate wrinkles and facial folds.” He went on to correctly predict, “Restylane represents the future of cosmetic dermal fillers in that it’s completely natural and biodegradable, is non-animal derived so it does not pose a risk of disease transmission, and has been shown to last longer than six months, which is better than any currently available non-permanent dermal filler.”
While the introduction of a hyaluronic-acid filler to the U.S. market was seemingly inevitable, it likely would have taken many years longer for it to receive FDA approval if it weren’t for Medicis, the company I founded in 1988. “In bringing hyaluronic-acid dermal fillers to market in the U.S., Jonah Shacknai forever changed the landscape of facial aesthetics,” says Vivian Bucay, M.D., a San Antonio-based board-certified dermatologist, “not only by providing us with an innovative way to restore facial contours but also by ensuring that we physicians were well trained in the science and best practices to achieve optimal results for our patients.”
In the nearly 17 years since Medicis received FDA approval for Restylane, the landscape for fillers has only improved — and become significantly more in-demand. According to the American Society of Aesthetic Plastic Surgery, its member physicians performed 58 percent more hyaluronic-acid injections in 2018 than they did just four years earlier, in 2014. To me, the continued proliferation of hyaluronic-acid and other types of dermal fillers seems to only expand the physician’s toolbox, increasing his or her ability to create the best possible results for patients.
Here’s how the dermal filler market has improved.
More FDA-approved hyaluronic acid fillers
When the FDA approved Restylane in 2003, it was specifically for the treatment of nasal labial folds, the lines running from the nose to the mouth that are also known as marionette lines. Since then, however, the FDA has approved multiple hyaluronic-acid dermal fillers (brand names include Juvederm and Belotero), as well as those made with other materials, for a host of uses, namely cheek augmentation and to treat volume loss on the hands.
More tailored treatments
The growing number of FDA-approved uses for hyaluronic-acid-based dermal fillers is partly because there are simply more products now available, each of which perform differently. Such iterations aren’t created just for the sake of having something new but instead offer varying densities, ratios of viscosity, and longevity that allows for tissue tailoring that wasn’t initially possible with Restylane. For example, Restylane Silk, the first FDA-approved product for lip augmentation, uses smaller, smoother hyaluronic acid particles that are intended to be injected more shallowly, enabling the practitioner to create a more natural-looking, fuller lip for the patient with less risk of bumps or lumps. Similarly, Juvederm now offers Juvederm Ultra, which specifically targets volume restoration in the mid-face region.
On top of the increased FDA-approved uses for hyaluronic-acid fillers, there are even more off-label uses (when a practitioner uses in a drug in a manner other than the treatment(s) the FDA approved it for). For instance, it’s become very popular for physicians to inject the filler in the bridge of the nose to achieve non-surgical nose augmentation, in the tear trough to fill in under-eye circles, and at the temples to subtly lift the face. While dermal fillers can be and are used safely in these areas, it’s important to note that these injection sites require greater knowledge of vasculature of the face, and patients should always ask about a practitioner’s experience with both the filler being used and the injection site.
More comfortable treatments
The introduction of lidocaine, a popular numbing agent, had an impact on the dermal filler landscape that truly can’t be understated. Before its arrival, physicians used a topical agent to numb the area being injected and often turned to dentists to instruct them on how to inject nerve blockers. Lidocaine, though, has proven instrumental in saving time for both doctors, who no longer have to wait for numbing agents to take kick in, and for patients, who are happy to avoid multiple injections or the use of nerve blocks, whose effect can last for several hours.
Introduction of hyaluronidase
As hyaluronic acid is a substance found naturally in the human body, products made with it are remarkably safe. With that in mind, the rare problems that do arise are typically not from the product itself but are more likely a result of faulty injection or the needle itself. On these exceptional occasions, physicians turn to hyaluronidase, an ingredient introduced in 2005 and known as the hyaluronic-acid eraser. The injectable enzyme dissolves hyaluronic acid in 24 to 48 hours (note that it doesn’t work on other types of filler), and its availability serves as a sort of safety net for patients and physicians alike, who know that a hyaluronic acid treatment can be easily reversed.
The responsibility of the physician
Since each new hyaluronic-acid and other dermal filler product is ultimately different from the next, it will behave differently, and a different depth of injection will be required. The onus, therefore, is on the physician or practitioner to learn how to use each new variation in order to ensure optimal and safe results.
Where do we go from here?
I was excited about the future of dermal fillers nearly two decades ago, when Restylane was first approved, and I remain equally excited about their future today because, as terrific as these products have become, I believe there is always room for improvement. Both Restylane and Juvederm products have continuously broken new ground, and I expect future iterations will be able to do even more and will be even longer-lasting. It might seem hard to beat the existing products, but, as we know from history, science always advances.