Temporary fillers are designed to be a short-term solution to a lifelong aesthetic issue. Some practitioners report patient fatigue with temporary fillers and a need for unique products that last longer. In addition to offering patients a unique treatment, longer-lasting fillers provide physicians the opportunity to offer a differentiated product that can enhance their practice economics.
The first FDA-approved permanent dermal filler is Artefill®, manufactured and marketed by Suneva Medical, San Diego (sunevamedical.com). It is composed of bovine collagen and unique, third-generation, engineered microspheres—and includes lidocaine for improved patient comfort. Its distinct formulation offers patients long-lasting wrinkle correction.
In addition, the proprietary microsphere production process provides tightly controlled microsphere size and an enhanced safety profile. In clinical trials, Artefill demonstrated a significant duration of correction and a positive safety profile with no significant device-related adverse events.
PSP asked four key luminaries to discuss their clinical experience with Artefill (www.Artefill.com). Three of the participants are plastic surgeons: Steven R. Cohen, MD, FACS, of La Jolla, Calif; Daniel C. Mills, MD, FACS, of Laguna Beach, Calif; and Kristin A. Boehm, MD, FACS, of Atlanta. We also spoke with dermatologist Gregory A. Nikolaidis, MD, of Austin, Tex.
PSP: What made you decide to bring Artefill into your practice?
Steven R. Cohen, MD, FACS: As the primary investigator for Artefill for the FDA trials, I saw excellent outcomes with low complication rates. Any adverse events that occurred could be easily treated and resolved. This was in contrast to results that some surgeons in the US were citing. I was impressed by the data and continue to see patients with excellent outcomes.
Daniel C. Mills, MD, FACS: In Orange County, patients have been asking for something that is longer lasting. For those patients who like having fillers and the results they can achieve, they may not want to come back every 6 to 9 months for another treatment. Artefill represents another option to keep those patients satisfied and in your practice. I have carefully reviewed the safety data, and the incidence of granulomas is equal to or even less than other well-established injectable products on the market.
Kristin A. Boehm, MD, FACS: I, admittedly, was hesitant about using Artefill, having heard of some of the complications associated with earlier formulations. The third-generation product was developed to minimize any incidence of untoward side effects seen with the previous generations of the product.
In addition, I visited the Suneva facility and was impressed with their corporate culture, which emphasizes meaningful collaboration with physicians. I found them to be a serious company that has a commitment to safety. The ongoing 5-year safety study assessing the product, adverse events, and treatment demonstrates that both patient safety and satisfaction are paramount with this product. I would not have offered Artefill to my patients if I were not convinced of its safety profile.
Gregory A. Nikolaidis, MD: I trained at [University of California] San Diego and had the opportunity to tour the Artefill facility, and was impressed. I have been using Artefill since then and have treated several hundred patients. The rate of satisfaction is extremely high.
There is a subgroup of patients who have injection fatigue and don’t want to come in every 6 months to get injected. We have also found that they will come in to have other procedures done, so I don’t think it takes away from our practice at all. I would also point out that it is an ideal treatment for both women and for men, who typically prefer something long-lasting and do not like to return too often for additional treatments.
PSP: How do you differentiate Artefill from other fillers when speaking with patients?
Cohen: Artefill is a nonresorbable filler, and its effects continue to improve over time in most patients. I tell patients up front that the results are long lasting, and I believe this contributes to the high degree of satisfied patients we are seeing with this product.
Mills: When I introduce Artefill to a new patient, I talk about the concept of longer-lasting fillers. Artefill includes a polymethyl methacrylate (PMMA), but the particles are uniform in size, which has the longest-lasting chance of duration. Unfortunately, we cannot use it for the lips, which is an area that patients are always looking for something more permanent for. But it is great for the nasolabial folds.
In a study I am currently involved in, 100% of my patients related that they had more correction or fill somewhere between 6 and 12 months than at 1 month. I am seeing that they are getting some neocollagenesis around the PMMA over time.
Boehm: One thing I emphasize to patients about Artefill compared to other dermal fillers is that it is more of a process than a quick, one-time remedy. The optimal result really involves more than one treatment, spaced at intervals of several weeks apart. While there is some immediate correction following injection, I believe the real result will be seen several months later when natural collagen deposition has occurred and fills the treated area.
Nikolaidis: It is usually in the case of the patient who is concerned about pricing or duration of fillers that I will segue into a discussion about Artefill. For example, the patients who say, “Doctor, do you have anything that lasts longer than 6 to 12 months, or is there something cheaper?” I tell patients that we have a nonresorbable product that can last many times longer than the other fillers, and that it appears to behave in a manner that is more natural than temporary fillers.
When I inject Artefill, I feel like the results are more natural. Some patients are concerned about having a nonresorbable filler, and those are generally not the patients that I recommend it for. I have some patients that have never been injected before, and ask for a longer-lasting or permanent product. I use the “permanent” phrase, but explain that they are going to continue to age and may need a touch-up in 5 to 7 years.
PSP: Where does Artefill fit within your aesthetic practice?
Cohen: For patients desiring permanent fillers, or who complain about filler fatigue, Artefill is the only nonresorbable FDA-cleared product currently available. If a patient prefers something long-lasting that is a natural and biologic product, I might use fat.
Mills: Artefill is a great filler that I would place somewhere between fat grafts and more temporary fillers. It is something you can pull off the shelf so you do not have to go through the more complex process of fat harvesting. I have been using Artefill for 3 years and continue to offer it to more and more patients.
Boehm: As with most things, different patients have different needs. Artefill can be a very useful option in several situations. Certainly, it can be a good option for long-lasting wrinkle correction for many patients. It can also help maintain or improve postop results following facial surgery—for example, in the nasolabial folds. The ability to restore volume noninvasively and with long duration is what makes Artefill unique among other commercially available filling agents.
Nikolaidis: To me, the unique selling point of Artefill is that it is very smooth and natural, and it feels like normal tissue when it is injected. I do not overcorrect during treatment. I have never seen any nodules or negative reactions after treating over 300 patients. In my practice, Artefill fills a niche that other products do not.
PSP: What are your main criteria for patient selection with Artefill?
Cohen: Patients with filler fatigue who would like long-term reduction of nasolabial folds are ideal candidates for Artefill. Patients today want choices, so I will discuss Artefill as an option when I think it is appropriate, and let the patient decide.
Mills: My main contraindication would be for someone who has never had a filler before. I will not inject a patient unless I have waited the full 28 days after skin testing, and I do not double test.
For patients who are not sure about Artefill, I will offer them a temporary product first. I explain it like this: “It is like trying on a dress before you buy it.” If a patient wants a long-lasting result, it will drive me more to selecting Artefill. I love it in the nasolabial lines. When I do a treatment, I fill to what I think is full correction. I also do not overfill. Patients often come back for a top-up at about a month, when I can pretty much see what they are going to get. I prefer to have patients come back to have a little more if they want it.
Boehm: The Artefill patient is someone who is willing to accept a gradual result with the end benefit being its duration. This is certainly appealing in addressing areas like the nasolabial folds. In addition, there are certain patients in whom having a permanent result without the need for ongoing injections is especially beneficial. It also applies to patients who are budget conscious. Artefill offers good value to filler patients.
Nikolaidis: Oftentimes, I use Artefill in conjunction with other fillers, including hyaluronic acid, poly-L-lactic acid, and calcium hydroxylapatite. For someone who needs a lot of volume, Artefill probably wouldn’t be my first choice.
My average treatment is two to four syringes, and two syringes is a minimum for most patients. I generally retreat in 6 to 12 months for a top-up, if needed. I prefer to undertreat with a particulate filler rather than to overtreat. I also like to use fillers after laser treatments, so if a patient is having fractionated resurfacing, I would use a laser first, then have the patient come back in a month or so to have filler done.
PSP: How does Artefill complement the temporary dermal fillers and neurotoxin agents you are currently using?
Cohen: Artefill is an extension of temporary fillers, and I often combine it with other fillers for different areas where Artefill is contraindicated, such as in the lips. Neurotoxins are complementary to all dermal fillers, whether permanent or temporary.
Mills: Artefill gives patients other choices in terms of longevity, but there are some areas that I prefer not to use it in—such as fine lines, around the eyes, and the vermillion. However, I prefer reversible fillers, as in hyaluronic acids, in the tear trough area.
Boehm: For patients who are new to injectables, having both temporary and more long-lasting fillers available is extremely beneficial.
Many patients like the appeal of a product with longevity, but want to be able to view the results first before making such a big commitment. In these cases, it can be especially effective to initially treat the patient with a temporary dermal filler to demonstrate realistic results, and at the same time place the Artefill skin test. This allows a patient to see what a filler can do and develop a certain level of comfort before choosing a long-lasting product.
Nikolaidis: With neuromodulators, I will use Artefill at the same time or before, depending on how much movement there is in the area. If there is more movement, I will do it before to immobilize the area I am trying to treat. We have patients avoid aspirin and other nonsteroidal anti-inflammatory agents for a week before and 4 to 6 weeks after to get better collagen stimulation.
We found that there is a subgroup of radio frequency skin-tightening patients that do not respond, and we found that if we get them off aspirin before treatment they get much better results. Post-treatment, we recommend SkinMedica TNS Recovery Complex because the growth factors aid in healing. Bruising with Artefill is minimal. In fact, it is less with Artefill than with hyaluronic acid fillers.
PSP: What advantages does Artefill offer to a medical practitioner, and why?
Cohen: Artefill is a cost-effective treatment for patients and provides doctors with a long-lasting and safe product. It allows you to cultivate a new group of patients into your practice, who may prefer long-lasting fillers.
Mills: Above all, the high acceptance from patients is a real advantage to the practitioner. They love it.
Boehm: Every patient has unique needs, and ascertaining what a patient wants is the first step of every consultation. For some, achieving natural correction without the need for repeated office visits and the associated cost, discomfort, and downtime is a real priority. To be able to offer this with Artefill and achieve patient satisfaction is certainly advantageous. Its safety and efficacy make Artefill a good treatment option that we can offer.
Nikolaidis: We keep our patients informed about Artefill through e-mail campaigns, postcards, and product brochures. My Artefill patients are my most loyal patients, and they come back for other things, whereas neuromodulator patients are the most fickle.
Patient loyalty is an important advantage. If physicians can get beyond that and realize that the Artefill patient will stick with them and come back because they are happy, they would reap the benefits, too.
Wendy Lewis is president of Wendy Lewis & Co Ltd, Global Aesthetics Consultancy, author of 11 books, and founder/editor of beautyinthebag.com. She can be reached at .