A Roundtable Discussion with W. Philip Werschler, MD, FAAD, FAACS; Edward M. Zimmerman, MD; Anita Mandal, MD; E. Victor Ross, MD; Craig F. Teller, MD; and Gregory Laurence, MD
Dr. Werschler is Assistant Clinical Professor of Dermatology at the University of Washington School of Medicine in Seattle, Washington. Dr. Zimmerman is Medical Director at Las Vegas Laser and Lipo in Las Vegas, Nevada. Dr. Mandal is with Mandal Plastic Surgery Center in Palm Beach Gardens, Florida. Dr. Ross is the director of the Laser and Cosmetic Dermatology Center at Scripps Clinic in San Diego, California. Dr. Teller is with Bellaire Dermatology in Bellaire, Texas. Dr. Laurence is with Germantown Aesthetics in Germantown, Tennessee.
Abstract: Injectable fillers provide a more youthful facial appearance by replacing lost volume, recontouring lines, and repositioning sagging structures associated with aging. Fillers are also used to repair scars from acne, trauma, or surgery, particularly scars that are soft and distensible. Efficacy of polymethylmethacrylate (PMMA)-collagen (Bellafill, Suneva Medical, San Diego, California) has been reported for the treatment of acne scars, and its safety has been evaluated in four United States clinical trials, including a five-year, post-approval safety study. Bellafill is the only PMMA filler approved by the United States Food and Drug Administration for the treatment of nasolabial folds and correction of acne scars. This article presents the transcript of a roundtable discussion on the use of Bellafill, alone and in combination with other procedures, for facial rejuvenation and the treatment of acne scars.
Funding: Funding for this roundtable discussion was provided by Suneva Medical, Inc.
Disclosures: Suneva Medical Inc. assisted in the development of this article. This article is based on a roudtable discussion that took place during the 2017 Annual Aesthetic & Medical Dermatology Symposium in Coeur d’Alene, Idaho. This article did not undergo peer review.
Keywords: Collagen stimulation, dermal filler, soft tissue augmentation, volumization
J Clin Aesthet Dermatol. 2018;11(6 Suppl):S3–S7
Introduction
Injectable dermal fillers are designed to restore volume in the aging face. Advantages over more invasive procedures are safety, shorter down time, and cost. Biodegradable fillers persist for several months to a few years while nonbiodegradable fillers are long lasting or permanent. The primary biodegradable products are hyaluronic acid (HA) and collagens while the major longer lasting products include polymethylmethacrylate (PMMA), poly-L-lactic acid, and calcium hydroxylapatite. Bellafill® (Suneva Medical, San Diego, California), a PMMA-collagen dermal filler, is currently the only PMMA filler approved by the United States Food and Drug Administration (FDA).
Several studies suggest that patients seeking nonsurgical facial aesthetic treatments might prefer a longer lasting filler over temporary fillers such as HA.1,2 In a patient survey of the American Academy of Facial Plastic and Reconstructive Surgeons (AAFPRS), 95 percent of respondents preferred longer lasting treatment over treatment with immediate results and shorter duration, while 60 percent felt that longevity of effects was more important than cost for a facial aesthetic procedure.1
Broder and Cohen2 compared the cost/benefit ratios for the HA product, Restylane® (Galderma Laboratories L.P., Fort Worth, Texas), and the PMMA product, Artefill® (currently Bellafill), for the correction of nasolabial folds.1 Their study showed that, over five years, the HA treatments cost $8,000, compared to $2,400 for the PMMA injections, and that, on average, the PMMA product provides a 333-percent higher pharmacoeconomic value over the HA product.
In addition to replacing lost volume, recontouring lines, and repositioning sagging structures associated with aging, injectable fillers are also used to repair scars from acne, trauma, and surgery, particularly scars that are soft and distensible.3 The major dermal fillers with clinical trials for the treatment of atrophic acne scars include PMMA, polyacrylamide, poly-L-lactic acid (PLLA), calcium hydroxylapatite, collagen, and HA.4 The efficacy of PMMA-collagen has been reported for the treatment of acne scars, and the safety of Bellafill has been evaluated in four United States clinical trials, including a five-year, postapproval safety study. Bellafill is the only PMMA filler approved by the FDA for the treatment of nasolabial folds and correction of acne scars.5,6
Nonenergy-based treatments, such as platelet-rich plasma (PRP), chemical reconstruction of skin scars (CROSS) with trichloroacetic acid (TCA), microneedling, autologous fat transfer, and stem cell therapy, have also emerged for acne scar treatment.7,8–11,12,13
A roundtable discussion on the use of Bellafill alone and in combination with other procedures for facial rejuvenation and the treatment of acne scars took place during the recent annual Aesthetic & Medical Dermatology Symposium in Coeur d’Alene, Idaho.
Roundtable discussion
Dr. Werschler (Moderator): This roundtable was sponsored by Suneva Medical, Inc. We are discussing new and expanding uses of Bellafill as a long-term collagen stimulator, alone and in combination with energy devices, stem cell technology, platelet-rich plasma, thread or suture lifting, and microneedling in aesthetic medicine. I am Dr. W. Philip Werschler, dermatologist, acting moderator of this roundtable. I participated in all of the clinical trials to evaluate the efficacy and safety of Bellafill, a product of Suneva Medical Inc.
Dr. Werschler: Dr. Anita Mandal, you’re a facial plastic surgeon in West Palm Beach, Florida. How do you position Bellafill in your practice? What procedures do you combine with Bellafill?
Dr. Mandal: I’ve used Bellafill for four years. I use it on every part of the face and on the hands. The most popular facial areas are the nasolabial folds, mouth corners, temple, and the entire forehead. About 80 percent of my Bellafill patients want an energy treatment as well. I use Bellafill for volumization in the upper face, and then I tighten the skin of the lower face and upper neck with radiofrequency (RF). I also inject Bellafill into a facial area and then tighten the skin of the same area (with RF) 10 to 14 days later without adverse effects. I’m exploring the use of PRP with micronized fat in certain areas of the face where the fat is more suitable.
Dr. Werschler: Did you say that you do the energy treatment (RF) 10 to 14 days after the Bellafill treatment?
Dr. Mandal: Yes. Patients come in for RF once a month for three months. Since most patients don’t want to wait two months after an RF treatment to start Bellafill, I inject Bellafill and follow with RF 10 to 14 days later with no loss of Bellafill in the treated tissues. I would be reluctant, however, to treat with RF 10 to 14 days after injecting a temporary filler.
Dr. Werschler: Thank you, Dr. Mandal. We also have Dr. E. Victor Ross, a dermatologist in San Diego and a recognized expert in the use of energy devices with dermal fillers in general and with Bellafill in particular. Dr. Ross, what are your thoughts on safety in the use of energy devices in combination with Bellafill, PRP, stem cells, and other new procedures?
Dr. Ross: These issues first came up when people were concerned about the interaction of Thermage® (Valeant Pharmaceuticals International, Inc., Pleasantville, California) RF energy with botulinum toxin type A, other neuromodulators, dermal fillers, and other energy devices, because Thermage treatments covered such a large volume of tissue. To address this, my colleagues and I did some studies about 10 years ago on animals and energy devices interacting with fillers.14 We saw no change in the effects of fillers when energy devices, including fractional lasers, were used to treat the injected areas.
Dr. Werschler: Thank you, Dr. Ross.
Dr. Teller: I’m Craig Teller, dermatologist from Houston, Texas. I would like to hear Dr. Ross’s views on combining energy devices for acne scars. The typical approach has been to treat with energy-based devices, such as fully ablative CO2, fractional ablative CO2, or even deeper chemical peels. Now, there seems to be a transition to microneedling and microneedling plus CO2. But in my practice, I’ve used Bellafill for acne scars, and it’s been an absolute home run. I’ve used it for protruding acne scars, boxcar scars, rolling scars, and even slightly distensible ice pick scars. Dr. Ross, since Bellafill is a stimulatory filler, it acts differently than HA. That said, what if I started with fractional CO2 resurfacing, followed with Bellafill, and finished with topical therapy? That’s different from what I’m currently doing, which gives me superior results. I use Bellafill first (to fill up spaces of scars), follow with fractional CO2 over that, and continue the stimulation with microneedling. If I started with Bellafill instead of the energy device, would I destroy Bellafill’s inflammatory and stimulatory response when I follow with the energy device? I’m hoping for a synergistic response.
Dr. Ross: I don’t think you will suppress the biostimulatory response of the filler by treating with the energy device after the filler. In my practice, I don’t use Bellafill first because many patients don’t want to pay for a filler as an initial treatment. I usually start with the laser and then suggest following with a filler. That’s why I use fillers later as a philosophical thing. But there are cases when adding Bellafill first is probably the best thing to do, particularly for deeper scars with some volume loss. Bellafill will fill the scars right away, and you’ll get a good response with the energy-based modalities.
Dr. Werschler: Thank you, Dr. Ross. Dr. Zimmerman, you are a cosmetic surgeon in Las Vegas. What do you think?
Dr. Zimmerman: I agree with Dr. Ross. I use Bellafill every day, and I love how it works. I regraft the acne scar tissue first and then fill the deficit with Bellafill. Once the bovine collagen of Bellafill is replaced by the patient’s own collagen, we are safe to follow with an energy device, because the melting point of PMMA is about 320 degrees Farenheit, or 160 degrees Celsius, and most of our energy-based devices don’t heat the target tissue that high, because it would destroy the tissue.
Dr. Werschler: Thank you, Dr. Zimmerman. Dr. Laurence, you are a cosmetic surgeon in Memphis, Tennessee. What are your thoughts?
Dr. Laurence: I’m a long standing user of Bellafill for its approved and off-label uses. I believe that every good treatment starts with a correct diagnosis. It’s important for us, as diagnosticians, to recognize that patients with acne scars often have deficiencies in facial volume as well. A patient might look in a mirror and focus on specific scars that bother him or her, but the patient doesn’t realize that those scars might not even be noticed by others. If, in addition to the scars, we also diagnose an imbalance in the face (resulting in a less attractive face), we should treat both the scars and the facial imbalance with Bellafill. By treating both the imbalance and the scars, we increase the likelihood of patient satisfaction. In other words, the patient might not get compliments just from an acne scar that’s completely resolved. These are the reasons I regard Bellafill as a long-term volumizer that can make the patient happier with his or her appearance, as well as fill an acne scar.
Dr. Werschler: Thank you, Dr. Laurence. Dr. Mandal, would you like to comment on that?
Dr. Mandal: For acne scars, I typically use the energy device first and, if necessary, follow up with fillers. For example, if I use an energy device that can both resurface and tighten skin, my patients are pleasantly surprised at the improvement in not only their acne scars but also their skin elasticity. That is why I reserve Bellafill for scars that are still noticeable after treatment with the energy device.
Dr. Teller: Dr. Werschler, I find that it’s difficult to get full correction with ice pick scars. I’ve started to use the chemical reconstruction of skin scar (CROSS) technique with trichloroacetic acid (TCA). What has everyone else used for ice pick scars?
Dr. Werschler: That’s a great point. The CROSS technique involves using a Q-tip or toothpick to add a high strength acid, usually TCA, to the deep ice pick scars to create a significant wound in the dermis. You can also use an energy device or chemical peel to bring the deeper scars to the surface. I use microneedling, ablative CO2, and fractionally ablative CO2 lasers. If the ice pick scars are not too numerous, the easiest treatment is punch excision. I take each scar out, put in a little suture, close it up, and move on to resurfacing. Would anyone like to comment on that?
Dr. Ross: I agree. We had a patient with different types of scars, including small ice pick scars, with little to no volume loss due to her young age. We did punch excision (no larger than 2 or 3mm), a standard erbium YAG laser with a 1- or 2-mm spot to efface some individual scars, and then fractional CO2 over the entire area. Four to 6 weeks later we used fillers on the residual scars. The problem with that approach is that the patient might be disappointed in the results with laser initially as sometimes 3 to 4 months is required to see the final result. The results would be more immediate if the filler was used first, but that’s a hard sell for some people.
Dr. Teller: I know of an ongoing Suneva-sponsored acne scar study in which microneedling is given every month for three months followed by Bellafill. The results so far are very impressive. But in my opinion, if you don’t have Bellafill in the combination, you’re missing the boat. I say this because dermatologists might be reticent to use Bellafill out of a concern for safety.
Dr. Werschler: I think what you say is true, Dr. Teller. If we look at fillers as a separate category, whether as stimulatory or volume replacement, there is a tendency to focus on HA because it’s safe, easy to use, and reversible with hyaluronidase. Yet Bellafill is the only filler with a published five-year safety study. With HA, it’s like saying, “I believe this product is safe, and although I don’t have a literature reference, I believe it’s because that’s what everybody says, and we have the experience of clinical use.” With Bellafill, we do have a five-year safety and effectiveness study that shows that adverse events are rare and that Bellafill’s safety profile is comparable to that of other dermal fillers on the market.
Dr. Teller: I’m surprised that this five-year study doesn’t give safety-conscious dermatologists a little more comfort.
Dr. Ross: We’ve all seen granulomas and other adverse events in non-HA and non-FDA-approved fillers. Unfortunately, some people put Bellafill in those groups. The truth is that Bellafill has no more risk than any HA filler. But some dermatologists think that it might not be as safe as an HA filler, and that’s an image that must be reversed. They might think that a more durable product is also more risky.
Dr. Teller: Practitioners might see “risky” as two-pronged. One is safety and the other is longevity. Will a long-term filler reduce my business by causing the patient to not return? I think it’s the opposite. My patients tell their friends to see me because I give them the long-term results with Bellafill.
Dr. Werschler: That’s an excellent point. There are highly skilled people who are comfortable with Bellafill and know how to inject it for the best results. Part of those results is the ongoing stimulation of the fibroblasts and collagen, leading to improvement of the dermal-intradermal interface. The collagen stimulation concept is also part of PRP, stem cells, and other innovative procedures on which Dr. Zimmerman is an expert.
Dr. Zimmerman: We use Bellafill in areas outside the face too. We integrate Bellafill injections with PRP for their combined biostimulatory and volumizing effects. The PRP, micronized fat, and Bellafill each have different strengths, but they work well together. We sell the filler not by the syringe but by the results, which often include an energy-based modality and PRP.
Dr. Teller: It sounds like you are recommending an outcome.
Dr. Zimmerman: That’s correct. And that outcome is not just the immediate effect; it includes the longevity and durability as well. We all know that dermal fillers are not the beginning, middle, and end of rejuvenation procedures. We also have surgical procedures, botulinum toxin type A, energy devices, skin care products, and the list goes on. The question then becomes, how does Bellafill fit in with growth factors, stem cells, activated platelets, and other new technologies?
Dr. Teller: With Bellafill, we immediately stimulate fibroblast proliferation, and this continues for a long time. What about HA? Has anyone ever determined if HA injections improve skin quality over the long-term?
Dr. Laurence: The skin quality of people whose hands are treated with Bellafill looks better, likely due to the stimulatory nature of the product. We also recognize that there are other modalities that can act synergistically with Bellafill. I have used PRP and polydioxanone (PDO) quill suture to optimize body and facial cosmetic surgery results for years. This autologous product and synthetic filament are both tissue stimulating. Now, I commonly offer both agents in combination with Bellafill for nonsurgical facial rejuvenation. My colleagues at this roundtable might eclipse my experience with hand rejuvenation, but I hope to offer more of this requested procedure. The really important issue here is we all now achieve much better results using a combination of modalities. Filling the hands with an HA space-occupying dermal filler is “old school.” Superior outcomes and safety result from combinations of modalities that target epidermal, dermal, and subdermal components of tissue decline.
Dr. Werschler: I agree, Dr. Ross. There is something about the dermal collagen masks and the stimulation of fibroblasts, just as in energy devices, where we wound the skin with RF, ultrasound, or CO2 lasers. We get similar results, which, in my opinion, are based on the wound healing cascade and subsequent stimulation of collagen production. The question then becomes, are we really, with all these techniques, finding the best and longest lasting way to stimulate collagen production? I ask this because with a short-term, nonstimulatory, and volume-replacement filler, are we missing the mark because the filler doesn’t have enough residence time in the tissue? It’s like going to the gym once or twice versus going three times a week for a year. Dr. Ross, can you comment on energy devices in that context?
Dr. Ross: There is a certain synergy between lasers, RF devices, and fillers. These short-term fillers give you a short-term response. So, it makes sense to use Bellafill with a long-term presence to give you long-term healthy skin.
Dr. Werschler: Dr. Mandal, as a plastic surgeon, you’ve been using these products for a long time. What are your thoughts about long-term collagen stimulation and overall skin quality versus short-term volume replacement?
Dr. Mandal: I’ve used the injectable PLLA Scultpra® (Galderma Laboratories L.P., Fort Worth, Texas), but it lacks the longevity. When I treat with Bellafill, 40 percent of my patients will come back nine months later saying that they look better now than they did one month after their treatment. I am a believer in the long-term stimulatory effect.
Dr. Werschler: I think you’re right on track. We’re talking about long-term stimulation, whether it’s based on energy, dermal fillers, PRP, stem cells, or other treatment modalities. We’re just taking different paths to the same destination. If we stop short of the destination, we never get the full effect. If we want a long-term rejuvenative effect, we need long-term products and procedures that deliver, not just a six- or nine-month product that you must inject again in nine months. Dr. Zimmerman, what are your thoughts on this?
Dr. Zimmerman: We’ve used Bellafill since it was FDA-approved in 2006. Our images show that patients continue to look volumized and improved over the years. I now recognize that Bellafill is truly a long-term product. We have military veterans who were injected with Bellafill before they went overseas. When they came back several years later, the results were quite amazing compared to patients who received shorter-acting fillers. We use Bellafill to sculpt the upper face, restore the mandible volume, and restore volume lost in the temporal area all the way back over the ears. We also use Bellafill off-label to help augment inverted nipples. As for me, many patients prefer to have a long-lasting filler over one that must be restored every 4 to 6 months. Men who shave their heads notice that they’ve lost some of their subcutaneous fat in their ear lobes, so we use Bellafill for that too. As an analogy, when you take a balloon and inflate it and stretch it, the stretched balloon, like the skin, has more glow. We’ve had a lot of success with Bellafill in non-facial areas too.
Dr. Werschler: Dr. Laurence, do you use Bellafill in non-facial areas?
Dr. Laurence: I have a thoughtful colleague who has used Bellafill to treat cellulite on the buttocks and thighs with high patient satisfaction. Even for mild-to-moderate cellulite, there are cost considerations, but small problem areas show substantial improvement after 2 to 5 syringes over a few treatment sessions. I plan to offer this procedure in my practice. The bottom line is that we now view Bellafill as a completely different product than we did when it was launched. It is an indispensable regenerative tool that fits nicely into our evolving understanding of how we achieve excellent facial and other aesthetics results.
I’d like to add that the average dermatologist needs to know that Bellafill for acne scars is a great conduit into a full-service, aesthetic dermatological practice. The product works together with other modalities, and, for acne scars, the effects are additive.
As for bruising and swelling, we know that the average patient will have minimal bruising, but an acne patient will have more. To address this, we tell the patient with acne what to expect after the Bellafill injection. We use every means available to minimize bruising and swelling in these patients.
Dr. Werschler: That’s a point well taken. Acne scars have one side that’s therapeutic and another side that’s aesthetic, and the techniques have become one and the same.
Dr. Teller, I have a metaphysical question for you. Our focus has been that fillers occupy space, absorb water, and (in the short term) stimulate collagen. Should we, instead, focus on the long-term, the aging pathology, and the downregulation of growth factors and collagen production? With energy devices, other fillers, PRP, and other treatments, would the best approach to therapy be the long-term or even the lifetime of the patient versus the short term, or residence time of the product?
Dr. Teller: I think patients want to know what they can achieve for the long-term rather than for three months, six months, or nine months. For acne scars, one of my favorite areas is in the mid face. I do see long-term improvement with Bellafill, and those patients do come back over the long-term and their skin tone has improved as well. There is a fear among dermatologists who don’t use Bellafill that when they inject a common filler, the filler will distort the face. Bellafill is nicely integrated into the skin over time. An appearance of natural aging ensues just as with a shorter-duration filler.
Dr. Werschler: Dr. Mandal, what have you observed over time in patients treated with Bellafill and have also had a facelift?
Dr. Mandal: I’ve done facelifts on patients who have had Bellafill and I don’t see anything unusual when I dissect tissues that might have Bellafill. But those patients have had Bellafill less than five years. I still assume that Bellafill will not last forever. I don’t, however, think that changes in the facial tissues occur that quickly (e.g., within 5 years).
Dr. Werschler: Dr. Zimmerman?
Dr. Zimmerman: We’ve had patients treated with Bellafill early on and then had upper and lower blepharoplasties as well as upper and lower facelifts. I never found any PMMA that I could recognize in the tissue of those patients. Even in patients who have had massive amounts of Bellafill injected by other providers, I’ve not found nodules or the like in the tissues. What I have found are nodules or puddles of calcium hydroxylapatite and kernels of PLLA very clearly in the tissues, so I’m comfortable with injecting Bellafill for adequate volumizing and I see no significant long-term derogatory effects.
Dr. Werschler: There seems to be a consensus that long-term stimulation of fibroblasts and other tissue components should be our focus. Maybe there is something emerging with PRP, stem cells, and with long-term stimulation of fibroblasts that is taking us to another level of understanding of the aging pathology, and that rejuvenation is perhaps more than just a quick hit. Maybe it’s more of a long-term treatment that we should address with a longer-term product. Have any panel members used Bellafill in conjunction with PRP, stem cells, or fat transfer?
Dr. Zimmerman: Absolutely. I ask patients to bring photographs of themselves 10 to 20 years ago to my consultation with them. I use the facial contours in those photographs as the basis for deciding how much volumizing agent they will need to reestablish those earlier contours. Then I discuss the options: water-based HA gels, long-lasting PMMA fillers, or micronized fat. I also explain the risks and side effects of each option, so patients can make informed decisions. They often choose Bellafill in combination with PRP.
Dr. Werschler: Do you inject Bellafill and PRP simultaneously?
Dr. Zimmerman: I inject them during the same visit; I inject Bellafill first because it has 0.3% lidocaine. I place the Bellafill very deeply in the supraperiosteal plane and the PRP superficially under the skin to give the skin that rosy glow. This also helps to control bruising from the 27G x 1.25-inch needle, as well as activate the Bellafill, release cytokines, and activate other healing factors. We also apply a homeopathic gel dressing (OcuMends®, Cearna Aesthetics, Chicago, Illinois) to decrease (the risk of) swelling, bruising, or both.
The average person needs 1 to 3cc of volume replacement for each year after the age of 25, just to keep even, so older patients expect to have more filler in their face to obtain the results. They also expect to have more PRP, microneedling, or both, to obtain a more youthful look.
Dr. Teller: Could you inject Bellafill in one visit and PRP a few months later?
Dr. Zimmerman: Treatments are individualized. Some patients want all syringes of Bellafill and PRP at one visit while others, due to budget considerations, want 4 to 6 syringes during the first visit and more as they gradually approach their required contour. We recognize that the body’s response to the built-in collagen (of Bellafill) takes time as you get older. The same is true for PRP, as older patients have it more frequently than younger patients. Some want PRP every six months and others every three months.
Dr. Laurence: I expect that our practice will be more proactive in combining Bellafill with micronized fat, PRP, stem cells, and other modalities.
Dr. Zimmerman: Combination therapy is sort of the hallmark of a dermatologist.
Dr. Werschler: What would you all like to contribute in closing comments?
Dr. Ross: One question is how deep we should inject the filler. This is critical and can be challenging.
Dr. Teller: I like the 26-gauge needle for acne scars because it provides a sense that I am creating the subcision and also creating a very natural pocket for the Bellafill to be in place. I don’t ever use the depot technique. I also use a fanning technique and get a nice aesthetic outcome. Bellafill contours to whatever I want it to do.
Dr. Teller: Dr. Werschler, let’s try to help the injectors who are new to Bellafill and who hesitate to adopt it into their practices. Dr. Zimmerman helped by suggesting that we allow the filler to come to room temperature before injection, so the filler is more malleable. If you get lumps, they are easily massaged just like most other fillers. Granulomas and reactions are extremely uncommon. When they do occur, 5-fluorouracil or intralesional Kenalog® (Bristol-Myers Squibb Company, Princeton, New Jersey) can be used.
Dr. Werschler: I agree Dr. Teller, and the adverse events in the Bellafill trials were manageable with conservative therapy in the same way they were with any other injectable product. These issues have occurred with all of us. Bellafill’s five-year safety study has proven there are no demons in the closet Dr. Laurence, do you have closing comments?
Dr. Laurence: After almost 10 years of using Bellafill, I don’t recommend massage after treatment, although the manufacturer does recommend gentle massage of the areas treated. I inject into multiple planes, including periosteal, and halfway in between where the tissue is thicker. A rule of thumb for a novice injector is to inject 0.1cc of Bellafill into an area of 3x3cm, even if the injection is very superficial. With this technique, I’ve never seen an issue in contour. If I see a spot that needs a lot of filler, I overfill that spot. I use a two-inch cannula (25 gauge), which allows me to evaluate and treat the face in a pan-facial way. The novice injector should not get too wrapped up in one little area; instead, he or she should think of the treatment as a process, and this will keep the patient in a safe situation.
Dr. Teller: Do you use a 25-gauge needle for acne scars?
Dr. Laurence: I use the 26-gauge needle that comes with the product. I’m in the process of changing to a Nokor™ needle (Delasco LLC, Council Bluffs, Iowa) for subcision, which will be much more effective.
I would also like to comment on the skin test associated with Bellafill. In my experience, Bellafill is incredibly safe. Of the few patients in my practice who have had a reaction, one said, “I know I will have a reaction because I react to everything.” In response to this, we’ve developed a waiver we offer to each patient. The waiver explains why we don’t feel a patient needs a skin test, and it discloses that the FDA recommends that patients do have the test.
Dr. Werschler: I think it’s appropriate to make sure everyone understands the labeling of Bellafill in the US. The skin test is one in which the patient is injected intradermally, typically in the volar forearm, and must wait 28 days. Most reactions, if they occur, will be sooner than 28 days; however, that is the FDA label. Bellafill is also approved in Canada where a skin test is at the discretion of the physician.
I agree with you, Dr. Laurence, in that the decision should be individualized between the patient and provider with appropriate education. If you have the appropriate consent form, you can certainly use it on any patient. There are many qualified injectors who feel that a skin test is not necessary. I’ve never seen a reaction in any of my patients.
In closing, I wonder if we’ve miscategorized the stimulatory fillers, particularly Bellafill, in the sense that the short-acting filler will replace volume and produce an aesthetic result. Are we also discovering that all along, we’ve had a product that can provide long-term collagen stimulation, and have we been using and categorizing Bellafill as a dermal filler when maybe it’s something more. Bellafill is a long-term collagen stimulator more akin to PRP, stem cells, and other types of stimulators. One of the mainstays of regenerative aesthetics is the “triad” of the lattice or framework being used, the growth factors being stimulated, and the cells being amplified. Maybe we need to rethink what Bellafill really is.
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