Bellafill® (formally Artefill®) is an injectable filler that provides natural looking correction while restoring facial volume. It is also effective in the treatment of acne scars.
Bellafill® is different from temporary injectable fillers. The unique microspheres in Bellafill® are not absorbed by the body and provide the support your skin needs for natural looking results. It also has been found to last longer* than other fillers.
If you have used temporary fillers in the past, then you know that they are eventually absorbed by your body and require frequent repeat injections to maintain the results you’ve come to love.
Dr. Pierone is the leading injector of Bellafill® in the United States and is a nationally recognized trainer and researcher. He has performed over 20,000 procedures with dermal fillers.
Before and After
How Does it Work?
Bellafill® is an FDA-approved, natural looking dermal filler comprised of collagen and PMMA microspheres.
Unlike other types of fillers, Bellafill® replaces collagen in the face and restructures the skin to support natural looking results.
The effects of Bellafill® come from the collagen, which is absorbed by the body over time. The PMMA microspheres provide enduring wrinkle correction by creating a support matrix for the body’s natural collagen. The unique microspheres in Bellafill® are not absorbed by the body and create a support matrix for wrinkle correction by working together with your body’s own collagen.
Upon injection, the collagen in Bellafill® visibly reduces the wrinkles right away and the microspheres provide support for your skin. Your body’s own collagen works together with the microspheres to provide natural feeling wrinkle reduction.
Body Area(s) & Procedure(s)
The U.S. Food and Drug Administration (FDA) has recently approved the dermal filler, Bellafill®, for the treatment of acne scars.
Bellafill® / Artefill® is priced $800 per syringe and $3,500 per box of 5. A full treatment can require anywhere from 2-5+ syringes. Product duration 5+ years.
What to Expect
Bellafill® is injected with the assistance of a microcannula, the latest revolution in injection techniques!
Here's what to expect:
Using a technique known as skin sculpting, we will literally slide the Microcannula under your skin so that the filler can be applied with practically no pain or bruising for the patient.
There is typically a low incidence of side effects with Bellafill®, but expect redness after treatment, mild swelling and mild discomfort 24 hours after treatment.
Important Safety Information
Bellafill® is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.
What distinguishes it from other fillers on the market?
One of the misconceptions about Bellafill is that it is a one and done procedure. As the bovine collagen is reabsorbed, the PMMA microspheres are surrounded by macrophages and multi-nucleated giant cells along with bands of naturally produced collagen. However this volume is less than the bovine collagen that was injected, so there is an overall reduction in volume as compared with the immediate result. Subsequent injection sessions require fewer Bellafill syringes to achieve correction since they build upon the previous permanent PMMA filler base. Practitioners and patients need to understand that with Bellafill they are using a truly permanent facial filler but that a series of treatment sessions will be needed to achieve optimal results.
Please comment on Bellafill's safety profile.
Skin testing for bovine collagen allergy is recommended before treatment with Bellafill. Personally, I don’t perform the bovine collagen skin test, because bovine collagen allergy is quite unusual, and if it occurs, it is easily managed. I include the omission of the skin test in my written informed consent for patients. Also, a negative skin test is not entirely predictive, and a bovine collagen hypersensitivity reaction may still occur. I have seen this happen in patients with a negative skin test. But again, if it does occur, this problem is easily managed with a short course of corticosteroids and antihistamines. It is also completely reversible.
The second safety issue is the possibility of producing a nodule or lump. This complication tends to be related to sub-optimal injection technique. The product itself is very smooth and when properly injected nodules should be quite rare. That said, Bellafill should only be injected by highly experienced practitioners who have mastered facial injection techniques. If lumps or nodules do develop, they may be effectively managed with serial injections of corticosteroids with or without injection of 5 fluorouracil. On rare occasions, surgical removal may become necessary.
Granulomas are the other potential complication related to facial fillers, including Bellafill. The company completed a five year safety study in over 1000 patients that showed a five year rate of granuloma of 1.7%. Granulomas typically present as single or multiple inflammatory nodules in the regions where Bellafill was injected. They are managed with serial injections of corticosteroids with or without injection of five fluorouracil. In some cases, hyaluronic acid-based fillers may be required to camouflage the granulomas as they are resolving. It should be noted that granulomas represent an overly robust immunologic reaction to the PMM A microspheres, and favorably respond to corticosteroid injections. Surgical removal is inappropriate, medical therapy is the proper course of action.
Who are good candidates for Bellafill?
Please describe patient satisfaction.
Is there anything you would like to add?
I am also several years into an FDA approved long-term safety and efficacy study of Bellafill for treatment of HIV related lipoatrophy. I have 30 subjects who have received over 30 syringes of Bellafill over a one year treatment and who then are followed for two additional years. The results have been overwhelmingly positive, and quite frankly, life-changing in this patient population.
I have surgeons and dermatologists who cite t permanent nature of Bellafill as the primary reason that they will not use this filler. For fair balance though, some of these practitioners would not hesitate to recommend a surgical procedure, which by their nature, may produce permanent problems as well.
Is it safe?
Will it work for me?
When will I see results?
What's the downtime?
How long does it last?
References: 1. Gottfried Lemperle, et. al., ArteFill® Permanent Injectable for Soft Tissue Augmentation: I. Mechanism of Action and Injection Techniques., Aesthetic Plast Surg. 2010 Jun;34(3):264–72. 2. Bellafill® [Instructions for Use]. San Diego, CA: Suneva Medical, Inc.; 2015. 3. Jacob CI, Dover JS, Kaminer MS. Acne scarring: A classification system and review of treatment options. J Am Acad Dermatol; July 2001; 109-117. 4. Data on file. Suneva Medical, Inc. 5. Haneke et al. Polymethyl Methacrylate Microspheres in Collagen. Semin Cutan Med Surg 23:227-232,2004. 6. Cohen et al. Artecoll: A Long-Lasting Injectable Wrinkle Filler Material: Report of a Controlled, Randomized, Multicenter Clinical Trial of 251 Subjects. Plast. Reconstr. Surg. 114: 964,2004. 7. American Academy of Dermatology, http://www.aad.org/media-resources/stats-and-facts/conditions/acne#.Uc2hG_nvt8F. 8. Journal of Plastic, Reconstructive and Aesthetic Surgery, 2008, http://www.sciencedirect.com/science/article/pii/S1748681508003951. 9. Formula PR Independent Study, 2013. 10. Suneva Medical AAD Advisory Board, August 2015, data on file.
Publication / Media Exposure The DUAL PRACTITIONER Infectious disease specialist Dr. Gerald Pierone talks with an assistant at his Facial Rejuvenation office. His aesthetics practice in Vero Beach grew out of his work with HIV/AIDS patients. BY MARY ANN...
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