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Introduction

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.

Bellafill Treatment Areas

How Does it Work?

How Bellafill works

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.

Acne Scar Treatment

The U.S. Food and Drug Administration (FDA) has recently approved the dermal filler, Bellafill®, for the treatment of acne scars. Bellafill® represents a significant clinical advancement as the only filler on the market approved for this disfiguring skin condition. Acne is the most common skin disorder in the U.S., affecting 40-50 million people and up to 95% of people with acne may go on to suffer from scarring. Bellafill® was studied extensively prior to its FDA approval and proven to be safe and effective for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.

“These types of acne scars affect millions of people and can have a profoundly negative impact on their self-esteem and self-confidence,” said Nicholas L. Teti, Jr., Chairman and CEO at Suneva Medical. “The results of this rigorous clinical study prove that Bellafill® reduces the appearance of acne scars—providing a solution to this widespread skin condition that previously had limited treatment choices. Bellafill® can have a transformational effect on a patient’s appearance and in turn, we hope an improvement in quality of life.”

In an independent study, more than 70% of respondents felt their acne scars negatively impacted their self-confidence, with 92% indicating self-confidence would be restored or improved if their acne scars were healed. (*reference) To help treat disfiguring acne scars, Bellafill® adds volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding skin. The treatment is a simple, in-office procedure with minimal to no downtime.

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Before and After

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What to Expect

Bellafill® is injected with the assistance of a microcannula, the latest revolution in injection techniques!

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.

Reference: www.bellafill.com

What does Bellafill® do?

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Proven to last for 5 years. Up to 10 Years*

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Provides Noticeable Results

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Look and feels natural

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Makes Economic Sense

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Proven Safe. Proven Smart.

Bellafill® Cost

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.

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FAQs

What distinguishes it from other fillers on the market?

Bellafill is the only FDA approved permanent filler. It is actually a hybrid product – 80% bovine collagen and 20% PMMA. The PMMA is the permanent component.

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.

The most common question that clinicians and patients have about Bellafill has to do with its safety profile. The obvious concern is that with a permanent filler, potential complications may be permanent as well. I think that there are three potential complications that need to be considered for anyone considering treatment with Bellafill.

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?

The best candidates for Bellafill are experienced patients who have had good results with facial fillers in the past, and are looking for a permanent result. For many people, facial filler fatigue may set in. It takes a commitment to continually see a practitioner for repetitive injections of temporary facial fillers. There are also many people who are thin, very active, and have higher metabolic rates who seem to require more frequent injections with temporary facial fillers. These fast metabolizer may also be good candidates for Bellafill.

Please describe patient satisfaction.

Patient satisfaction is typically quite high. If you look on the website Real Self, Bellafill approval rating is 90%. My practice experience mirrors this positive patient response. The great majority of patients are satisfied and appreciate the permanent results. I often see return patients who remain pleased with the series of Bellafill treatments that they received years before.

Is there anything you would like to add?

Although it is an off label indication, my use of Bellafill has evolved over the last five years. I now very often will use Bellafill as a deep structural filler directly on periosteum to mimic bone volume. This includes the malar eminence, the mandible, and chin. If you think about it, the truth is that this product may be used as a substitute for a surgical facial implant.

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?

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. Patients who have had a positive reaction to the Bellafill® Skin Test, have a history of severe allergies, have known bovine collagen allergies, are allergic to lidocaine, have bleeding disorders or are prone to thick scar formation and/or excessive scarring should not receive Bellafill®. The safety of Bellafill® for use during pregnancy, breastfeeding, or in patients under 21 has not been established. You may experience temporary swelling, redness, pain, bruising, lumps/bumps, itching, and discoloration at the treatment site. These side effects are usually transient and typically resolve within 1–7 days. You may experience lumps/bumps/papules that may occur more than one month after injection and that may persist. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, lumps/bumps, acne, and increased sensitivity at treatment sites. Infrequently, granulomas may occur and may be treated by Dr. Pierone. Based on the 5-year Post-Approval Study on nasolabial folds with 1,008 patients, long-term safety of Bellafill® for up to 5 years has been established.(2)

Will it work for me?

In a clinical trial, Bellafill® was shown to work equally well with all skin types, and in men and women. Patients who have had a positive reaction to the Bellafill® Skin Test, have a history of severe allergies, have known bovine collagen allergies, are allergic to lidocaine, have bleeding disorders or are prone to thick scar formation and/or excessive scarring should not receive Bellafill®.

When will I see results?

Bellafill® replaces lost volume in the skin below the wrinkle for correction that is noticeable and lasting.(2)

What's the downtime?

You can return to normal activities right away. As with any injectable dermal filler, you may experience temporary swelling, redness, pain, bruising, lumps/bumps, itching, and discoloration at the treatment site. These side effects are usually transient and typically resolve within 1-7 days.

How long does it last?

The PMMA microspheres provide a microscopic ‘matrix’ to support your body’s own natural collagen production and re-create the firm structure of younger-looking skin for lasting correction, proven effective through 5 years(2). This number is potentially much higher but has not been tested in long duration clinical trials.

www.bellafill.com/FAQ
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.

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Dr Gerald Pierone Jr

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* Medical Disclaimer

The medical information on this site is provided as an information resource only. It is not designed to and does not provide medical advice, professional diagnosis, opinion, treatment or services to you or to any other individual and is not to be used or relied upon for any diagnostic or treatment purposes. This information is not intended to be patient education, does not create any patient-physician relationship, and should not be used as a substitute for professional diagnosis and treatment. More information

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