Bellafill® Long-Lasting Wrinkle Filler

Bellafill®
Long-Lasting Wrinkle Filler

Dermal fillers are great, but do you wish to restore your own youthful skin rather than just replacing it? BellaFill is distinctive among injectable options for that reason. In addition to plumping smile lines instantly, BellaFill also helps re-create the firmer structure of younger-looking skin.

Each BellaFill injection is a mixture of bovine collagen, which provides immediate support; and biocompatible microspheres, which provide lasting support. These microspheres have been used in medical applications for more than 60 years. They create a microscopic ‘matrix’ to support your body’s own natural collagen production, and ultimately strengthen the layers of the skin. This provides the support your skin needs for wrinkle correction and younger looking skin.

What is
BELLAFILL®?

If you want an injectable wrinkle filler that provides lasting wrinkle correction, ask your Licensed Provider about Bellafill®.

Bellafill® is an FDA and Health Canada approved dermal filler for the correction of facial wrinkles known as nasolabial folds or smile lines. It is a unique, injectable collagen filler with microspheres that can instantly smooth facial wrinkles (nasolabial folds) for beautiful, natural-looking results that last. If you are ready to stop constantly filling and start replacing, Bellafill may be right for you.

What to Expect with
Bellafill®

Treatment with Bellafill® is very similar to treatment with conventional injectable fillers. The main difference is that Bellafill® requires a skin test in the United States to identify those patients who may have an allergy to bovine collagen or lidocaine. Lidocaine is provided to minimize discomfort during injection.

Before

After

Before

DR Before Bellafill

After

DR After Bellafill

1

First Appointment:

Your skin test. A small amount of purified bovine collagen gel is injected in the forearm to ensure you have no adverse reactions to bovine collagen and/or lidocaine.

2

Second appointment:

Four weeks later, if there have been no adverse reactions to the initial test, you are ready for treatment. Upon injection, you will usually see immediate improvement to lines and wrinkles. The amount of Bellafill® required will depend on the severity of the lines/wrinkles being addressed.

3

Third appointment:

A follow-up is suggested at 4-6 weeks. This also allows you to decide if you would like to further enhance or correct the area.

Enjoy a youthful look that lasts.

REASONS TO CHOOSE
Bellafill®

HOW BELLAFILL® WORKS:
Bellafill® replaces lost volume in the skin below the wrinkle for results that are immediate and lasting. The injectable gel is comprised of 80% purified collagen and 20% PMMA (polymethylmethacrylate) microspheres (add Lemperle reference).

BELLAFILL KEEPS ON WORKING:
Bellafill® is different. It restores rather than just fills for natural enduring results. In clinical studies, efficacy was observed out to 12 months.* (Primary efficacy endpoint was at 6 months)

BELLAFILL® IS AN EXCEPTIONAL COSMETIC TREATMENT
Bellafill® offers a new level of filler rejuvenation. In addition to immediately adding volume to smooth away facial wrinkles known as smile lines, Bellafill® helps your skin re-create its own firmer structure for beautiful, younger-looking skin and lasting results.*

ENJOY A YOUTHFUL LOOK
THAT LASTS.

Bellafill® contains lidocaine to lessen the discomfort from the procedure. With proper placement, Bellafill® cannot be felt after treatment. You may see immediate results in wrinkle correction and can return to your normal daily activities after the procedure.

As with any injectable filler, you may experience temporary pain, swelling and reddening at the treatment site. These side effects are usually gone within a few days. Occasionally, there is transient bruising that typically disappears within 7 days. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, and increased sensitivity at injection sites. Two other rare potential side effects of all fillers may be lumps and granulomas, both of which may be treated by your Licensed Provider. Be sure to call your Licensed Provider immediately if you notice any unusual skin reactions around the treatment area.

Be sure to call your Licensed Provider immediately if you notice any unusual skin reactions around the treatment area.

Bellafill® is FDA and Health Canada approved for the correction of facial wrinkles known as nasolabial folds or smile lines. Patients who have a positive reaction to the Bellafill skin test, a history of severe allergies, known bovine collagen allergies, are allergic to lidocaine, prone to thick scar formation and/or excessive scarring should not receive Bellafill®. Mild swelling and redness can occur at the treatment site but generally subside after 24 hours. The safety of Bellafill® for use during pregnancy, breastfeeding or in patients under 18 has not been established. Long-term safety and effectiveness of Bellafill® beyond one year has not been established. For more Safety Information please consult with your physician and the patient labeling that can be found by visiting www.bellafill.com.

FREQUENTLY ASKED
QUESTIONS

Q: WHAT IS BELLAFILL®?
A: Bellafill® is a unique injectable collagen filler with microspheres that support production of the body’s own collagen for beautiful, natural-looking results that last.


Q: WHAT ARE THE MICROSPHERES IN BELLAFILL® MADE OF?
A: The tiny microspheres in Bellafill® are half the diameter of a human hair, so small that they are virtually invisible to the eye. The microspheres are made of polymethylmethacrylate (PMMA), one of the most widely used materials in medicine for 65 years. a non-degradable inert material used for various medical purposes over the last century.


Q: HOW DOES IT WORK?
A: The collagen in Bellafill® provides immediate volume and lift while the microspheres create a matrix that supports collagen production in your skin over time. The microspheres are not absorbed by the body and provide a support matrix for lasting correction1.


Q: IS IT SAFE?
A: Yes. The safety profile of Bellafill® is comparable to the temporary fillers you are familiar with and perhaps already using.


Q: WHAT ARE GRANULOMAS?
A: Granulomas are inflammatory reactions that may occur with all fillers and can be treated. Bellafill® was studied in the longest and largest filler safety study ever conducted. In this long terms safety study, the granuloma rate was 1.7% and majority had resolved or improved with treatment by the end of the study.


Q: WILL IT WORK FOR ME?
A: In a clinical trial, Bellafill® was shown to work equally well with all skin types, and in men and women. If you have a history of severe allergies, have known bovine collagen allergies, are allergic to lidocaine, or are prone to thick scar formation and/or excessive scarring, tell your provider.


Q: WHEN WILL I SEE RESULTS?
A: Bellafill® replaces lost volume in the skin below the wrinkle for immediate correction and lasting results.


Q: WHAT’S THE DOWNTIME?
A: You can return to normal activities right away. As with any injectable dermal filler, mild swelling and redness can occur at the treatment site that generally subside after 24 hours.


Q: HOW LONG DOES IT LAST?
A: Bellafill® provides a microscopic ‘matrix’ to support your body’s own natural collagen production, and ultimately strengthen the layers of the skin. This provides the support your skin needs for wrinkle correction and younger looking skin, with results that last. In clinical trials, Bellafill® showed significant improvement in smile lines at 3 months and 6 months after treatment, and continued to show improvement at 12 months.


Q: CAN BELLAFILL® BE USED IN MY LIPS?
A: No.

 

For full safety information, please refer to the Instructions for Use and patient label copy.

Bellafill®
Details

BELLAFILL® (FORMALLY ARTEFILL®) IS AN INJECTABLE FILLER THAT PROVIDES NATURAL LOOKING CORRECTION.
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.

BELLAFILL® CAN RESTORE FACIAL VOLUME AND 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, natural looking results and makes it an excellent dermal filler!

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.

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.

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.