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Radiesse® Physicians — Frequently Asked Questions

What is RADIESSE filler?

RADIESSE filler is a safe, next generation cosmetic dermal filler that is aiming to become the new standard for the correction of facial lines and wrinkles such as nasolabial folds. Years of rigorous clinical testing has proven that RADIESSE filler lasts longer than CosmoPlast® to deliver a natural look that lasts. RADIESSE filler is made of tiny, smooth calcium hydroxylapatite (CaHA) microspheres suspended in an aqueous gel carrier (RADIESSE filler is approximately 30% CaHA and 70% gel carrier by volume).

How does RADIESSE filler work?

RADIESSE filler is injected into the skin in a minimally invasive procedure and stimulates the body to produce collagen - to produce long-lasting results.  The patient's tissue integrates in and around RADIESSE filler, forming a soft, natural structure with the characteristics of the surrounding tissue.  The gel carrier is gradually absorbed over time, and the CaHA particles slowly dissolve into calcium and phosphate ions through normal metabolic processes.

Is a skin test required?

RADIESSE filler is biocompatible and does not require pre-testing.

Are there any side effects?

There are few reported side effects and those reported are commonly associated with injection of filler materials. These may include swelling, bruising, pain, itching, and tenderness at the injection site. These conditions are typically resolved on their own within one to two days.

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Will RADIESSE filler become hard or noticeable to touch?

No, RADIESSE filler will remain soft and pliable and will take on the characteristics of the surrounding soft tissue.

How long will RADIESSE filler last?

In facial cosmetic applications, RADIESSE filler should provide a correction that may last a year or more in many patients, results vary.

Is RADIESSE filler permanent?

No. The gel carrier dissipates over a few months, allowing for new tissue infiltration. The CaHA particles slowly dissolve into calcium and phosphate ions through normal metabolic processes.

How long after the initial treatment should a patient receive follow-up treatment?

The ability to mount a tissue response is variable from person to person (age, smoking, exercise etc.). In certain cases the RADIESSE gel can reabsorb faster than new tissue is developed. Thus, to extend correction time, a follow-up appointment scheduled at 2-3 months is suggested to ensure ample time for new tissue development and provide the patient maximum benefit.

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How is the product supplied?

RADIESSE filler is provided in a sterile, pre-filled, single use syringe, individually packaged in a foil pouch and boxed for convenient storage. Each pre-filled syringe contains 1.3 cc of RADIESSE filler. BioForm Medical also offers a 0.3 cc syringe intended for touch-ups and small volume applications.  When opening the foil pouch the presence of several drops of water or moisture is normal and should be expected. The contents of the syringe are intended for single use only and can not be re-sterilized or stored for future use once the pouch is opened.

For information about Radiesse® VoiceGel and VoiceGelST (used for vocal fold augmentation) or RADIESSE filler for HIV-associated Facial Lipoatrophy, contact the BioForm Medical Customer Service Team at (866) 862-1211.

What is the storage and shelf life?

Storage should be at a normal, controlled room temperature of between 15° C and 32° C (59° F and 90° F). RADIESSE filler remains stable during shipping with no requirement for special handling, such as refrigeration or protection from freezing or arid environments. However, long term storage of product at temperatures outside the range listed or in locations where severe and repeated temperature cycling occurs (outside the temperature range listed) should be avoided.

The expiration date is two years from the date of manufacture when the product is stored properly in its original unopened packaging. Use of the product during its listed shelf life will ensure full performance. The product is not to be used if the expiration date has been exceeded.

How long can I store RADIESSE filler?

RADIESSE filler, once removed from its original foil-pouch packaging, should be used immediately. In its original sealed packaging, RADIESSE filler can be stored at room temperature for up to two years. Open products should not be restored or reused.

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Is RADIESSE filler FDA-Approved?

Yes. RADIESSE filler received FDA approval for the correction of moderate to severe folds and wrinkles, including nasolabial folds.

Does RADIESSE filler have additional clearances?

Yes. In the United States, RADIESSE filler has received 510(k) FDA Clearance for radiographic tissue marking, correction of oral/maxillofacial defects, and correction of vocal fold insufficiency. RADIESSE filler is also approved by the FDA for the correction of HIV-associated facial lipoatrophy. Additionally, RADIESSE filler has several other clearances across the world.

Does BioForm Medical assist me with marketing RADIESSE filler to my patients?

Yes. At BioForm Medical, we are your partners in RADIESSE filler, not a simple supplier. We provide an extensive portfolio of marketing tools to help you announce RADIESSE filler to your patients. We also have marketing programs that help you promote your partnership with RADIESSE filler through co-op programs, as well as opportunities to join programs such as The RADIESSE Challenge.

How do I purchase RADIESSE filler?

Please contact the BioForm Medical Customer Service Team at (866) 862-1211.

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