Frequently Asked Questions - Radiesse

WHAT IS RADIESSE DERMAL FILLER?
HOW DOES RADIESSE DERMAL FILLER WORK?
IS A SKIN TEST REQUIRED? DO I NEED TO OVER-CORRECT?
ARE THERE ANY SIDE EFFECTS?
HOW MANY TREATMENTS WILL PATIENTS NEED?
HOW LONG AFTER THE INITIAL TREATMENT SHOULD A PATIENT RECEIVE FOLLOW-UP TREATMENT?

HOW LONG WILL RADIESSE DERMAL FILLER LAST?
WILL RADIESSE DERMAL FILLER BECOME HARD OR NOTICEABLE TO THE TOUCH?
IS RADIESSE DERMAL FILLER PERMANENT?

HOW IS RADIESSE DERMAL FILLER SUPPLIED?
HOW SHOULD I STORE RADIESSE DERMAL FILLER?
HOW LONG CAN I STORE RADIESSE DERMAL FILLER?
HAS RADIESSE DERMAL FILLER BEEN REVIEWED BY A NOTIFIED BODY?
HOW DO I PURCHASE RADIESSE DERMAL FILLER?

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WHAT IS RADIESSE DERMAL FILLER?
RADIESSE dermal filler is composed of smooth calcium hydroxylapatite (CaHA) microspheres (diameter of 25µm to 45µm) suspended in a sodium carboxymethylcellulose gel carrier. RADIESSE dermal filler is approximately 30% CaHA and 70% gel carrier by volume.

HOW DOES RADIESSE DERMAL FILLER WORK?
RADIESSE dermal filler is injected into the skin in a minimally invasive procedure. Initially, it acts as a filler for immediate results. It stimulates the body to produce collagen for long-lasting results. The patient’s own tissue integrates in and around the microspheres in RADIESSE dermal filler, forming a soft, natural structure with the characteristics of the surrounding tissue. The gel carrier is gradually absorbed, and the CaHA particles slowly dissolve into calcium and phosphate ions through normal metabolic processes.

 

 

IS A SKIN TEST REQUIRED?
No. Pretreatment skin sensitivity testing is not required. Because RADIESSE dermal filler has a 100% biocompatible formulation, it has a minimal risk of causing a toxic or allergic response.

DO I NEED TO OVER-CORRECT?
No. RADIESSE dermal filler delivers a one-to-one correction, providing more augmentation per cc than products that do require over-correction to achieve an optimal outcome.

ARE THERE ANY SIDE EFFECTS?
There have been very few side effects reported in clinical trials and actual usage. However, some common injection-related reactions could occur, such as edema, swelling, pain, itching, discoloration, and tenderness at the injection site. These conditions typically resolve on their own within one to two days.

HOW MANY TREATMENTS WILL PATIENTS NEED?
Many patients will achieve their desired result after just one treatment. A touchup may be required.

HOW LONG AFTER THE INITIAL TREATMENT SHOULD A PATIENT RECEIVE FOLLOW-UP TREATMENT?
The ability to mount a tissue response varies from person to person (depending on such factors as age, smoking, exercise, etc.). In certain cases, the gel carrier may be reabsorbed more quickly than new tissue is developed. Thus, to extend correction time, we suggest a follow-up appointment be scheduled two to three months after treatment. At the follow-up appointment, a touchup may be indicated to ensure ample time for new tissue development and provide the maximum patient benefit.

HOW LONG WILL RADIESSE DERMAL FILLER LAST?
In facial cosmetic applications, treatment results should last up to a year or more for many patients. Individual results may vary, depending on age, skin type, lifestyle, and muscle activity.

WILL RADIESSE DERMAL FILLER BECOME HARD OR NOTICEABLE TO THE TOUCH?
No. RADIESSE dermal filler stays soft and pliable and will take on the characteristics of the surrounding tissue.

IS RADIESSE DERMAL FILLER PERMANENT?
No. The gel carrier dissolves after a few months, allowing for new tissue infiltration. Over time, the CaHA particles slowly degrade into calcium and phosphate ions through normal metabolic processes.

HOW IS RADIESSE DERMAL FILLER SUPPLIED?
RADIESSE dermal filler is provided in sterile, prefilled, single-use syringes that are individually packaged in a foil pouch and boxed for convenient storage. Each prefilled syringe contains 1.3 cc of RADIESSE dermal filler. BioForm Medical also offers a 0.3 cc syringe intended for touchups 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 cannot be resterilized or stored for future use once the pouch is opened.

HOW SHOULD I STORE RADIESSE DERMAL FILLER?
RADIESSE dermal filler should be stored at a normal, controlled room temperature of between 15°C and 32°C (59°F and 90°F). RADIESSE dermal filler remains stable during shipping and does not require special handling, such as refrigeration or protection from freezing or arid environments. The product should not be stored long-term at temperatures outside the range listed or in locations where severe and repeated temperature cycling occurs (outside the temperature range listed).

HOW LONG CAN I STORE RADIESSE DERMAL FILLER?
In its original unopened packaging, RADIESSE dermal filler can be stored at room temperature for up to two years. Use of the product during its listed shelf life will ensure full performance. The product should not be used if the expiration date has passed. Once removed from its original foil-pouch packaging, RADIESSE dermal filler should be used immediately. Open products should not be stored or reused.

 

HAS RADIESSE DERMAL FILLER BEEN REVIEWED BY A NOTIFIED BODY?
Yes. RADIESSE dermal filler has received CE mark certification for use in plastic and reconstructive surgery. It has also received US FDA approval for the correction of moderate to severe folds and wrinkles, including nasolabial folds, correction of the signs of HIV-associated facial lipoatrophy and 510(k) clearances for radiographic tissue marking, correction of oral/maxillofacial defects, and correction of vocal fold insufficiency.


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