Radiesse® / Radiesse® with lidocaine

Published on 16/03/2015 by admin

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6 Radiesse® / Radiesse® with lidocaine

Bassel H. Mahmoud, David M. Ozog

Summary and Key Features

• The ideal soft tissue filler for facial augmentation should be non-allergenic, and provide a natural look and feel

• The ideal soft tissue filler should require minimal downtime and exhibit few side effects

• Fillers can be permanent or temporary

• Calcium hydroxylapatite (CaHA) is well suited for facial augmentation and contouring

• CaHA has demonstrated a favorable safety profile

• CaHA longevity is approximately 15 months in active tissues of the face and may approach 24 months in more static locations

• CaHA is approved by the US Food and Drug Administration for correction of moderate to severe facial lines and folds and correction of soft tissue loss from HIV lipoatrophy

• Unlike collagen or hyaluronic acid filler materials, CaHA injection does not require overcorrection

• CaHA particles become fixed in position over time, do not migrate, and take on the natural characteristics of the soft tissue

• CaHA filler showed a high overall level of patient satisfaction, a remarkable safety profile, and clinical longevity

Introduction

Soft tissue augmentation began in 1893 with free fat grafting, but became more popular with the introduction of bovine collagen injections in the late 1970s. Dermal filler injections are now the most common aesthetic treatments performed worldwide. The ideal soft tissue filler for facial augmentation should be non-allergenic, durable, cost-effective, and provide a natural look and feel. Also it should degrade naturally, require no reconstitution or refrigeration, have a long shelf-life, evoke minimal pain on injection, require minimal downtime, and exhibit few side effects.

Dermal fillers are used for injection into the mid- to deep dermis for the correction of moderate to severe wrinkles and folds, restore age-related facial soft tissue volume loss, augment existing facial structures, and improve nasal function. Some have limited indications for correction of facial lipoatrophy in HIV and acne scarring. There are many injectable types of filler on the international market, but only a small number have US Food and Drug Administration (FDA) approval. Fillers can be permanent or temporary and are classified into three categories: collagens, hyaluronic acids (HAs), and biosynthetic polymers.

The effects of biological products such as collagen and HA typically last for less than 1 year after treatment. Semipermanent fillers, including poly-l-lactic acid and calcium hydroxylapatite (CaHA), were observed to persist for 1–2 years in patients. Non-absorbable fillers such as polymethylmethacrylate, silicone oil, and polyacrylamide gel achieved the longest lasting aesthetic results, persisting for longer than 2 years.

CaHA, also known as Radiesse® (BioForm Medical Inc., San Mateo, CA), consists of a 30% concentration of 25–45 mm spherical particles suspended in sodium carboxymethylcellulose gel. Its unique profile makes it particularly well suited for facial augmentation and contouring. In particular, its biocompatibility, ease of use, and enhanced durability offer physicians flexibility in both injection and areas of application. CaHA was first used in 2002, and was initially approved for vocal cord augmentation, radiographic soft tissue marking, and maxillofacial defect correction. In these applications, it demonstrated a favorable safety profile and was rapidly adopted for off-label use in facial contouring. In December 2006 CaHA, Radiesse®, received FDA approval for soft tissue augmentation in the USA. The product may be stored for 2 years at room temperature. The correction ratio is 1 : 1 implant to tissue volume. The longevity is reported to be approximately 14–15 months in active tissues of the face and may approach 18–24 months in more static locations. In addition to the site of injection, factors influencing longevity include the patient’s age, ability to synthesize soft tissue, and rate of metabolism.

Pearl 1

The correction ratio for calcium hydroxylapatite filler is 1 : 1 implant to tissue volume.

Indications for calcium hydroxylapatite

CaHA is FDA approved for facial soft tissue augmentation, specifically for correction of moderate to severe facial lines and folds and correction of soft tissue loss from HIV lipoatrophy, vocal cord augmentation, and as a radiological tissue marker. In addition, the off-label use of CaHA has been reported by Ridenour & Kontis for the infraorbital rim, nose, internal nasal valve, and malar/submalar augmentation.

Specific characteristics of calcium hydroxylapatite

Tzikas reported that injection volumes required with CaHA are considerably less than those required with collagen or HA products. In addition, unlike collagen or HA filler materials, which typically require a certain degree of overcorrection, a conservative approach is best with CaHA injection, with no need for overcorrection, because it naturally provides for a 1 : 1 correction. However, Tzikas was unable to correlate the volume of filler injected with the duration of effect. Good longevity was noted, with more than 80% of patients reporting persistence of results at 12 months. The majority of patients return in 12–18 months for additional injection; Busso & Karlsberg have estimated that the average duration of effect is 14–15 months in patients treated with cheek augmentation. In a clinical trial for lipoatrophy by Silvers and colleagues, skin thickness measurements at 12 months remained statistically better than those at baseline. CaHA is highly biocompatible with minimal acute reactions to injection and no reported serious side effects; its particles become fixed in position over time, do not migrate, and take on the natural characteristics of the soft tissue as new collagen is deposited. In one study, CaHA was successfully used in patients up to 85 years old. However, because these patients have poorer skin elasticity with deeper lines and grooves, they may have a decreased fibroelastic response that may limit results. Therefore, they often need larger volumes of filler with repeat injections and should be counseled to help avoid unrealistic expectations.

Mechanism of action

Following injection of CaHA, the gel carrier is phagocytized, and the CaHA particles act as a scaffold for new tissue formation and collagen deposition. Over time, the CaHA particles are broken down into calcium and phosphate ions and slowly removed via the body’s normal metabolic pathways. When CaHA is placed in soft tissue, new collagenous matrix forms at the implant site. Collagen proliferation and slow degradation of the microspheres lead to a prolonged duration of effect up to 2 years.

Injection techniques

In general, for dermal fillers, the depth of the defect determines the depth of injection; the deeper the defect, the more viscous the filler. CaHA is typically placed in the mid- to deep dermis or subdermal planes. Four techniques for injection are reported: serial puncture, linear threading, fanning, and cross-hatching.

Pearl 2

Calcium hydroxylapatite is typically placed in the mid- to deep dermis or subdermal planes.

Serial puncture

The skin is pulled to stabilize the defect and multiple boluses of filler are delivered along the defect line. The injection sites should be close enough to form a continuous smooth bead; small gaps are then molded with massage. This technique is useful for acne scarring, shallow forehead rhytides, the glabella, philtrum enhancement, and non-surgical rhinoplasty. Consider treating rolling acne scars with subcision prior to filler placement to create a receptive pocket for the implant and to prevent ‘doughnutting’ or placement of filler around rather than under the scar.

Linear threading (Figs 6.1, 6.2)

The full length of the needle is advanced along the wrinkle or fold to create a tunnel for filler placement. Injection can be anterograde as the needle is advanced or retrograde as it is withdrawn. Anterograde delivery may displace small blood vessels and decrease bruising, particularly in the marionette lines and pre-jowl sulcus, but retrograde delivery allows more uniform placement, the preference being largely operator dependent. Linear threading is best for the nasolabial folds and vermilion contour. Serial threading uses elements of both techniques and is useful in wider folds.

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Figure 6.1 A 51-year-old female had an injection of 1.5 mL of Radiesse® in the nasolabial folds, left medial cheek, and pre-jowl / sulcus marionette lines using Radiesse® with lidocaine: (A) before, (B) after, via the linear-threading technique.

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Figure 6.2 A 64-year-old female had an injection of the nasolabial folds using Radiesse® with lidocaine: (A) before, (B) after, via the linear-threading technique.

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