Calcium Hydroxylapatite Soft Tissue Fillers

Expert Treatment Techniques

Jani Van Loghem, Jani Van Loghem

• Editorial: CRC Press
• Año: 2020
• ISBN:
  9781351679206
• Edición: 1
• Categoría: Medicine
• Categoría: Medical Theory, Practice & Reference

Calcium Hydroxylapatite: Expert Treatment Techniques is a hands-on reference book, created with the input of the world's leading experts on the use of this leading biostimulatory soft tissue filler. It can be used by all aesthetic medical professional injectors to study the relevant anatomy, aesthetic target sites, and injection techniques and to review the safest and most effective treatment protocols available for this versatile product. As a training aid the book contains multiple photographic sequences as well as schematic diagrams to help in clarifying the proposed techniques. The book includes not only the official on-label indications; various international experts also share their ways of tweaking the standard protocols and their innovations. There are links to procedural videos in the companion site accessed via our Instructor & Student Resources tab.

1

RADIESSE®

The story of calcium hydroxylapatite

Oumama Draoui, Jani van Loghem, Wouter J. Peeters, and Pieter Siebenga

Contents

The history

Background

The science

Safety profile of CaHA

The benefits of CaHA

Conclusion

Dilution and injection technique

RADIESSE® injectable implant: Instructions for use

Consultation: Expectations

References

The history

Calcium hydroxylapatite (CaHA) can be found in nature; it is a natural mineral found in stone also present in bone and teeth of animals. CaHA is also a human mineral and essentially is composed of calcium and phosphate. Prior to its use in aesthetic medicine, CaHA, the active component of RADIESSE®, was used in several other therapeutic indications including dental, orthopaedic and ear, and nose and throat (ENT) procedures. It underwent rigorous safety and efficacy evaluations by the European Medicines Agency (EMA) and US Food & Drug Administration (FDA) with good results before being approved for aesthetic use [1].

In the early 1990s, a CaHA product marketed as Coaptite (developed by Bristol-Meyers Squibb) was used to treat urinary incontinence. In 1999, the technology was acquired by U.S.-based BioForm Medical and was further developed for facial indications until 2001, when the first patients were treated. In 2003, FDA clearance was obtained for a product marketed as Radiance that was later rebranded as Radiesse. In the aesthetic field, Radiesse received initial approval in 2004 by the EMA as a medical device. In 2006, it received a CE mark for plastic and reconstructive surgery, to be used for deep dermal and subdermal soft-tissue augmentation of the facial area. In the same year, the FDA approved Radiesse for the treatment of moderate-to-severe rhytids and folds, such as the nasolabial fold, as well as for the restoration and/or correction of lipoatrophy in patients with human immunodeficiency virus (HIV) [2]. In 2015, the FDA also approved Radiesse for use in nonfacial indications, such as hand augmentation. In 2009, the producing company BioForm Medical was acquired by the German pharmacological company Merz Pharma, and Radiesse was relaunched in several markets worldwide which resulted in a steep growth of sales. The patented formulation of Radiesse resulted in a ten-year monopoly and, in 2013, the market opened for additional producers of CaHA products. Since the introduction of the CaHA product in 2003, no changes have been made to the formulation until 2016, when a lidocainized version was released into the U.S. market and further rolled out globally. In 2018, at least two other manufacturers have started producing CaHA products according to the specifications of Radiesse. Because most research and experience, so far, has been carried out and acquired with Radiesse, the research and techniques discussed in this book are performed with that product. However, other CaHA products with similar properties could be used as well when applying the different techniques covered in this book.

Background

RADIESSE® is a CaHA-based filling product indicated for volumizing indications and administered with deep dermal or subdermal injections [2]. It acts both to restore and reposition lost volume as well as improve skin quality. For the latter, the target cell is the fibroblast to which CaHA injection brings its main “nutrient”: calcium.

Calcium is a mineral component of the nails, teeth, and bones (about 1 kg in a medium-sized adult) but is also present in the skin and soft tissues (about 10 g). It is therefore biocompatible and plays an essential role in many metabolic and physiologic processes such as cell differentiation, gene transcription regulation, muscle contraction, and cell adhesion. The chemical stock form of calcium in the body is CaHA, a mineral structure that contains two elements: calcium and phosphate in the form of Ca2+ and PO43− ions. The human body, similar to all vertebrates, can induce mechanisms of CaHA production and catabolism when calcium storage or mobilization is required [3].

RADIESSE® is composed of 30% CaHA microspheres suspended in 70% of an excipient gel mainly composed of water (sterile water for injection), glycerine, and sodium carboxymethylcellulose (CMC). The CaHA microspheres participate in the triple effect of Radiesse: filling, stimulation of collagen and elastin production, and a skin-tightening effect induced by a cellular action on fibroblasts. The CaHA microspheres are spherical and smooth surfaced to minimize skin trauma during injection and the occurrence of serious side effects (including granulomas) [4,5]. During their manufacture, they are calibrated to a size of between 25 and 45 µm, which is the optimal size for avoidance of macrophage phagocytosis. Since few macrophages were seen, it is suggested that CaHA micro spheres are degraded mostly by enzymatic breakdown and to a lesser extent by phagocytosis, which ensures total resorbability/absorbability [4]. RADIESSE(+)® has exactly the same composition as Radiesse and contains in addition 0.3% lidocaine hydrochloride, added in powder form during manufacture.

The science

The CaHA microspheres

The chemical formula of CaHA is Ca10[PO4]6[OH]2. The CaHA microspheres are approximately 25–45 µm in diameter. As they are larger than 15 µm, normal phagocytosis is not possible by macrophages. Instead, they will slowly dissolve by a mechanism not yet clarified, probably by macrophages exocytosing acidifying substances, leading to increased dissolving of CaHA into calcium and phosphate ions. The smooth surface of the microspheres has micropores of approximately 2 µm in diameter (see Figures 1.1,1.2).

Figure 1.1 Scanning electron microscopic image of norma...