To mark the 10-year anniversary of calcium hydroxylapatite’s (CaHA) use in the U.S. aesthetic field, three physicians have compiled and published a comprehensive review of the dermal filler’s evolution in the Journal of Clinical and Aesthetic Dermatology.
Authors Jani van Loghem, M.D., Amsterdam; Yana Alexandrovna Yutskovskaya, M.D., Vladivostok, Russia; and Wm. Philip Werschler, M.D., Spokane, Wash., note that a host of ways to categorize dermal fillers has been proposed but that no universally accepted system is in place. However, one classification system — based on primary mechanism of action (MOA) — is widely used, if not universally accepted. In this system, dermal fillers are categorized based on either collagen biostimulation or replacement volume as a primary MOA. The authors contend that in this system, CaHA (Radiesse, Merz Aesthetics) is unique because it provides both replacement volume and collagen biostimulation as a primary MOA.
Radiesse: 3-D Evolution
In the years since Radiesse first received EU approval in 2003 for deep dermal and subdermal soft tissue augmentation of the facial area, the range of its uses has evolved. In 2006, Radiesse received FDA approval for the correction of moderate-to-severe facial wrinkles and folds and for correcting facial fat loss in people with the human immunodeficiency virus. This evolution, write the authors, has coincided with aesthetic medicine’s progression from a surface-oriented, two-dimensional approach to a three-dimensional approach that addresses both soft and hard tissue-volume loss in both the face and the hands.
The authors suggest that this uniqueness and versatility, combined with the filler’s superior viscosity and elasticity, have been major contributors to Radiesse’s popularity, both among physicians and patients.
“Long-term clinical experience, clinical research, peer-reviewed publications and regulatory approvals have combined to demonstrate the safety and efficacy of CaHA,” they write.
One of those trials evaluated Radiesse for the treatment of facial lipoatrophy in 100 HIV patients who were receiving highly active antiretroviral therapy. In this open-label study, all patients reported significant improvement at 12 months, and 91 percent reported significant improvement at 18 months. Perhaps just as important, quality-of-life data collected at 12 months showed that 100 percent of patients found Radiesse treatment beneficial. Since then, the authors write, Radiesse has been used for a number of aesthetic facial and hand indications.
Another milestone occurred in 2009, when the FDA approved a protocol for mixing Radiesse with lidocaine. On Jan. 30, the FDA gave final approval for Radiesse to be pre-mixed with lidocaine.
“This is really important as it relates to patient comfort and safety,” Dr. Werschler tells Cosmetic Surgery Times. “Having it pre-mixed means the integrity of the syringe is maintained until ready to use, just the same as other fillers are pre-mixed, including Juvederm and Restylane. Also, there is patient comfort in having lidocaine in the syringe, which decreases immediate and post-injection pain.”
‘Reaching Market Maturity’
The authors note that in 2013, Radiesse reached a distribution milestone with more than five million syringes shipped for a variety of aesthetic indications without any safety concerns. Radiesse is now available in more than 50 countries.
With more than 5 million syringes of Radiesse injected, the product has become a popular choice by aesthetic physicians for working on facial shape, volume and contouring, according to Dr. Werschler.
“As more injectors use Radiesse in these applications,” he says, “the nuances of injection technique are refined and taught to others. In some ways, you can describe this as a ‘normalization of technique,’ and in this regard Radiesse is reaching market maturity.”
As that happens, researchers are investigating more uses for the dermal filler.
“Looking toward the future, clinical trials for the use of Radiesse for hand augmentation have been completed and the file has been submitted to the FDA,” says Dr. Werschler. “Approval is pending as early as this spring to summer. Radiesse is uniquely suited for hand augmentation, and this will be the first approval of any dermal filler for hands. As a new ‘body part’ to market, this has the potential to tremendously expand the reach of aesthetic services in an entirely new direction.”
The review notes that Dr. Werschler is on the advisory board of, speak for and receives honoraria from Merz Aesthetics, and that Dr. van Loghem is a consultant for Merz. The review reports no relevant conflict of interest for Dr. Yutskovskaya.
Injection Protocols for 'Global Facial Approach'
The authors suggest the following injection protocols for what they call “a global facial approach” to various treatment areas:
- Frontal concavity (parallel and superior to eyebrow) — Mark frontal concavity prior to injection, and inject only at the subgaleal/supraperiosteal plane
- Temporal concavity — Submuscular/Supraperiosteal/Subdermal injection protocols
- Brow lift — Submuscular/Supraperiosteal or subcutaneous dermal injection at the level of the lateral bone to the peak/middle of brow. Needle or cannula technique. The authors’ technique is only for supraperiosteal placement, as vascular entry cannulation is too risky in this area
- Zygomatic area — Multilevel approach: Needle or cannula technique. Cannula, two-point technique. Zygomatic arch entry point and medial zygoma entry point. Above alar-tragal line: Inject only at the periosteal level. Below alar-tragal line: Inject more superficially (dermal/subdermal junction)
- Mandibular augmentation — Two point cannula technique. Mandibular angle: Placement at dermal/subdermal junction for skin-tightening and redefinition. Point (depot) technique at the mandibular angle may help to define the lateral jaw. Pre-jowl sulcus entry point: Multilevel technique (dermal/subdermal junction plus supraperiosteal placement). Supraperiosteal placement to augment masseter projection.