Radiance, an Injectable Calcium Hydroxylapatite
Radiance is a new injectable product for facial rhytids and lip augmentation with the potential of having long lasting effects. Radiance consists of calcium hydroxy laatite suspended in gel (carboxymethylcellulose). Because calcium hydroxylapatite is a normal constituent of bone, it should not elicit a chronic inflammatory or immune response. Additionally, the gel carrier doesn't require allergy testing, as does collagen. Radiance is FDA approved for injectable use as a tissue marker in vocal cords and the bladder neck, and has been shown to remain in the body for over three years. The longest follow-up for injection as a facial filler has been 2.5 years in the Italian study.
Currently, Radiance is under review for FDA approval as a facial filler, with current use as a facial filler considered off-label. The off-label use of a medically approved device by the FDA is allowed because of the 1997 amendment of the Federal Food, Drug and Cosmetic Act 6, which states: "Nothing in (FD&C Act) shall be construed to limit or interfere with the authority of the healthcare practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate healthcare practitioner-patient relationship."
Listed below are pearls of how to use Radiance:
- Radiance does not contain lidocaine: therefore, some patients will tolerate numbing with a topical anesthetic, followed by ice on the area to be injected or may need a nerve blocker.
- Use a 26 or 27 gauge needle with a threading technique and inject into the deep dermis or subdermal for facial rhytids and expressions and submucosal for the lips.
- Do not over-correct. If anything, under-correct and reinject one week later if neede
- Following injection, mold and massage the area of injection as needed. The area(s) of injection may be molded up to four days.
Members of our New Technologies and Devices Committee were particularly interested in identifying red lip injection techniques since there has been significant problems with lumps developing in the lips that require surgical excision. To try and answer this question, I spoke at length with Miles Graivier, M.D., who has been involved with the clinical studies of Radiance and has injected over 275 patients with the longest follow-up of 12 months. He and Dave Jansen, M.D., presented their preliminary data at the ASAPS meeting in Boston, May 2003. To quote him directly, "When I inject under the white roll and try vermilion, I inject the potential space just above the orbicularis. When I get around posterior, under the wet mucosa, I go just into the superficial portion of the orbicularis. I know if I'm too superficial if the mucosa tents up around the needle when I insert it."
With this injection technique, inserting the needle with bevel down at an approximate 30-degree angle to the skin and injecting a small amount with each pass, he has decreased the risk of developing nodules in the lip. If a lump or nodule develops, and it is noted in the first seven to 10 days, Dr. Graivier cracks the nodule (squeeze aggressively). The patient should massage the lump for three weeks. Upon follow-up, if the nodule is still present, inject with approximately 0.1 cc of Kenalog 10. Massage and have patient return in four weeks. If still present, reinject and continue massage for four weeks. If nodule is still present, excise with stab incision (#11 blade), squeeze, and contour with small iris scissors.
My use of this product has been short-term. Over the last four months, I have used Radiance in over 20 patients. I have injected Radiance into melolabial folds, facial depressions, acne scars, corners of lips, marionette rhytids, glabellar rhytids, peri-oral vertical rhytids, and more recently, lips. I have followed up with all patients and have had no complications. All patients were happy with the results of the augmentation. I have not seen any reabsorption of the material up until now. The cost of a 1 cc syringe of Radiance is $500 with the price to the patient ranging from $1,250 - $1,500.