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By Paul S. Nassif, MD, FACS, Beverly Hill, CA
New Technologies Update
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 epressions and submucosal for the lips.
- Do not over-correct. If anything, under-correct and reinject one week later if needed.
- 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 to Miles Graivier, MD, 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, MD, 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 ten 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 resorption 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.
If any of our members would like a copy of the consent
and injection techniques of Dr. Gravier, please e-mail me, at
psnassif@winstarmail.com or read the July 2003 article about Radiance by
Dr. Tzikas in Cosmetic Surgery Times.
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