LAS VEGAS Don't overpromise results to patients considering facial soft tissue augmentation with Radiesse, says a facial plastic and reconstructive surgeon who has now treated 1,174 patients with the filler previously known as Radiance FN.
"I think like most technologies, when we first get them, we kind of oversell them. We think they're a lot better than they really are," said Thomas L. Tzikas, M.D., a physician in private practice in Del Ray, Fla.
The early word on Radiesse, a filler made of spherical particles of synthetic calcium hydroxylapatite, was that it would last between 3 and 5 years, justifying its high price tag. Current prices for a 1-vial treatment range from $800 to $1,400.
But Dr. Tzikas told colleagues at a facial cosmetic surgery symposium that 1 vial often isn't enough to achieve satisfactory correction of facial structures, such as the nasolabial folds. Moreover, its results are unpredictable after 2 years.
"How long does it last? In my experience, it definitely lasts 1 year. There are variable results at 1.5 years and longer," he said at the meeting sponsored by the Multi-Specialty Foundation for Facial Aesthetic Surgical Excellence.
Dr. Tzikas' experience with Radiesse, manufactured by BioForm Inc., is considerable. He conducted a pivotal trial of the filler in 90 patients, concluding that it was highly effective and well tolerated, with excellent results and high patient satisfaction at 6 months (Arch. Facial Plast. Surg. 2004;6:2349).
Over time, he's treated more than 10 times that number of patients, ranging in age from 21 to 85.
He continues to praise the product's convenience (delivered, as it is, in prefilled vials) and safety (requiring no sensitivity testing and resulting in no serious adverse events in years of use in otolaryngology, oral surgery, or orthopedics).
He likes it as subdermal filler for deep rhytids, marionette lines, deep acne and traumatic scars, and the nasolabial folds.
"It's a very nice bulking agent," he explained, comparing the results achieved by 1 syringe of Radiesse (1 mL) with what can be accomplished using 2.5 cc of Zyplast, a bovine collagen filler.
But he has virtually ceased using Radiesse for the lips or for vertical lip rhytids.
"I don't think it's a user-friendly material in the lips," said Dr. Tzikas.
He found a 5.9% incidence of lip nodules in 341 patients whose lips he treated, and despite the reduction in nodules as his experience increased, he still feels the results don't justify the risks in treating that area.
Specifically, he said 12% of his first 100 lip patients developed nodules, compared with 2% of his second hundred patients.
"It really, really decreases with just being more conservative. Don't go too superficial in lips," he said.
Lip nodules generally resolve on their own within 69 months, but they can also be treated with Kenalog injections and massage, or by disrupting them with a 22-gauge needle and manual compression.
Using too much Radiesse superficially can also result in nodules along the nasolabial grooves, which can take up to a year to resolve, he said at the meeting.
Dr. Tzikas noted that older patients may require larger volumes of Radiesse or more treatments, since their diminished fibroblastic response prevents robust long-term correction.
"I would advise taking very good [before and after] photos of patients. They spend a fair amount of money, and they expect more from fillers," he said, showing an image of a patient who received 3 cc of Radiance FN 2 years before the photo was taken. Although the material could still be palpated under the skin, "the clinical effect is basically gone," he said.
BioForm of Franksville, Wisc., has supported Dr. Tzikas' studies of Radiesse, but he has no financial interest in the company.