An article in the July/August issue of the Archives of Facial Plastic Surgery reports that the use of Radiance FN/Radiesse injectable implant material appears effective and well tolerated by patients undergoing facial soft tissue augmentation, and patient satisfaction with treatment is high.
According to information in the article, plastic and reconstructive surgery is among several clinical indications for soft tissue augmentation. All the components of this material have been extensively used in implants and drug delivery systems, and its biocompatibility has been tested extensively in preclinical studies.
A visit to the the manufacturers website, BioForm Medical shows that Radiance FN is now being marketed as Radiesse, an injectable implant, used for plastic and reconstructive surgery including subdermal soft tissue augmentation and restoration of the facial area. It provides a matrix into which the body's own tissue can grow and maintain the implant in place.
Thomas L. Tzikas, M.D., who is in private practice in Delray Beach, Fla., evaluated the clinical efficacy and patient satisfaction of a new product developed for soft tissue augmentation (Radiance FN/Radiesse). Dr. Tzikas studied 90 patients, aged 25 to 85, who underwent soft tissue injections with the product. The primary areas treated were lips, nasolabial (nose and upper lip) folds, glabellar rhytids (skin wrinkles in the area between the eyebrows), marionette lines (lines at the corner of the mouth), prejowl depressions, acne scars, and surgical soft tissue defects. Patients were surveyed after treatment and for up to six months for pain, ecchymosis (skin discoloration caused by the escape of blood into the tissues from ruptured blood vessels), skin erythema (redness resulting from inflammation), nodules (small lumps, swelling, or collection of tissue), softness, appearance, and satisfaction.
"In terms of efficacy, at six months, appearance, softness, and overall patient satisfaction were rated good or excellent in 74 percent, 80 percent, and 88 percent of patients, respectively," Dr. Tzikas writes.