July 20, 2004 CHICAGO – The use of an injectable implant material appears effective and well tolerated by patients undergoing facial soft tissue augmentation, and patient satisfaction with treatment is high, according to an article in the July/August issue of The Archives of Facial Plastic Surgery, one of the JAMA/Archives journals.
According to information in the article, plastic and reconstructive surgery is among several clinical indications for soft tissue augmentation. According to the article, 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.
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). 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.
"Moderate or severe pain occurred with injection in 59 percent of patients, but disappeared two to five minutes after injection," he continues. "Erythema, edema [excess fluid in the tissues], and ecchymosis were common immediately after treatment but resolved in all patients within two weeks. Seven patients had persistent visible mucosal lip nodules, four of whom required intervention."
This product has been used for facial plastic surgery in more than 5,000 patients in the United States, Argentina, and Italy, but the follow-up to date has only been approximately three years. Dr. Tzikas suggests several questions remain regarding its use.
"Are there long-term adverse reactions associated with treatment?" he asks. "Does the implant stay soft in the face in the long term? How predictable is its use in mobile regions of the face?"
"As we gain additional experience with this promising new material, we will be better able to determine its most appropriate use and long-term safety profile," he concludes.
(Arch Facial Plast Surg. 2004;6:234-239. Available post-embargo at archfacial.com)
Editor's Note: This study was supported in part by BioForm Inc., Franksville, Wis. The author has no relevant financial interest in BioForm Inc. This study was presented in part at the Combined Otolaryngic Spring Meeting of the American Academy of Facial Plastic and Reconstructive Surgery; May 2, 2003; Nashville, Tenn.
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