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Evaluation of a Calcium Hydroxylapatite-Based Implant (Radiesse) for Facial Soft-Tissue Augmentation

Jansen, David A. M.D.; Graivier, Miles H. M.D.

doi: 10.1097/01.prs.0000234903.55310.6a

Background: Soft-tissue fillers have become increasingly prominent in the practice of facial aesthetic medicine. The authors sought to evaluate the long-term clinical efficacy and safety of a calcium hydroxylapatite-based filler (Radiesse) for facial soft-tissue augmentation.

Methods: A total of 609 subjects received calcium hydroxylapatite injections in several facial areas: the nasolabial folds, marionette lines, oral commissure, cheeks, chin, lips, and radial lip lines. Follow-up patient satisfaction surveys were conducted at 6 months and again between 12 and 24 months. Treatment satisfaction was based on a scale of 1 (least satisfied) to 5 (most satisfied) using subjective self-evaluation of preoperative photographs. Subjects were also asked whether they would use the treatment again. Adverse events were recorded immediately after treatment and at follow-up visits.

Results: Of the total number of survey requests, 155 subjects provided 6-month follow-up data and 112 subjects provided long-term 12- to 24-month data. The average satisfaction rating at 6 months was 3.94. A total of 138 of 155 subjects (89 percent) at 6 months and 83 of 112 (74 percent) at 12 to 24 months stated that they would use the treatment again. The only side effect observed was the development of easily treated nodules, reported by 42 of 338 of lip mucosa augmentation subjects (12.4 percent) and six of 163 of subjects (3.7 percent) who had treatment for radial lip lines. The proportion of subjects with lip nodules decreased to 8.8 percent when the implant volume was decreased.

Conclusions: The calcium hydroxylapatite-based implant is a safe, long-lasting, highly effective, and well-tolerated agent for many areas of facial soft-tissue augmentation.

New Orleans, La.; and Atlanta, Ga.

From the Section of Plastic and Reconstructive Surgery, Department of Surgery, Tulane University.

Received for publication April 21, 2005; accepted October 3, 2005.

Presented in part at the 73rd Annual American Society of Plastic Surgeons, Plastic Surgery Educational Foundation, and the American Society of Maxillofacial Surgeons Scientific Meeting, in Philadelphia, Pa., on October 10, 2004.

Radiesse is approved by the FDA for soft-tissue augmentation applications, including the treatment of oral/maxillofacial defects, vocal fold medialization and augmentation, and as a tissue marker; other uses are “off-label.” Radiesse is currently under review by the FDA for facial soft-tissue augmentation applications.

David A. Jansen, M.D., Department of Plastic and Reconstructive Surgery, Tulane University Health and Sciences Center, 1430 Tulane Avenue, SL-22, New Orleans, La. 70112,

©2006American Society of Plastic Surgeons