Evaluation of a calcium hydroxylapatite-based implant (Radiesse) for facial soft-tissue augmentation.
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.
Jansen
David A
DA
Section of Plastic and Reconstructive Surgery, Department of Surgery, Tulane University, New Orleans, USA. djansen@tulane.edu
Graivier
Miles H
MH
D000328:Adult; D001672:Biocompatible Materials / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002610:Cheek; D002680:Chin; D003357:Cosmetic Techniques / Q000009:adverse effects; D017886:Durapatite / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008046:Lip; D008047:Lip Diseases / Q000209:etiology; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D017060:Patient Satisfaction; D012060:Rejuvenation; D012189:Retrospective Studies; D015595:Skin Aging; D016896:Treatment Outcome
D001672:Biocompatible Materials; D017886:Durapatite