This study sought to assess the radiographic appearance produced by calcium hydroxylapatite soft tissue filler (CaHA; Radiesse, BioForm Medical Inc.) following augmentation to correct the nasolabial folds or facial wasting associated with human immunodeficiency virus lipoatrophy.
A total of 58 patients, with either lipoatrophy or pronounced nasolabial folds, were treated with CaHA. Radiographic (X-ray) and computed tomographic (CT) imaging studies were conducted pre- and posttreatment in most patients; the images were sent to an independent laboratory to be analyzed by two evaluators who were board-certified radiologists and blinded to study purpose, product, and patient condition.
While results for X-ray evaluation showed inconsistencies in visualization of CaHA, CT scans showed consistent visualization in nearly all cases in patients who were imaged immediately after treatment. In addition, the results indicated no obscuration of underlying structures by CaHA and no evidence of CaHA migration.
Earlier clinical trials established CaHA as a safe and effective soft tissue filler. This CaHA study shows no overt radiographic safety concerns. CaHA is unlikely to be confused with conventional abnormal and adverse radiographic findings. The product is not always visible on X-ray. Although usually visible on CT scans, its appearance is distinct from surrounding bony structures and does not interfere with normal analysis. In addition, the product does not obscure underlying structures on CT scans.
*Department of Dermatology and Skin Science; ‡Department of Ophthalmology and Visual Sciences; §Department of Radiology, University of British Columbia, Vancouver, British Columbia, Canada; †New York University School of Medicine, New York, New York
Address correspondence and reprint requests to: Alastair Carruthers, MD, Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada V5Z 4E8, or. e-mail: firstname.lastname@example.org
The studies described in this manuscript were sponsored by BioForm Medical Inc. (San Mateo, California) and were part of the company's presentation to the US FDA for facial cosmetic approval. Financial support for preparation of this manuscript was provided in part by an educational grant from BioForm Medical, Inc. Drs. Carruthers and Dr. Liebeskind have received consulting fees for educational presentations that include BioForm products. No physician had any direct financial interest in the company at the time of the study or the preparation of the manuscript.