Five-Year Retrospective Review of Safety, Injected Volumes, and Longevity of the Hyaluronic Acid Belotero Basic for Facial Treatments in 317 Patients

September 2012 | Volume 11 | Issue 9 | Original Article | 1032 | Copyright © September 2012


Ulrich Kühne MD,a Matthias Imhof MD,a Marei Kirchmeir MD, a David J. Howell PhD RRTb

aAesthetische Dermatologie, Bad Soden, Germany bSan Francisco, CA

Abstract
Background: Hyaluronic acids (HA) fillers abound in the European community, many with different names in different countries. One such HA is Belotero Basic, recently approved by the FDA in the United States.
Objective: The objective of this article is to report on use of this HA in a German clinic, over a period of 5+ years, in 317 patients (668 treatments).
Methods and Materials: Authors retrospectively examined patient charts of 317 patients (312 females), aged 24 to 87 years. Chart review showed areas treated, range of volumes per area, and mean volumes. Patient satisfaction data was collected anecdotally over the five years.
Results: Volumes of the HA injected ranged from 0.2 mL to 3.0 mL, depending on the area being treated. No serious adverse events were noted in the chart review, nor was any Tyndall effect observed in the treated areas. Anecdotal information suggests high patient satisfaction with results, based on the return of these patients to the clinic for other treatments over the more than five years.
Conclusion: Belotero Basic provides aesthetically pleasing results for treatment of facial defects, without carrying a risk of serious adverse events. North American physicians now have a new HA to consider as part of their treatment protocols.

J Drugs Dermatol. 2012;11(9):1032-1035.

INTRODUCTION

Although the pace of adoption of dermal fillers in the US has grown rapidly in the first ten years or so of the 21st century, the panoply of dermal fillers available has thus far been considerably smaller than the options available in Europe. Physicians in both the US and Europe have multiple options for facial treatments. They can select from calcium hy- droxylapatite, polymethyl methacrylate, and poly-L-lactic acid, for example. 1 Human collagen and some silicone as well con- tinue to be used in the US; acrylamid manifests as an option in Europe. The most striking difference, however, would appear to be in the wide array of hyaluronic acid (HA) choices. American physicians have tended to select from a handful of HAs. In con- trast, estimates of available HA choices in Europe have been as high as 120 different HA products. 2
The abundance of HA options in Europe has on the one hand been a proverbial blessing. On the other, however, while the abundance has not been exactly a curse, it has been an abiding challenge to easily recall the properties of the numerous products. Adding to the challenge is the nomenclature issue in various European communities. In Switzerland, for example, the HA Belotero is known as Esthelis; even within Germany, another HA is marketed as Succeev and also as Jolidermis. This multiple-name phenomenon is not particularly problematic in one's own country, of course, but it can become so on occasion, for example, when one travels to another member of the European Community for continuing medical education, not to mention travel to North America for meetings with medical colleagues. The abundance of options and nomenclature also poses a challenge for knowledgeable comparisons of safety and longevity.
As products already approved in Europe seek approval in the US, the challenge of recognition of a European product with a new American name arises. In the patients reported here, for example, the HA Belotero Basic (Merz Aesthetics, Frankfurt am Main, Germany) in Europe becomes Belotero Balance in North America. Regardless of the name, the German investigators have been using this particular product for more than five years. The manufacturers of this HA received FDA approval for its use in late 2011. The authors felt that a longitudinal view of the product would be helpful to our American colleagues. Accordingly, our experiences with its safety and longevity in 317 patients are described herein.
Study Objective
The purpose of this retrospective, noncontrolled, nonrandomized, single-site, multi-patient study was to determine the safety and efficacy of the hyaluronic acid Belotero Basic, based on a chart review of 317 patients, all of whom were treated in our clinic over a period of 5 years.
Close Menu