ArteFill: A Long-Lasting Injectable Wrinkle Filler Material???-Summary of the U.S. Food and Drug Administration Trials and a Progress Report on 4- to 5-Year Outcomes

Abstract

ArteFill, the successor product to Artecoll, is an injectable wrinkle filler composed of polymethylmethacrylate microspheres and bovine collagen, which offers long-lasting and probably permanent augmentation of wrinkles and skin contour deformities. The pivotal U.S. Food and Drug Administration study consisted of 251 subjects at eight centers in the United States who received injections of ArteFill or bovine collagen dermal filler (control) in 1334 wrinkles of the glabella, nasolabial folds, radial upper lip lines, and corners of the mouth. The efficacy data generated by masked observers using a photographic Facial Fold Assessment Scale demonstrated a significant improvement with ArteFill compared with collagen at 6 months (p < 0.001) in the nasolabial folds. In the ArteFill group, 12-month follow-up was obtained for 111 subjects (86.7 percent) and showed persistence of significant wrinkle correction. A subgroup of 69 patients who received ArteFill were recalled 4 to 5 years later. Five patients reported six late adverse events that occurred from 2 to 5 years after the initial injection; four of the adverse events were mild cases of lumpiness and two were severe. The total number of late adverse events was six of 272 (2.2 percent) wrinkles injected. Among the 272 wrinkles evaluated at 5 years, two events (0.7 percent) in one patient were rated as severe (a nodular, minimally inflammatory to noninflammatory reaction in both nasolabial folds). Investigator Facial Fold Assessment ratings at 4 to 5 years were improved from baseline by 1.67 points (p < 0.001).

Clinical Experience with Polymethylmethacrylate Microsphere Filler Complications

“…However, we recommend that intractable lip granulomas/nodules be treated with surgical excision, including the lip mucosa and orbicularis oris muscle [15]. Injection of polymethylmethacrylate microspheres into the orbicularis oris muscle is to be avoided as it may result in the formation of nodules that can be palpated in the wet mucosa, and lip augmentation with polymethylmethacrylate microsphere filler should be avoided because the hyperkinetic muscle activity in these areas seems to create more nodularity even if injection is into the muscle [16].…”

Weichteilaugmentation mit einem permanenten Filler

“…Ein Zehnjahresbericht zu Artecoll® wurde 2003 [15] publiziert und für den semipermanenten Filler Radiesse® gibt es eine 52-Monats-Studie [16]. Cohen et al [17,18] untersuchten über fünf Jahre die Sicherheit und Wirksamkeit von ArteFill®.…”

Endoskopische Antirefluxtherapie - was bleibt übrig?

“…Knochenzement, Zahnfüllungen oder intraokuläre Linsen, gefunden hat. Eine intradermale und subkutane Implantation von PMMA gilt als sicher und wurde bei mehr als 400 000 Patienten zur Korrektur von Gesichtsfalten verwendet [37][38][39]. Bisher gibt es bei Refluxkrankheit nur eine einzige Studie mit 10 Patienten mit einem positiven Ergebnis ohne schwerwiegende Komplikationen [40].…”