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.

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).

Reconstruction of complex orbitocranial deformities using bioresorbable mesh, sterilized orbital models, and in situ contouring.

PURPOSE: To assess the efficacy of bioresorbable mesh in reconstruction of orbitocranial deformities. METHODS: A retrospective case series evaluating 6 orbits of 6 patients, ages 12 to 70 years old, with large multicontoured orbitocranial defects that were repaired using bioresorbable macroporous mesh. Both functional (presence of diplopia, ocular motility, exophthalmometry, and vertical globe position) and cosmetic outcomes were evaluated. RESULTS: Follow-up time ranged from 20 to 48 months (mean, 29.1 months). After surgery, all patients reported cosmetically pleasing results. Diplopia resolved in all patients. Ocular motility, exophthalmos, enophthalmos, and vertical globe positioning improved in all patients. One patient had new onset of mild enophthalmos and hypoglobus after surgery. No cases of implant exposure or instability occurred. Complications included one patient with skin breakdown over a previous site of irradiation and one patient with ptosis requiring surgical correction. CONCLUSIONS: Bioresorbable macroporous mesh combined with bone grafts is a useful and accurate method to reconstruct complex multicontoured orbitocranial defects.

Clinical experience with a new fast-resorbing polymer for bone stabilization in craniofacial surgery.

Polylactic acid (PLA) and polyglycolic acid have been successfully used as suture material during the past 30 years and have been successfully used in various orthopedic and craniofacial applications, with increasing frequency during the past 15 years. To eliminate some of the problems seen with the longer-lasting Macropore PLA product and other longer-lasting resorbable systems, a new fast-resorbing polymer (FRP) was manufactured by Macropore-Medtronic Neurologic Technologies, Inc. from commercially available 85:15 poly(D,L-lactide-co-glycolide) raw material using traditional melt-processing techniques. The delivery system is easily used and uses essentially the same instrumentation. One hundred and sixty eight patients who had implantation of the FRP were studied. Detailed clinical evaluation was completed after surgery and at each postoperative visit. Overall, there was a 2.1% implant-related complication rate, which compared favorably to the 8.5% implant-related complication rate associated with the longer-lasting PLA product. All patients who received FRP implants have had maintenance of stable bony fixation, followed by bony healing and satisfactory or excellent cosmetic results. The results from the FRP study indicate that the FRP material and implants are safe and effective in craniomaxillofacial applications.

Artecoll: a long-lasting injectable wrinkle filler material: Report of a controlled, randomized, multicenter clinical trial of 251 subjects.

Artecoll, an injectable wrinkle filler composed of polymethylmethacrylate microspheres and bovine collagen, is widely available outside the United States. For domestic availability, a multicenter Investigational Device Exemption study was required by the U.S. Food and Drug Administration. This study consisted of 251 subjects at eight centers who received injections of Artecoll or the currently approved collagen dermal filler (control) in 1334 wrinkles of the glabella, nasolabial fold, radial upper lip lines, and corner-of-the-mouth lines. The treatments were randomized, and follow-up safety, efficacy, investigator success rating, and subject satisfaction rating data were collected at 1, 3, and 6 months. The safety data, measured as adverse events and immunoglobulin G serum levels, were low and similar for both groups. The efficacy data, measured by masked observers using a photographic facial fold assessment scale, demonstrated a combined significant improvement with Artecoll compared with collagen at 6 months (p < 0.001). At 6 months, the investigator success ratings and the subject satisfaction ratings for each of the four injections sites were superior for Artecoll (p < 0.001). In the Artecoll group, 12-month follow-up was obtained for 111 subjects (86.7 percent) and showed persistence of significant augmentation. Artecoll had fewer adverse events reported throughout the 12-month safety study period than the control group did in 6 months, although the difference was not statistically significant.

Craniofacial reconstruction with a fast resorbing polymer: a 6- to 12-month clinical follow-up review.

OBJECT: Resorbable polymer implants have become a compelling option in the treatment of acquired and congenital craniofacial deformities. In particular, the resorbable polylactide and polyglycolide polymers have demonstrated excellent safety profiles in multiple in vitro, animal, and clinical studies and are currently being used in a wide variety of craniofacial applications. In pediatric craniofacial reconstruction a desirable attribute of fixation is early resorption, which may limit the duration of any effect on cranial growth. In this paper the authors discuss the biomaterial properties of a fast resorbing polymer (FRP) and the clinical results in a series of patients who participated in a 6- to 12-month study. METHODS: The authors performed craniofacial reconstruction by using FRP implants in 29 patients beginning in August 2002. All patients experienced maintenance of stable bone fixation followed by bone healing. Cosmetic results were rated satisfactory or excellent, except for one unsatisfactory cosmetic result caused by disease progression. CONCLUSIONS: Results of this study support the effectiveness of an FRP implant in a variety of craniofacial surgical procedures including craniosynostoses, fibrous dysplasia, cranial defects, and encephaloceles.

MacroPore resorbable devices in craniofacial surgery.

Resorbable polymer implants have become a compelling option in the treatment of acquired and congenital craniofacial deformities. The resorbable polylactide (PLa) and polyglycolide (PGa) polymers in particular have demonstrated excellent safety profile sin multiple in vitro, animal, and clinical studies and are currently being used in a wide variety of craniofacial applications. In this article, the authors discuss the biomaterial properties of PLa and PGa resorbable implants and provide an overview of the use of these polymers in craniofacial surgery. They conclude by relating their experience with an ongoing clinical series using MacroPore PLDLa and FRP implants for various applications,including Le Fort osteotomies, midface/monobloc internal distraction, and craniosynostosis reconstruction.

Fronto-orbital and cranial osteotomies with resorbable fixation using an endoscopic approach.

Over the past 3 years the authors have used modified minimally invasive endoscopic techniques in the surgical correction of craniosynostosis. For selected patients, these techniques offer an alternative to traditional techniques, minimizing postoperative morbidity and the need for cranial banding. Long-term follow-up will be needed to assess the ultimate efficacy of these techniques. Traditional techniques for repair of craniosynostosis have historically had a record of excellent aesthetic results with acceptable morbidity. Ultimately, each patient is best served by a customized plan, developed and implemented by a multidisciplinary team capable of the full range of techniques.

Surgical strategies in the treatment of complex obstructive sleep apnoea in children.

Complex OSA in children is a challenging problem that requires careful team management. Evaluation includes history, physical examination and appropriate radiological and endoscopic studies. Twelve-channel polysomnography, with or without a pH probe, is mandatory in children with OSA to determine the severity and to document the efficacy of treatment. A variety of individual problems and nuances arise and will continue to do so. Clinical experience and a high degree of suspicion in the craniofacial population is necessary to rule out the existence of OSA in a given patient. Newer treatment modalities, such as distraction osteogenesis of the mandible and midface, have revolutionised treatment of OSA during childhood. Although still the gold standard of care, tracheostomy is not a benign procedure and the toll on both the patient and family can be devastating.

Midface distraction following Le Fort III and monobloc osteotomies: problems and solutions.

Distraction osteogenesis has been used increasingly for midfacial advancement in patients with syndromic craniosynostosis and in severe developmental hypoplasia of the midface. In these patients, the degree of advancement required is often so great that restriction of the adjacent soft tissues may preclude stable advancement in one stage. Whereas distraction is an ideal solution by which to gradually lengthen both the bones and the soft tissues, potential problems remain in translating the distraction forces to the midface. In these patients, severe developmental hypoplasia may be associated with weak union between the zygoma and the maxilla, increasing the chance of zygomaticomaxillary dysjunction when using internal devices that translate distraction force to the maxilla through the zygoma. Eight cases are reported in which either internal or external distraction systems were used for midface advancement following Le Fort III (n = 7) or monobloc (n = 1) osteotomies. Cases of patients in whom hypoplasia at the zygomaticomaxillary junction altered or impaired plans for midface distraction were reported from three host institutions. Seven patients had midface hypoplasia associated with syndromic craniosynostosis, and one patient had severe developmental midface hypoplasia. The distraction protocol was modified to successfully complete midface advancement in light of weakness at the zygomaticomaxillary junction in seven patients. Modifications included change from an internal to an external distraction system in two patients, rigid fixation and bone graft stabilization of the midface in one patient, and plate stabilization of a fractured or unstable zygomaticomaxillary junction followed by resumption of internal distraction in four patients. Previous infection and bone loss involving both malar complexes precluded one patient from being a candidate for an internal distraction system. Using a problem-based approach, successful advancement of the midface ranging from 9 to 26 mm at the occlusal level as measured by preoperative and postoperative cephalograms was undergone by all patients. Advantages and disadvantages of the respective distraction systems are reviewed to better understand unique patient characteristics leading to the successful use of these devices for correction of severe midface hypoplasia.