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.

Dermal fillers. The next generation.

In today's busy and demanding world, we no longer have the luxury of taking weeks to recover from a surgical procedure and are more frequently seeking quicker alternatives. The use of dermal fillers meets this need but in no way replaces a surgical intervention. Previously, bovine collagen was the only approved dermal filler. However, today there are several options available including a human collagen, a variety of hyaluronic acids, and a permanent injectable product. Each of the products has different uses, indications, and adverse reactions. The experienced injector now has a wider selection of products from which to choose to ensure that the patient receives what is best suited for his or her particular situation. These new products are becoming increasingly popular, due to acceptability and affordability, but are not without potential complications and adverse reactions. This article discusses the use of Cosmoderm/Cosmoplast, Hylaform, Restylane/Perlane, and Artecoll dermal fillers.

Artecoll granuloma: a rare adverse reaction induced by microimplant in the treatment of neck wrinkles.

BACKGROUND: Artecoll is now being widely used as an injectable aesthetic microimplant for the treatment of wrinkles because of its long-lasting cosmetic effects and the rarity of late complications, including foreign body granulomas. Recently, however, several cases of Artecoll-induced granulomas on the face have been reported, especially in patients receiving overly superficial or overly correcting implants. METHODS AND RESULTS: A 50-year-old Korean woman who had been treated with Artecoll for the correction of the neck wrinkles presented 4 years later with an extensive Artecoll-induced foreign body granuloma along the injection sites in the neck. After three intralesional injections of triamcinolone acetonide, the lesions had almost disappeared. CONCLUSION: To our knowledge, this case is the first report of an extensive Artecoll-induced granuloma on the neck. Our findings suggest that Artecoll not be used as implant material in thin and constantly movable skin, such as that of the neck.

Orofacial granulomas after injection of cosmetic fillers. Histopathologic and clinical study of 11 cases.

BACKGROUND: Purposely, cosmetic injections in orofacial tissues of various resorbable, biodegradable, or permanent fillers may be followed by development of foreign-body granulomas. The aim of this article is to contribute to the histologic identification of the filler material. METHODS: Histologic and clinical features of 11 cases of granulomas on orofacial fillers are described. RESULTS: Only 3/11 patients knew the nature of the injected product. Four histologic patterns were found: (i) Artecoll, (ii) Dermalive, and (iii) New-Fill granuloma, all three of the classic giant cell granuloma type, differing in respect of foreign particles; and (iv) Liquid Silicone granuloma, which featured a cystic and macrophagic type. Information was often missing or misleading, patients or practitioners being reluctant to give the details. CONCLUSION: Increasing demand for orofacial tissue augmentation makes pathologists face new, and sometimes, puzzling granuloma types. Identification of the foreign product might be required for therapeutic or medico-legal reasons.

Soft tissue augmentation using artecoll: a personal experience.

Artecoll is a dermal wrinkle filler that will be released in 2005 as Artefill. As one of the eight lead investigators for the U.S. study that compared Artecoll to Zyplast, I am reporting my experience with this new filler. Background information, injection technique, training, and other caveats are shared with focus on safety and up-to-date information on the product's status.

Human histology and persistence of various injectable filler substances for soft tissue augmentation.

An increasing number of soft tissue filler substances have been introduced to the beauty market outside the U.S. which lack experimental and clinical data in support of their claim. Ten commercially available filler substances were examined for biocompatibility and durability: 0.1 cc of each substance was injected deep intradermally into the volar forearm of one of the authors and observed for clinical reaction and permanence. At 1, 3, 6, and 9 months the test sites were excised, histologically examined, and graded according to foreign body reactions classification. Collagen (Zyplast) was phagocytosed at 6 months and hyaluronic acid (Restylane) at 9 months. PMMA microspheres (Artecoll) had encapsulated with connective tissue, macrophages, and sporadic giant cells. Silicone oil (PMS 350) was clinically inconspicuous but dissipated into the tissue, causing a chronic foreign body reaction. Polylactic acid microspheres (New-Fill) induced a mild inflammatory response and had disappeared clinically at 4 months. Dextran microspheres (Reviderm intra) induced a pronounced foreign body reaction and had disappeared at 6 months. Polymethylacrylate particles (Dermalive) induced the lowest cellular reaction but had disappeared clinically at 6 months. Polyacrylamide (Aquamid) was well tolerated and remained palpable to a lessening degree over the entire testing period. Histologically, it dissipated more slowly and was kept in place through fine fibrous capsules. Polyvinylhydroxide microspheres suspended in acrylamide (Evolution) were well tolerated, slowly diminishing over 9 months. Calcium hydroxylapatite microspheres (Radiance FN) induced almost no foreign body reaction but were absorbed by the skin at 12 months. Host defense mechanisms react differently to the various filler materials, but all substances-resorbable or nonresorbable-appeared to be clinically and histologically safe, although all exhibit undesirable side effects. Since the mechanism of late inflammation or granuloma formation is still unknown, early histological findings are not useful in predicting possible late reactions to filler substances.

Late-onset granulomatous reaction to Artecoll.

BACKGROUND: Artecoll is permanent filler that is used for the correction of facial wrinkles. It has been used mainly in Europe in the last 9 years. It is a suspension of 25% polymethylmethacrylate microspheres of 30 to 40 microns in diameter and 75% athecollagen. OBJECTIVE: To report a side effect of a late-onset granulomatous reaction to Artecoll. METHODS: We report the case of a 54-year-old woman who presented with longitudinal hard nodules with slight overlying erythema in the glabella and nasolabial folds 14 months after she was treated with Artecoll injections to her glabellar and nasolabial wrinkles. An excisional biopsy of a glabellar nodule was performed. RESULTS: Microscopic examination of hematoxylin and eosin-stained specimen revealed histiocytic granulomas with giant cells and vacuoles, a picture of Artecoll granulomas. Treatment with topical steroids showed no improvement. Intralesional injections of Kenalog caused temporary disappearance of the granulomas. A few months later the nodules reappeared. No further treatment was done. CONCLUSION: Artecoll injection to wrinkles of the face can cause delayed granulomatous reaction. This side effect is not reversible and should be addressed in the informed consent.

Soft tissue augmentation with artecoll: 10-year history, indications, techniques, and complications.

Most of the biologic filler materials that increase the thickness of the corium in a wrinkle line are phagocytosed within a certain time. Therefore, a lasting effect can only be achieved with nonresorbable synthetic substances. Artefill consists of 20 volume percent microspheres of polymethyl-methacrylate and 80 volume percent of bovine collagen. Beneath the crease, the microspheres with their exceptional surface smoothness stimulate fibroblasts to encapsulate each individual one of the 6-million microspheres contained in 1 mL of Artefill. Collagen is merely a carrier substance that prevents the microspheres from agglomerating during tissue ingrowth. The 20 volume percent of microspheres in Artefill provides the scaffold for the 80% volume of connective tissue deposition, a complete replacement of the injected collagen. The filler material beneath a crease acts like a splint and prevents the possibility of its further folding, thereby allowing the diminished thickness of the corium in a crease to recover. This recovery process is well known even in older patients with facial paralysis or after a stroke, whose facial wrinkles and furrows on the paralyzed side disappear over time.