ABSTRACT

Microspheres of acrylic polymer, methylmethacrylate, PMMA, 30-50 µm microspheres in a suspension of bovine collagen molecules, in 3.5% and 0.3% lidocaine. Marking: CE 0344 51490TE01 Grade III, ISO 13485:2003. Producer: Artes Medical, Inc., San Diego, CA, USA. Commercialized by: Artes Medical, Inc, San Diego, CA, USA. Presentation: three syringes of 0.8 ml and two syringes of 0.4 ml, needles of 26G1/2. Storage: between 2 and 10°C, and let warm up to room temperature before use. Histology: microspheres of 30-50µm are polymerized and have a smooth, round surface with the absence of electrical charge that allows them to resist phagocytosis or dislocation. One month after injection we find the microspheres encapsulated by a fine coat of collagen, macrophages, and fibroblasts. Between 3 and 6 months the bovine collagen is absorbed and replaced

by human collagen. For 9 months microspheres remain unchanged.1,3

Website: https://www.artecoll-usa.com/ Contact information: Artes Medical Corp, 4660 Jolla Village Drive, Suite 825, San Diego, CA 92122, USA. Preclinical review: https://www.fda.gov/ohrms/dockets/ ac/03/briefing/3934b1_02_precl-fda.pdf

Polymeric acrylic gel, alkylimide 4% gelled in 96% apyrogenic water. Marking: CE 0123. Producer: Polymekon, via Savona 19/A, 20144 Milan, Italy. Commercialized by: Medi Form, 77/79 rue Marcel Dassault, 92100 Boulogne, France. Presentation:

• Bio-Alcamid Lips: two syringes of 1 ml with 23G needle

• Bio-Alcamid Face: one syringe of 3 ml with 19G needle • Bio-Alcamid Body: two syringes of 5 ml with tip

catheter.