James J. Romano, MD
BACKGROUND
Artecoll is an exciting implantable and injectable material recently introduced as a study in the United States. It is not new, however, and it has been used in over 100,000 patients outside of the United States and is still currently in use in these countries. It is proposed to be a lasting correction for wrinkles and other skin defects. Its basic element is known as polymethyl methacrylate (PMMA). This has been used for the past fifty years in humans in such forms as the cement for fixing hip joint replacements, repair of skull defects, a bone substitute, artificial lenses, and dentistry. It has been used for the treatment of wrinkles since 1989.
THE PRODUCT
Artecoll is a suspension of chemically inert, biocompatible, extremely small synthetic particles or microscopic spheres mixed with collagen. The microsphere particles are composed of polymethyl methacrylate (PMMA). The process to produce these microspheres is unique and produces extremely purified particles that allow for excellent filling and minimize reaction or infection. The microspheres become surrounded by our own body collagen, which serves as the structure for filling the defect.
THE STUDY
Artecoll has been approved by the United States Food and Drug Administration for a research study as an investigational device. It is not yet approved for widespread distribution. As an implant material, it is a Class III device requiring FDA clearance by the Pre-Market Approval (PMA) route. Artecoll is being evaluated in accordance with the Investigational Device Exemption (IDE) regulations to gain safety and efficacy data intended for inclusion in the PMA application. The purpose of the study is to determine the safety and effectiveness of the material for treatment of wrinkles. It will be compared with collagen. Patients will be randomly assigned to receive either Artecoll or collagen. Patients will undergo a blood test and a skin test. Once these are determined to be normal, the injections can begin. Up to three injections will be administered over the next month. You will be followed up next year for a total of five to seven visits or more. Dr. Romano is one of only ten doctors in the country approved to participate in this study. The fees and potential risks and further details will be discussed at the time of your visit.
TECHNIQUE
The skin is anesthetized by a topical anesthetic cream in the areas to be treated. In a fashion similar to collagen, it is injected under the skin with a very tiny needle. The procedure takes only minutes and is performed in the office. You will immediately see the results of the implantation and can determine if you are satisfied or want more in the treated areas. There is no residual pain or discomfort, and you can wash and put on makeup within hours. After about three months the collagen is degraded and the Artecoll persists, which then becomes surrounded by your own natural collagen.
