Roccia Maria, França Katlein, Castillo David, Tchernev Georgi, Wollina Uwe, Tirant Michael, Valle Yan, Guarneri Claudio, Fioranelli Massimo, Lotti Torello
University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India.
University of Miami School of Medicine, Miami, Florida, United States.
Open Access Maced J Med Sci. 2017 Dec 30;6(1):156-162. doi: 10.3889/oamjms.2018.001. eCollection 2018 Jan 25.
Since the beginning of the twentieth century, there have been attempts at creating artificial hair to treat baldness. Major evolution took place at the end of 1970's when, unfortunately, artificial hair treatments were applied without appropriate medical controls, resulting in sub-standard results from the use of unsuitable materials and technique. The large improper use of this technique in North America from no medical personnel and with dangerous fibres led the Food and Drug Administration (FDA) to suspend the procedure in 1983. In Europe, a new trial on artificial hair procedure started at the beginning of 1990's. In 1995 the European Union (UE) recognised the artificial hair implant as a legitimate medical treatment and outlined the rules related to that procedure. In 1996, biocompatible fibres (Biofibre®) produced by Medicap® Italy were approved by the UE Authorities and by the Australian Therapeutic Goods Administration (TGA) as medical devices for hair implant. An effective medical protocol was developed during the following years to provide correct guidelines for appropriate treatment, and to reduce possible related complications. Automatic Biofibre® hair implant represents the last achievement in this hair restoration technique with significant advantages for the patients.
自20世纪初以来，人们一直在尝试制造人造毛发以治疗秃头症。重大进展发生在20世纪70年代末，不幸的是，当时人造毛发治疗在没有适当医疗控制的情况下进行，由于使用了不合适的材料和技术，导致效果不达标准。在北美，由于没有医务人员且使用危险纤维，这种技术被大量不当使用，导致美国食品药品监督管理局（FDA）在1983年暂停了该手术。在欧洲，20世纪90年代初开始了一项关于人造毛发手术的新试验。1995年，欧盟（UE）认可人造毛发植入为一种合法的医疗治疗方法，并概述了与该手术相关的规则。1996年，意大利Medicap®公司生产 的生物相容性纤维（Biofibre®）被欧盟当局和澳大利亚治疗用品管理局（TGA）批准为用于毛发植入的医疗器械。在接下来的几年里，制定了一个有效的医疗方案，为适当的治疗提供正确的指导方针，并减少可能的相关并发症。自动Biofibre®毛发植入代表了这种毛发修复技术的最新成果，对患者具有显著优势。
