title: Regulatory science of new technology: tendency of medical professionals' interests on silicone breast implants.
abstract: New technology related to artificial organs is most attractive for worldwide researchers. We believe they must contribute for the future patients against untreatable diseases. Regulatory science is a new science to establish 'social acceptance' of new technology into the clinical market as soon as possible. In the history of silicone breast implants, we could recognize risks many times; however, we missed such chances to prevent a subsequent crisis. We analyzed the trend of published literature related to silicone breast implants to review the medical professionals' interests on such risks. This trend showed, despite issues of a social acceptance of silicone breast implants in a few countries, other countries' medical professionals had no interest. Our hypothesis is 'medical professionals face the government and do not have contributed to re-establish the social acceptance of new technologies for patients'. Any technology does not have the complete evidence of safety, efficacy and quality, despite regulatory authorities' review and approval with clinical evidences. medical professionals need to conduct subsequently the epidemiological study, to take a meta-analysis periodically and to create/update the guidance for their patients under their professional ethics after the marketing of new technologies. We need to take seriously the 'lesson learned' from the history of silicone breast implants for all kind of new technologies existed in the present.
authors.affiliation: Cooperative Major in Advanced Biomedical Science, Joint Graduate School of Tokyo, Women's Medical University and Waseda University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-0054, Japan. t-nakazaki@ruri.waseda.jp.
authors.forename: Tomomichi
authors.initials: T
authors.lastname: Nakazaki
authors.affiliation: Department of Development Promotion, Clinical Research, Innovation and Education Center, Tohoku University Hospital (CRIETO), Miyagi, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Ikeda
authors.affiliation: Department of Advanced Science and Engineering, Faculty of Science and Engineering, Waseda University, Tokyo, Japan.
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Iwasaki
authors.affiliation: Department of Modern Mechanical Engineering, Faculty of Science and Engineering, Waseda University, Tokyo, Japan.
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Umezu
mesh_terms: D001291:Attitude of Health Personnel; D018427:Breast Implants; D004059:Diffusion of Innovation; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D020034:Silicone Gels
chemical_list: D020034:Silicone Gels
keywords: Medical professionals’ interest; New technology; Regulatory science; Silicone breast implant; Social acceptance