Regulatory science of new technology: tendency of medical professionals’ interests on silicone breast implants

Tomomichi Nakazaki, Koji Ikeda, Kiyotaka Iwasaki, Mitsuo Umezu

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)


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.

Original languageEnglish
Pages (from-to)283-288
Number of pages6
JournalJournal of Artificial Organs
Issue number3
Publication statusPublished - 2016 Sep 1
Externally publishedYes


  • Medical professionals’ interest
  • New technology
  • Regulatory science
  • Silicone breast implant
  • Social acceptance

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Biomaterials
  • Biomedical Engineering
  • Cardiology and Cardiovascular Medicine


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