Innovative surgery and the precautionary principle

J Med Philos. 2013 Dec;38(6):605-24. doi: 10.1093/jmp/jht047. Epub 2013 Oct 24.


Surgical innovation involves practices, such as new devices, technologies, procedures, or applications, which are novel and untested. Although innovative practices are believed to offer an improvement on the standard surgical approach, they may prove to be inefficacious or even dangerous. This article considers how surgeons considering innovation should reason in the conditions of uncertainty that characterize innovative surgery. What attitude to the unknown risks of innovative surgery should they take? The answer to this question involves value judgments about the acceptability of risk taking when satisfactory scientific information is not available. This question has been confronted in legal contexts, where risk aversion in the form of the precautionary principle has become increasingly influential as a regulatory response to innovative technologies that pose uncertain future hazards. This article considers whether it is appropriate to apply a precautionary approach when making decisions about innovative surgery.

Keywords: precautionary principle; surgical innovation; unknown risks.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomedical Technology / ethics
  • Cost-Benefit Analysis
  • Decision Making
  • Human Rights
  • Humans
  • Risk Assessment
  • Surgical Procedures, Operative / ethics*
  • Uncertainty