Ethical Challenges in High-Risk Innovative Surgery

  • Shuddhadeb RayEmail author
  • Michael O’Connor
  • Peter Angelos


The fields of surgery and anesthesia have storied histories with advances in care fueled by innovation by creative individuals striving to improve the care of their patients. Ethical dilemmas arise when contemplating how to allow innovation to continue for the benefit of future patients while mitigating harm to current patients. In this chapter, we explore ethical issues in high-risk innovative surgery from the perspectives of the key stakeholders: the surgeon, the patient, the anesthesiologist, the medical device industry, and other members of the healthcare team.


Innovation Informed Consent Medical Devices High-Risk Surgery Surgical Ethics 


  1. 1.
    Khan MN. The relief of mitral stenosis. An historic step in cardiac surgery. Tex Heart Inst J. 1996;23(4):258–65; discussion 265–6.PubMedPubMedCentralGoogle Scholar
  2. 2.
    Harken DE, Ellis LB. The surgical treatment of mitral stenosis; valvuloplasty. N Engl J Med. 1948;239(22):801–9.CrossRefPubMedGoogle Scholar
  3. 3.
    Acierno LJ. The history of cardiology. New York: Parthenon Publishing Group; 1994. p. 597–697.Google Scholar
  4. 4.
    Siegler M. Ethical issues in innovative surgery: should we attempt a cadaveric hand transplantation in a human subject? Transplant Proc. 1998;30(6):2779–82.CrossRefPubMedGoogle Scholar
  5. 5.
    Angelos P. Surgical ethics and the challenge of surgical innovation. Am J Surg. 2014;208(6):881–5.CrossRefPubMedGoogle Scholar
  6. 6.
    Beauchamp TL, Childress JF. Principles of biomedical ethics. 7th ed. Oxford: Oxford University Press; 2009.Google Scholar
  7. 7.
    Cobb LA, Thomas GI, Dillard DH, Merendino KA, Bruce RA. An evaluation of internal-mammary-artery ligation by a double-blind technic. N Engl J Med. 1959;260(22):1115–8.CrossRefPubMedGoogle Scholar
  8. 8.
    Dinçler S, Koller MT, Steurer J, Bachmann LM, Christen D, Buchmann P. Multidimensional analysis of learning curves in laparoscopic sigmoid resection: eight-year results. Dis Colon Rectum. 2003;46(10):1371–8; discussion 1378–9.CrossRefPubMedGoogle Scholar
  9. 9.
    Bridgewater B, Grayson AD, Au J, Hassan R, Dihmis WC, Munsch C, et al. Improving mortality of coronary surgery over first four years of independent practice: retrospective examination of prospectively collected data from 15 surgeons. BMJ. 2004;329(7463):421.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Kavarana MN, Sade RM. Ethical issues in cardiac surgery. Future Cardiol. 2012;8(3):451–65.CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Bernard HR, Hartman TW. Complications after laparoscopic cholecystectomy. Am J Surg. 1993;165(4):533–5.CrossRefPubMedGoogle Scholar
  12. 12.
    U S Food and Drug Administration Home Page [Internet]. [cited 2015 June 5]. Available from:
  13. 13.
    Dixon PR, Grant RC, Urbach DR. The impact of marketing language on patient preference for robot-assisted surgery. Surg Innov. 2015;22(1):15–9.CrossRefPubMedGoogle Scholar
  14. 14.
    Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009;198(3):420–35.CrossRefPubMedGoogle Scholar
  15. 15.
    Schwarze ML, Bradley CT, Brasel KJ. Surgical “buy-in”: the contractual relationship between surgeons and patients that influences decisions regarding life-supporting therapy. Crit Care Med. 2010;38(3):843–8.CrossRefPubMedPubMedCentralGoogle Scholar
  16. 16.
    Province of Manitoba The Pediatric Cardiac Surgery Inquest Report [Internet]. [cited 2015 Jun 6]. Available from: Accessed 13 June 2015.
  17. 17.
    United States Food and Drug Administration. Premarket approval application. General information. Accessed 13 June 2015.
  18. 18.
    Richard IC. Health IT and patient safety: building safer systems for better care. Washington, DC: National Academies Press (US); 2011.Google Scholar
  19. 19.
    Wall LL, Brown D. The perils of commercially driven surgical innovation. Am J Obstet Gynecol. 2010;202:30.e1–4.CrossRefGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Shuddhadeb Ray
    • 1
    Email author
  • Michael O’Connor
    • 2
  • Peter Angelos
    • 3
  1. 1.Department of SurgeryWashington University School of MedicineSaint LouisUSA
  2. 2.Department of Anesthesia and Critical CareThe University of ChicagoChicagoUSA
  3. 3.Department of Surgery, MacLean Center for Clinical Medical EthicsThe University of Chicago MedicineChicagoUSA

Personalised recommendations