The SAGES Manual Ethics of Surgical Innovation

1. Front Matter

   Pages i-xvii

   PDF

2. Historical Perspective of Surgical Innovation

   • John G. Hunter

   Pages 1-7

3. Examples of Innovation by Surgeons: Percutaneous Endoscopic Gastrostomy and Its Ethical Implications

   • Jeffrey L. Ponsky, John H. Rodriguez

   Pages 9-12

4. Examples of Innovation by Surgeons: Endoscopic Variceal Ligation

   • Gregory Van Stiegmann

   Pages 13-24

5. Examples of Surgical Innovation by Surgeons: Natural Orifice Transluminal Endoscopic Surgery

   • Peter Nau, David W. Rattner

   Pages 25-36

6. Managing Conflict of Interest

   • David W. Easter, Tazo Inui

   Pages 37-48

7. The FDA/CDRH Perspective on Device Innovation

   • Herbert Lerner, Martha W. Betz

   Pages 49-60

8. The FDA and Surgical Innovation

   • S. D. Schwaitzberg, C. J. Schwaitzberg

   Pages 61-71

9. Getting an Idea from Paper to Patient

   • Raymond P. Onders

   Pages 73-80

10. How and Why Work with an Industry Partner?

    • Maria S. Altieri, Caitlin Halbert, Aurora Pryor

    Pages 81-87

11. Status and Impact of Evolving Medical Device Venture Capital Landscape on Innovation

    • Richard S. Stack, William N. Starling, Mudit K. Jain, James Melton

    Pages 89-110

12. Corporate Perspective in Surgical Innovation Ethics: A Literature Review

    • Myriam J. Curet

    Pages 111-128

13. Innovations in Surgery: Responsibilities and Ethical Considerations

    • Lee L. Swanström

    Pages 129-136

14. Device Development for the Innovative Clinician: Intellectual Property and Regulatory Basics

    • Jeffrey Ustin, Jeffrey L. Ponsky

    Pages 137-145

15. Training and Credentialing in New Technologies

    • Meredith C. Duke, Timothy M. Farrell

    Pages 147-157

16. Informed Consent and Surgical Innovation

    • Lelan F. Sillin, Arthur L. Rawlings, Phillip P. Shadduck

    Pages 159-169

17. Semantics and Patient Perceptions of New Technologies

    • David R. Urbach

    Pages 171-178

18. Tracking Outcomes of New Technologies

    • Rizwan Ahmed, Chady Atallah, Anne O. Lidor

    Pages 179-189

19. Balancing the Surgeon’s Responsibility to Individuals and Society

    • Bruce D. White, Luke C. Gelinas

    Pages 191-211

20. Paying for New Technology: Insurance Company Perspective

    • Richard Dal Col, Donna Stewart

    Pages 213-221

      This text provides a comprehensive review of the ethical issues involved with the development, evaluation, and introduction of new treatments of gastrointestinal diseases.  How several landmark surgical innovations were developed are described to show the challenges faced, and the ethical dilemmas these innovators dealt with.  The challenges of dealing with regulatory issues, and how to work with industry partners, and investors when working on a new therapy is described.  Once a new technology has been brought to the market, standards need to be developed regarding the training, credentialing and adoption of the new technology.  There are insufficient standards of how to balance the desire to provide patients the latest therapy with the obligation that patients receive informed consent about the new technology, and the relationship that the physician may have had with product development.   The book describes the national perspective of paying for new technology, and provides one insurance company’s approach to the introduction of innovative therapy.       

The Sages Manual Ethics of Surgical Innovation will be a resource for surgeons, researchers and health policy personnel to understand the ethical issues related to the development, introduction and adoption of innovative therapies for gastrointestinal diseases. Although the context for discussion is the application of innovation to gastrointestinal disease, the ethical issues are applicable to any discussion of innovative medical or procedural therapies.

• Endoscopic Variceal Ligation
• Micro laparoscopy
• NOTES
• POEM
• Surgical Innovation
• Diaphragmatic Pacing

“This book provides a comprehensive review of the ethical issues involved in the development of new therapies for gastrointestinal diseases. … This book is a must read for residents at all levels, fellows, and faculty. … This book is of the highest quality. It provides an in-depth review of the multiple ethical issues important in surgical innovation, information that has been lacking in other surgical textbooks.” (Luis J. Garcia, Doody’s Book Reviews, August, 2016)

• Department of Surgery, Albany Medical College, Albany, USA

  Steven C. Stain

• Division of General Surgery, Stony Brook School of Medicine, Stony Brook, USA

  Aurora D. Pryor

• Department of Surgery, Triangle Orthopaedic Associates, Durham, USA

  Phillip P. Shadduck

Steven Stain, MD, Department of Surgery
Albany Medical Center,
Albany, NY, USA

Aurora Pryor, MD
Division of Bariatric, Foregut and Advanced Gastrointestinal Surgery. Department of Surgery.  Stony Brook University Medical Center.
Stony Brook, NY, USA

Phillip P. Shadduck, MD, FACS 
Department of Surgery, Triangle Orthopaedic Associates
Plaza, Durham, NC, USA

Policies and ethics