The Innovation and Evolution of Medical Devices

1. Front Matter

   Pages i-xii

   PDF

2. Introduction: Why a Case Study of Vaginal Mesh Kits?

   • S. Abbas Shobeiri

   Pages 1-11

3. The Innovation of Medical Devices

   • S. Abbas Shobeiri

   Pages 13-60

4. Business Aspects of Vaginal Mesh Kits: Lessons Learned

   • Neeraj Kohli

   Pages 61-70

5. Medical-Legal Aspects of Transvaginal Mesh Kit Complications: A Historical Perspective and the US Food and Drug Administration Review Process

   • Bruce Patsner

   Pages 71-101

6. Medical Device Marketing and the Ethics of Vaginal Mesh Kit Marketing

   • Roberta N. Clarke

   Pages 103-123

7. Medical Device Innovation and Errors: The Patient Perspective

   • Sherrie J. Palm

   Pages 125-142

8. Pelvic Floor Anatomy as It Relates to the Design and Development of Vaginal Mesh Kits

   • Jonia Alshiek, S. Abbas Shobeiri

   Pages 143-171

9. Basic Science of Vaginal Mesh

   • Katrina Knight, Pamela Moalli, Rui Liang

   Pages 173-194

10. Vaginal Mesh for Prolapse: An Epidemiologic and Historical Perspective

    • Cheryl B. Iglesia, Pakeeza A. Alam

    Pages 195-202

11. Innovation Breeds Innovation: How Pelvic Floor Ultrasound Filled the Diagnostic Gap for Vaginal Mesh Kit Complications

    • Jonia Alshiek, S. Abbas Shobeiri

    Pages 203-231

12. Surgical Considerations for Vaginal Mesh Complications

    • Farzeen Firoozi, Howard B. Goldman

    Pages 233-242

13. Complications of Transobturator Synthetic Slings

    • Melissa R. Kaufman, Laura Chang-Kit, Elizabeth T. Brown, Roger R. Dmochowski

    Pages 243-262

14. Vaginal Mesh and Pain Complications

    • Ghazaleh Rostaminia, Tanaz Ferzandi, S. Abbas Shobeiri

    Pages 263-279

15. Outcomes of Vaginal Mesh Surgeries

    • Miles Murphy, Michael Ting, Vincent R. Lucente

    Pages 281-302

16. Back Matter

    Pages 303-309

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This text provides a central resource for physicians, entrepreneurs, and the MBA students about how innovation occurs in medical device industry.  The book uses the rise and fall of vaginal mesh kits to highlight the evolution of responses by the physicians, patients and the regulatory bodies.  There are specific chapters reviewing the US regulatory issues and business practices that were consequential to withdrawal of most vaginal mesh kits from the US market.  The book is meant to be concise, evidence-based, and practical for the first time readers to understand the innovation forces.  Concise textual information from acknowledged experts is complemented by high-quality diagrams and images to provide a thorough update of this rapidly evolving medical device industry.  The case study chapters fully elucidate the anatomical basis that led to conceptualization of vaginal mesh kits, their introduction into the market, medicolegal and business implications followed with innovation that occurred by the surgeons to utilize ultrasound for and innovative surgeries to overcome device complications. With a luxurious number of well-marked pictures, readers will gain a clear understanding of the medical device innovation and evolution.  Innovation and Evolution of Medical Devices: The vaginal Mesh Kits provides a rich practical resource written in a simple a step-by- step approach for all readers in their approach to new medical devices and technologies.

• Endovaginal imaging
• mesh implants
• transobturator synthetic slings
• Intraoperative ultrasonography
• mesh complications

• INOVA Health System, Falls Church, USA

  S. Abbas Shobeiri

S. Abbās Shobeiri, MD, FACS, FACOG
Professor of Obstetrics and Gynecology, 
Virginia Commonwealth University School of Medicine Inova Fairfax Campus
Professor, Cell Biology & Anatomy, Graduate College, OUHSC 
Vice Chair, Gynecologic Subspecialties,
Falls Church, VA 

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