Introduction: Why a Case Study of Vaginal Mesh Kits?

  • S. Abbas ShobeiriEmail author


Through the course of understanding why vaginal mesh kits failed in the market, I came to realize that the cycle of medical device innovation, introduction, failure, litigation, and withdrawal was prevalent in the medical device industry. With this book, I hope to compile an impartial account of the innovation of the medical device cycle and use the vaginal mesh kit example for specifics. As such, the book is divided in two sections. The first section is useful for the corporate leaders, medical device industry representatives, Master of Business or Health Administration (MBA/MHA) students, and medical device utilizers. It details the innovation of medical devices, business development aspects of new devices, medicolegal aspects of medical devices and a review of the FDA process, the ethics of the medical device industry, and finally a unique patient perspective on medical device innovations. The second half of this book is written by both the pro-mesh and anti-mesh authorities in the field of urogynecology to dissect the vaginal mesh kit complications as a case study of what could be done better and how the medical profession responded. It comprises the pertinent anatomy on why a medical device solution may have made sense, the basic science of mesh, the epidemiology of vaginal mesh complications, the evolution of ultrasound for mesh imaging, operative responses for vaginal mesh and sling complications, and the outcomes of vaginal mesh surgeries.


Innovation Credentialing Swiss cheese 


  1. 1.
    Rostaminia G, Shobeiri SA, Quiroz LH, Nihira MA. Referral pattern for vaginal mesh and graft complications to the University of Oklahoma Pelvic and Bladder Health Clinic. J Okla State Med Assoc. 2012;105(9):356–8.PubMedGoogle Scholar
  2. 2.
    Murphy M, Holzberg A, Raalte HV, Kohli N, Goldman HB, Lucente V, Pelvic Surgeons Network. Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”. Int Urogynecol J. 2012;23(1):5–9.CrossRefGoogle Scholar
  3. 3.
    Manonai J, Rostaminia G, Denson L, Shobeiri SA. Clinical and ultrasonographic study of patients presenting with transvaginal mesh complications. Neurourol Urodyn. 2016;35(3):407–11.CrossRefGoogle Scholar
  4. 4.
    Javadian P, Quiroz LH, Shobeiri SA. In vivo ultrasound characteristics of vaginal mesh kit complications. Female Pelvic Med Reconstr Surg. 2017;23(2):162–7.CrossRefGoogle Scholar
  5. 5.
    Javadian P, Shobeiri SA. The disability impact and associated cost per disability in women who underwent surgical revision of transvaginal mesh kits for prolapse repair. Female Pelvic Med Reconstr Surg. 2017. [Epub ahead of print].
  6. 6.
    U.S. Food and Drug Administration. Reclassification of urogynecologic surgical mesh instrumentation. Executive Summary. Gastro-entrology-Urology Medical Devices Advisory Committee Panel. 26 Feb 2016.Google Scholar
  7. 7.
    Paul M, Littman D, Patrick J, Culligan M. The rapid evolution of vaginal mesh delivery systems for the correction of pelvic organ prolapse, Part I: clinical data. Female Patient. 2009;34:32–8.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.INOVA Health SystemFalls ChurchUSA

Personalised recommendations