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

  • Bruce Patsner


The medical and legal issues surrounding transvaginal mesh and mesh kits in the treatment of pelvic organ prolapse (POP) are more than a decade old and in a sense represent the gynecologic version of some of the earlier controversy that surrounded the use of mesh for treatment of abdominal hernia repairs. At present there is an enormous number of mesh-related medical malpractice and product liability lawsuits moving through state civil courts throughout the United States even though the majority of mesh kits have been voluntarily removed from US markets by the respective medical device manufacturers. Understanding how the medical profession, patients, the US Food and Drug Administration, and the medical device industry have contributed to the present patient safety debacle requires some understanding of medical device regulation and the behavior of the medical profession, industry, and plaintiff’s bar in response to mounting – and increasingly public – patient safety concerns. This chapter will attempt to provide the necessary background to understand the mesh controversy and give the reader a sense of the actions of the various stakeholders over time.


Vaginal mesh Mesh kits Litigation Medical device approval US Food and Drug Administration 


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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Bruce Patsner
    • 1
    • 2
    • 3
  1. 1.Department of Obstetrics and GynecologyVirginia Commonwealth University School of MedicineRichmondUSA
  2. 2.Quality and Patient Safety, Inova Fairfax Women’s HospitalFalls ChurchUSA
  3. 3.Department of Obstetrics and Gynecology, Inova Fairfax Women’s HospitalFalls ChurchUSA

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