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

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The Innovation and Evolution of Medical Devices

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Abstract

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.

Of each particular thing, ask: what is it in itself? What is its nature?

Marcus Aurelius

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Notes

  1. 1.

    Each case being litigated can easily take 5–10 years between the filing of the initial complaint and the decision of a jury, particularly if a manufacturer elects to individually litigate the case of every single patient.

  2. 2.

    Statement of Janet Woodcock, Director of the Center for Drug Evaluation and Research, before the House Subcommittee on Oversight and Investigations, 10; “6th Congress (1990), “FDA does not generally regulate the practice of pharmacy or the practice of medicine – the States traditionally have regulated both the prescribing and dispensing of drugs.” See also Peter Barton Hutt, Regulation of the Practice of Medicine under the Pure Food and Drug Laws, 33. J.A. Food and Drug Officials 3 (1969)

  3. 3.

    Access to the Center for Devices and Radiological Health is open to the public at www.cdrh.fda.gov

  4. 4.

    Note: A decision tree for facilitating the determination of substantial equivalence was developed by FDA. See Office of Device Evaluation, Guidance on the CDRH Premarket Notification Review Program (CDRH website (www.cdrh.fda.gov).

  5. 5.

    The information required in a 510(k) premarket notification appears in several section of the Code of Federal Regulations.

  6. 6.

    The medical device reporting requirements are found in 21 C.F.R. § 803.

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Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Virginia Commonwealth University School of Medicine, Richmond, VA, USA

    Bruce Patsner

  2. Quality and Patient Safety, Inova Fairfax Women’s Hospital, Falls Church, VA, USA

    Bruce Patsner

  3. Department of Obstetrics and Gynecology, Inova Fairfax Women’s Hospital, Falls Church, VA, USA

    Bruce Patsner

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  1. INOVA Health System, Falls Church, VA, USA

    S. Abbas Shobeiri

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Patsner, B. (2019). Medical-Legal Aspects of Transvaginal Mesh Kit Complications: A Historical Perspective and the US Food and Drug Administration Review Process. In: Shobeiri, S. (eds) The Innovation and Evolution of Medical Devices. Springer, Cham. https://doi.org/10.1007/978-3-319-97073-8_4

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  • DOI: https://doi.org/10.1007/978-3-319-97073-8_4

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