Advertisement

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

  • Bruce Patsner
Chapter

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.

Keywords

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

References

  1. 1.
    Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H, Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004;104(4):805–23.CrossRefGoogle Scholar
  2. 2.
    Goldberg, Persky, White, P.C. Transvaginal mesh: injuries and your rights. serious complications associated with surgical mesh for transvaginal repair of POP are not rare. http://www.gpwlaw.com/practice/surgical-mesh. Accessed 2 Mar 2017.
  3. 3.
    Patsner B. Understanding the surgical mesh controversy. Food and Drug Law Institute Update. Jul-Aug 2012, p. 6–10.Google Scholar
  4. 4.
    Rosenblatt PL, Dessie SG. Transvaginal mesh. Past, present, and future. Contemporary OB/GYN. 2016;61(10):20–8.Google Scholar
  5. 5.
    Nager CW. Midurethral slings: evidence-based medicine vs the medicolegal system. Am J Obstet Gynecol. 2016;214(6):708.e1–5.CrossRefGoogle Scholar
  6. 6.
    Leghorn J, Brophy E, Rother P. The First Amendment and FDA restrictions on off-label uses: the call for a new approach. Food Drug Law J. 2008;63(2):391–406.PubMedGoogle Scholar
  7. 7.
    The Food and Drug Administration Modernization Act of 1997 (FDAMA). 21 C.F.R. § 807.20(a)(2).Google Scholar
  8. 8.
    Federal Food, Drug, and Cosmetic Acct, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 331-397 [2006]).Google Scholar
  9. 9.
    Shapiro JK. Labeling and advertising of medical devices. In: Colonna TE, Shapiro JK, editors. Promotion of biomedical products: regulatory consideration. Washington, D.C.: Food and Drug Law Institute; 2006. p. 5.Google Scholar
  10. 10.
    Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976) (codified at 15 U.S.C. §55 (1994) and 21 U.S.C. passim [1994]).Google Scholar
  11. 11.
    Junod S. Commemorating the 40th anniversary of the 1976 Medical Device Amendments. Food Drug Law J. 2017;72(1):26–31.PubMedGoogle Scholar
  12. 12.
    21 U.S.C § 360c(1)(1)(a).Google Scholar
  13. 13.
    Kahan JS, Wilson EC Jr. Medical devices. In: Adams DG, Cooper RM, Hahn MJ, Kahan JS, editors. Food and drug law and regulation. Washington, D.C.: Food and Drug Law Institute; 2008.Google Scholar
  14. 14.
    21 U.S.C. § 321(h). The definition was modified slightly by the Safe Medical Devices Act of 1990.Google Scholar
  15. 15.
    21 U.S.C. § 360c(a)(1).Google Scholar
  16. 16.
    21 U.S.C. § 360(e) and 360(h).Google Scholar
  17. 17.
    Gostin LO. The deregulatory effects of preempting tort litigation: FDA regulation of medical devices. JAMA. 2008;299(19):2313–6.CrossRefGoogle Scholar
  18. 18.
    U.S. Food and Drug Administration. FDA Executive Summary. Obstetrics & Gynecology Devices Advisory Committee Meeting, 8–9 Sept 2011. Surgical mesh for treatment of women with pelvic organ prolapse and stress urinary incontinence. Washington, D.C.Google Scholar
  19. 19.
    Weinberg Group. FDA strengthens regulatory requirements for transvaginal mesh. https://weinberggroup.com/fda-news/regulatory-requirements-for-transvaginal-mesh/. Accessed 2 Mar 2017.
  20. 20.
    Elhauge E. The limited regulatory potential of medical technology assessment. Va Law Rev. 1996;82(8):1525–622.CrossRefGoogle Scholar
  21. 21.
    21 C.F.R. § 803.50(a).Google Scholar
  22. 22.
    21 C.F.R. § 803.53.Google Scholar
  23. 23.
    21 C.F.R. § 803.56.Google Scholar
  24. 24.
    21 C.F.R.. §803.55.Google Scholar
  25. 25.
    Safe Medical Devices Act of 1990, Pub. L. No. 101-629, 104 Stat. 4511 (1990).Google Scholar
  26. 26.
    U.S. Food and Drug Administration Modernization Act, Pub. L. No 105-115, 111 Stat. 2295 (1997).Google Scholar
  27. 27.
    U.S. Food and Drug Administration. Center for Devices and Radiological Health. Medical device tracking: guidance for industry and FDA Staff 25 Jan 2010. http://www.fda.gov/MedicalDevices/DeviceRegulationsandGuidance/GuidanceDocuments/ucm071756.htm. Accessed 5 Jun 2017.
  28. 28.
    Patsner B. Direct-to-consumer advertising of restricted, surgically implanted medical devices: what does the advertising arena look like, and whose regulatory problem is it? William Mitchell Law Review. 2013;39(4):1207–28.Google Scholar
  29. 29.
    Henderson J, Humphrey DC. Medical devices and off-label communication: statutory amendment discussion draft defines “scientific exchange. Food and Drug Law Institute Update, Sep–Oct 2016. p. 16–20.Google Scholar
  30. 30.
    U.S. Food and Drug Administration. Center for Devices and Radiological Health. Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. July 2011.Google Scholar
  31. 31.
    Norton PA. New technology in gynecologic surgery. Is new necessarily better? Obstet Gynecol. 2006;108(3 Pt 2):707–8.CrossRefGoogle Scholar
  32. 32.
    Iglesia CB, Sokol AI, Sokol ER, Kudish BI, Gutman RE, Peterson JL, Shott S. Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol. 2010;116(2 Pt 1):293–303.CrossRefGoogle Scholar
  33. 33.
    Rabin RC. Trial of synthetic mesh in pelvic surgery ends early. The New York Times. 22 Oct 2010. http://www.nytimes.com/2010/10/26/health/research/26complications.html. Last accessed 25 May 2017. “The bottom line is not only there were more complications, but the mesh didn’t prove any better than traditional surgery”.
  34. 34.
    U.S. Food and Drug Administration. Department of Health and Human Services. Proposed Rule: Reclassification of surgical mesh for transvaginal pelvic organ prolapse repair and surgical instrumentation for urogynecologic surgical mesh procedures; designation of special controls for urogynecologic surgical mesh instrumentation. Document 79 FR 24634. 21 CFR 884. 1 May 2014.Google Scholar
  35. 35.
    U. S. Food and Drug Administration Executive Summary. Reclassification of urogynecologic surgical mesh instrumentation. Gastroenterology-Urology Medical Devices Advisory Committee Panel. 26 Feb 2016.Google Scholar
  36. 36.
    Committee Opinion No. 694: management of mesh and graft complications in gynecologic surgery. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2017;129(4):e102–8.Google Scholar
  37. 37.
    Committee on Practice Bulletins-Gynecology, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 79: pelvic organ prolapse. Obstet Gynecol. 2007;109(2 Pt 1):461–73.Google Scholar
  38. 38.
    ACOG Committee on Practice Bulletins—Gynecology. ACOG Practice Bulletin No. 85: pelvic organ prolapse. Obstet Gynecol. 2007;110(3):717–29.CrossRefGoogle Scholar
  39. 39.
    WBUR’s CommonHealth (Boston University). Surgery under scrutiny: what went wrong with vaginal mesh. http://commonhealth.legacy.wbur.org/2011/11/surgery-under-scrutiny-what-went-wrong-with-vaginal-mesh. Accessed 2 Mar 2017.
  40. 40.
    European Commission. Scientific Committee on Emerging and Newly Identified Health Risks. Opinion on the safety of surgical meshes used in urogynecological surgery. 3 Dec 2015. https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_049.pdf. Accessed 15 May 2018.
  41. 41.
    Medicines and Healthcare Products Regulatory Agency, MHRA. A summary of the evidence on the benefits and risks of vaginal mesh implants. 28 Oct 2014. https://www.gov.uk/government/publications/vaginal-mesh-implants-summary-of-benefits-and-risks.
  42. 42.
    Kudish BI, Iglesia CB. Posterior wall prolapse and repair. Clin Obstet Gynecol. 2010;53(1):59–71.CrossRefGoogle Scholar
  43. 43.
    Worcester S. Kit-specific training is required for mesh kits: appropriate training needed for good outcome for anterior compartment prolapsed surgical treatment. Ob Gyn News (Mdedge / Frontline Medical Communications). 2 Dec 2010. https://www.mdedge.com/obgynnews/article/50906/gynecology/kit-specific-training-required-mesh-kits-appropriate-training. Accessed 15 May 2018.
  44. 44.
    Patsner B. Capture of academic medicine by big pharma. Health Law Perspectives (University of Houston Health Law & Policy Institute). Feb 2009. https://www.law.uh.edu/healthlaw/perspectives/2009/(BP)%20academic.pdf. Accessed 15 May 2018.
  45. 45.
    Rockoff JD, Wang SS. J&J to stop selling surgical mesh. The Wall Street Journal. 5 June 2012. https://www.wsj.com/articles/SB10001424052702303506404577448422586204212. Accessed 15 May 2018.
  46. 46.
    Perrone M. J&J to stop selling pelvic mesh tied to lawsuits. The Boston Globe. 5 Jun 2012. Boston.com. http://archive.boston.com/business/healthcare/articles/2012/06/05/jj_to_stop_selling_pelvic_mesh_tied_to_lawsuits/. Accessed 15 May 2018.
  47. 47.
    Riegel v Medtronic, Inc. 552 U.S. 312 (2008).Google Scholar
  48. 48.
    Patsner B. Riegel v. Medtronic, Inc.: revisiting pre-emption for medical devices. J Law Med Ethics. 2009;27(2):305–17.CrossRefGoogle Scholar
  49. 49.
    Walter JR, Hayman E, Tsai S, Ghobadi CW, Xu S. Medical device approvals through the premarket approval pathway in obstetrics and gynecology from 2000 to 2015: process and problems. Obstet Gynecol. 2016;127(6):1110–7.CrossRefGoogle Scholar
  50. 50.
    Medtronic v Lohr, 518 U.S. 470 (1996).Google Scholar
  51. 51.
    Strom P. Boston Scientific wins first transvaginal mesh trial. 4 Aug 2014. https://stromlaw.com/boston-scientific-wins-first-transvaginal-mesh-trial/. Accessed 15 May 2018.
  52. 52.
    Toutant C. NJ high court declines appeal in $11m pelvic mesh verdict. 7 Dec 2016. New Jersey Law Journal. https://www.law.com/njlawjournal/almID/1202774119961/nj-high-court-declines-appeal-in-11m-pelvic-mesh-verdict/?back=law. Accessed 15 May 2018.

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

Personalised recommendations