Advertisement

Business Aspects of Vaginal Mesh Kits: Lessons Learned

  • Neeraj Kohli
Chapter

Abstract

Although the clinical aspects of a medical device take priority in use and implementation, the business and economic aspects of the commercial device can be equally important in introduction, adoption, and perseverance. Many of these factors depend on both the physician and the medical device company. Similar to products previously introduced, vaginal mesh kits followed basic business principles, resulting in either success or failure. This chapter will review some of the business aspects of vaginal mesh kits and lessons learned during introduction, adoption, and evaluation.

Keywords

Vaginal mesh US Food and Drug Administration Business Hype cycle McKinlay’s seven-stage model 

References

  1. 1.
    Fenn J, Raskino M. Mastering the hype cycle: how to choose the right innovation at the right time. Boston: Harvard Business Press; 2008.Google Scholar
  2. 2.
    Richardson AC. Paravaginal repair. In: Benson JT, editor. Female pelvic floor disorders. New York: W.W. Norton & Co.; 1992.Google Scholar
  3. 3.
    Ward K, Hilton P. Minimally invasive synthetic suburethral slings: emerging complications. Obstetr Gynaecol. 2007;7(4):223–32.Google Scholar
  4. 4.
    U.S. Food and Drug Administration. FDA Public Health Notification. Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. 20 Oct 2008.Google Scholar
  5. 5.
    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. Jul 2011.Google Scholar
  6. 6.
    Reynolds WS, Gold KP, Ni S, Kaufman MR, Dmochowski RR, Penson DF. Immediate effects of the initial FDA notification on the use of surgical mesh for pelvic organ prolapse surgery in Medicare beneficiaries. Neurourol Urodyn. 2013;32(4):330–5.CrossRefGoogle Scholar
  7. 7.
    McKinlay JB. From “promising report” to “standard procedure”: seven stages in the career of a medical innovation. Milbank Mem Fund Q Health Soc. 1981;59(3):374–411.CrossRefGoogle Scholar
  8. 8.
    Wright J. Hormone replacement therapy: an example of McKinlay’s theory on the seven stages of medical innovation. J Clin Nurs. 2005;14(9):1090–7.CrossRefGoogle Scholar
  9. 9.
    Bø K, Herbert RD. When and how should new therapies become routine clinical practice? Physiotherapy. 2009;95(1):51–7.CrossRefGoogle Scholar
  10. 10.
    Wall LL, Brown D. The perils of commercially driven surgical innovation. Am J Obstet Gynecol. 2010;202(1):30.e1–4.CrossRefGoogle Scholar
  11. 11.
    Oliveira R, Silva A, Pinto R, Silva J, Silva C, Guimarães M, et al. Short-term assessment of a tension-free vaginal tape for treating female stress urinary incontinence. BJU Int. 2009;104(2):225–8.CrossRefGoogle Scholar
  12. 12.
    Solà V, Ricci P, Pardo J. Third generation sub-mid urethral mesh: experience with 110 TVT-SECUR. Arch Esp Urol. 2009;62(5):376–86.CrossRefGoogle Scholar
  13. 13.
    Debodinance P, Amblard J, Lucot JP, Cosson M, Villet R, Jacquetin B. TVT Secur: prospective study and follow up at 1 year about 154 patients. J Gynecol Obstet Biol Reprod. 2009;38(4):299–303.CrossRefGoogle Scholar
  14. 14.
    Meschia M, Barbacini P, Ambrogi V, Pifarotti P, Ricci L, Spreafico L. TVT-secur: a minimally invasive procedure for the treatment of primary stress urinary incontinence. One year data from a multi-centre prospective trial. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20(3):313–7.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Boston UrogynecologyNewton-Wellesley Hospital/Brigham and Women’s HospitalWellesleyUSA
  2. 2.Department of Obstetrics and GynecologyHarvard Medical SchoolBostonUSA

Personalised recommendations