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Media Coverage of the 2019 United States Food and Drug Administration Ordered Withdrawal of Vaginal Mesh Products for Pelvic Organ Prolapse - Beyond the Abstract

Transvaginal polypropylene mesh implants for the treatment of pelvic floor disorders have gained significant media coverage over the last decade, catalyzed by the public health notice issued by the United States Food and Drug Administration (FDA) in 2008 and the subsequent update in 2011 regarding the adverse events related to the urogynecology use of surgical mesh.1-2 Since the 2011 FDA update, there has been a considerable rise in the number of legal claims and litigation related to implanted pelvic mesh.3 Simultaneously, the internet and social media have become more common sources of health information for patients, as they have facilitated easy access to medical information online.4-6 Surveys demonstrate that 35% percent of U.S. adults have searched the internet to discover what medical condition they or an acquaintance may have.7 Consequently, at times the doctor essentially serves as a second opinion to what the patient may have already read online.8 On April 16th, 2019, the FDA ordered manufacturers of transvaginal mesh for the treatment of pelvic organ prolapse (POP) to stop the sales and distribution of their products.9 This withdrawal did not pertain to mesh used for stress urinary incontinence (SUI), or to the transabdominal use of mesh for POP (e.g., sacrocolpopexy). Health organizations have noted that the FDA withdrawal and the media coverage surrounding it spurred confusion among patients.10-12 Our study assessed online user behavior on pelvic-mesh related articles after the withdrawal and evaluated article accuracy.



Internet search patterns and social media behavior around the time of the April 2019 FDA withdrawal of transvaginal mesh products for the treatment of POP revealed that some of the most disseminated information did not accurately or thoroughly distinguish the type of mesh implant (e.g., POP versus SUI) discussed. This reinforces the importance of counseling our patients in the office about mesh for POP and SUI, as many may have preconceived notions about the safety of these products. Although many women have suffered from complications of mesh implants, the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction both agree that mesh mid-urethral slings for SUI are effective, safe, and durable.13 We are concerned that the misinformation propagated in articles published surrounding the withdrawal of transvaginal mesh products has the potential to raise fear and anxiety over mesh MUS, the gold standard treatment for SUI. This may also make women less likely to seek care for SUI in the first place, and therefore continue to suffer silently from this bothersome problem. We believe our research highlights the need for continued education amongst our patients and the general public regarding the mesh controversy. 

Written by: Poone S. Shoureshi, MD and Kamran P. Sajadi, MD, Urology, Oregon Health and Science University, Portland, Oregon, United States

References: 

  1. Public Health Notifications (Medical Devices) - FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. http://wayback.archive-it.org/7993/20170111190506/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Accessed August 2, 2019.
  2. Health C for D and R. Public Health Notifications (Medical Devices) - FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. http://wayback.archive-it.org/7993/20170111190506/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Accessed August 27, 2019.
  3. Souders CP, Eilber KS, McClelland L, et al. The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics. Female Pelvic Med Reconstr Surg. 2018;24(1):21-25. doi:10.1097/SPV.0000000000000433
  4. McNab C. What social media offers to health professionals and citizens. Bull World Health Organ. 2009;87(8):566. doi:10.2471/BLT.09.066712
  5. Moorhead SA, Hazlett DE, Harrison L, Carroll JK, Irwin A, Hoving C. A New Dimension of Health Care: Systematic Review of the Uses, Benefits, and Limitations of Social Media for Health Communication. J Med Internet Res. 2013;15(4). doi:10.2196/jmir.1933
  6. Ybarra ML, Suman M. Help seeking behavior and the Internet: A national survey. International Journal of Medical Informatics. 2006;75(1):29-41. doi:10.1016/j.ijmedinf.2005.07.029
  7. Health Online 2013 | Pew Research Center. https://www.pewinternet.org/2013/01/15/health-online-2013/. Accessed August 2, 2019.
  8. Gualtieri LN. The Doctor As the Second Opinion and the Internet As the First. In: CHI ’09 Extended Abstracts on Human Factors in Computing Systems. CHI EA ’09. New York, NY, USA: ACM; 2009:2489–2498. doi:10.1145/1520340.1520352
  9. Health C for D and R. Urogynecologic Surgical Mesh Implants. FDA. http://www.fda.gov/medical-devices/implants-and-prosthetics/urogynecologic-surgical-mesh-implants. Published April 16, 2019. Accessed June 17, 2019.
  10. MacMillan C. Transvaginal Mesh: What Women Should Know - Stories at Yale Medicine. Yale Medicine. https://www.yalemedicine.org/stories/transvaginal-mesh/?fbclid=IwAR3q2HRf4Bi-YleO6ZzCXeAm6XRmkkfh60atU0I4N6hwNJicGmyVzRhfzlU. Accessed June 27, 2019.
  11. FDA Announcement on Transvaginal Mesh for Prolapse - President’s Perspective - News | AUGS. https://www.augs.org/fda-announcement-on-transvaginal-mesh-for-prolapse/. Accessed August 2, 2019.
  12. Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction | Update: Important Message About FDA Statement on MUS. https://sufuorg.com/about/news/message-about-fda-statement-on-mus.aspx. Accessed June 27, 2019.
  13. AUGS SUFU MUS Statement. https://www.augs.org/assets/1/6/AUGS-SUFU_MUS_Position_Statement.pdf
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