Inaccuracies in News Media Reporting About the 2019 US Food and Drug Administration Ban on Transvaginal Mesh for Pelvic Organ Prolapse Repair

Author:

Ray Shagnik,Clifton Marisa M.,Koo Kevin

Publisher

Elsevier BV

Subject

Urology

Reference18 articles.

1. Office of the Commissioner. FDA takes action to protect women's health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. FDA. Available at:http://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-womens-health-orders-manufacturers-surgical-mesh-intended-transvaginal. 2019. Accessed February 16, 2020.

2. Office of the Commissioner. FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks.FDA. Available at:http://www.fda.gov/news-events/press-announcements/fda-strengthens-requirements-surgical-mesh-transvaginal-repair-pelvic-organ-prolapse-address-safety. 2019. Accessed February 16, 2020.

3. Center for Devices and Radiological Health. 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. Available at:http://wayback.archive-it.org/7993/20170111190506/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Accessed February 27, 2020.

4. Center for Devices and Radiological Health. Safety communications - UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse: FDA safety communication. Available at:http://wayback.archive-it.org/7993/20170111231226/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Accessed February 27, 2020.

5. Transvaginal mesh: a historical review and update of the current state of affairs in the United States;Iyer;Int Urogynecol J,2017

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