Title: Updates in Urogynecology: The Mesh Controversy – Implications for Our Clinical Practices

Isuzu Meyer, MD, MSPH Assistant Professor Division of Urogynecology and Pelvic Reconstructive Department of and Gynecology University of Alabama at Birmingham

Pelvic floor disorders including and urinary/ are prevalent conditions affecting 1 in 4 women in the United States. As the prevalence of pelvic floor disorders continues to rise, OBGYN providers frequently encounter patients with these highly burdensome conditions. The recent FDA announcement on transvaginal mesh has created confusion and concerns in the general public especially due to the overwhelming media coverage both in lay and medical press. This session will provide updates in the use of mesh in urogynecologic surgery, discussing a brief overview of the recent FDA announcement regarding vaginal mesh as well as the management of mesh complications after surgery in a clinical vignette presentation.

I. Lecture Objectives: At the end of this session, the participant will be able to: 1. Describe a brief summary of the FDA announcement on vaginal mesh 2. Describe potential complications related to urogynecologic surgery using mesh 3. Describe the management of mesh and graft complications

II. Lecture Outline: 1. 2019 FDA announcement on transvaginal mesh: i. Timeline of FDA’s actions regarding transvaginal mesh ii. What was the key message in the FDA announcement? iii. Counseling points for patients with mesh 2. Mesh Complications – Clinical vignettes i. Types of complications ii. Management of mesh complications

III. References 1. U.S. Food and Drug Administration. “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; April 2019. Available at https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect- womens-health-orders-manufacturers-surgical-mesh-intended-transvaginal. Retrieved January 3, 2020 2. Pelvic Organ Prolapse. ACOG Practice Bulletin No. 214. American College of Obstetricians and Gynecologists. Obstet Gynecol 2019;134(5):e126-142 3. Management of mesh and graft complications in gynecologic surgery. Committee Opinion No. 694. (Reaffirmed 2019) American College of Obstetricians and Gynecologists. Obstet Gynecol 2017;129:e102–8.