Goran Rac1, Austin Younger1, James Q Clemens2, Kathleen Kobashi3, Aqsa Khan4, Victor Nitti4, Ilana Jacobs5, Gary E Lemack5, Elizabeth T Brown6, Roger Dmochowski6, Lara MacLachlan7, Arthur Mourtzinos7, David Ginsberg8, Michelle Koski9, Ross Rames1, Eric S Rovner1. 1. Department of Urology, Medical University of South Carolina, Charleston, South Carolina. 2. Department of Urology, University of Michigan Health Science Center, Ann Arbor, Michigan. 3. Section of Urology and Renal Transplantation, Virginia Mason Medical Center, Seattle, Washington. 4. Department of Urology, New York University Langone Medical Center, New York, New York. 5. Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas. 6. Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee. 7. Institute of Urology, Lahey Hospital and Medical Center, Burlington, Massachusetts. 8. Institute of Urology, Keck Medicine of University of Southern California, Los Angeles, California. 9. Urology of Kaiser Permanente Medical Center, San Diego, California.
Abstract
AIMS: To investigate the possible effects of the Food and Drug Administration (FDA) Public Health Notifications in 2008 and 2011 regarding surgical trends in transvaginal mesh (TVM) placement for stress urinary incontinence (SUI) and related mesh revision surgery in Female Pelvic Medicine & Reconstructive Surgery (FPMRS) practice in tertiary care academic medical centers in the United States. METHODS: Surgical volume for procedures performed primarily by FPMRS surgeons at eight academic institutions across the US was collected using Current Procedural Terminology (CPT) codes for stress urinary incontinence repair and revision surgeries from 2007 to 2013. SAS statistical software was used to assess for trends in the data. RESULTS: There was a decrease in the use of synthetic mesh sling for the treatment of SUI at academic tertiary care centers over the past 7 years; however, this was not statistically significant. While the total number of surgical interventions for SUI remained stable, there was an increase in the utilization of autologous fascia pubovaginal slings (AFPVS). The number of mesh sling revision surgeries, including urethrolysis and removal or revision of slings, increased almost three-fold at these centers. CONCLUSIONS: These observed trends suggest a possible effect of the FDA Public Health Notifications regarding TVM on surgical practice for SUI in academic centers, even though they did not specifically warn against the use of synthetic mesh for this indication. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study. However, such data may provide alternative insights into reasons for the observed trends. Neurourol. Urodynam. 36:1155-1160, 2017.
AIMS: To investigate the possible effects of the Food and Drug Administration (FDA) Public Health Notifications in 2008 and 2011 regarding surgical trends in transvaginal mesh (TVM) placement for stress urinary incontinence (SUI) and related mesh revision surgery in Female Pelvic Medicine & Reconstructive Surgery (FPMRS) practice in tertiary care academic medical centers in the United States. METHODS: Surgical volume for procedures performed primarily by FPMRS surgeons at eight academic institutions across the US was collected using Current Procedural Terminology (CPT) codes for stress urinary incontinence repair and revision surgeries from 2007 to 2013. SAS statistical software was used to assess for trends in the data. RESULTS: There was a decrease in the use of synthetic mesh sling for the treatment of SUI at academic tertiary care centers over the past 7 years; however, this was not statistically significant. While the total number of surgical interventions for SUI remained stable, there was an increase in the utilization of autologous fascia pubovaginal slings (AFPVS). The number of mesh sling revision surgeries, including urethrolysis and removal or revision of slings, increased almost three-fold at these centers. CONCLUSIONS: These observed trends suggest a possible effect of the FDA Public Health Notifications regarding TVM on surgical practice for SUI in academic centers, even though they did not specifically warn against the use of synthetic mesh for this indication. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study. However, such data may provide alternative insights into reasons for the observed trends. Neurourol. Urodynam. 36:1155-1160, 2017.
Authors: Sara Z Dejene; Michele Jonsson Funk; Virginia Pate; Jennifer M Wu Journal: Female Pelvic Med Reconstr Surg Date: 2021-09-30 Impact factor: 1.913
Authors: Casey G Kowalik; Joshua A Cohn; Andrea Kakos; Patrick Lang; W Stuart Reynolds; Melissa R Kaufman; Mickey M Karram; Roger R Dmochowski Journal: Int Urogynecol J Date: 2018-01-29 Impact factor: 2.894