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Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence.
JAMA Surg. 2017 03 01; 152(3):257-263.JS

Abstract

Importance

Mesh, a synthetic graft, has been used in pelvic organ prolapse (POP) repair and stress urinary incontinence (SUI) to augment and strengthen weakened tissue. Polypropylene mesh has come under scrutiny by the US Food and Drug Administration.

Objective

To examine the rates of mesh complications and invasive reintervention after the placement of vaginal mesh for POP repair or SUI surgery.

Design, Setting, and Participants

This investigation was an observational cohort study at inpatient and ambulatory surgery settings in New York State. Participants were women who underwent transvaginal repair for POP or SUI with mesh between January 1, 2008, and December 31, 2012, and were followed up through December 31, 2013. They were divided into the following 4 groups based on the amount of mesh exposure: transvaginal POP repair surgery with mesh and concurrent sling use (vaginal mesh plus sling group), transvaginal POP repair with mesh and no concurrent sling use (vaginal mesh group), transvaginal POP repair without mesh but concurrent sling use for SUI (POP sling group), and sling for SUI alone (SUI sling group).

Main Outcomes and Measures

The primary outcome was the occurrence of mesh complications and repeated invasive intervention within 1 year after the initial mesh implantation. A time-to-event analysis was performed to examine the occurrence of mesh erosions and subsequent reintervention. Secondary analyses of an age association (<65 vs ≥65 years) were conducted.

Results

The study identified 41 604 women who underwent 1 of the 4 procedures. The mean (SD) age of women at their initial mesh implantation was 56.2 (13.0) years. The highest risk of erosions was found in the vaginal mesh plus sling group (2.72%; 95% CI, 2.31%-3.21%) and the lowest in the SUI sling group (1.57%; 95% CI, 1.41%-1.74%). The risk of repeated surgery with concomitant erosion diagnosis was also the highest in the vaginal mesh plus sling group (2.13%; 95% CI, 1.76%-2.56%) and the lowest in the SUI sling group (1.16%; 95% CI, 1.03%-1.31%).

Conclusions and Relevance

The combined use of POP mesh and SUI mesh sling was associated with the highest erosion and repeated intervention risk, while mesh sling alone had the lowest erosion and repeated intervention risk. There is evidence for a dose-response relationship between the amount of mesh used and subsequent mesh erosions, complications, and invasive repeated intervention.

Authors+Show Affiliations

Department of Urology, Weill Cornell Medical College, New York-Presbyterian Hospital, New York.Obstetrics, Gynecology, and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio.Department of Healthcare Policy and Research, Weill Cornell Medical College, New York, New York.Department of Urology, Weill Cornell Medical College, New York-Presbyterian Hospital, New York.Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts5Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.Department of Healthcare Policy and Research, Weill Cornell Medical College, New York, New York.

Pub Type(s)

Journal Article
Observational Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27902825

Citation

Chughtai, Bilal, et al. "Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence." JAMA Surgery, vol. 152, no. 3, 2017, pp. 257-263.
Chughtai B, Barber MD, Mao J, et al. Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence. JAMA Surg. 2017;152(3):257-263.
Chughtai, B., Barber, M. D., Mao, J., Forde, J. C., Normand, S. T., & Sedrakyan, A. (2017). Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence. JAMA Surgery, 152(3), 257-263. https://doi.org/10.1001/jamasurg.2016.4200
Chughtai B, et al. Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence. JAMA Surg. 2017 03 1;152(3):257-263. PubMed PMID: 27902825.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence. AU - Chughtai,Bilal, AU - Barber,Matthew D, AU - Mao,Jialin, AU - Forde,James C, AU - Normand,Sharon-Lise T, AU - Sedrakyan,Art, PY - 2016/12/3/pubmed PY - 2017/7/1/medline PY - 2016/12/1/entrez SP - 257 EP - 263 JF - JAMA surgery JO - JAMA Surg VL - 152 IS - 3 N2 - Importance: Mesh, a synthetic graft, has been used in pelvic organ prolapse (POP) repair and stress urinary incontinence (SUI) to augment and strengthen weakened tissue. Polypropylene mesh has come under scrutiny by the US Food and Drug Administration. Objective: To examine the rates of mesh complications and invasive reintervention after the placement of vaginal mesh for POP repair or SUI surgery. Design, Setting, and Participants: This investigation was an observational cohort study at inpatient and ambulatory surgery settings in New York State. Participants were women who underwent transvaginal repair for POP or SUI with mesh between January 1, 2008, and December 31, 2012, and were followed up through December 31, 2013. They were divided into the following 4 groups based on the amount of mesh exposure: transvaginal POP repair surgery with mesh and concurrent sling use (vaginal mesh plus sling group), transvaginal POP repair with mesh and no concurrent sling use (vaginal mesh group), transvaginal POP repair without mesh but concurrent sling use for SUI (POP sling group), and sling for SUI alone (SUI sling group). Main Outcomes and Measures: The primary outcome was the occurrence of mesh complications and repeated invasive intervention within 1 year after the initial mesh implantation. A time-to-event analysis was performed to examine the occurrence of mesh erosions and subsequent reintervention. Secondary analyses of an age association (<65 vs ≥65 years) were conducted. Results: The study identified 41 604 women who underwent 1 of the 4 procedures. The mean (SD) age of women at their initial mesh implantation was 56.2 (13.0) years. The highest risk of erosions was found in the vaginal mesh plus sling group (2.72%; 95% CI, 2.31%-3.21%) and the lowest in the SUI sling group (1.57%; 95% CI, 1.41%-1.74%). The risk of repeated surgery with concomitant erosion diagnosis was also the highest in the vaginal mesh plus sling group (2.13%; 95% CI, 1.76%-2.56%) and the lowest in the SUI sling group (1.16%; 95% CI, 1.03%-1.31%). Conclusions and Relevance: The combined use of POP mesh and SUI mesh sling was associated with the highest erosion and repeated intervention risk, while mesh sling alone had the lowest erosion and repeated intervention risk. There is evidence for a dose-response relationship between the amount of mesh used and subsequent mesh erosions, complications, and invasive repeated intervention. SN - 2168-6262 UR - https://www.unboundmedicine.com/medline/citation/27902825/Association_Between_the_Amount_of_Vaginal_Mesh_Used_With_Mesh_Erosions_and_Repeated_Surgery_After_Repairing_Pelvic_Organ_Prolapse_and_Stress_Urinary_Incontinence_ L2 - https://jamanetwork.com/journals/jamasurgery/fullarticle/10.1001/jamasurg.2016.4200 DB - PRIME DP - Unbound Medicine ER -