TY - JOUR
T1 - Transvaginal mesh kits - How "serious" are the complications and are they reversible?
AU - Lee, Dominic
AU - Dillon, Benjamin
AU - Lemack, Gary
AU - Gomelsky, Alex
AU - Zimmern, Philippe
N1 - Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2013/1
Y1 - 2013/1
N2 - Objective: To review the merit of the U.S. Food and Drug Administration-issued warnings on the use of transvaginal mesh in women with pelvic organ prolapse because of escalating complications. Materials and Methods: On institutional review board approval, we reviewed the data from 2 tertiary institutions managing complications of transvaginal mesh. The data recorded included mesh type, details of surgical removal, and patient-reported clinical outcomes. Results: From 2006 to March 2011, 58 women were evaluated. Their mean age was 54.6 years (range 32-80), with a mean follow-up of 13 months (range 6-67). The mean interval to mesh excision surgery from the original prolapse surgery was 21 months (range 2-60). Of the 58 women, 35 (60%) had undergone concurrent midurethral sling surgery with the transvaginal mesh surgery. Also, 21 of the 58 patients (36%) had undergone initial mesh removal attempts before their referral to either tertiary institution. Most women presented with multiple complaints, with mesh extrusion the most frequently reported (n = 43 [74%]). Of the 58 women, 17 (29%) required re-excision of residual mesh, 13 once and 4 twice. Five women developed recurrent symptomatic pelvic organ prolapse (7%). The residual rate of dyspareunia and pelvic pain was 14% and 22%, respectively. Fourteen women (24%) were treated successfully, with complete resolution of all presenting symptoms. Conclusion: As outlined in the Food and Drug Administration notifications, patients should be forewarned that some transvaginal mesh complications are life altering and might not always be surgically correctable.
AB - Objective: To review the merit of the U.S. Food and Drug Administration-issued warnings on the use of transvaginal mesh in women with pelvic organ prolapse because of escalating complications. Materials and Methods: On institutional review board approval, we reviewed the data from 2 tertiary institutions managing complications of transvaginal mesh. The data recorded included mesh type, details of surgical removal, and patient-reported clinical outcomes. Results: From 2006 to March 2011, 58 women were evaluated. Their mean age was 54.6 years (range 32-80), with a mean follow-up of 13 months (range 6-67). The mean interval to mesh excision surgery from the original prolapse surgery was 21 months (range 2-60). Of the 58 women, 35 (60%) had undergone concurrent midurethral sling surgery with the transvaginal mesh surgery. Also, 21 of the 58 patients (36%) had undergone initial mesh removal attempts before their referral to either tertiary institution. Most women presented with multiple complaints, with mesh extrusion the most frequently reported (n = 43 [74%]). Of the 58 women, 17 (29%) required re-excision of residual mesh, 13 once and 4 twice. Five women developed recurrent symptomatic pelvic organ prolapse (7%). The residual rate of dyspareunia and pelvic pain was 14% and 22%, respectively. Fourteen women (24%) were treated successfully, with complete resolution of all presenting symptoms. Conclusion: As outlined in the Food and Drug Administration notifications, patients should be forewarned that some transvaginal mesh complications are life altering and might not always be surgically correctable.
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U2 - 10.1016/j.urology.2012.07.098
DO - 10.1016/j.urology.2012.07.098
M3 - Article
C2 - 23200966
AN - SCOPUS:84871987346
SN - 0090-4295
VL - 81
SP - 43
EP - 49
JO - Urology
JF - Urology
IS - 1
ER -