Pelvic mesh complications in women before and after the 2011 FDA public health notification

Female Pelvic Medicine and Reconstructive Surgery

Volumn 19, Issue 6, 2013, Pages 333-338

  Rice, Nicklaus Trent ^a,b   Hu, Yan ^a   Slaughter, James Chris ^a   Ward, Renee Melva ^a  

^a VANDERBILT UNIVERSITY   (United States)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

FDA public health notification; Mesh complication; Pelvic floor disorders; Pelvic organ prolapse; Stress urinary incontinence

Indexed keywords

FLOORS; SLINGS;

FDA PUBLIC HEALTH NOTIFICATION; MESH COMPLICATION; PELVIC FLOOR DISORDERS; PELVIC ORGAN PROLAPSE; STRESS URINARY INCONTINENCES;

PUBLIC HEALTH;

MERSILENE; POLITEF;

ADULT; ARTICLE; BLADDER NECK STENOSIS; COHORT ANALYSIS; CONSULTATION; CONTROLLED STUDY; CYSTOVAGINAL FISTULA; DEVICE SAFETY; DEVICE THERAPY; DISEASE CLASSIFICATION; FEMALE; FOOD AND DRUG ADMINISTRATION; GYNECOLOGIC SURGERY; HUMAN; MAJOR CLINICAL STUDY; MEDICAL DEVICE COMPLICATION; MEDICAL HISTORY; MESH COMPLICATION; MESH EROSION; MESH EXPOSURE; MIDDLE AGED; PAIN; PELVIC FLOOR DISORDER; PRACTICE GUIDELINE; RETROSPECTIVE STUDY; SACRAL COLPOPEXY; SUBURETHRAL SLING; SURGICAL MESH; VAGINAL MESH; VAGINAL SUPPORT DEVICE; ADOLESCENT; PATIENT SAFETY; PELVIC ORGAN PROLAPSE; PUBLIC HEALTH; STRESS INCONTINENCE; UNITED STATES; YOUNG ADULT; URINARY INCONTINENCE, STRESS;

ADOLESCENT; ADULT; FEMALE; HUMANS; MIDDLE AGED; PATIENT SAFETY; PELVIC ORGAN PROLAPSE; PUBLIC HEALTH; RETROSPECTIVE STUDIES; SUBURETHRAL SLINGS; SURGICAL MESH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; URINARY INCONTINENCE, STRESS; YOUNG ADULT;

EID: 84891533934     PISSN: 21518378     EISSN: 21544212     Source Type: Journal    
DOI: 10.1097/SPV.0b013e3182a330c1     Document Type: Article

References (18)

1. Brubaker L, Norton P, Albo ME, et al. Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study. Am J Obstet Gynecol 2011;205:498 e1-6.
2. Houwert RM, Roovers JP, Venema PL, et al. Outcome and complications of retropubic and transobturator midurethral slings translated into surgical therapeutic indices. Am J Obstet Gynecol 2010;202:75.e1-75.e7.
3. Barber MD, Gustilo-Ashby AM, Chen CC, et al. Perioperative complications and adverse events of the MONARC transobturator tape, compared with the tension-free vaginal tape. Am J Obstet Gynecol 2006;195:1820-1825.
4. Maher CF, Qatawneh AM, Dwyer PL, et al. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol 2004;190:20-26.
5. Paraiso MF, Walters MD, Rackley RR, et al. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol 2005;192:1752-1758.
6. Visco AG, Weidner AC, Barber MD, et al. Vaginal mesh erosion after abdominal sacral colpopexy. Am J Obstet Gynecol 2001;184:297Y302.
7. Begley JS, Kupferman SP, Kuznetsov DD, et al. Incidence and management of abdominal sacrocolpopexy mesh erosions. Am J Obstet Gynecol 2005;192:1956-1962.
8. Nygaard I, Brubaker L, Zyczynski HM, et al. Long-term outcomes following abdominal sacrocolpexy for pelvic organ prolapse. JAMA 2013;309(19):2016Y2024.
9. Sung VW, Rogers RG, Schaffer JI, et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol 2008;112:1131-1142.
10. Maher CM, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women: the updated summary version Cochrane review. Int Urogynecol J 2011;22:1445Y1457.
11. Murphy M for the Society of Gynecologic Surgeons Systemic Review Group. Clinical practice guidelines on vaginal graft use from the Society of Gynecologic Surgeons. Obstet Gynecol 2008;112:1123-1130.
12. Abed H, Rahn DD, Lowenstein L, et al. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J 2011;22:789-798.
13. Food and Drug Administration. FDA safety communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Silver Spring (MD): FDA; 2011. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Accessed on January 13, 2012.
14. Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap)Va metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377-381.
15. Haylen BT, Freeman RM, Swift SE, et al. An international urogynecological association (IUGA)/international continence society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Int Urogynecol J 2011;22:3-15.
16. Tunitsky E, Abbott S, Barber MD. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications. Am J Obstet Gynecol 2012;206:442.e1Y442.e6.
17. Gowda M, Kit LC, Reynolds W, et al. Interobserver variability when employing the IUGA/ICS classification system for complications related to prostheses and grafts in female pelvic floor surgery. Int Urogynecol J 2013;Epub 3/28/13.
18. Skala C, Renezeder K, Albrich S, et al. The IUGA/ICS classification of complications of prosthesis and graft insertion: a comparative experience in incontinence and prolapse surgery. Int Urogynecol J 2011;22: