Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: Population based cohort study

BMJ (Online)

Volumn 350, Issue , 2015, Pages

  Chughtai, Bilal ^a   Mao, Jialin ^b   Buck, Jessica ^a   Kaplan, Steven ^a   Sedrakyan, Art ^b  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b Department of Healthcare Policy and Research ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGE DISTRIBUTION; AGED; ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; FEMALE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GYNECOLOGIC SURGERY; HUMAN; MAJOR CLINICAL STUDY; MIDDLE AGED; OUTCOME ASSESSMENT; PATIENT SAFETY; PELVIC ORGAN PROLAPSE; POPULATION RESEARCH; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; PROPENSITY SCORE; RETREATMENT; RISK BENEFIT ANALYSIS; SURGICAL MESH; SURGICAL RISK; UNITED STATES; URINE RETENTION; HYSTERECTOMY; POSTOPERATIVE COMPLICATIONS; RECURRENT DISEASE; REOPERATION; RISK FACTOR; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME;

ADULT; AGED; COHORT STUDIES; FEMALE; HUMANS; HYSTERECTOMY; MIDDLE AGED; NEW YORK; PATIENT SAFETY; PELVIC ORGAN PROLAPSE; POSTOPERATIVE COMPLICATIONS; PROPENSITY SCORE; RECURRENCE; REOPERATION; RISK FACTORS; SURGICAL MESH; TREATMENT OUTCOME;

EID: 84936760064     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h2685     Document Type: Article

References (36)

1. FDA. Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. 2011. www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf.
2. FDA. FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. 2008. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm.
3. FDA. MAUDE - Manufacturer and user facility device experience. Secondary MAUDE - Manufacturer and user facility device experience 2015. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.
4. FDA. Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse: FDA safety communication. 2011. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.
5. FDA. Surgical mesh for the treatment of women with pelvic organ prolapse and stress urinary incontinence: FDA executive summary. 2011. www.fda.gov/downloads/UCM270402.pdf.
6. Ura A. Women want Texas' help in pelvic mesh fight. 2014. www.nytimes.com/2014/07/13/us/women-want-texas-help-in-pelvicmesh-fight.html.
7. Meier B. FDA orders surgical mesh makers to study risks. 2012. www.nytimes.com/2012/01/05/health/research/fda-orders-more-studyon-surgical-mesh-risks.html.
8. Pelvic Mesh Lawyers. Surgical mesh lawyers offer free case review after FDA issues warning regarding serious complications from transvaginal placement of of surgical mesh in repair of pelvic organ prolapse. Home page. www.pelvicmeshlawyers.com/default.asp.
9. Khan AA, Eilber KS, Clemens JQ, et al. Trends in management of pelvic organ prolapse among female Medicare beneficiaries. Am J Obstet Gynecol 2014;212:463.e1-8.
10. Rogo-Gupta L, Rodriguez LV, Litwin MS, et al. Trends in surgical mesh use for pelvic organ prolapse from 2000 to 2010. Obstet Gynecol 2012;120:1105-15.
11. Reynolds WS, Gold KP, Ni S, et al. Immediate effects of the initial FDA notification on the use of surgical mesh for pelvic organ prolapse surgery in medicare beneficiaries. Neurourol Urodyn 2013;32:330-5.
12. Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol 2003;188:108-15.
13. Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89:501-6.
14. Wu JM, Hundley AF, Fulton RG, et al. Forecasting the prevalence of pelvic floor disorders in US women: 2010 to 2050. Obstet Gynecol 2009;114:1278-83.
15. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA 2008;300:1311-6.
16. Mettu JR, Colaco M, Badlani GH. Evidence-based outcomes for mesh-based surgery for pelvic organ prolapse. Curr Opin Urol 2014;24:370-4.
17. Sung VW, Rogers RG, Schaffer JI, et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol 2008;112:1131-42.
18. Altman D, Vayrynen T, Engh ME, et al. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med 2011;364:1826-36.
19. Hiltunen R, Nieminen K, Takala T, et al. Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol 2007;110:455-62.
20. Sokol AI, Iglesia CB, Kudish BI, et al. One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse. Am J Obstet Gynecol 2012;206:86.e1-9.
21. Anger JT, Khan AA, Eilber KS, et al. Short-term outcomes of vaginal mesh placement among female Medicare beneficiaries. Urology 2014;83:768-73.
22. Maher C, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2013;4:CD004014.
23. New York State Department of Health. Statewide Planning and Research Cooperative System (SPARCS). 2014. www.health.ny.gov/statistics/sparcs/.
24. Elixhauser A, Steiner C, Harris DR, et al. Comorbidity measures for use with administrative data. Med Care 1998;36:8-27.
25. Rassen JA, Shelat AA, Myers J, et al. One-to-many propensity score matching in cohort studies. Pharmacoepidemiol Drug Saf 2012;21(suppl 2):69-80.
26. Cummings P, McKnight B, Weiss NS. Matched-pair cohort methods in traffic crash research. Accid Anal Prev 2003;35:131-41.
27. Margulies RU, Lewicky-Gaupp C, Fenner DE, et al. Complications requiring reoperation following vaginal mesh kit procedures for prolapse. Am J Obstet Gynecol 2008;199:678.e1-4.
28. Smith AJ, Dieppe P, Vernon K, et al. Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales. Lancet 2012;379:1199-204.
29. Makela KT, Matilainen M, Pulkkinen P, et al. Failure rate of cemented and uncemented total hip replacements: register study of combined Nordic database of four nations. BMJ 2014;348:f7592.
30. Kaufman Y, Singh SS, Alturki H, et al. Age and sexual activity are risk factors for mesh exposure following transvaginal mesh repair. Int Urogynecol J 2011;22:307-13.
31. Mistrangelo E, Mancuso S, Nadalini C, et al. Rising use of synthetic mesh in transvaginal pelvic reconstructive surgery: a review of the risk of vaginal erosion. J Minim Invasive Gynecol 2007;14:564-9.
32. Hannestad YS, Rortveit G, Sandvik H, et al. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trøndelag. J Clin Epidemiol 2000;53:1150-7.
33. Koski ME, Chamberlain J, Rosoff J, et al. Patient perception of transvaginal mesh and the media. Urology 2014;84:575-82.
34. Kongoasa N, Voralu K, Mokrzycki M. Does prior vaginal prolapse surgery affect synthetic mesh erosion rates? Obstet Gynecol 2014;123(suppl 1):1S.
35. FDA. FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse. 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm.
36. Cook JA, McCulloch P, Blazeby JM, et al. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ 2013;346:f2820.