Use of vaginal mesh in the face of recent FDA warnings and litigation

American Journal of Obstetrics and Gynecology

Volumn 203, Issue 2, 2010, Pages 103.e1-103.e4

  Mucowski, Sara J ^b   Jurnalov, Catalin ^a   Phelps, John Y ^a,b  

^a UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

^b University of Texas Medical Branch School of Medicine   (United States)

Author keywords

informed consent; lawsuit; mesh; pelvic organ prolapse; stress urinary incontinence

Indexed keywords

FOOD AND DRUG ADMINISTRATION; GYNECOLOGIC SURGERY; HUMAN; INFORMED CONSENT; LAW SUIT; MEDICAL LIABILITY; MEDICAL RECORD; MESH SLING; NOTE; PELVIC ORGAN PROLAPSE; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; QUALITY OF LIFE; SAFETY; STRESS INCONTINENCE; VAGINA RECONSTRUCTION;

EID: 77955652846     PISSN: 00029378     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ajog.2010.01.060     Document Type: Article

References (19)

1. H.P. Drutz, and M. Alarab Pelvic organ prolapse: demographics and future growth prospects Int Urogynecol J Pelvic Floor Dysfunct 17 Suppl 2006 S6 S9
2. US Food and Drug Administration FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence October 20, 2008 Available at: http://www.fda.gov/cdrh/safety/102008-surgicalmesh.html Accessed Feb. 5, 2009
3. US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE) Available at: http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfMAUDE/search.CFM Accessed Jan. 15, 2009
4. V.W. Sung, R.G. Rogers, J.I. Schaffer, et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review Obstet Gynecol 112 2008 1131 1142
5. M. Murphy Clinical practice guidelines on vaginal graft use from the Society of Gynecologic Surgeons Obstet Gynecol 112 2008 1123 1130
6. National Institute for Health and Clinical Excellence Interventional procedure guidance 267, "Surgical repair of vaginal wall prolapse using mesh" and "Treating vaginal wall prolapse with surgery using mesh." Issued June 2008 Available at: http://guidance.nice.org/uk/IPG267/ Guidance/pdf/English Accessed March 3, 2010
7. Linsley v C.R. Bard Inc, 2000 WL 343358, E.D.La (2000).
8. McNichols v Johnson & Johnson, 461 F Supp 2d 736 (US Dist 2006).
9. Riegel v Medtronic Inc, 552 US, 312, (2008).
10. Canterbury v Spence, 464 F.2d 772 (DC Cir 1972).
11. Polcari v Dottino, 35 AD3d 190 (2006).
12. D.R. Ostergard Lessons from the past: directions for the future Do new marketed surgical procedures and grafts produce ethical, personal liability, and legal concerns for physicians? Int Urogynecol J Pelvic Floor Dysfunct 18 2007 591 598
13. A.R. Kane, and C.W. Nager Midurethral slings for stress urinary incontinence Clin Obstet Gynecol 51 2008 124 135
14. M. Abdel-Fattah, I. Ramsay West of Scotland Study Group Retrospective multicenter study of the new minimally invasive mesh repair devices for pelvic organ prolapse BJOG 115 2008 22 30 (Pubitemid 350209616)
15. US Food and Drug Administration Premarket notification 510(k) Available at: http://www.fda.gov/CDRH/DEVADVICE/314.html Accessed March 15, 2009
16. American College of Obstetricians and Gynecologists Innovative practice: ethical guidelines ACOG committee opinion no. 352 Obstet Gynecol 108 2006 1589 1595
17. M. Kapp Patient autonomy in the age of consumer-driven health care: informed consent and informed choice J Health Biomed Law 2 2006 1 31
18. S.M. Jakus, A. Shapiro, and C.D. Hall Biologic and synthetic graft use in pelvic surgery: a review Obstet Gynecol Surv 63 2008 253 266
19. W.G. Davila, H.P. Drutz, and J. Deprest Clinical implications of the biology of grafts: conclusions of the 2005 IUGA grafts roundtable Int Urogynecol J Pelvic Floor Dysfunct 17 Suppl 2006 51 55