Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery

Female Pelvic Medicine and Reconstructive Surgery

Volumn 19, Issue 4, 2013, Pages 191-198

  Clemons, Jeffrey L ^a   Weinstein, Milena ^b   Guess, Marsha K ^c   Alperin, Marianna ^d   Moalli, Pamela ^e   Gregory, William Thomas ^f   Lukacz, Emily S ^g   Sung, Vivian W ^h   Chen, Bertha H ⁱ   Bradley, Catherine S ^j  

^a Multicare Health System   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c YALE UNIVERSITY   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e UNIVERSITY OF PITTSBURGH   (United States)

^f OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^g UNIVERSITY OF CALIFORNIA SAN DIEGO HEALTH SYSTEM   (United States)

^h WOMEN AND INFANTS HOSPITAL   (United States)

ⁱ STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^j UNIVERSITY OF IOWA   (United States)

more..

Author keywords

Mesh; Pelvic organ prolapse; Sling; Surgery

Indexed keywords

REPAIR; SLINGS; UROLOGY;

ELECTRONIC SURVEY; FOOD AND DRUG ADMINISTRATION; FREQUENCY OF USE; MESH; PELVIC ORGAN PROLAPSE; RECONSTRUCTIVE SURGERY; STRESS URINARY INCONTINENCES; WILCOXON SIGNED RANK TEST;

SURGERY;

ADULT; ARTICLE; DEVICE SAFETY; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL EDUCATION; MEDICAL SOCIETY; PELVIC ORGAN PROLAPSE; PELVIC RECONSTRUCTIVE SURGERY; PELVIS GRAFT; PELVIS SURGERY; STRESS INCONTINENCE; TISSUE GRAFT; TOOL USE; TRANSABDOMINAL MESH; TRANSVAGINAL SLING; CLINICAL PRACTICE; DEVICE APPROVAL; EQUIPMENT; HEALTH CARE SURVEY; MIDDLE AGED; PLASTIC SURGERY; PRODUCT SAFETY; SUBURETHRAL SLING; SURGICAL MESH; UNITED STATES; UTILIZATION REVIEW;

ADULT; CONSUMER PRODUCT SAFETY; DEVICE APPROVAL; FEMALE; HEALTH CARE SURVEYS; HUMANS; MALE; MIDDLE AGED; PELVIC ORGAN PROLAPSE; PHYSICIAN'S PRACTICE PATTERNS; RECONSTRUCTIVE SURGICAL PROCEDURES; SOCIETIES, MEDICAL; SUBURETHRAL SLINGS; SURGICAL MESH; UNITED STATES; URINARY INCONTINENCE, STRESS;

EID: 84882965682     PISSN: 21518378     EISSN: 21544212     Source Type: Journal    
DOI: 10.1097/SPV.0b013e31829099c1     Document Type: Article

References (12)

1. Nygaard I, Barber MD, Burgio KL, et al; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA 2008;300(11):1311-1316.
2. Jelovsek JE, Barber MD. Women seeking treatment for advanced pelvic organ prolapse have decreased body image and quality of life. Am J Obstet Gynecol 2006;194(5):1455-1461.
3. Subak LL,Waetjen LE, Eeden SVD, et al. Cost of pelvic organ prolapse surgery in the United States. Obstet Gynecol 2001;98:646-651.
4. Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89:501-506.
5. Denman MA, Gregory WT, Boyles SH, et al. Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol 2008;198(5):555.e1-555.e5.
6. FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. Available at: http://www.fda.gov/medicaldevices/ safety/alertsandnotices/publichealthnotifications/ucm061976.htm. Date issued: October 20, 2008. Page last updated: March 09, 2012
7. FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. Available at: http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm Date issued: July 13, 2011.
8. Maher C, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2010; (4):CD004014.
9. Sung VW, Rogers RG, Schaffer JI, et al; Society of Gynecologic Surgeons Systematic Review Group. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol 2008; 112(5):1131-1142.
10. Maher CM. Surgical management of pelvic organ prolapse in women: the updated summary version Cochrane review. Int Urogynecol J 2011;22(11): 1445-1457.
11. American Urogynecologic Society's Guidelines Development Committee. Guidelines for providing privileges and credentials to physicians for transvaginal placement of surgical mesh for pelvic organ prolapse. Female Pelvic Med Reconstr Surg 2012;18(4):194-197.
12. Ogah J, Cody JD, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2009;(4):CD006375.