Transvaginal placement of surgical mesh for pelvic organ prolapse: More FDA concerns - Positive reactions are possible

International Urogynecology Journal

Volumn 23, Issue 1, 2012, Pages 11-13

  Haylen, Bernard T ^a,g   Sand, Peter K ^b   Swift, Steven E ^c   Maher, Christopher ^d   Moran, Paul A ^e   Freeman, Robert M ^f  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b Evanston Continence Centre   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^d WESLEY HOSPITAL   (Australia)

^e WORCESTERSHIRE ROYAL HOSPITAL   (United Kingdom)

^f DERRIFORD HOSPITAL   (United Kingdom)

^g ST VINCENT'S CLINIC   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

BLEEDING; DATA BASE; DOCUMENTATION; DYSPAREUNIA; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HUMAN; IMPLANT; MEDICAL INFORMATION; MESH EROSION; PATIENT COUNSELING; PELVIC ORGAN PROLAPSE; PELVIS PAIN SYNDROME; POSTOPERATIVE COMPLICATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROSTHESIS; REVIEW; RISK BENEFIT ANALYSIS; STAFF TRAINING; STRESS INCONTINENCE; SURGICAL APPROACH; SURGICAL RISK; SURGICAL TECHNIQUE; SURGICAL TRAINING; TRANSVAGINAL MESH; ARTICLE; FEMALE; IMPLANTATION; PATIENT SAFETY; PROSTHESIS FAILURE; SURGICAL EQUIPMENT; UNITED STATES;

FEMALE; HUMANS; PATIENT SAFETY; PELVIC ORGAN PROLAPSE; PROSTHESIS FAILURE; PROSTHESIS IMPLANTATION; SURGICAL MESH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84860677273     PISSN: 09373462     EISSN: 14333023     Source Type: Journal    
DOI: 10.1007/s00192-011-1580-3     Document Type: Review

References (10)

1. FDA (2011) FDA Safety Communications: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. http://www.fda.gov/MedicalDevices/Safety/AlertandNotices/ucm262435. htm. Accessed 13 July 2011
2. Urogynecologic surgical mesh: Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse (2011) http://www.fda.gov/ MedicalDevices/Safety/AlertandNotices/ucm262760.pdf
3. Haylen BT, Freeman RM, Swift SE, Cosson M, Davila GW, Deprest J, Dwyer PL, Fatton B, Kocjancic E, Lee J, Maher C, Petri E, Rizk DE, Sand PK, Schaer GN, Webb RJ (2011) An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses and grafts in female pelvic floor surgery. Int Urogynecol J 22:3-15
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5. Inglesia C, Sokol AI, Sokol ER, Kudish BI, Gutman RE, Peterson JL, Shott S (2010) Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 116(2):293-303
6. Cassidenti AP (2011) A reproducible technique to perform full thickness vaginal wall dissection for POP mesh placement that minimizes mesh exposure rates. IUGA Lisbon abstracts. http://www.abstractsonline.com/plan/AuthorIndex. aspx?letters=CA. Accessed June 2011
7. Milani AL, Lucente V, Urquhart C, Hinoul P, Cosson M (2011) Two-year clinical outcomes of a trocar-guided transvaginal mesh repair utilizing a new light-weight synthetic mesh. Int Urogynecol J 22(Suppl 1):S26
8. Jia X, Glazener C, Mowat G, MacLennan G, Bain C, Fraser C, Burt J (2008) Efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse: systematic review and meta-analysis. Br J Obstet Gynaecol 115(11):1350-1361
9. Maher C et al (2010) Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 4:CD004014
10. Summers A, Winkel LA, Hussain HK, DeLancey JOL (2006) The relationship between anterior and apical compartment support. Am J Obstet Gynecol 194:1438-1443