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Mesh related complications in pelvic reconstructive surgery

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Mesh related complications in pelvic reconstructive surgery

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    1. Mesh related complications in pelvic reconstructive surgery Christian Falconer Dept. of Obstetrics & Gynecology Danderyd Hospital In acknowledgement to Paul Riss, Vienna, for some slides Finnish Society of Gynaecological Surgery Helsinki 2008-09-26

    2. Illustration of complications How to get data on complications Incidence - Relevance (Management)

    3. Bladder perforation

    4. Voiding difficulties – kinking of urethra

    5. Retropubic hematoma

    6. Tape erosion into urethra

    7. Tape erosion into bladder

    8. Tape erosion into vagina

    9. Urethrovaginal fistula

    10. Vaginal adenosis 5 yrs after TVT

    11. Cutaneovaginal fistula after retropubic sling (TVT)

    12. Prepubic abscess after retropubic sling

    13. Thigh abscess after transobturator tape

    14. Thigh abscess after transobturator tape

    15. Gluteal hematoma after Apogee®

    16. Defect healing 1 yr after Anterior Prolift®

    17. 8 yrs after Abdominal sacropexy with Gore®

    18. 8 yrs after Abdominal sacropexy with Gore®

    19. Necrotizing osteomyelitis after TVT

    20. Defect healing 1 yr after Anterior Prolift®

    21. Necrotizing fasciitis 2 wks after vaginal HE and posterior Prolift®

    22. Proposed classification of mesh complications

    23. How to get data on complications

    24. Case reports Case series Trials Registries Companies Government agencies

    28. Registry Advantages Multicenter experience Large numbers Reduced bias Prerequisites All complications reported All cases done entered

    29. Registry Example bladder perforation Austrian TVT Registry

    30. TVT World Registry

    31. Registries ? It is good to know what we are doing ? Inclusion bias ? Calculation of frequencies only when all patients are included

    34. Incidence of complications

    35. Incidence of bladder perforation in TVT Year Country Data N % Tamussino 2001 AU R 2795 2.7 Kuuva 2002 FI R 1455 3.8 Ward 2002 UK T 178 9.0 Karram 2003 US CS 350 4.9 Andonian 2005 CA T 43 23.0 Lord 2006 AU T 147 0.7

    36. Incidence of bladder perforation in TVT Year Country Data N % Tamussino 2001 AU R 2795 2.7 Kuuva 2002 FI R 1455 3.8 Ward 2002 UK T 178 9.0 Karram 2003 US CS 350 4.9 Andonian 2005 CA T 43 23.0 Lord 2006 AU T 147 0.7

    37. Bleeding complications with TVT Koelle D et al. Am J Obstet Gynecol. 2005,193:2045-9 N % Overall 5578 151 2.7 Increased intraoperative bleeding 106 1.9 Reoperation 45 0.8 Laparotomy 34 Transvaginal 4 Suprapubic catheter site 3 Unknown 4 Time to Reoperation 45 Less than 24 hours 39 2-10 days 20 11/56 days 41 Source of bleeding Arterial 12 1 external iliac artery injury 1 obturator artery injury Venous 88

    38. Bleeding complications with TVT Koelle D et al. Am J Obstet Gynecol. 2005,193:2045-9 N % Overall 5578 151 2.7 Increased intraoperative bleeding 106 1.9 Reoperation 45 0.8 Laparotomy 34 Transvaginal 4 Suprapubic catheter site 3 Unknown 4 Time to Reoperation 45 Less than 24 hours 39 2-10 days 20 11/56 days 41 Source of bleeding Arterial 12 1 external iliac artery injury 1 obturator artery injury Venous 88

    39. Ward & Hilton ICS 2006 Many tape related complications may be missed operative injuries Tape erosion may occur several years after surgery

    40. 289 women (219 Gynecare, 70 AMS) Bladder injury 1.6 % Rectal injury 1.1 % Serious vascular injuries 2 Buttock pain 5.2 % Vaginal erosion 10.0 % Bladder erosion 1 Serious infection 2

    41. 248 women (Prolift) Major complications 11 (4.4%) Bladder perforation 5 Urethra perforation 1 Rectal perforation 4 Bleeding >1000ml 1 Minor complications 36 (14.5%) UTI 16 Urinary retention 4 Fever 4

    42. Who is looking at a complication? The patient The surgeon #1 The surgeon #2 The ombudsman The trial lawyer The company making the product

    43. The patient‘s perspective “EGGS“ Expectations Goals set Goals achieved Satisfaction

    44. The surgeon #1 The Bottle of Champagne No complaints from patient Good anatomical result on follow-up Unintended consequence Complication

    45. The surgeon #2

    46. The surgeon #2

    47. The surgeon #2 Dangerous procedure Terrrible complications Overuse of surgery / uncritical indications Incompetent surgeon / faulty technique

    48. How to avoid complications Selection of patient Alternative options Selection of procedure Proven technique Adequate training Registries Trials

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