1. Vaginal Repair of Apical Prolapse Mesh Kit vs. Vaginal Suture Repair Marie Fidela R. Paraiso, M.D. Head, Division of Urogynecology Professor of Surgery Cleveland Clinic Lerner College of Medicine at Case Western Reserve University Cleveland, OH

2. Disclosures None None

3. Food for Thought Best practices are difficult to define when discussing innovation because of lack of data to support newer kit procedures. Best practices are difficult to define when discussing innovation because of lack of data to support newer kit procedures. However, quality data are lacking with respect to traditional suture repair procedures as well. However, quality data are lacking with respect to traditional suture repair procedures as well. Comparative data show that synthetic mesh implantation in the anterior wall results in better anatomic cure rates. Comparative data show that synthetic mesh implantation in the anterior wall results in better anatomic cure rates.

4. ICUD Modification of Oxford System Levels of Evidence 1. RCTs 2. Prospective cohort 3. Retrospective case control 4. Case series 5. Expert opinion without evidence

5. *Pelvic Organ Prolapse Approximately half of women 50 and older are affected. Approximately half of women 50 and older are affected. Women feel their pelvic organs bulging or protruding out of the vaginal opening and may experience pelvic pain. Women feel their pelvic organs bulging or protruding out of the vaginal opening and may experience pelvic pain. Urination and/or bowel movements may be difficult. Urination and/or bowel movements may be difficult. Women may also experience pain with intercourse and decreased body image. Women may also experience pain with intercourse and decreased body image.

8. Enterocoele

9. Repairs Requiring Graft Augmentation or “Kits” for Pelvic Organ Prolapse

10. Current Vaginal Mesh Kits with Trocars Prolift ® System Avaulta ® System Perigee ® Sling /Apogee ® Sling Apogee and Perigee are registered trademarks of AMS Research Corporation. | Avaulta is a registered trademark of C.R. Bard, Inc. | Gynecare Prolift is a registered trademark of Johnson & Johnson Corporation Potential Limitations Blind pass of needles through unfamiliar anatomy Blind pass of needles through unfamiliar anatomy Proximity to neurovascular structures Proximity to neurovascular structures Vaginal apex support Extent of anterior vaginal wall support unless modified Gap failure Many surgeons have switched to trocarless kits without any data!

12. Mesh Systems without Trocars Sacrospinous Ligament Arcus Tendineous Pinnacle® Pelvic Floor Repair Kit Capio® Suture Capturing Device Uphold Procedure Prosima—non fixated with VSD

13. Society for Gynecologic Surgeons Systematic Review Group Guidelines Obstet Gynecol 112(5):1123-30, 2008 Biologic grafts and absorbable synthetic grafts offer no advantage over native tissue repair for anterior or posterior vaginal wall Biologic grafts and absorbable synthetic grafts offer no advantage over native tissue repair for anterior or posterior vaginal wall No data to guide recommendations regarding non-absorbable synthetic mesh in the posterior wall or for vaginal apical suspension. No data to guide recommendations regarding non-absorbable synthetic mesh in the posterior wall or for vaginal apical suspension. It is suggested that non-absorbable synthetic mesh may improve anatomic outcomes of anterior vaginal wall repair, but there are trade- offs in regards to the risk of adverse events It is suggested that non-absorbable synthetic mesh may improve anatomic outcomes of anterior vaginal wall repair, but there are trade- offs in regards to the risk of adverse events

14. 249 articles 19 conference abstracts 249 articles 19 conference abstracts 160 articles excluded Traditional vaginal 54 studies Sacral colpopexy 43 studies Vaginal mesh kits 24 studies 89 articles 19 conference abstracts included included 89 articles 19 conference abstracts included included Systematic Review of Apical Prolapse Surgeries Diwadkar et al, 2009, Obstet Gynecol 2009, 113:3670-73.

15. Conclusions of Review Traditional vaginal procedures Traditional vaginal procedures Highest reoperation rate for prolapse recurrence Highest reoperation rate for prolapse recurrence Lowest rates of complications that required surgical intervention Lowest rates of complications that required surgical intervention Lowest total reoperation rate Lowest total reoperation rate Vaginal mesh kits Vaginal mesh kits Shortest follow-up period Shortest follow-up period Highest rate of complications that required surgical intervention Highest rate of complications that required surgical intervention Highest total reoperation rate (recurrence + complications) Highest total reoperation rate (recurrence + complications)

16. Graft Implants Inert, inactive, permanent materials Bioactive, conductive, remodeling tissues Cellular: regenerate or signal to scaffold Tissue and organ engineering Anatomy ≠ Function

17. Vaginal Prolapse Surgery: No Mesh or Mesh? Sacral colpopexy and mid-urethral slings are the most proven surgeries using mesh Sacral colpopexy and mid-urethral slings are the most proven surgeries using mesh Grafts tend to improve anatomic success in most prolapse repairs, but there is usually no significant difference in QOL and sexual function after traditional vs. mesh surgery Grafts tend to improve anatomic success in most prolapse repairs, but there is usually no significant difference in QOL and sexual function after traditional vs. mesh surgery Grafts always increase complications and cost but many surgeons use vaginal grafts routinely and with great success Grafts always increase complications and cost but many surgeons use vaginal grafts routinely and with great success Surgeons should use what is best in their hands Surgeons should use what is best in their hands

18. What are we doing at the Cleveland Clinic? Route of Surgery: Route of Surgery: Vaginal 65%, Laparoscopic 20%, Robotic 10%, Open 5% Vaginal 65%, Laparoscopic 20%, Robotic 10%, Open 5% I do most kit procedures in our division: uterine sparing, recurrent, non-sexually active, co-morbid, vaginal route indicated or preferred I do most kit procedures in our division: uterine sparing, recurrent, non-sexually active, co-morbid, vaginal route indicated or preferred Referral center mesh removal (kits, augmentation) Referral center mesh removal (kits, augmentation) We have been doing robotic surgery in Gyn since 2000; for prolapse since 2006 We have been doing robotic surgery in Gyn since 2000; for prolapse since 2006 Tend to be “early adopters” but with a skeptical eye; “early studiers” so we can make recommendations on “Best Practice” Tend to be “early adopters” but with a skeptical eye; “early studiers” so we can make recommendations on “Best Practice”

19. Concluding Comments I believe that augmented vaginal repairs and robotic surgery will continue to be part of the future of pelvic reconstructive surgery but not in their current form. I believe that augmented vaginal repairs and robotic surgery will continue to be part of the future of pelvic reconstructive surgery but not in their current form. New innovations in these technologies are already on the way! New innovations in these technologies are already on the way! New biocompatible mesh, flexible-single port robots, stem cell therapy, gene therapy and biomarkers are in development! New biocompatible mesh, flexible-single port robots, stem cell therapy, gene therapy and biomarkers are in development!

20. When adopting innovative techniques into your surgical practice: Do your homework: Review the available literature & package insert Do your homework: Review the available literature & package insert Go to a training session Go to a training session Have your first 5-10 procedures proctored by a surgeon experienced in the technique Have your first 5-10 procedures proctored by a surgeon experienced in the technique Inform the patient Inform the patient Critically reflect on your experience Critically reflect on your experience Track your outcomes Track your outcomes Keep up on the new data Keep up on the new data Talk to colleagues Talk to colleagues

21. Thanks for your attention!