LSU 1 Roger Dmochowski MD, FACS Dept of Urology Vanderbilt University Medical Center Nashville, TN

LSU 2

LSU Mesh typeNumber of patients Length of follow-up Successful outcome Sivaslioglu 2007Self cut45 mesh 45 no mesh 12Mesh 91% No mesh 72 Niemenan 2008Self cut105 mesh 97 no mesh 24Mesh 89 No mesh 59 Nguyen 2008Kit38 mesh 37 no mesh 12Mesh 87 No mesh 55 Carey 2009Self cut69 mesh 70 no mesh 12Mesh 81 No mesh 67

LSU 4 EROSION EXTRUSION

LSU FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence Issued: October 20, 2008 Dear Healthcare Practitioner: This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.

LSU  Obtain specialized training for each mesh placement technique, and be aware of its risks.  Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.  Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).  Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

LSU Year# of reports Total RankAdverse Events# MDR’sPercentile rate % 1Pain Erosion Infection Urinary Problems Organ Perforation1108.3

LSU Year (s)# of reports Total Source: FDA Advisory Panel, OB-GYN. September 2011

LSU  UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse released July 13, 2011.

LSU 10  Complications UNIQUE to mesh  Extrusion “Vaginal Erosion” rate – % [10.3%(FDA)] Hardiman P, et al: BJOG, 2000  Urinary Tract Erosion – True incidence unknown  Mesh related pain – trigger points / bands / contraction (12%, 2.8% re-op) Caquant J OB GYN Res 2008  Complications of prolapse surgery  Pain  Dyspareunia:  Up to 20% using anterior mesh (6.3% extrusion)  Higher incidence expected in posterior compartment. Milani, et al: BJOG, 2005

LSU  Comparative effectiveness data (large volume) demonstrates effectiveness.  1 st generation slings (retropubic and TOT) are equally effective to colposuspension  Vaginal mesh erosion at 3.5%  Retropubic vs obturator “trade-off” in complications  2 nd generation slings possibly less effective than MUS  Reoperation for SUI 2x likely, and erosion rates higher 11 Source: FDA Advisory Panel, OB-GYN. September 2011

LSU  Increase in activity in MAUDE database, signals safety issues  Tissue repair, not device – no MAUDE reporting  Erosion and contraction are unique complication of mesh procedures  No proven anatomic or clinical benefit in apical or posterior compartment repairs  Anatomic “benefit” to anterior compartment, but no proven clinical benefit – no clear benefit  RR of re-operation for revision was 2.26X greater in women with mesh  1-2 year follow-up bias re-op rate to mesh procedures 12 Source: FDA Advisory Panel, OB-GYN. September 2011

LSU  Did not recommend re-classification of MUS  Will remain class 2, with “special exception”  Premarket review: New SUI Slings  No premarket data for 1 st generation slings  Premarket data for 2 nd generation mini-slings  Must be Class II comparison to MUS  Post-Market Review: FDA cleared, marketed  No post-market data for 1 st generation  Post-market data for 2 nd generation 13 Source: FDA Advisory Panel, OB-GYN. September 2011

LSU  Re-classify mesh for POP to Class III  Require any new product or device to undergo rigorous PMA clinical trials prospectively prior to launch  Post-market 522 studies with design mandated by FDA for devices on market  Any alteration in device will be Class III  During the Interim PMA analysis, cleared products will be available. 14 Source: FDA Advisory Panel, OB-GYN. September 2011

LSU  Multiple authors report a 90+ % success rate  Many consider gold standard  Synthetic mesh superior to biologic materials  Maher et al (Cochrane database, 2007)  Culligan et al (Am J Obstet Gynecol, 2008)  Mesh erosion rate of approx 1% (PPM)  Nygard et al (Obstet Gynecol, 2004) 15 Blanchard K, Vanlangendonck R, Winters J : Urology, 2004

 Biologic Materials:  Variability in outcomes btw grafts  Intermediate failures more common  Think Transformation  Synthetic Mesh  Type I Macroporous monofilament most desirable  Abdominal sacrocolpopexy:  Nonabsorbable mesh is fairly standard  Recent adverse publicity is not about this  Posterior vaginal repair: mesh disadvantages appear to outweigh advantages  Anterior vaginal repair:  Balance pros and cons  Inform patient; involve her in choice  Think technique and volume!  Biologic Materials:  Variability in outcomes btw grafts  Intermediate failures more common  Think Transformation  Synthetic Mesh  Type I Macroporous monofilament most desirable  Abdominal sacrocolpopexy:  Nonabsorbable mesh is fairly standard  Recent adverse publicity is not about this  Posterior vaginal repair: mesh disadvantages appear to outweigh advantages  Anterior vaginal repair:  Balance pros and cons  Inform patient; involve her in choice  Think technique and volume!

 DIFFERENTIATE: Mesh MUS from mesh POP procedures  JUDICIOUS: Routine mesh usage for POP discouraged. Strict selection  INFORM: Informed consent should be complete and thorough as standard  Inform of potential mesh benefit (why)  Inform of non-mesh alternatives  Inform of mesh related complications  Inform of potential permanence of procedure

 ATTENTION: Physician must understand, recognize and competently intervene when complications arise Most Important:  COMMUNICATION: Starts with evaluation and counseling.  Explain any adverse event and communicate management plan with patient

 Many more robotic ASC procedures (expensive)  Vaginal surgeons:  Those doing tissue repairs before, will be doing more  Those only doing kits will be doing less (or none at all)  Less mini-slings  Hopefully no change in MUS  Less strict anatomic criteria for success  More QOL inclusion as standard

 FDA has performed role as enforcement agency…  Litigation is next. This could very easily change the landscape  Emerging claims of auto-immune disease after mesh  Aka: Breast implantation lawsuit  These trends may include MUS  Be Proactive: Educate and instruct SUI ? POP patients – assiduously