Mesh surgery; rationale and concepts? Jan-Paul Roovers uro-gynaecologist, AMC Amsterdam medical director Alant Vrouw Amsterdam Pelvic floor center Amsterdam
Ultimate goals of prolapse surgery Optimal restoration of pelvic floor dysfunction Optimal restoration of altered anatomy Minimal damage to the patient Minimal complications Minimal pain Minimal de novo dysfunction Fast recovery
Every surgeon hopes to be a winner
Why does native tissue repair fail? 1. Anterior colporraphy is intended to repair a central defect in the anterior vaginal wall and not a para-vaginal (or lateral) defect. 2. In anterior colporraphy there is an intention to plicate the fascia. However, there is no fascia. 3. Anterior colporraphy results in reduced surface of the anterior vaginal wall. 4. To little attention of middle compartment
Central versus lateral Defect Studies have shown 70 to 80% of defects are lateral paravaginal
Anterior colporraphy stresses connection between pubocervical fascia and arcus tendineous
Why does native tissue repair fail? 1. Anterior colporraphy is intended to repair a central defect in the anterior vaginal wall and not a para-vaginal (or lateral) defect. 2. In anterior colporraphy there is an intention to plicate the fascia. However, there is no fascia. 3. Anterior colporraphy results in reduced surface of the anterior vaginal wall. 4. To little attention of middle compartment
Why does native tissue repair fail? 1. Anterior colporraphy is intended to repair a central defect in the anterior vaginal wall and not a para-vaginal (or lateral) defect. 2. In anterior colporraphy there is an intention to plicate the fascia. However, there is no fascia. 3. Anterior colporraphy results in reduced surface of the anterior vaginal wall. 4. To little attention of middle compartment
Why does native tissue repair fail? 1. Anterior colporraphy is intended to repair a central defect in the anterior vaginal wall and not a para-vaginal (or lateral) defect. 2. In anterior colporraphy there is an intention to plicate the fascia. However, there is no fascia. 3. Anterior colporraphy results in reduced surface of the anterior vaginal wall. 4. To little attention of middle compartment
Apical support Considerable part of anterior vaginal wall recurrences is caused by too little attention for the apical compartment John de Lancey
Anterior Prolapse with mesh Comparative data 70 60 50 40 30.Anterior colporr mesh implant 20 10 0 Sand Weber Hiltunen Meschia N'Guyen Sivaslioglu Estonia, Cork, September april 20 2012 21, 2012
Theoretical background of mesh 1. It replaces native tissue that is proven to be weak. 2. It induces new collagen formation. 3. It can correct anatomical defects that can not be corrected by conventional surgery. 4. It increases support by augmentation of the supportive surface. January 9, 1012 Karlskrona
Development of mesh Augmentation mesh Trans-obturator kit Single incision kit
Augmentation mesh defect reinforcment overlay implant is implant foreign is there body to and improve triggers outcome host response
Trans-obturator mesh
Disadvantages of trans-obturator mesh Blind needle passage Damage to nerves Damage to vessels Lack of level 1 support
Single incision techniques
Concept of single incision [1] A mesh in the anterior or posterior compartment is combined with an apical repair
Apical support Considerable part of anterior vaginal wall recurrences is caused by under-treatment of apical compartment John de Lancey Estonia, Cork, September april 20 2012 21, 2012
Concept of single incision [2] The axis of the vagina is physiologic Not to horizontal (like in sacrospinous) Not to vertical (like in promotory fixation)
Multi-level procedure
Axis of the vagina Method Unilateral SSL fixation with 2 sutures, placed 2 cm apart on patients right side Traditional AC when necessary Results 75 women with average age of 69 Mean follow-up was 8.5 months Apical reoccurrence was 6.7% Comments Anterior access to the SSL results in a normal horizontal axis to the upper two thirds of the vagina H. A. Winkler et a. OBGYN; Vol. 95, No. 4, April 2000 SPFN, June 9, 2012
Concept of single incision [3] There is a bilateral apical suspension without to much tension on the cervix or vault
Bilateral sacrospinous ligament fixation
Concept of single incision [4] There is no deviation of the vagina
Deviation of the vagina
Concept of single incision [5] The dynamic capacity of the vagina is preserved
Mobility of the vagina Sexual function Lowman, et al. Am J Obs & Gyn, 2008
Single incision approach-elevate anterior (AMS)
Results: Percent Success (< Stage I) Results: Percent Success (< Stage I) Apical Posterior 100% 80% 93,3% 94,4% 84,2% 85,7% 88,2% 91,5% Success 60% 40% 20% 0% N=30 N=97 Stage II Stage III/IV All Stages Baseline Stage January 9, 1012 Karlskrona
Results: Adverse Events Results: Adverse Events Event* # of events # of Pts (%) Days to Onset (median, min-max) Surgical Revision (% of pts) Resolved (% of event) Extrusion 12 11 (7.9%) 140 (19-807) 3 (27.3%) 7 (58.3%) Constipation 3 3 (2.2%) 7 (1-181) 0 (0%) 3 (100%) Pain/Discom fort Buttock 3 3 (2.2%) 127 (0-404) 0 (0%) 3 (100%) Hematoma 2 2 (1.4%) 6 (0-11) 1 (50.0%) 2 (100%) Infectionvaginal 2 2 (1.4%) 28 (15-41) 0 (0%) 2 (100%) UTI 2 2 (1.4%) 50 (11-89) 0 (0%) 2 (100%) Wound dehiscence 2 2 (1.4%) 21 (6-35) 0 (0%) 2 (100%) January 9, 1012 Karlskrona
Results: Percent Success (< Stage I) Results: Percent Success (< Stage I) Apical Anterior 100% 80% 95,1% 88,6% 96,9% 87,0% 95,9% 87,4% Success 60% 40% 20% 0% Stage II Stage III/IV >Stage I (Total) Baseline stage January 9, 1012 Karlskrona
Results: Adverse Events Results: Adverse Events Event* # of events # of Pts (%) Days to Onset (median) Resolved (% of event) UTI 9 8 (5.6%) 56 7 (77.8%) Extrusion 8 8(5.6%) 82 7 (87.5%) Dyspareunia 6 6 (4.2%) 94 6 (100%) Urinary Retention 5 5 (3.5%) 1 5 (100%) Pain/Discomfort Buttock 5 5 (3.5%) 2 4 (80.0%) UI de novo stress 5 5 (3.5%) 15 2 (40.0%) Hematoma 3 3 (2.1%) 6 3 (100%) Granuloma Formation 3 3 (2.1%) January 9, 1012 Karlskrona 54 2 (66.7%)
Improvement continues Products Doctors Patient-selection Patient-preparation Organsation of care
Density g/m^2 50 40 30 20 10 0 IntePro Lite Mesh Kit Density Comparison 50 34.1 39.3 28 25.4 ProLift +M Prolift/Gynemesh Avaulta Solo Pinnacle/Uphold Ref 1: TR4032, rev 2; TR4271, rev 1 Ref 2: Prolift +M post-absorption January density 9, = 1012 28g/m2 Karlskrona per company literature
Construct of filaments Pore size Interstitium nature fibre/filament diameter density of product: weight (g/m 2 ) weaving strength (N/cm) Integration pore size (µm) < 50-75 µm encapsulation (Klosterhalfen 02) Filament: mono or multifilament Integration, mechanical anchoring, angiogenesis at 75-200 µm (Law 1991)
Learning curve
Risk factors of mesh-related complications [1] Prolift procedure (N = 294) Exposure in 34 patients (12%) Risk factors for mesh exposure: Smoking OR 3.1 (95% CI 1.1-8.7) Total mesh OR 3.0 (95% CI 1.2-7.0) Experience OR 0.5 (95% CI 0.3 0.8) per decade Withagen et al Obstet Gynecol 2011
Risk factors of mesh-related complications [2] Different mesh procedures (N = 353) Primary procedure in 224 (65%) Exposure in 30 patients (9%) Risk factors for mesh exposure: Smoking OR 3.5 (95% CI 1.2-10.3) > Para 2 OR 2.6 (95% CI 1.1-6.5) Inflammatory disease OR 5.1 (95% CI 1.2 22.2) Nordic TVM Group Neurourol Urodyn 2012
Are we on the right way? Option 1 We should improve our native tissue repairs in order to not need mesh Option 2 We should continue to improve mesh techniques to oppose all patients to its benefits
What really matters? There is an ongoing process of improving the outcome of vaginal mesh surgery Single incision vaginal mesh-kits provide a phsyiologic and safe solution for prolapse-surgery To have optimal results with innovative surgical procedures physicians need to acquire [1] specific technical skills [2] knowledge about peri-operative care and [3] access to optimal infrastructure