Mesh surgery; rationale and concepts?

Transcription

1 Mesh surgery; rationale and concepts? Jan-Paul Roovers uro-gynaecologist, AMC Amsterdam medical director Alant Vrouw Amsterdam Pelvic floor center Amsterdam

2 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

3 Every surgeon hopes to be a winner

4 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

5 Central versus lateral Defect Studies have shown 70 to 80% of defects are lateral paravaginal

6 Anterior colporraphy stresses connection between pubocervical fascia and arcus tendineous

7 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

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10 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

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14 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

15 Apical support Considerable part of anterior vaginal wall recurrences is caused by too little attention for the apical compartment John de Lancey

16 Anterior Prolapse with mesh Comparative data Anterior colporr mesh implant Sand Weber Hiltunen Meschia N'Guyen Sivaslioglu Estonia, Cork, September april , 2012

17 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

18 Development of mesh Augmentation mesh Trans-obturator kit Single incision kit

19 Augmentation mesh defect reinforcment overlay implant is implant foreign is there body to and improve triggers outcome host response

20 Trans-obturator mesh

21 Disadvantages of trans-obturator mesh Blind needle passage Damage to nerves Damage to vessels Lack of level 1 support

22 Single incision techniques

23 Concept of single incision [1] A mesh in the anterior or posterior compartment is combined with an apical repair

24 Apical support Considerable part of anterior vaginal wall recurrences is caused by under-treatment of apical compartment John de Lancey Estonia, Cork, September april , 2012

25 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)

26 Multi-level procedure

27 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

28 Concept of single incision [3] There is a bilateral apical suspension without to much tension on the cervix or vault

29 Bilateral sacrospinous ligament fixation

30 Concept of single incision [4] There is no deviation of the vagina

31 Deviation of the vagina

32 Concept of single incision [5] The dynamic capacity of the vagina is preserved

33 Mobility of the vagina Sexual function Lowman, et al. Am J Obs & Gyn, 2008

34 Single incision approach-elevate anterior (AMS)

35 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

36 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 (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

37 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

38 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%)

39 Improvement continues Products Doctors Patient-selection Patient-preparation Organsation of care

40 Density g/m^ IntePro Lite Mesh Kit Density Comparison 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, = g/m2 Karlskrona per company literature

41 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) < µm encapsulation (Klosterhalfen 02) Filament: mono or multifilament Integration, mechanical anchoring, angiogenesis at µm (Law 1991)

42 Learning curve

43 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 ) Total mesh OR 3.0 (95% CI ) Experience OR 0.5 (95% CI ) per decade Withagen et al Obstet Gynecol 2011

44 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 ) > Para 2 OR 2.6 (95% CI ) Inflammatory disease OR 5.1 (95% CI ) Nordic TVM Group Neurourol Urodyn 2012

45 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

46 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