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Complications of mesh and should we use it ? - www.jinekoklojivegebelik.com

Complications of mesh and should we use it ? - www.jinekoklojivegebelik.com

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Complications of mesh and should we use it ? - www.jinekoklojivegebelik.com Complications of mesh and should we use it ? - www.jinekoklojivegebelik.com Presentation Transcript

  • Complications of mesh and should we use it ? Michelle M Fynes MD MRCOG DU Lead Consultant Department of Reconstructive Pelvic Surgery & Urogynaecology St. George’s Hospital London, UK
  • Objectives
    • Indications for mesh
    • Mesh types
    • Complications with mesh
    • Should we use mesh ?
  • What are the indications for Meshes in POP surgery?
      • Recurrent prolapse
      • Complex primary prolapse?
      • High risk of failure?
      • All primary prolapse surgery ???
  • Synthetic Meshes
  • Mesh Properties
    • Material
    • Pore size
    • Mono or multifilament (interstices)
    • Interstical size
    • Fiber diameter and flexibility
    • Tensile strength
    • Non-absorbable / Absorbable
  • Classification - Synthetic Birch, Fynes 2002 Cellgard Mersilene Gore-Tex Prolene/ Marlex Vicryl/ Vypro I/ II Trade Name Submicro Mono Polypropylene Sheet IV Macro/ Micro Multi Polyethylene III Micro Multi Expanded PTFE II Macro Macro Mono/ Multi Polypropylene Polyglactin 910 I Pore Size Fibre Type Component Type
  • Mersilene Gortex Teflon Marlex Polypropylene
  • Polypropylene after 7 Days: The fibers of the polypropylene mesh are easily distinguished from the surrounding tissue. There is an acute inflammatory response occurring on the surface of the graft & also in the immediate area surrounding the implant. Collagen deposition is minor. Polypropylene Fiber Strong Inflammation
  • Collagen Polypropylene Fiber Strong Inflammation Polypropylene after 2 years: The fibers of the polypropylene mesh are still easily distinguished from the surrounding tissue. Deep seeded inflammation continues to be seen along the surface of the graft, though it is much more focal than the inflammation seen immediately after implantation. Collagen has been deposited around the fibers and blood vessels can be seen.
  • EROSION RATES
    • Gore-Tex 6 -12 %
    • Mersilene 4 - 6 %
    • Polypropylene 0 - 3 %
    • TVT <1 %
    Metanalysis Continence Procedures 2002
  • Mesh complications
  • EXTRUSION OR EROSION?
    • Increased with :
    • Infection
    • Mesh type
    • Vaginal incision
    • Mesh tension
    • Tissue integrity
    • Placement depth
  • Sould we use mesh?
  • Anterior Compartment
  • Polypropylene RCT Julian, T.M. Am J Obstet Gynecol 1996; 175: 1472-75. Anterior 25% 0% (mesh) 34% (no mesh) 24 Prospective (recurrent) 24 Julian (1996) Erosion Recurrence Follow-Up Study Type n Study
  • Vicryl RCT Koduri S et al Int Urogynacol J Pelvic Floor Dysfunc 2000; 11(Suppl):s86 Sand, P.K. et al. Am J Obstet Gynecol 2001; 184 (7) Weber, A.M., et al. Am J Obstet Gynecol, 2001; 185(6) Anterior 0% 70% (no mesh) 58% ultralateral 54% mesh (non significant) Mean 23.3 months RCT 140 Polyglactin 910 (Vicryl) Weber 0% 25% (with mesh) 43% (no mesh) p=0.02 12 months RCT Recurrent 21 Primary 140 161 Polyglactin 910 (Vicryl) Sand ? 13% no mesh 1% mesh 12 months RCT 125 Polyglactin 910 (vicryl) Koduri Erosion Failure Follow-Up Study Type N Prosthesis Type Study
  • Polypropylene Non-Randomised Anterior 5% 3% 18 Case series 103 Polypropylene Eglin 3.8% 5% cysto 0% recto 27 Case series 52 + hyste(28%) entero(9.5%) recto (28%) Polypropylene Adhoute 8.3% 8.4% 24 Case Series 87 84 follow-up Polypropylene de Tayrac 9% 6% 29 Retrospective review 64 Polypropylene Dwyer 7% 3% 6.7 Observational 30 Polypropylene Yan 7.5% - 16.4 Observational 40 Polypropylene (Tension-free) Bader - 2.2% 18 Recurrent 138 Polypropylene (Tension free) Natale 2.1% 0% 36 Retrospective (primary) 142 Polypropylene (Tension free) Flood Erosion Recurrence Follow-Up Study Type N Prosthesis Study
  • Vypro Non-Randomised Denis S et al Conference A bstract 620 : C ombined IUGA and ICS Annual Meeting, Paris, August 2005. Anterior 40% 50% 7.9 Case Series 106 (84 AVR) Vypro Denis Erosion Recurrence Follow-Up Study Type N Prosthesis Type Study
  • Posterior Compartment
  • Polypropylene Non-randomised Parker, M.C. et al Annals of the Royal College of Surgeons of England 1993; 75(3): 193-4. Watson, S.J., et al J Am Coll Surg. 1996. 183: 257-61 Adhoute F et al. Prog Urol. 2004; 14(2): 192-6. Fox, S.D. and S.L. Stanton, BJOG 2000. 107(11): 1371-5. De Tayrac, R et al. Int Urogynecol. J Pelvic Floor Dysfunct. 2005, 21 (Epub ahead of print) Posterior 3.8% (cystocele) Cystocele 5% Rectocele 0% 27 Observational 52 Prolene Soft Adhoute 12% 8% 22.7 Observational 26 Prolene Soft De Tayrac 3% 0% of stage II and III 14 Observational 29 Mersilene Fox 29 Observational 9 Polypropylene Watson Observational 4 Polypropylene Parker Erosion Recurrence Follow-Up Study Type N Prosthesis Type Study
  • Anterior & Posterior Sexual Function Polypropylene Milani et al, BJOG 2005;112 (1): 107-111 6.5% 13% Erosion ↑ 63% 17 31 Posterior ↑ 20% 17 32 Anterior 6% 17 63 Total Cohort Dyspareunia Anatomical Failure Follow-up n
  • Particular Issues with Synthetic Mesh
    • Erosion 13%
    • Dyspareunia 18% -> 36%
    • Overactive bladder 28% -> 56%
    Salvatore (2002)
  • Costs
    • VYPRO (20 x 20) £180
    • Prolene (30 x 30) £123
    • Prolene (15 x 15) £ 46
    • Prolene (15 x 7.5) £ 23
    All prices exclusive of VAT
  • Biological Meshes
  • Classification - Biological Vaginal Mucosa Rectus Fascia Fascia Lata AUTOLOGOUS Dura Mater Fascia Lata ALLOGRAFT Porcine Small Intestine Porcine Dermis Bovine Pericardium XENOGRAFT
  • Autologous /Allografts
    • Biological mesh – eg: Fascia lata
    • Allograft - ‘Graft vs Host’
    • Dependent on preparation technique
    • Results in surgical failure
    Fitzgerald 1998
  • SIS Porcine Small Intestinal Submucosa Pelvicol - Porcine dermis XENOGRAFTS
  • SIS after 2 Years: The area of implant must be determined based on the location of the surrounding musculature and the fibroadipose tissue of the abdominal wall. There is no evidence of SIS and no evidence of inflammation. Muscle bundles and organized collagen can be seen in the area where the implant had been placed, but the area of implant cannot be discerned from the surrounding tissues. Organized Collagen Fat Overlying Abdominal Muscle Layer Muscle
  • Donor or Vector Disease
    • CADAVERIC :
    • HIV = 1/1.67 Million
    • ANIMAL :
    • BSE = 1/2.O Million
    FDA Guidelines Simonds 1994
  • Particular Issues with Xenograft / Allograft
    • Autolysis
    • Seroma
    • Failure
  • Evidence?
  • Anterior Compartment
  • Dehydrated Fascia Lata Grafts RCT Gandhi et al. AJOG 2005(192). 1649-54 Anterior none 21% patch 29% no patch NS 1 2 RCT 162 76 patch 78 no patch Dehydrated Fascia lata Gandhi Erosion Recurrence Follow-Up Study Type N Prosthesis Type Study
  • Fascia Lata Non-Randomised Kobashi, K.C., et al. J Urol 2002. 168: 2063-8. Groutz A et al. Urology. 2001; 58(2): 179-83 Powell CR et al J Urol 2004;171(1):264-7. Anterior Not mentioned Objective 19% subjective 2% Cystocele 4% enteroceles 12% symptomatic rectoceles 24.7 Case Series 58 2 Fascia lata Powell 0% 0% 20.1 Observational 21 Solvent- dehydrated cadaveric fascia Groutz 0% 1.5% (cystocele) 9.8% (apical) 12.4 Observational study 132 Cadaveric Fascia lata Kobashi Erosion Recurrence Follow-Up Study Type N Prosthesis Type Study
  • Acellular Dermal Grafts Non-Randomised Salomon, L.J., et al. European Urology 2004; 45(2): p. 219-25. Gomelsky A et al J Urol 2004; 171(4):1581-4. Clemons JL et al. Am J Obstet Gynecol. 2003;189 (6):1612-8; discussion 1618-9. Oestergaard S et al. Conference abstract: combined IUGA and ICS Annual Meeting, Paris, August 2004 Arya L, Novi J, Myers D. Conference abstarct: Combined IUGA and ICS Annual Meeting, Paris, August 2004 . Anterior None Cadaveric 69% Porcine 4% Cadaveric 22 porcine 18 Retrospective repeated measures study Porcine 72 Cadaveric 45 Porcine dermal vs cadaveric dermal graft Arya Not mentioned 13% (Grade 2 ) 6 Observational Cystocele >Gr 2 31 Porcine Dermis Oestergard 64% sexually active - no problems no erosion 41 % objective 3% subjective 18 Observational study 6 recurrent II 24 prim + Recur III 3 Grade IV 33 Acellular dermal matrix (Alloderm) Clemons 1 Grade 2 – 8.6% Grade 3 –4.3% 24 Retrospective chart review 70 65 sling 50 BIF Porcine dermis grafts Gomelsky ? 19% 14 Observational 27 Porcine skin collagen implant Salomon Erosion Recurrence Follow-Up Study Type N Prosthesis Study
  • Posterior Compartment
  • Non-Randomised Acellular Dermal Grafts Posterior none 39% objective Significant improvement in QOL scores 12 Case series 33 Collagen allograft Altman 0.5% erosion 0.5 % abcess 5% 18 Case series 188 Human dermal graft Alloderm Chaudhry none Porcine 1% Human 9.6% Porcine 14.2 Human 20.9 Retrospective porcine 100 human 95 Porcine dermal graft vs Human dermal graft Moore none Ap -0.3 to -2.3 Bp 1.2 to -2.5 12 Case series 35 Porcine dermal Pelvisoft Dell none 7% (on POP-Q) 12.9 Prospective descriptive 43 Dermal allograft Kohli Erosion Recurrence Follow-Up Study Type N Prosthesis Type Study
  • Prolene Soft ® vs Pelvicol ® RCT Cervigni, M et al. ICS 2004 Abstracts of Papers no. 118. Anterior 2.7% Pelvicol 8.3% Prolene soft 2.8% Pelvicol 8% Prolene soft 68% Pelvicol 58% Prolene soft 8.8 Pelvicol 8.1 Prolene soft RCT 72 Pelvicol® vs Prolene soft® Cervigni Erosion Symptomatic Failure Anatomical Failure Follow-Up Study Type n Prosthesis Type Study
  • Porcine Dermis Graft Sexual Function Posterior PISQ= Prolapse and Incontinence Sexual Function Questionnaire Novi J et al. IUGA 2005 abstract 36 19.9 P=0.001 9.9 Change in PISQ 101.3 92.7 Post-op PISQ Score 81.4 83.6 Pre-op PISQ Score Porcine Dermis Graft Site Specific Repair
  • Costs Veritas (Bovine Pericardium) 6 x 8 £650 Veritas (Bovine Pericardium) 4 x 15 £650 Tutoplast (Donor Fascia Lata) 6 x 8 £496 Stratasis (Porcine SIS - 4 ply) 7 x 20 £210 Stratasis (Porcine SIS - 4 ply) 7 x 10 £168 Symphasis (Porcine SIS – 8 ply) 7 x 20 £250 All prices exclusive of VAT
  • Conclusions
    • No substantive evidence to support the routine use of mesh in POP surgery
    • Confine to recurrent and complex cases
    • Experienced POP surgeons
    • Good patient selection
    • Type 1 monofilament macroporous lightweight polypropylene
    • ? Xenograft
    • ? Hybrid
    • Further research – RCT and pooled audit
    • National morbidity & outcome register