Choosing vaginal mesh '' Why When and Which

1
Choosing vaginal mesh ..Why? When? and Which?

• Bruce Farnsworth FRANZCOG
• Centre for Pelvic Reconstructive Surgery
• Sydney Adventist Hospital
• Sydney, Australia

2
Medical Consultancies

• BARD Pty Ltd, USA
• Biocontrol Pty Ltd, Israel
• Johnson Johnson, USA
• Tyco Health Care Ltd, USA
• Device Technologies, Sydney Australia
• Cook Australia Pty Ltd
• American Medical Systems
• Uroplasty Netherlands
• Endotherapeutics Pty Ltd, Australia

3
Pelvic Surgery

• Every honest surgeon of extensive and long
  experience will have to admit that he is not
  entirely and absolutely satisfied with his
  longterm results of all his operations for
  prolapse and allied conditions
• Richard Te Linde

4
ROLE OF MESH

• bridge a gap in the tissues
• Reinforce weakened tissues
• Primary surgery
• Recurrent surgery

5
Benefits of Mesh

• Durable support reduced recurrence
• Avoids donor site incision rectus fascia,
  fascia lata
• No risk of viral/DNA transmission
• Stabilises tissues and improves wound healing

6
Recurrent Cystocoele

• Incidence (following anterior colporrhaphy)
• 3 20 Porges and Smilen, 1994
• Goff, 1933
• Stanton et al, 1982
• Macer, 1978
• Walter et al, 1982

7
Recurrent Rectocoele

• Retrospective review
• 231 women
• Treated with levatorplasty
• Mean follow up 42 months
• 24 recurrent large rectocoele
• Kahn Stanton BJOG 1997

8
SURGICAL MESH

• Used by general surgeons since 1950s
• Use when fascial tissues are weak
• To avoid fascial harvesting
• Now the standard for primary hernia repair

9
MESH IN GYNAECOLOGY

• sacrocolpopexy
• sacrohysteropexy
• anterior and posterior repairs
• suburethral slings
• mesh colposuspensions

10
A starting point
11
Complications of Abdomino-sacrocolpopexy with Mesh
12
Mesh colposuspension
13
(No Transcript)
14
The Controversy.

• Not whether to use mesh
• but rather
• Is vaginal mesh safe ?
• Which mesh ?

15
Desirable properties of a Surgical Mesh

• Easy handling
• Sterilisable
• Inexpensive
• Minimal foreign body reaction
• Resists mechanical stress
• Low risk of
• rejection
• Infection
• erosion

16
PERMANENT MESH

• Mersilene
• Goretex
• Teflon
• Silastic
• Polypropylene (prolene, marlex, atrium)

17
Life choices for a piece of mesh

• Integration
• Rejection and expulsion
• Encapsulation

18
MERSILENE MESH

• Polyester fibre mesh
• Multifilament
• Polyethylene terephthalate
• Used for suburethral slings and colposacropexies
• 3 mesh erosion for colposacropexy
• Visco et al, 1999

19
GORETEX MESH

• Polytetraflouroethylene
• Minimal inflammatory response
• Not incorporated into surrounding tissues
• 25 removal rate for slings
• Weinberger Ostergard 1996
• 3 mesh erosion for colposacropexy
• Van Lindert 1993

20
(No Transcript)
21
ABSORBABLE PARTIAL ABSORBABLE MESH

• Dexon
• Vicryl
• Biological mesh
• Pelvisoft, SIS
• Vipro and Vipro 2
• New partially absorbable options
• Seratom,Avaulta,AMS

22
Both coated and uncoated polypropylene meshes
elicit a mild foreign body reaction and minimal
fibrotic response without evidence of vaginal
epithelial erosion.

• Histologic response of porcine collagen-coated
  and uncoated polypropylene grafts in a rabbit
  vagina model. Am J Obstet Gynecol 2008 Feb 21 epub

23

New Zealand white rabbit
24
The Ideal Implantable Biomaterial

• Not be physical modified by tissue fluids.
• Be chemically inert.
• Not excite an inflammatory or foreign body
  reaction.
• Be non-carcinogenic.
• Not produce a state of allergy or
  hypersensitivity.
• Be capable of resisting mechanical strains.
• Be capable of being fabricated in the form
  required.
• Be capable of being sterilised.

Cumberland Scales, (1950)
25
Essential Properties of Synthetic Mesh

• Biostability which is influenced by adsorption
  and absorption.
• Promotion of normal cellular differentiation.
• Provision of cell growth supports.
• Limits inflammation and infection.
• Allows for angiogenesis.
• Biocompatibility
• Ideal pore size.

26

• Pathology of Traditional Mesh for Hernia Repair
  after Long Term Implantation in Humans
  
• Der Chirurg 2000 p.43-51
• B. Klosterhalfen, U.Klinge, B. Hermanns, V.
  Shumpelick
• Institute of Biomaterial Implant Pathology
• Aachen, Germany

27
Selected Mesh Modifications

• Polymer
• Quantity of Polymer (weight,density,thickness)
• Pore Size
• Size of the Contact Surface
• Fiber Structure
  (Monofilament, Multifilament)
• Specific configuration or weave of Mesh

28
LIGHT WEIGHT POLYPROPYLENE MESH

• light-weight polypropylene meshes, whereby the
  primary textile characteristics predict the later
  inclusion behavior of the individual mesh
  modifications.
• light-weight or reduced material polypropylene
  meshes present a significantly improved
  biocompatibility

29
Polypropylene Mesh
Prolene is far superior to other synthetic
meshes.

• Well tolerated
• Resists infection and sinus tract formation
• Rapid host tissue fixation with complete
  incorporation into the host tissue.
• Facilitates tissue in-growth for rapid sling
  fixation without suturing

30
Evolution of Mesh
31
A personal journey1988-1997

• Anterior and Posterior Repair
• Burch Colposuspension
• Stamey needle suspension
• Sacrospinous fixation

32
Sacrospinous fixation

• Good Level 1 attachment solved by use of the
  endostitch
• Vaginal attachment problem solved by attaching to
  bridge repair rather than directly to the
  epithelium

33
(No Transcript)
34
Vaginal Bridge Repair
35
(No Transcript)
36
1998-2000

• Total vaginal reconstruction commenced with
  multiple bridge repairs attached to arcus and
  sacrospinous ligaments.
• Fascial plication to secure distal repair
• Perineal body repair

37
2001 PIVS with Vipro2 Mesh
38
Gynemesh
39
2001
The Honda Repair
40
2001
Relevant Mesh Attachments
41
(No Transcript)
42
(No Transcript)
43
(No Transcript)
44
(No Transcript)
45
2001 Total Vaginal Reconstruction
46
Meanwhile in Paris
47
Development of Prolift2002-2004

• The TVM Technique Emergence J de Gynecologie
  Obstetrique at biologie de la reproductionBerroca
  l, Clave, Cosson, Debodinance, Garbin, Jacquetin,
  Rosenthal, Salet-Lizee, Villet (2004) 33577-587
• TVM means tension-free vaginal mesh
• Disillusion with existing technique
• Preliminary observation of 2 years leading to
  technical standardisation of implant and surgical
  approach
• Le Choix des Armes meeting, Marseilles March
  2002

48
Principles of TVM Technique

• Tension-free placement
• Broad coverage of the implants
• No suturing mesh to vagina
• No trimming of the vagina
• Flexible Anterior, Posterior, and Total (with
  without hysterectomy)

49
Prolift Kit
50
(No Transcript)
51
(No Transcript)
52
Lessons From the French Experience

• Avoid hysterectomy if possible (to reduce mesh
  exposure)
• Tension-free placement of mesh to allow for
  shrinkage
• Short vaginal incisions, minimal suturing of mesh
• Non splitting dissections leaving full
  thickness fascia on the vaginal mucosa
• Large volume dilute LA solutions

53
Apogee
A vaginal vault prolapse repair system that
includes posterior vaginal wall defects. Vault /
Enterocle / Rectocele
54
Perigee
55
AvaultaBioSynthetic Support System
Anterior
Posterior
56
When to use mesh ?

• Surgeon Issues
• training
• experience
• medicolegal issues
• hospital accreditation
• Patient Issues
• Information, research and choice
• Tissue quality
• Previous surgery and other treatment
• Mesh issues
• Design
• Mesh configuration
• availability

57
Patient Selection

• Generally Older
• Sexually Active
• Symptomatic Stage II or Greater Vault Prolapse
• Require minimally invasive procedure - open
  abdominal contraindicated
• Previous failure
• Multiple defects

58
Patient Selection

• Contraindications
• Pregnancy
• Tissue necrosis
• Any patient not suitable for surgery

59
Which ?

• Which Surgeon
• Which Technique
• Which mesh

60
Which homemade mesh

• Surgipro
• Gynemesh
• Vipro
• Atrium
• TiMesh
• Biological

61
Which kit

• Prolift
• Apogee and Perigee
• Avaulta
• Others

62
Research Department
63
120 patients Apogee/Perigee93 success after 1
yearHigher erosion rate with Perigee

• Follow up after polypropylene repair of
  anterior and posterior compartments in patients
  with recurrent prolapse. Gauruder-Barmester et
  al. Int Urogyn J Pelvic Floor Dysfunction 2007
  18 1059

64
This first report from an ongoing multicenter
study suggests that transvaginal mesh surgery
with the Prolift(R) system is associated with
satisfactory outcomes 2 months after surgery.
There were no severe adverse events attributed to
the polypropylene mesh.

• Short-term outcome after transvaginal mesh
  repair of pelvic organ prolapse. Altman D et al.
  Int Urogynecol J Pelvic Floor Dysfunct. 2007 Dec
  12 Epub ahead of print

65
40 patients post meshMesh supported 43 of
anterior wall, 53 posterior wall

• Sonomorphological evaluation of polypropylene
  mesh implants after vaginal mesh repair in women
  with cystocole or rectocoele. Tunn R et al.
  Ultrasound Obstet Gynecol 2007 29 449-52.

66
76 patients controlled trialMesh repair less
recurrence after 1 yearSimilar levels of
complications

• Outcomes after anterior vaginal prolapse
  repair. Nguyen JN, Burchette RJ. Obstet Gynecol
  2008 111 891-898

67
How do we move forward ?

• Evidence based medicine
• Randomised controlled trials
• Alternative study designs for evidenced based
  practice

68
Adequately powered randomised controlled clinical
trials are urgently needed.

• Surgical management of pelvic organ prolapse
  in women a short version Cochrane review. Maher
  C, Baessler K, Glassener CM, Adams EJ, Hagen S.
  Neurourol Urodyn 200827(1)3-12

69

• Although highly successful in investigating
  remedial therapy, randomized clinical trials have
  sometimes created rather than clarified
  controversy
• Feinstein AR. Ann Int Med 1983 Oct
  99(4)54-550

70
Quantitative Data Errors

• Methodological/statistical problems
• Source of funding bias
• Technical bias
• Publication bias - data exclusion
• This leads to systematic bias in favour of
  experimental and commercially profitable
  interventions
• Gupta J
  Eval Clin Prac
• 
  20039(2)111-121

71
The only valid option to analyse complex
multifactorial surgical alternatives
PBE-CPI, a practice-based evidence approach to
clinical practice improvement
72
Practice-Based Evidence for Clinical Practice
Improvement Study Design

• Analyzes the content and timing of individual
  steps of a health care process, in order to
  determine how to achieve
• superior medical outcomes for the
• least necessary cost over the
• continuum of a patients care

73
Characteristics of a Practice-Based Evidence
Study

• Non-experimental Follows outcomes of treatments
  actually prescribed
• Inclusive Uses patient populations undergoing
  routine clinical care
• Pragmatic Uses actual clinical outcomes

74
Advantages of a Practice-Based Evidence Study

• Can simultaneously study outcomes of a large
  variety of treatments
• Can address complex questions regarding treatment
  timing and conditional effectiveness
• Can look at treatment effectiveness in whole
  clinical populations
• More heterogeneous - reflecting clinical reality
• Less patient selection bias, since no requirement
  to consent to experiment

75
Practice-based Evidence for Clinical Practice
Improvement

• PBE-CPI is a comprehensive analysis of patient,
  process, and outcome variables
• PBE-CPI studies are based on everyday clinical
  practice, not controlled circumstances.

76
PBE-CPI and RCT
RCT
Progenitor of RCTs
Practice effects of RCT results
PBE-CPI
77
Discover Best Practices

• PBE-CPI data allow investigation of effects of
  combinations of treatments on outcomes,
  controlling for patient differences.
• PBE-CPI data allow discovery of practices
  associated with better functional and clinical
  outcomes at lower cost.

78
Now what .

• Clinicians will continue to seek out innovation
  in new therapies
• RCTs will not be able to answer the questions
  that need to be answered in a timely manner
• Clinicians must base their actions on the
  principle of informed consent and audit
  techniques such as PBE-CPI

79
Practice Audit / PBE-CPI

• Includes all patients
• Treatment Indications
• Treatment Details
• Outcome Measures
• Anatomical
• Bladder
• Bowel
• Sexual

80
Dr Bruce FarnsworthPractice Audit since 2001

• Over 1000 pelvic reconstructive surgery
  procedures since 1997
• Detailed Preop assessment with POPQ/ultrasound
  and DeLancey assessment since 2001
• Self administered QOL questionnaires pre-op, 3
  months post-op then annually

81
What good things have we found ?

• Durability rates greater than 90
• Improved bladder, bowel and sexual dysfunction
  overall
• Low risk of infection
• Low morbidity, No mortality
• High patient satisfaction

82
What bad things have we found ?

• Significant problems in a very small number of
  patients
• Major prolapse may be associated with significant
  urethral and anorectal dysfunction
• Referred complications often indicate inadequate
  training and experience

83
Ensure the mesh covers the defect
84
Ensure the mesh is strong enough to provide
support
85
Do not place mesh in the wrong position
If it is in the way it will be hit by something
86
Ensure adequate apical (Level 1) support
87
What changes are coming ?

• Movement to light weight mesh
• Move away from biological mesh
• Improved techniques
• Increasing specialization of pelvic
  reconstructive surgeons
• Development of multidisciplinary teams
• Steady improvement in anatomical and functional
  outcomes

88
Experience is a wonderful thing
It enables you to recognize a mistake when you
make it again
89
(No Transcript)