D.ssa Natale Corso GLUP TV - 22-23 marzo 2013

1. HIGHLIGHTS IN CHIRUGIA RICOSTRUTTIVA
PELVICA
Franca NataleFranca Natale
U.O.C di UroginecologiaU.O.C di Uroginecologia
Ospedale S. Carlo-IDI, RomaOspedale S. Carlo-IDI, Roma
(Primario: Prof. M. Cervigni)(Primario: Prof. M. Cervigni)
Treviso, 23-23 marzo 2013
CHIRURGIA RICOSTRUTTIVA PROTESICA:CHIRURGIA RICOSTRUTTIVA PROTESICA:
STEPS CHIRURGICI IRRINUNCIABILI, COME ESTEPS CHIRURGICI IRRINUNCIABILI, COME E
PERCHÈPERCHÈ

2. NO DISCOSURENO DISCOSURE
Franca Natale, MD, PhDFranca Natale, MD, PhD

3. FDA UPDATE ON TV MESHFDA UPDATE ON TV MESH
SAFETY AND EFFECTIVENESSSAFETY AND EFFECTIVENESS
o Over 1,000 reports of complicationsOver 1,000 reports of complications associated withassociated with
surgical mesh devices used to repair POP and SUI,surgical mesh devices used to repair POP and SUI,
usually placed transvaginallyusually placed transvaginally
o Complications included: erosion, infection, pain, urinaryComplications included: erosion, infection, pain, urinary
problems, bowel, bladder and blood vessel perforation,problems, bowel, bladder and blood vessel perforation,
dyspareuniadyspareunia
o Treatment of complications included: additionalTreatment of complications included: additional
surgery, IV therapy, blood transfusion, drainage ofsurgery, IV therapy, blood transfusion, drainage of
hematomas or abscesseshematomas or abscesses

4. FDA UPDATE ON TV MESHFDA UPDATE ON TV MESH
SAFETY AND EFFECTIVENESSSAFETY AND EFFECTIVENESS
o Specific characteristic of patients at risk forSpecific characteristic of patients at risk for
complications have not been determinated.complications have not been determinated.
o Contributing factors include: the overall health of theContributing factors include: the overall health of the
patient, the mesh materials, the size and shape of thepatient, the mesh materials, the size and shape of the
mesh, the surgical technique used, concomitantmesh, the surgical technique used, concomitant
procedures undertaken (e.g. hysterectomy) andprocedures undertaken (e.g. hysterectomy) and
estrogen statusestrogen status

5. FDA UPDATE ON TV MESHFDA UPDATE ON TV MESH
SAFETY AND EFFECTIVENESSSAFETY AND EFFECTIVENESS
IN POP SURGERYIN POP SURGERY
DETERMINATIONS:DETERMINATIONS:
Serious adverse events areSerious adverse events are notnot rarerare
TV POP repair with mesh does not conclusivelyTV POP repair with mesh does not conclusively
improve clinical outcomes over traditional repairsimprove clinical outcomes over traditional repairs
Surgical mesh for POP repair should beSurgical mesh for POP repair should be reclassifiedreclassified
from Class II to Class IIIfrom Class II to Class III
Continued evaluation of outcomes through analysisContinued evaluation of outcomes through analysis
of published literature, epidemiological research,of published literature, epidemiological research,
collaborations with professional societies,collaborations with professional societies,
postmarket sudiespostmarket sudies

6. FDA UPDATE ON TV MESHFDA UPDATE ON TV MESH
SAFETY AND EFFECTIVENESSSAFETY AND EFFECTIVENESS
IN POP SURGERYIN POP SURGERY
RECOMMENDATIONS:RECOMMENDATIONS:
 Registries requiredRegistries required
 Surgeon training standardizedSurgeon training standardized
 Consent process more stringentConsent process more stringent
 Indications for mesh use clarifiedIndications for mesh use clarified
 Apply mini-slings (not others)Apply mini-slings (not others)
 Inform patients about complications and their effectsInform patients about complications and their effects
on QoLon QoL

7. Grade D RecommendationGrade D Recommendation
There is no evidence to support theThere is no evidence to support the
routine use of biological or permanentroutine use of biological or permanent
synthetic grafts for transvaginal POPsynthetic grafts for transvaginal POP
repair.repair.
4th ICI ‘084th ICI ‘08

8. POPPOP
LOCATIONLOCATION11
 Anterior only 40%
 Anterior and apex 20%
 Posterior only 7%
 Posterior and apex 10%
 All three compartments 18%
11
Olsen et.al. 199Olsen et.al. 199
22
Shull et al. 1992Shull et al. 1992
33
Holley et al. 1995Holley et al. 1995
44
Samuelsson et al. 1999Samuelsson et al. 1999
55
Shull et al. 2000Shull et al. 2000
66
Weber et al. 2001Weber et al. 2001
 Anterior compartment involvedAnterior compartment involved 78%78%
 Highest failure in anteriorHighest failure in anterior
compartment reportedcompartment reported 30-70%30-70%2-62-6

9. PELVIC ORGAN PROLAPSEPELVIC ORGAN PROLAPSE
SURGICAL FAILURESURGICAL FAILURE
• inappropriate choice of procedureinappropriate choice of procedure
• inappropriate choice of suture materialsinappropriate choice of suture materials
• lack of surgical expertiselack of surgical expertise
• persistent increase in intra-addominal pressurepersistent increase in intra-addominal pressure
• deficiences in tissue qualitydeficiences in tissue quality
Birch C and Fynes MM, 2002Birch C and Fynes MM, 2002

10. The use of mesh or graft inlays at the time of anteriorThe use of mesh or graft inlays at the time of anterior
vaginal wall repairvaginal wall repair MAY REDUCE THE RISK OFMAY REDUCE THE RISK OF
RECURRENT CYSTOCELERECURRENT CYSTOCELE
ANTERIOR VAGINAL SEGMENTANTERIOR VAGINAL SEGMENT
Cochrane ‘10Cochrane ‘10
Maher C, Feiner B, Baessler K, Glazener CMAMaher C, Feiner B, Baessler K, Glazener CMA

11. AVOIDING OR REDUCINGAVOIDING OR REDUCING
COMPLICATIONSCOMPLICATIONS
RESTORING NORMAL ANATOMY ANDRESTORING NORMAL ANATOMY AND
FUNCTIONFUNCTION

12. • NON-INFECTIOUS
COMPLICATIONS
• INFECTIOUS COMPLICATIONS
MESH-RELATED COMPLICATIONS

13. LOCAL RESPONSES:
– Foreign body reactions
– Fibrosis with subsequent tissue contraction
– Calcification
– Thrombosis
– Erosion
– Fistula (vesico-vaginal or recto-vaginal)
NON-INFECTIOUS COMPLICATIONS
Patry G ’04; Hilger WS ‘06

14. •Ostructive voiding difficulties (overcorrection)
•De novo detrusor overactivity
•Urinary incontinence
•Dyspareunia
•Local chronic pain
•Paralytic ileus
•Dyschaezia
NON-INFECTIOUS COMPLICATIONS
DYSFUNCTIONS
Thorell E ‘04

15. • Type 1: defect of healing
• Type 2: infection of the graft
• Type 3: shrinkage of the mesh
• Type 4: erosions
INFECTIOUS COMPLICATIONS
CLASSIFICATIONS
Debodinance ‘06

16. • persistent vaginal discharge or bleeding
• urinary and faecal incontinence
• non-specific pelvic pain
• dyspareunia
INFECTIOUS COMPLICATIONS
CLINICAL MANIFESTATIONS
Debodinance ‘06

17. MESH-RELATED COMPLICATIONS
PAIN SYNDROME AND DYSPAREUNIA
Dietz‘03, Krause’06
• after Abdominal SCP is rare
• after transvaginal insertion:
• de novo dyspareunia & mesh erosion 9%
• de novo dyspareunia without erosion 11%
The exact origin is not clear but the lack of plastic deformation or
high stiffness and the marked fibrosis surrounding the mesh could
be the answer.

18. NATIVE TISSUE REPAIR VS. MESH REPAIRNATIVE TISSUE REPAIR VS. MESH REPAIR

19. FACTORS THAT INFLUENCE EROSIONFACTORS THAT INFLUENCE EROSION
• Pore sizePore size
• TensionTension
• AnchoringAnchoring
• Mesh loadMesh load
• ColpotomyColpotomy
• Mucosal incisionMucosal incision
• Mucosal dissectionMucosal dissection
• Suture typeSuture type
• SUTURE CLOSURESUTURE CLOSURE
• SeromaSeroma
• Inflammatory responseInflammatory response
• Delayed hypersensitivityDelayed hypersensitivity
reaction (PDH)reaction (PDH)
• Tissue bufferTissue buffer

20. L’USO DI SUTURE A PUNTI STACCATI DELLA PARETE VAGINALEL’USO DI SUTURE A PUNTI STACCATI DELLA PARETE VAGINALE
ANTERIORE E’ UNA POSSIBILE SOLUZIONE PER RIDURREANTERIORE E’ UNA POSSIBILE SOLUZIONE PER RIDURRE
L’INCIDENZA DI EROSIONI?L’INCIDENZA DI EROSIONI?
F. Natale , C. La Penna, M. Panei,F. Natale , C. La Penna, M. Panei,
M. Agostini, A. Mako, M. CervigniM. Agostini, A. Mako, M. Cervigni
Dept. of Urogynecology, S. Carlo-IDI Hospital, RomeDept. of Urogynecology, S. Carlo-IDI Hospital, Rome

21. SUTURASUTURA
CONTINUACONTINUA
SUTURA ASUTURA A
PUNTI STACCATIPUNTI STACCATI
TECNICA CHIRURGICATECNICA CHIRURGICA

22. RISULTATIRISULTATI
CARATTERISTICHE DEMOGRAFICHECARATTERISTICHE DEMOGRAFICHE

23. EROSIONIEROSIONI
(median F-U 12 mos)(median F-U 12 mos)
Fisher exact testFisher exact test

24. • reducing amount of the material used (pores > 75 µm, lighter and
softer monofilament polypropropylene mesh)
• performing antisepsis of the perineum, vulva and vagina
• covering of the anus and the perineum
• embedding mesh within an antisepsis solution
• changing gloves before handling mesh
• handling the tissue gently, dissecting in avascular space and
performig adequate haemostasis
1. PREVENT INFECTIOUS COMPLICATIONS

25. • positioning the mesh deeply
• placing the mesh in without excessive tension
• avoiding removal of the excessive vaginal wall
• rinsing intermittently mesh with as antibiotic-containing solution
until operation finish, with a sufficient duration of contact with
antibiotics
• using peri-operatively intravenous antimicrobical agents
1. PREVENT INFECTIOUS COMPLICATIONSC

26. • Knitted polyester mesh: - erosion 0-33%
• Silicone meshes: - erosion 19%
- infection 5%
• Dacron: - rejection 19%
• PTFE: - erosion 0-30%
- rejection 30%
- removal 35%
- sinus tract formation 10%
INCIDENCE OF MESH-RELATED INFECTIONS

27. MersileneMersilene GoretexGoretex
TeflonTeflon MarlexMarlex PolypropylenePolypropylene
2. TYPE OF MESH2. TYPE OF MESH
MultyfilamentMultyfilament

28. PROPERTIES DETERMININGPROPERTIES DETERMINING
MESH – TISSUE INTERACTIONSMESH – TISSUE INTERACTIONS
 PorosityPorosity
 scar mobility, flexibility, fibroblast infiltration,scar mobility, flexibility, fibroblast infiltration,
leukocyte passage, mechanical anchorageleukocyte passage, mechanical anchorage
 Density- weave/thickness, pliability, stiffnessDensity- weave/thickness, pliability, stiffness
 Mono versus MultifilamentMono versus Multifilament
 Edges - suture line integrationEdges - suture line integration
 Suture type – adhesions, infectionSuture type – adhesions, infection

29. ARE ALL POLYPROPYLENES SIMILAR?ARE ALL POLYPROPYLENES SIMILAR?
 Multifilament vsMultifilament vs
monofilamentmonofilament
 Pore sizePore size
 WeaveWeave

30. DIFFERENT KNITTING = DIFFERENTDIFFERENT KNITTING = DIFFERENT
RESULTSRESULTS

31. PROLENE
LIGHT-WEIGHTED MESHLIGHT-WEIGHTED MESH

32. MeshMesh
Pliability andPliability and ReliabilityReliability
MeshMesh
Pliability andPliability and ReliabilityReliability
Improvements over IntePro *
◊ 64% reduction in stiffness
◊ 47% reduction in density
• IntePro lite has a density of 24g/m2
Benefits of IntePro Lite
◊ More pliable resulting in better
anatomical conformity
◊ Soft and light helping to minimize mesh
bunching
◊ Low mesh density results in less
implanted mesh with the same quality
repair
Improvements over competitive meshes*
◊ IntePro Lite vs. Gynemesh PS
• 54% less stiff
• 49% lower in density
◊IntePro Lite vs. Pelvitex
• 82% less stiff
• 76% lower in density
Average Mesh Stiffness
0
5
10
15
20
IntePro Lite Gynemesh PS Pelvitex
Average Mesh Density
0
20
40
60
80
100
120
IntePro Lite Gynemesh PS Pelvitex

33. COLLAGEN COATED SOFTCOLLAGEN COATED SOFT MESHMESH
 Low densityLow density
 Large poresLarge pores
 Soft weaveSoft weave
 HydrophilicHydrophilic
atelocollagenatelocollagen
porcine coatingporcine coating

34. Mesh properties – Type IMesh properties – Type I comparisonscomparisons
Characteristics Pelvitex
(Avaulta)
Marlex Gynaemes
h PS
Mesh Density (g/m2
) 36 90 41
Mesh thickness 0.4 0.74 0.45
Mesh Pore
dimension (mm
average)
1.44 x 1.68 1.75 x 2.53

35. COMBINATION OF PROLENE & MONOCRYLCOMBINATION OF PROLENE & MONOCRYL
GYNEMESH MGYNEMESH M
Monocryl fiber cross PROLENE fiberMonocryl fiber cross PROLENE fiber Absence of Monocryl fiber afterAbsence of Monocryl fiber after thethe
resorptionresorption
ªªCobb W et al Textile Analysis of Heavy-weight, middle-weight and light-weight Polypropylene is Porcine Ventral Hernia Repair. Journal of Surgical Research 2006,Cobb W et al Textile Analysis of Heavy-weight, middle-weight and light-weight Polypropylene is Porcine Ventral Hernia Repair. Journal of Surgical Research 2006,
136: 1-7136: 1-7
After resoprtionAfter resoprtion
Increases pore sizeIncreases pore size
Increased flexibilityIncreased flexibility
Reduced densityReduced density

36. PROLIFT+MPROLIFT+M
POLYGLECAPRONE25 BIOCOMPATIBILITYPOLYGLECAPRONE25 BIOCOMPATIBILITY
(MONOCRYL) SUPPLEMENTATION ON OF A(MONOCRYL) SUPPLEMENTATION ON OF A
POPYPROPYLENE MESHPOPYPROPYLENE MESH
 Less Foreign body reaction involving lessLess Foreign body reaction involving less
macrophages migrationmacrophages migration
 Monocryl portion is reabsorbed in 56-84 daysMonocryl portion is reabsorbed in 56-84 days
 Easy to handleEasy to handle
 Less fibrosisLess fibrosis
 Reduced shrinkageReduced shrinkage

37. HYBRID MATERIALSHYBRID MATERIALS
Avaulta PlusAvaulta Plus™™ CollagenCollagen
 Acellular lyophylizedAcellular lyophylized
porcine collagenporcine collagen
 1.8 mm pores – 55 / sq in1.8 mm pores – 55 / sq in
 0.36mm thick0.36mm thick
 New cross-linkingNew cross-linking
processprocess
 Sutured to Solo mesh bySutured to Solo mesh by
PP 5.0 suturePP 5.0 suture
 Protectant barrierProtectant barrier
between Avaulta Solobetween Avaulta Solo™™
meshmesh and vaginal mucosaand vaginal mucosa
 Tissue ingrowthTissue ingrowth
1.8 mm1.8 mm
PoresPores
55 / sq in55 / sq in

38. AVAULTA PLUSAVAULTA PLUS™ GRAFT DETAIL™ GRAFT DETAIL
PP 5.0 SuturePP 5.0 Suture
Porcine BarrierPorcine Barrier
Avaulta SoloAvaulta Solo™™
MeshMesh

39. Mesh Density ComparisonMesh Density Comparison
24,2
34,1
47,8
99,8
0
10
20
30
40
50
60
70
80
90
100
Grams/meter^2
IntePro Lite Avaulta Solo Gynemesh PS Pelvitex
Density (g/m^2)

40. PelvicolPelvicol
SIS
Porcine small intestinal
sub mucosa
Porcine dermisPorcine dermis
XENOGRAFTSXENOGRAFTS

41. 180 patients with recurrent POP180 patients with recurrent POP ≥ grade 2≥ grade 2
Two groups (computer generated randomization list)Two groups (computer generated randomization list)
Group One: Prolene softGroup One: Prolene soft®®
Group Two: PelvicolGroup Two: Pelvicol®®
Procedures: Tension-free Cystocele Repair (TCR) +Procedures: Tension-free Cystocele Repair (TCR) +
Levator Myorraphy (LM)Levator Myorraphy (LM)

42. MESH EROSIONSMESH EROSIONS
PelvicolPelvicol®®:0 patients:0 patients
GynemeshGynemesh®®: 6 patients (6.45%): 6 patients (6.45%)
vsvs
P 0.02P 0.02
Cystocele stage ≤1Cystocele stage ≤1
71% in the Gynemesh71% in the Gynemesh®® and 55% in the Pelvicoland 55% in the Pelvicol®® groupgroup
ANATOMICAL CORRECTIONANATOMICAL CORRECTION

43. NEW PROPOSALNEW PROPOSAL
THE TITANISATION OF MESH IMPLANTSTHE TITANISATION OF MESH IMPLANTS
A thin (approx. 30-50 nm) highly
biocompatible titanium oxide surface is
appliade to a plastic mesh

44. ADVANTAGES OF TITANISATIONADVANTAGES OF TITANISATION
• Low inflammation rates.Low inflammation rates.
• Natural incorporation and vascularisationNatural incorporation and vascularisation
(no encapsulation).(no encapsulation).
• Low shrinkage and migration rates.Low shrinkage and migration rates.
• Shorter convalescence.Shorter convalescence.
• Outstanding biocompatibility: implant isOutstanding biocompatibility: implant is
not perceived as a foreign object by thenot perceived as a foreign object by the
human body.human body.

45. BiocompatibilityBiocompatibility
 A vessel has already grown after 12
week

46. Neo fasciaNeo fascia
6 mesi follow up6 mesi follow up

47. UNTIL NOW, THERE IS NO PERFECT POP REPAIRUNTIL NOW, THERE IS NO PERFECT POP REPAIR
MATERIAL !MATERIAL !
Max. intravaginal pressure for selected activitiesMax. intravaginal pressure for selected activities
vs. burst pressure of meshesvs. burst pressure of meshes
2222
7979
9696
122122
163163
875875 950950
2424
9898 102102
132132
00
100100
200200
300300
400400
500500
standing
standing
Lifting
5
kg
Lifting
5
kgValsalva
Valsalvacoughing
coughing
bearing
dow
n
bearing
dow
n
Abs.M
axim
un
Abs.M
axim
un
PVD
F
superlight
PVD
F
superlight
Prolit+
M
afterAbsorption
Prolit+
M
afterAbsorption
G
ynem
esh
PS
G
ynem
esh
PS
activityactivity
cmwatercmwater
Mean (Mouritsen,Mean (Mouritsen,
2007) n=23, POP2007) n=23, POP
Median, (O'Dell,Median, (O'Dell,
2007) n=122007) n=12
healthyhealthy
MeshMesh
Pelvic FloorPelvic Floor
materials are stillmaterials are still
over-engineeredover-engineered
 we need lesswe need less
foreign bodyforeign body
materialmaterial
MaterialsMaterials
correlated tocorrelated to
measured femalemeasured female
pelvic physiologicalpelvic physiological
characteristicscharacteristics
PP
(8g/m
PP
(8g/m22
))

48. 3. AVOID, IF POSSIBLE,3. AVOID, IF POSSIBLE, CONCOMITANT HYSTERECTOMYCONCOMITANT HYSTERECTOMY
de TAYRAC, EGLIN et al., IUGA 2005de TAYRAC, EGLIN et al., IUGA 2005
 Univariate logistic regression on 277 patientsUnivariate logistic regression on 277 patients
with 34 erosions (12.3%)with 34 erosions (12.3%)
39% Prolene39% Prolene®®
/ 61% Soft Prolene/ 61% Soft Prolene®®
Concomitant hysterectomyConcomitant hysterectomy
nn 164 (59.2%)164 (59.2%)
erosion rateerosion rate 18.3% vs 0%18.3% vs 0%
OR 5.7OR 5.7 pp<0.001<0.001
 Multicenter study on 230 patients with 15 erosions (6.5%)Multicenter study on 230 patients with 15 erosions (6.5%)
collagen-coated polypropylene (Pelvitexcollagen-coated polypropylene (Pelvitex®®
))
Concomitant hysterectomyConcomitant hysterectomy
nn 84 (36.5%)84 (36.5%)
erosion rateerosion rate 12% vs 2.2%12% vs 2.2%
pp<0.05<0.05
COLLINET, COSSON et al., 2005COLLINET, COSSON et al., 2005

49. 4. SURGEON EXPERIENCE4. SURGEON EXPERIENCE
 TheThe LEARNING CURVELEARNING CURVE
 Univariate logistic regression on 198 patientsUnivariate logistic regression on 198 patients
with 14 erosions (7.1%):with 14 erosions (7.1%):
CONSULTANT VS FELLOWCONSULTANT VS FELLOW
Erosion rates: 2.9% vs 15.6%Erosion rates: 2.9% vs 15.6%
ACHTARI, DWYER et al., 2005ACHTARI, DWYER et al., 2005
4,1
12,5
18,8
0
5
10
15
20
25
30
1 2 3
11stst
yearyear 22ndnd
year 3year 3rdrd
yearyear
19%19%
13%13%
4%4%

50. 5. WHERE WE PUT THE MESH5. WHERE WE PUT THE MESH
 With ASC 0.5%
 Vaginal Implantation – 3-19%
MESH EXPOSUREMESH EXPOSURE
USING POLYPROPYLENEUSING POLYPROPYLENE
WHY ?WHY ?

51. HISTOLOGY OF VAGINAL “FASCIA”HISTOLOGY OF VAGINAL “FASCIA”
Non-Keratinized Stratified
Squamous Epithelium
Directly fused on:
Thin Lamina Propria
Concentric Layers of
Smooth Muscle
Fibrous “Coat”
derived from
Dense Irregular
connective tissue} Bailey’s Textbook of Histology
Williams & Wilkins 1971
TraditionallyTraditionally
used asused as
PubocervicalPubocervical
oror
RectovaginalRectovaginal
““Fascia”Fascia”
in repairsin repairs

52. Reiffenstuhl et al. Vaginal Operations: Surgical Anatomy and Technique 1994Reiffenstuhl et al. Vaginal Operations: Surgical Anatomy and Technique 1994
Iatrogenically bisectedIatrogenically bisected
vaginal wallvaginal wall
Vaginal Fibromuscular wallVaginal Fibromuscular wall
•non-keratinized stratifiednon-keratinized stratified
squamous epitheliumsquamous epithelium
fused withfused with
•concentrically arrangedconcentrically arranged
smooth musclesmooth muscle
Fascial “capsule”Fascial “capsule”
•formed from condensationformed from condensation
of irregular loose areolarof irregular loose areolar
endopelvic connective tissueendopelvic connective tissue
Potential graftPotential graft
placement sitesplacement sites
▓▓
▓▓
Vaginal Wall AnatomyVaginal Wall AnatomyVaginal Wall AnatomyVaginal Wall Anatomy
Surgical Placement of MeshSurgical Placement of MeshSurgical Placement of MeshSurgical Placement of Mesh
TrueTrue
vesicovaginalvesicovaginal
spacespace
BladderBladder
WallWall

53. 6. WHEN USE PROSTHESIS6. WHEN USE PROSTHESIS
GeneralGeneral
indicationsindications
SpecificSpecific
situationssituations
BeneficialBeneficial::
Recurrent prolapseRecurrent prolapse
Large cystoceleLarge cystocele
Vault prolapseVault prolapse
Individual issuesIndividual issues
Not beneficialNot beneficial::
Primary casePrimary case
Posterior wallPosterior wall
Prolapse < stage 2Prolapse < stage 2
Younger ageYounger age
Pain presentPain present
IUGA 2011 Mesh RTIUGA 2011 Mesh RT

54. AVOIDING OR REDUCINGAVOIDING OR REDUCING
COMPLICATIONSCOMPLICATIONS
RESTORING NORMAL ANATOMY ANDRESTORING NORMAL ANATOMY AND
FUNCTIONFUNCTION

55. De Lancey LevelsDe Lancey Levels
Level 1Level 1
Level 2Level 2
Level 3Level 3

56. RESTORING NORMAL ANATOMYRESTORING NORMAL ANATOMY
 Fascial integrity along entire vaginalFascial integrity along entire vaginal
canalcanal
 Ligamentous apical supportLigamentous apical support
 Vaginal caliberVaginal caliber
 Normalize vaginal hiatus (levator support)Normalize vaginal hiatus (levator support)
 Normalize perineal supportNormalize perineal support

57. RESTORING NORMAL ANATOMYRESTORING NORMAL ANATOMY
 Fascial integrity along entire vaginalFascial integrity along entire vaginal
canalcanal
 Reattach fascia to apex/cuff/uterusReattach fascia to apex/cuff/uterus
 Ligamentous apical supportLigamentous apical support
 Reattach Utero-sacral/Cardinal ligamentsReattach Utero-sacral/Cardinal ligaments
 Vaginal caliberVaginal caliber
 Normalize vaginal hiatus (levator support)Normalize vaginal hiatus (levator support)
 Normalize perineal supportNormalize perineal support

58. RESTORING NORMAL ANATOMYRESTORING NORMAL ANATOMY
 Fascial integrity along entire vaginalFascial integrity along entire vaginal
canalcanal
 Reattach fascia to apex/cuff/uterusReattach fascia to apex/cuff/uterus
 Replace/reinforce fascia with a graftReplace/reinforce fascia with a graft
 Ligamentous apical supportLigamentous apical support
 Reattach Utero-sacral/Cardinal ligamentsReattach Utero-sacral/Cardinal ligaments
 Recreate ligaments with a tape/graftRecreate ligaments with a tape/graft
 Vaginal caliberVaginal caliber
 Normalize vaginal hiatus (levator support)Normalize vaginal hiatus (levator support)
 Normalize perineal supportNormalize perineal support

59. TTension-freeension-free CCystoceleystocele RRepairepair
(T.C.R.)(T.C.R.)
• apposition of mesh (tension-free)apposition of mesh (tension-free)
• fixation at paraurethral levelfixation at paraurethral level
Cervigni et al ‘07Cervigni et al ‘07
Vaginal Mesh FixationVaginal Mesh Fixation
EvolutionEvolution

60. …”the tension” placed on suburethral slings varies
considerably among surgeons and ”plays a direct role”
in post-operative rates of retention and erosion!
C. Iglesia, D. Fenner, L. Brubaker, 1997
The Rationale

62. ASSOCIATED PROCEDURES

63. PROLIFTPROLIFT
(Gynecare)(Gynecare)
Anterior MeshAnterior Mesh Posterior MeshPosterior Mesh

64. Perigee/ApogeePerigee/Apogee®®
(AMS)(AMS)

65. AvaultaAvaulta ®®
- Bard- Bard

66. DEFICIENCIES OF ANTERIOR T-ODEFICIENCIES OF ANTERIOR T-O
APPROACHAPPROACH
Unable to reach vaginal apex
Not an apical POP repair
Unable to reach ischial spine
Leaves upper vagina unprotected
Unclear if sling needed for SUI patient

67.  Comprehensive level II repair,Comprehensive level II repair, BUTBUT still lacking thestill lacking the
ability to restore the apical compartmentability to restore the apical compartment
A. Gauruder-Burmester et al. 2006A. Gauruder-Burmester et al. 2006
WHY RESTORE APEX FROM ANTERIORWHY RESTORE APEX FROM ANTERIOR
COMPARTMENT?COMPARTMENT?
May provide a more comprehensive Level IMay provide a more comprehensive Level I
and Level II anatomical supportand Level II anatomical support2,3,42,3,4
1.1. R. P. Goldberg, et al., American College of OBGYN; Vol. 98, NO.2, August 2001R. P. Goldberg, et al., American College of OBGYN; Vol. 98, NO.2, August 2001
2.2. K. V. Amrute et al. Neurourology and Urodynamics; 26:53-58 (2007)K. V. Amrute et al. Neurourology and Urodynamics; 26:53-58 (2007)
3.3. J. Lowder et al. Am. J. OBGYN 2008;Vol. 111, No. 1J. Lowder et al. Am. J. OBGYN 2008;Vol. 111, No. 1
4.4. Summers et al. Am. J. OBGYN 2006;1994:1438-43Summers et al. Am. J. OBGYN 2006;1994:1438-43
DEFICIENCIES OF ANTERIOR T-ODEFICIENCIES OF ANTERIOR T-O
APPROACHAPPROACH

68. Elevate BenefitsElevate Benefits
 Designed for SafetyDesigned for Safety
 Depth limiting featureDepth limiting feature
 Minimal blind needle passesMinimal blind needle passes
 Finger tip palpationFinger tip palpation
 SimpleSimple
 Release mechanism designedRelease mechanism designed
to allow easy tip deploymentto allow easy tip deployment
 Small fixation tips requiringSmall fixation tips requiring
low insertion forcelow insertion force
 Protective sheath to easeProtective sheath to ease
needle placementneedle placement
 Minimally InvasiveMinimally Invasive
 Total Trans-vaginalTotal Trans-vaginal
 No external stab incisionsNo external stab incisions
 Small fixation tips designedSmall fixation tips designed
to minimize tissue traumato minimize tissue trauma

69. Pull Out Force ComparisonPull Out Force Comparison
Obturator InternusObturator Internus
5.6
2.3
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
lbf
Elevate Anterior Prolift Anterior
Pull Out Force
TR5186 (pg 12)

71. PROXIMAL ARMS PLACEMENTPROXIMAL ARMS PLACEMENT
Fully actuate the introducer to deliver the tubular arm through theFully actuate the introducer to deliver the tubular arm through the
ligamentligament
Use firm, downward pressure while actuating the deviceUse firm, downward pressure while actuating the device
When actuating the handle don’t pull nor maintain the meshWhen actuating the handle don’t pull nor maintain the mesh

72. Place finger on ridges on head of devicePlace finger on ridges on head of device
PROXIMAL ARMS PLACEMENTPROXIMAL ARMS PLACEMENT

73. Insert the introducer into the vaginal dissection laterally through the dissectedInsert the introducer into the vaginal dissection laterally through the dissected
plane toward the cephalad aspect of the ischiopubic ramus.plane toward the cephalad aspect of the ischiopubic ramus.
DISTAL ARMS PLACEMENTDISTAL ARMS PLACEMENT

74. ““Repeat on contralateral side using a second deployment tool”Repeat on contralateral side using a second deployment tool”
MESH POSITIONING AND SECUREMENTMESH POSITIONING AND SECUREMENT

75. KITS COMPARISONKITS COMPARISON
Trocar- basedTrocar- based
 Improved adjustabilityImproved adjustability
 External skin incisionsExternal skin incisions
 Risks of trocar passageRisks of trocar passage
Internal fixationInternal fixation
 Anterior+Apex repairAnterior+Apex repair
 Less tissue damageLess tissue damage
 Deeper TVLDeeper TVL
 Use of SSLsUse of SSLs
 Greater vascular risk ?Greater vascular risk ?
 Less pain ?Less pain ?

76. •Mini-invasivityMini-invasivity
•Stantardized kitsStantardized kits
FUTURE PERSPECTIVEFUTURE PERSPECTIVE
OF PROSTHETIC SURGERYOF PROSTHETIC SURGERY
•High technology materialsHigh technology materials
•Autologous bio-enginering materialsAutologous bio-enginering materials