1. The Ins and Outs of Pelvic
Organ Prolapse
Dr. Kristina Cvach
Urogynecology Fellow
University of British Columbia
1
Presentation Overview
• Epidemiology of prolapse
• Female pelvic anatomy
• Etiology of prolapse
• Management of prolapse
• Grafts in pelvic surgery
2

2. POP
• Prolapse likened to a hernia of pelvic
contents through genital hiatus
• Significant QOL issues
– Physical discomfort
– Effect on urinary, bowel and sexual function
– Body image
3
Surgery for Urinary Incontinence or
Pelvic Organ Prolapse
12
11.1%
29% reoperation
10
Incidence (%)
7.5%
8
6
4.7%
4
2.8%
2
0.9%
0.1%
0
20-39 30-39 40-49 50-59 60-69 70-79
Age Group
Olsen et al. Obstet Gynecol 1997:89(4):501-506 4

3. Anatomy
• Bony pelvis
• Pelvic diaphragm
• Endopelvic fascia
5
Anatomy - Bony pelvis
x
x
6

4. Anatomy
• Pelvic diaphragm
– Levator Ani :
puborectalis,
pubococcygeus, x
ileococcygeus x
– Coccygeus muscle x
x
7
Anatomy
• Endopelvic fascia
– Continuous sheet of connective tissue
– Fibromuscular layer
– Supports pelvic viscera and pelvic muscles
– Ligaments are condensations of CT
8

5. 9
Etiology of prolapse
10

6. Etiology of POP
• Normal form maintained by action of pelvic
diaphragm and endopelvic fascia
• Pelvic diaphragm
– Resting tone
– Active contraction during raised intra-abdominal
pressure
• Endopelvic fascia
– Provides support to viscera during relaxation of
pelvic diaphragm
11
Etiology of POP
• Disruption of fascia and/or pelvic
diaphragm results in POP
– Stretching/tearing of fascia
– Neuropathic injury - pudendal nerve
– Disruption of muscle attachment
12

7. Page 27 of 30 International Urogynecology Journal
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Etiology of POP
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Re
36
• Risk factors 37
38
– Age : effect on connective tissue and muscle
39 vi
function 40
ew
vi
41
– Vaginal parity : tearing/detachment of CT and
42
levator ani, neuropathy
43
ew
44
– Menopause : role of estrogen unclear
45
– Previous pelvic surgery : hysterectomy
46
47
– Race
48
– Chronic increased intra-abdominal pressure :
49
COPD, constipation, obesity
50
51
– Lifestyle : high-impact activities
52
53 14
54
55

8. Etiology of POP - Parity
15
Management of POP
• Prolapse presents
with wide range of
clinical findings
• Management guided
by patient symptoms
Jelovsek 2007 16

9. Management of Prolapse
Conservative
Observation Pessary
Asymptomatic
Progression 11%
Regression 2% (1)
(1)Bradley CS et al. Obstet Gynecol. 2007 Apr;109(4):848-54. 17
Pessary
PESSRI Study
Cundiff et al. Am J Obstet Gynecol 2007;196(4):405.e1-8 18

10. Management of POP
Surgery
• Choice of procedure
– Patient characteristics: age, suitability for
surgery, primary or recurrent prolapse, site of
prolapse, risk for recurrence
– Surgeon experience and preference
19
Management of Prolapse
Surgery
Obliterative Reconstructive
•Colpocleisis •Apex
•Anterior
•Posterior
Compensatory
•Use of graft
20

11. Reconstructive Surgery
Apex
Abdominal Vaginal
Sacrocolpopexy
Open(1)
78-100% (apex)
58-100% (any)!
Laparoscopic(2)
94%
(1) Nygaard et al. Obstet Gynecol 2004;103:805-23
(2)Ganatra AM, et al., Eur Urol 2009. Epub Feb 4
21
Reconstructive Surgery
Apical compartment
22

12. Reconstructive Surgery
Apex
Abdominal Vaginal
Sacrocolpopexy Sacrospinous ligament suspension
Open ! 63-97%
! 78-100%(apex)
! 58-100%
(any)!
Laparoscopic
! 93-98%
Nichols et al. J Pelvis Surg 1996;2:87-94
Lantzsch et al. Arch Gynecol Obstet 2001;265:21-25
Benson et al. Am J Obstet Gynecol 1996;175:1418-1422
Paraiso et al. Am J Obstet Gynecol 1996;175:1423-1430 23
Reconstructive Surgery
Apical compartment
X
24

13. Reconstructive Surgery
Apical compartment
25
Reconstructive Surgery
Apex
Abdominal Vaginal
Sacrocolpopexy Sacrospinous ligament suspension
Open ! 63-97%
! 78-100%(apex)
! 58-100%(any)! Ileococcygeal fixation
Laparoscopic ! 53%
! 93-98%
Maher et al.Obstet Gynecol 2001;98:40-44 26

14. Reconstruve Surgery
Apical compartment
x
27
Reconstructive Surgery
Apex
Abdominal Vaginal
Sacrocolpopexy Sacrospinous ligament suspension
Open ! 63-97%
! 78-100%(apex)
! 58-100%(any)! Ileococcygeal fixation
Laparoscopic ! 53%
! 93-98%
Uterosacral ligament suspension
! ! 82-96%
Yazdany et al. Curr Opin Obstet Gynecol 2008, 20:484-488 28

15. Reconstructive Surgery
Apical compartment
29
Reconstructive Surgery
Anterior Posterior
Traditional colporraphy Traditional colporraphy
! 37-57% ! 76-96%
30

16. Reconstructive Surgery
31
Reconstructive Surgery
Anterior Posterior
Traditional colporraphy Traditional colporraphy
37-57% ! 76-96%
Site-specific repair Site-specific repair
75-97% ! 56-100%
32

17. Procedure Level I Level II Level III
Sacrocolpopexy
+
Sacrospinous
fixation +
USL fixation
+
Iliococcygeal fixation
+
Colporraphy
+
Site specific repair
+
33
Grafts
34

18. Grafts in Pelvic Surgery
• Introduced in an effort to address the high
reoperation rate of prolapse surgery
• Graft provides reinforcement of fascial repair
by acting as a scaffold for tissue ingrowth
35
Grafts in Pelvic Surgery
• Graft cut to size &
shape required
• Placed or sutured
• May be combined
with apical support
procedure
36

19. Grafts in Pelvic Surgery
• “Ideal” Graft
• High efficacy
• Low cost
• Low complication rate
• Doesn’t exist!
• Biologic ! vs ! Synthetic grafts
! Autologous! ! Absorbable
! Allograft! ! Non-absorbable
! Xenograft
37
Grafts in Pelvic Surgery-
Biologic
• Autologous - fascia lata, rectus sheath
– Pros:
• No risk of communicable disease
• No erosion
• Incorporated without disintegration
– Cons:
• Separate incision, increased operating time
• Inconsistent quantity and quality
• Pain at donor site
• Herniation at donor site
38

20. Grafts in Pelvic Surgery-
Biologic
• Allograft - cadaveric fascia lata, dura, dermis
• Xenograft - porcine dermis/small intestine,
bovine pericardium
• Pros:
– Low erosion risk
• Cons:
– Potential for prion/viral infection; rejection
– Expensive ($200 - $1200)
– Availability(cadaveric)
– Limited durability: processing may weaken material
39
Grafts in Pelvic Surgery-
Synthetic
• Absorbable (Vicryl, Dexon) vs
• Non-absorbable (Prolene, Gore-tex, Teflon) vs
• Combined (Vypro)
• Pros:
– Cost-effective cf. allo- & xenograft
– Consistent material and availability
– No disease transmission
• Cons:
– Infection
– Erosion: vagina, urethra/bladder, bowel
40

21. Synthetic Non-absorbable
Mesh
• Synthetic mesh classified according to:
– pore size: macro (>75 microns) vs microporous (<10
microns)
– weave: mono vs multifilament
• Pore size important in determining host
inflammatory response and tissue incorporation
41
Synthetic Non-absorbable
Mesh Classification
• Type I - macroporous, monofilament
– Prolene, Marlex
• Type II - microporous(<10 microns), mono &
multifilament
– Gore-tex
• Type III - macroporous, multifilament
– Mersilene, OBtape, IVS tunneler
• Type IV - submicronic pores, not used in pelvic
surgery
42

22. Synthetic Non-absorbable
Mesh Classification
Type I Type II Type III
Large pores Small pores Large pores
Monofilament Multifilament Multifilament
43
Evidence for grafts in pelvic
surgery
• “Evidence” difficult to determine
– Varying quality of study design
• Majority are retrospective
• Definition of outcomes varies - objective, subjective
• Follow-up periods vary
– Different materials used
– Different techniques
• Graft shape
• Placement
44

23. Evidence for grafts in pelvic
surgery
• Sacrocolpopexy
– “Gold standard” for apical prolapse repair
– 8 RCT’s
– Prolene most studied graft
Maher C 2007. Surgical Management of Pelvic Organ
Prolapse in Women (Review). Cochrane Collaboration 45
Evidence for grafts in pelvic
surgery
• Vaginal prolapse repair
• Systematic review & meta-analysis
– 49 studies - RCT (6 full, 11 abstracts), 7
non-randomised comparative studies, 1
prospective registry, 24 case series (>50
women)
– Comparator either no mesh or different
mesh
• 50% used non-absorbable synthetic mesh
Jia et al. BJOG 2008;115:1350-61 46

24. Evidence for grafts in pelvic
surgery
• Anterior wall repair
– 10 RCT’s, 1148 women
– Mesh/graft (any type) better than no mesh
• RR 0.48 (95% CI 0.32-0.72)
• Improved results with non-absorbable synthetic
mesh (RR 0.24 CI 0.13-0.43) cf biological graft
(RR 0.55 CI 0.37-0.81) and absorbable synthetic
(RR 0.74 CI 0.46-1.18)
47
Evidence for grafts in pelvic
surgery
• Posterior vaginal repair
– Role for mesh less clear as native tissue
repair yields 76-90% success rates
– 9 studies (3 RCT’s), 417 women
– Trend in crude rates for better outcomes
with non-absorbable mesh cf absorbable
mesh/biologic graft and no mesh - too few
data for statistical analysis
48

25. Evidence for grafts in pelvic
surgery- Posterior
Author N F/U Outcome
Sand 01 PC 70 12m 90%
Vicryl 73 92%
Paraiso 06 PC 37 17m 86%
SSR 37 78%
Porcine SIS 32 54%
Lim 06 SSR 31 12m No significant difference in
(AUGS abstract) Vypro2 25 anatomical outcomes
Vicryl 9
49
Mesh kits
• FDA - does not require pre-market
approval for medical devices
• Pre-market notification of proposed
device only requires demonstration of
“substantial equivalence” to another
legally US marketed device
50

26. Mesh kits
• Introduced 2001
• Gynecare (Johnson & Johnson):
– Prolift
• American Medical Systems:
– Perigee
– Apogee
• Bard
– Avaulta
51
Mesh Kits - Anatomy
x
x
x
52

27. Mesh Kits
Perigee Apogee
Prolift
Avaulta Anterior and Posterior
53
Mesh Kits
54

28. Mesh Kits
55
Mesh Kits
56

29. Mesh Kits - Literature
Level III Evidence
Author Device N F/U Anatomical Mesh
cure erosion
Cosson 05 Prolift 687 3m 94% 6.7%
Garunder- Perigee 120 12m 93% 11%
Burmester 07 Apogee
Altman 07 Prolift 123 2m Anterior 87% -
Posterior 91%
Combined 88%
Abdel-Fatah Prolift (76%) 289 3m 94-100% 10%
08
Perigee/Apogee (24%)
Van Raalte 08 Prolift 97 19m Overall 86% 0%
Apex 96%
Balakrishnan Apogee 35 6m 97% 25%
08
Elmer 09 Prolift 232 12m Anterior 79% 11%
Posterior 82% 57
Mesh Complications - Erosion
• Sacrocolpopexy
– Median erosion rates 3.4% (Prolene 0.5%,
Teflon 5.5%) (1)
– Risk factors for erosion(2)
• Current smoking OR 5.2
• Concurrent hysterectomy OR 4.9
• Gore-tex mesh OR 4.2
(1) Nygaard et al. Obstet Gynecol 2004;103:805-23
(2) Cundiff et al. AmJOG 2008;199:688.e1-e5 58

30. Mesh Complications - Erosion
• Transvaginal mesh
– Paucity of quality
data
– Mesh erosion greater
with synthetic non-
absorbable mesh
(10%) cf biological
graft (6%) and
synthetic absorbable
mesh (0.7%)
Jia et al. BJOG 2008;115:1350-61 59
FDA - Center for Devices and
Radiological Health
• FDA Public Health Notification: Serious
Complications Associated with
Transvaginal Placement of Surgical Mesh
in Repair of Pelvic Organ Prolapse and
Stress Urinary Incontinence
• Issued: October 20, 2008
60

31. FDA - Center for Devices and
Radiological Health
• Obtain specialized training for each mesh placement
technique, and be aware of its risks.
• Be vigilant for potential adverse events from the mesh,
especially erosion and infection.
• Watch for complications associated with the tools used
in transvaginal placement, especially bowel, bladder
and blood vessel perforations.
61
FDA - Center for Devices and
Radiological Health
• Inform patients that implantation of surgical mesh is
permanent, and that some complications associated
with the implanted mesh may require additional surgery
that may or may not correct the complication.
• Inform patients about the potential for serious
complications and their effect on quality of life,
including pain during sexual intercourse, scarring, and
narrowing of the vaginal wall (in POP repair).
• Provide patients with a written copy of the patient
labeling from the surgical mesh manufacturer, if
available.
62

32. SGS Guidelines for Use of
Vaginal Graft
• Anterior compartment
– Non-absorbable synthetic mesh may
improve anatomical outcomes of anterior
vaginal wall repair, but there are significant
trade-offs in regard to the risk of adverse
events
Murphy M. Obstet Gynecol 2008;112(5):1123-1130
63
SGS Guidelines for Use of
Vaginal Graft
• Posterior compartment
– It is suggested that native tissue repair remains
appropriate in posterior vaginal wall repair when
compared with biologic and absorbable synthetic
graft
– There are no comparative studies to guide any
recommendation for the use of non-absorbable
synthetic mesh in posterior vaginal wall repair when
compared with native tissue repair
64

33. SGS Guidelines for Use of
Vaginal Graft
• Multiple compartment
– There are no comparative studies to guide
any recommendation for the use of biologic,
absorbable synthetic or non-absorbable
synthetic mesh in multiple compartment
repair when compared with native tissue
repair
65
SGS Guidelines for Use of
Vaginal Graft
• Need adequately powered randomized
comparative studies
– Outcomes assessments using validated,
standardized tools
– Subjective (function) AND objective cure
(form)
– Follow-up at least 1 year, ideally 5+ years
– Complications
66

34. Pre-operative Patient
Counseling when using Graft
• Unknown durability
• Risk of erosion
• Lack of long-term data on adverse events
– Chronic pain
– Dyspareunia
– Fistula
– Infection
– Delayed erosion/exposure
67
Summary
• Pelvic organ prolapse is a complex
problem
• Lack of high quality evidence to guide
surgical management
• Use of graft in pelvic surgery is under
evaluation, currently no strong evidence
to guide it’s use
68

35. Summary
• Use of graft
– Sacrocolpopexy
– Recurrent prolapse
– High risk for recurrence
• Full disclosure of risks to patient
69
THANKYOU
70