• 子宮脫垂合併膀胱及直腸膨出。

(1)

Debate – Vaginal surgery for POP -To mesh

吳銘斌

Ming-Ping Wu

^1,2,

Director, Div. Urogynecology & Pelvic Floor Reconstruction, Dept. Obstetrics and Gynecology¹,

Chi Mei Foundation Hospital, Tainan, Taiwan;

College of Medicine, Taipei Medical University², Taipei, Taiwan

(2)

Pelvic organ prolapse (POP)

個案&待解決的問題

• 子宮脫垂合併膀胱及直腸膨出。

¾ 傳統的治療方式就是子宮切除。

• Q1:難道患有子宮脫垂就一定要切除子宮嗎？

• Q2:切除了子宮，脫垂現象就會完全改善嗎？

• Q3:萬一、以後膀胱再脫垂時怎麼辦呢？

(3)

POP-Q

-3 -5 -5

3 3 5

-2 -5 -5

+2 +5 +5

7 3 7

+2 +3 0

Bump RC 1996 AJOG

Post-OP Pre-OP

Post-op 3 mons Pre-Op

(4)

Classification pelvic reconstructive surgery

• Anterior compartment

¾ Anterior repair/ paravaginal repair + prosthestic reinforcement

¾ Continence surgery ± sling, Burch colposuspension, bulking agents

• Middle compartment

¾ Abdominal hysterectomy+ sacrocolpopexy

¾ Vaginal hysterectomy+ iliococcygeus/ sacrospinous fixation

¾ Abdominal or vaginal sacrospinous/ sacrohysteropexy

• Posterior compartment

¾ Posterior repair

¾ Rectopexy

¾ Anal sphincter repair

Birch C 2002 Curr Opin Obstet Gynecol

+ prosthestic reinforcement + prosthestic reinforcement

(5)

Why do we need prostheses in pelvic reconstructive surgery ?

• The high recurrence rate after surgery for pelvic organ prolapse (POP) makes the more refined reconstructive surgery imperative

¾ High failure rate 30% (Olsen AL 1997 Obstet Gynecol)

• The long-term anatomic outcomes of traditional cystocele repair

¾ High failure rate 37% (Quiroz LH 2006 Contemp Ob/Gyn)

• Therefore, biological and synthetic prostheses

merged as adjuvant materials.

(6)

Reasons for surgical failure

• Poor patient selection

• Suboptimal surgical technique

• Inappropriate choice of suture materials

• Persistence of predisposing risk factors

¾ Poor tissue quality

¾ Impaired healing

¾ Chronic increased intra-abdominal pressure

• due to COPD, asthma, or constipation

¾ High-grade cystocele

¾ Age 60 or above

Whitesides JL 2005 Obstet Gynecol Surv

(7)

pubovervical f.

Rectovaginal f.

bladder rectum

vagina

bladder rectum

vagina

Pelvic support

Sacro-spinous lig ATFP

(8)

Pelvic organ prolapse (POP)

X X X

It breaks but not attenuates !!!

(9)

Key questions considering prosthetic materials

1) Does it improve the function of the repair?

2) Does it improve the durability of the repair?

3) Does the graft increase the rate of complication?

(10)

History of prosthesis

• Inguinal hernia repair in general surgery

¾ 43% recurrence in the suture repair group

¾ 24% in the mesh augmented repair group

• Luijendij R 2000 NEJM

• History of synthetic non-absorbable prostheses

¾ 1903 metallic silver mesh

¾ 1938 Nylon

¾ 1956 Dacron (Mersilene)

¾ 1958 polypropylene (Marlex)

(11)

Advantages of prostheses

• the surgeon can repair all vaginal defects faster and with less effort.

• Well anatomic support

¾ anterior compartment, anchored to ATFP

• Level II attachment

¾ Posterior compartment, to the level of the ischial spine,

• level I support. (DeLancey 1992 JOL Am J Obstet Gynecol)

• Concomitant surgery

¾ POP + SUI

¾ using different shaped materials.

(12)

The purposes of prosthesis in pelvic reconstructive surgery

•

The purposes of prostheses in pelvic reconstructive surgery are

¾to substitute the lacking supportive tissue,

¾to reinforce the inadequate tissue,

¾to generate new supportive tissue,

¾to consolidate the insufficient surgical

technique.

(13)

The Evolution of Pelvic Reconstructive Surgeries

VTH+ A-P colporrhaphy

Abdominal sacro- colpopexy± mesh

Vaginal repair of anterior, posterior compartment + mesh

Sacro-spinous lig. suspension

Tension-free vaginal mesh + procedural kits*

Biologic materials**

Huang KH & Wu MP Incont Pelvic Floor Dysfunc

*Prolift (J&J); Perigee+Apogee (AMS);

post. IVS (Tyco); Nazca (Promedon)

**SIS (Cook); Pelvicol (Bard)

???

(14)

Ideal prostheses

Must

• Have better in vivo

response than autologous tissue

• Be chemically inert

• Be able to be modeled in the required shape

• Be able to sterilized

• Be resistant to infection

Must not

• Physically modified by tissue fluids

• Induced an inflammatory reaction or antibodies

• Be carcinogenic

• Induce allergy or hypersensitvity

• Promote adhesion at the surface of contact or

viscera

Cossen M 2003 Int Urogyn J

(15)

The different prostheses in pelvic reconstructive surgery

Baessler & Maher 2006 Curr Opin Obs Gyn

(16)

The comparison of the microscopic appearance of synthetic prostheses.

Birch C 2005 Best Proc Res Clin Obstet Gynecol

(17)

Classification of Synthetic Prostheses

Type Fiber type Pore size

component Brand names I Monofilament

macroporous

>

75µ

polypropylene Prolene (Ethicon) Marlex (Bard)

Atrium (Atrium) II monofilament

microporous

<

10µ

ePTFE Gore-Tex (Gore)

III Multifilament micro/macroporous

polyethylene Mersilene (Ethicone) Teflon (Dupont)

SurgiPro (Tyco) IV submicronic < 1µ polypropylene

sheet

Silastic (Dow Corning) Cellgard (Hoescht)

Birch C 2002 Curr Opin Obstet Gynecol

(18)

Different Synthetic Prostheses

(19)

Classification of absorbable synthetic &

biologic prostheses

Type Fiber type Pore size

component Brand names

absorbable mono/

multifilament

Polypropyle/

polyglactin 910

Vypro (Ethicone)

Multi filament

Polyglactin 910

Vicyl (Ethicone)

Xenograft Porcine small

intestine Bovine

pericardium

SIS (Cook)

Pelvicol (Bard)

Allograft Dura mater

Fascia lata

Autologous Rectus shealth

Fasica lata

Vaginal mucosa

(20)

The Evolution of Pelvic Reconstructive Surgeries

Tension-free vaginal mesh

± procedural kits*

(21)

Abdominal sacro-colpopexy with synthetic mesh: surgical outcomes

Birch C Fynes MM 202 Curr Opin Obstet Gynecol

(22)

Abdominal sacro-colpopexy with synthetic mesh: surgical outcomes

• A systematic review of 98 articles

¾ success rates for apical support of 78–100%

¾ support of all segments of 58–100%

• [Nygaard IE 2004 Obstet Gynecol ].

• Synthetic rather than biological prostheses

¾ randomized trial

¾ polypropylene mesh (91% cure) better than cadaveric fascia lata (68% cure) (p= 0.007) at 1 year follow-up

¾ in favor of the polypropylene mesh group at POP-Q

points Aa and C, as well as overall prolapse stages, sig.

• [Culligan PJ 2005 Obstet Gynecol].

(23)

The Evolution of Pelvic Reconstructive Surgeries

± procedural kits*

(24)

Anterior compartment repairs with prosthetic reinforcement

Birch C 2005 Best Practice & Research Sig.

Sig.

The available data on permanent synthetic prostheses

sparse, small, retrospective series, short-term follow-up.

(25)

Anterior vaginal wall prolapse repair with nonabsorbable mesh

• high anatomical cure rates

¾ polypropylene meshes 87%, 91.6%, 100%

(Salvatore S 2002 Neurourol Urodyn, de Tayrac R 2005 J Reprod Med, Milani R et al. 2005 BJOG)

• with relatively high mesh erosion rates

¾ 8.3%, 13% (de Tayrac R et al. 2005 J Reprod, Salvatore S al. 2002 Neurourol Urodyn, Med, Milani R et al. 2005 BJOG)

• Worsening dyspareunia

¾ anterior mesh repair, 20%

¾ posterior mesh repair 63% (Milani R et al. 2005 BJOG)

• Comparable incidence of de novo dyspareunia

¾ In patients with (9%) without (11%) vaginal erosion (p=0.85) (Deffieux X et al. 2007 Int Urogyn J)

(26)

How do you read this?

(27)

The Evolution of Pelvic Reconstructive Surgeries

± procedural kits*

*Prolift (J&J); Perigee+Apogee (AMS);

post. IVS (Tyco); Nazca (Promedon)

(28)

Advantages of procedural kits-I

• Simple and efficient surgical technique

¾Reduced surgery time

¾Short learning curve

¾Simple and precise transfer of the anchoring arms.

¾Simplified tension-free system

(29)

Advantages of procedural kits-II

• Improved tissue integration

¾ Macroporous polypropylene mesh

¾ promotes tissue in-growth and minimizes erosion and exposition risk.

• Anatomically-designed needle system

¾ Minimally invasive needles enable easy and accurate placement.

¾ The handle’s ergonomic design provides optimal control over the needle’s insertion.

(30)

Gynecare Prolift Pelvic Floor Repair System Prolift

(31)

Gynecare Prolift Pelvic Floor Repair System Prolift

Anterior incision

(32)

The Perigee System

American Medical Systems, Minnetonka, MN, USA

(33)

Nazca POP repair system

Promedon (Cordoba, Argentina)

Nazca TC Prepubic Approach + Transobturator Approach

(34)

TVT-O

Ant. Prolift or Perigee

Post. Prolift or Apogee or post IVS

A B

Preserved uterus

Gynecare, J&J AMS; Tyco

Options TVM +/- TVT-O

Hysterectomized

(35)

TVM- Prolift

• A retrospective multicentric study

(N=106),

¾ perioperative and immediate post-operative results,

• Success rate:

95.3% (failure rate 4.7%)

¾ recurrent prolapse even asymptomatic or low grade symptomatic prolapse

• Mesh exposure

4.7% (5/110)

¾ 2/ 5 required a surgical management

• Prolift seems to be a safe technique to correct POP.

¾ However, anatomical and functional results of a long-term follow-up has not yet to confirm the effectiveness and safety of the procedure

¾ [Fatton B 2006 Int Urogyn J].

(36)

Mesh erosion or migration

• Current available mesh

¾ polypropylene 0.5%,

¾ polyethylene terephthalate (Mersilene) 3.1% (J&J)

¾ Gore-Tex 3.4% (Gore)

¾ polyethylene 5.0% (Marlex) (Bard)

¾ Teflon 5.6% (DuPont) Nygaard IE 2004 Obstet Gynecol.

Huang KH & Wu MP Incont Pelvic Floor Dysfu

(37)

Mesh erosion due to different materials

•

Type II, III : 20–30%

¾woven, multi-filamentous in nature

¾limited host-tissue ingrowth

¾leading to erosions, draining sinuses, and fistulae.

(Debodinance P et al. 1999 Eur J Obstet Gynecol Reprod Biol ],[Julian TM 1996 Am J Obstet Gynecol)

¾17% intravaginal slingplasty (Tyco.)

(Siegel AL et al. 2005 J Urol)

•

Type I: 0.5- 5%

(Fatton B et al. 2007 Int Urogyn J)

(38)

Mesh erosion due to different approaches

• Approach

¾ abd. sacro-colpopexy 3.2%

¾ sacral colpoperineopexy 4.5%

¾ Suture vaginally, introduce mesh abd. 16%

¾ Introduce mesh vaginally 40%

(Visco AG 2001 Am J Obstet Gyneol)

• Techniques

¾ Erosion 17.5%Æ 2.7%

¾ in the avoidance of T-shaped colpotomies,

concomitant hysterectomy and perineal incision

(Debodinance P 2004 J Gynecol Obstet Biol Reprod)

(39)

Take-home message-1

• The high recurrence rate after surgery for pelvic organ prolapse (POP) makes the more refined reconstructive surgery mandatory.

• The prostheses are viewed as a scaffold for tissue in-growth and not as a permanent bridge.

• The use of synthetic prostheses is well established in sacro-colpopexy,

¾ controversial for repair of anterior and posterior wall defects.

(40)

Take-home message-2

• Synthetic prostheses may have slightly higher success rates but higher erosion rate

¾ biologic materials: better tolerated & lower erosion rate.

• Which prostheses (synthetic or biological) is

superior in vaginal surgery currently: inconclusive

• Ideal prostheses with various characters are not available currently,

¾ synthetic non-absorbable, synthetic absorbable, mixed synthetic, or biological?

The surgeons themselves should be the

decision-makers, not the manufacturers!

(41)

Thank you!

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