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12. Minimizin

the Risk of Sterilization Failure 113

4 mm

or c

ips an

2 cm

or rings) t

an e

ectrocoagu

ation met

s (3–4 cm).

However, t

e exact etio

ogy o

umen regeneration remains unc

ear.

actors suc

as an in

ivi

’s tu

“

ing” response, preexisting

pro

erative tu

isease (e.g., en

osa

pingiosis),

egree o

avascu

arity,

interva

rom operation are

y to mo

y tu

umen regeneration

ity [18,21–25]. Present

y t

ere is no evi

ence to suggest t

at operator

in steri

ization tec

nique pre

isposes to tu

umen regeneration, an

ere-

ore t

is mec

anism o

steri

ization

ure wou

e consi

ere

e non

neg

igent an

epen

ent o

operator error.

edicole

al Consequences

e psyc

ogica

ysica

mor

ity

owing

steri

ization

ten

s to

itigation [26]. A gyneco

ogist

as a

uty to in

orm women o

e ris

ure, to carry out t

e operation in accor

ance wit

accepte

goo

ica

practice, an

to avoi

oreseea

e comp

ications. Women w

ave

ergone steri

ization per

orme

neg

igent

y are entit

to recover

amages

accor

ing to:

le 12

.3.

Classification S

stem for Mechanism of Sterilization Failure

endent on the Sterilization Method

ent

Initial tubal nonocclusion (poor operator technique), e.

., slippa

e or overclosure of

ilshie cli

Wron

structure “sterilized”

Improperl

maintained equipment (e.g., noncalibrated or nonserviced Filshie clip

app

licator), which contributed to initial tubal nonocclusion.

Nonnegligen

Initial tubal nonocclusion (true method failure), reported extremely rarely and

ccurring despite correctly applied techniqu

The ends of the fallopian tube reconnecting spontaneously (recanalization)

Fistula developing at the occluded portion of the tube

Independent of the Ster

zat

on Method*

Occurs w

e woman

as a

rea

y conceive

in t

e cyc

e prior to steri

izatio

In the case o

Filshie clip, the woman conceives

ollowing sterilization in the

emainder o

the menstrual cycle because the ovulatory ovum is proximal to the tubal

teri

ization point (

utea

-p

ase pregnancy

)

In the case o

hysteroscopic sterilization, the woman conceives within the 3-month

nterval poststerilization and/or prior to con

irmation o

ective sterilization by HSG

r u

trasoun

* Most studies on sterilization failure have excluded such pre

nancies from their reported final

nalysis

https://t.me/med1917

14 R. Varma and J.K. Gu

•

Wrongful conception. In addition, an action in contract may also

arise if the sterilization procedure was performed outside the NHS

in the private sector

•

Neg

igence. A

reac

uty arises w

en an operation is not carrie

out in accordance with practice accepted as proper by a reasonable

y o

gyneco

ogists (Bo

am test). Neg

igence a

so occurs w

there is omission in appropriate preoperative counseling.

Wrong

irt

. T

e neg

igent act

eprive

e mot

er o

e possi

bility to prevent the conception of a disabled child or to have a lawful

ortion

omen are entit

to recover genera

amages

or pain an

ering

uring

regnancy and delivery, and loss of earnings during pregnancy. A recent judg

ent in the Australian High Court led the Australian government to amend

he Civil Liberty Act to restrict the amount of damages that could be awarded

n suc

situations [27]

n t

e majority o

steri

ization cases, even t

ose in t

e a

vance

tages o

itigation, t

e mec

anism o

ure remains un

nown, as t

ere is no

orm requirement

or suc

cases to un

ergo systematic inquiry or to

eporte

to any supervisory nationa

registry. T

e RCOG s

consi

er t

equirement at t

e time o

e steri

ization gui

ine review in 2007 [1]. T

us,

common scenario in t

ega

setting is to cast ju

gment on t

neg

igence or nonneg

igence in cases wit

nown mec

anism o

steri

iza

ion

ure. Base

on poo

ing t

e 81 cases o

steri

ization

ure wit

ocu

ente

interva

to pregnancy an

mec

anism o

ure, we propose

. That a greater proportion of early (within 12 months from opera

tion) t

ate (a

ter 12 mont

rom operation) steri

ization

ures

occurre

y a neg

igent mec

anism. T

us, t

e time interva

to ster

ization

ure may

e pre

ictive o

neg

igence. Our ana

ysis o

131

cases o

steri

ization

ure (in press pu

ication) s

owe

at ster

ilization failure occurred signiﬁ

cantly earlier in negligent than in

nonneg

igent

ure mec

anisms (mean

ure interva

s, 7.5 vs 14.2

months; hazard ratio 2.35 [95% conﬁ

dence interval (CI) 1.31–4.21])

. Initia

nonocc

usion is more

y to

to ear

y steri

ization

ure (wit

in 1 year), an

as it is

ess

y to

amage t

e tu

e, t

resu

ting pregnancy is more

y to

e intrauterine t

an ectopic.

Converse

ate steri

ization

ure arising

rom tu

recana

ization

or ﬁ

stula formation is more likely to result in an abnormal lumen,

pre

isposing to a

ecrease

ris

pregnancy,

ut s

pregnancy

occur, t

ere wou

e an increase

ris

ectopic pregnancy. T

point is grap

ica

y i

ustrate

in Figure 12.1.

ent

Assessment

f Ev

enc

EDLINE (1966–2006), t

e Coc

rane

rary (2006), an

e RCOG were

earc

or re

evant ran

omize

contro

tria

s, systematic reviews,

etaana

yses, an

evi

ence-

ase

gui

ines re

ating to steri

ization. T

https://t.me/med1917

12. Minimizin

the Risk of Sterilization Failure 115

earches were performed usin

the relevant medical sub

ect headin

(MeSH)

terms, includin

“sterilization, tubal”; “sterilization”; “sterilization sexual”;

“sur

ica

instruments”; “e

ectrocauter

”; “cauter

”; “

uris-

ence”; “ma

ractice”; “me

ica

errors”; “treatment

ure”; an

“ris

factors”. The ma

orit

of publications were retrospective observational studies,

case reports, an

reviews, wit

a paucit

prospective contro

tria

s or

metaanalyses [1,9,28]. The deﬁ

nitions of the types of evidence used in this

apter are as

enote

in t

e RCOG c

inica

overnance a

vice [29]. W

ere

possi

e, recommen

ations on strate

ies to minimize steri

ization

ure are

annotated with the level of evidence that supports them (A, B, C, or GPP [

ood

ractice

oint]), as in

icate

in Ta

e 12.4

ng the R

sks of Ster

zat

on Fa

lur

atient Selection

(

Level GPP

)

ere is

imite

evi

ence t

at preexisting gyneco

ogica

pat

ogy, in

addition to increasing the technical difﬁ

culty of performing the sterilization

proce

ure, in

epen

ent

y pre

isposes to steri

ization

ure. Factors inc

preexisting tu

isease,

istory o

omina

or pe

vic surgery,

istory o

pelvic inﬂ

ammatory disease, previous ectopic pregnancy, pregnancy or post-

partum state, o

esity, prior use o

an intrauterine contraceptive

evice, previ

ous induced abortion, congenital uterine anomalies, ﬁ

roi

s, en

ometriosis,

osa

pingo

astosis an

enomyosis [10,11,19,30–34]. T

e myt

sterilization protects against pelvic inﬂ

ammatory disease has recently been

enge

[35].

le 12

Levels of Evidence Used in This Cha

ter

A Requires at least 1 randomized controlled trial as part o

a body o

literature o

overall good quality and consistency addressing the

speci

ic recommendation (evidence levels Ia, Ib)

B Requires the availability o

well-controlled clinical studies but no

randomized clinical trials on the topic o

recommendations (evidence

eve

s IIa, II

, III

)

C Requires evidence obtained

rom expert committee reports or opinion

and/or clinical experiences o

respected authorities; indicates an

absence o

directly applicable clinical studies o

good quality (evidence

eve

)

Good practice Recommended best practice based on the clinical experience o

point (GPP) guideline development group (equivalent to authors o

this chapter)

https://t.me/med1917

16 R. Varma and J.K. Gu

repregnanc

Test

ng and T

ng of Procedure

elation to Menstrual Cycle (Level C

)

oth hysteroscopic and laparoscopic tubal occlusion may be performed

t any time during the menstrual cycle provided that the clinician is certain

hat the woman has used effective contraception up until the da

of the

eration

t is recommended practice that all women have a urine pregnancy test

rior to sterilization. Routine preoperative same-da

urine pre

nanc

testin

hould be done as this has been shown to reduce the incidence of

re- and

ost

roce

ure pregnancies, t

atter group terme

utea

-p

ase pregnancies (see

e 12.3 an

section

ow) [36]. However, suc

a test may sti

y neg-

tive in a very ear

y pregnancy. A serum

uman c

orionic gona

otropin (

CG)

reoperative

y may

e consi

ere

;

owever, i

ere is any

t, t

en t

e ster

lization should be deferred until the follicular phase of a subsequent cycle.

rocedure Contrace

tion and the Need to Continue

Unt

l Onset of Next Menstrual C

cle (to Reduce R

sk of

uteal-phase Pregnancy) (Level GPP

)

ontraception is immediately effective if the patient is using the combined

ill (if commenced between day 1 and day 5 of period) and the Mirena intra-

terine s

stem. However, with laparoscopic tubal occlusion, contraception is

ikel

to be completel

effective onl

the onset of the next menses. There

ore, for this method, preprocedure contraception measures should be contin-

ed until the onset of next menses to

revent lutea

hase pre

nanc

failure

Table 12.3). This is where sterilization has occurred just after ovulation, and

he ovum is already proximal to the tubal occlusion, enabling pregnancy to

ccur in this luteal phase through poststerilization “unprotected” intercourse.

Studies have identiﬁ

ed the occurrence of luteal pregnancy in 0.32% to 0.6% of

terilization cases [10,36–38]

omen selectin

steroscopic sterilization (Essure) need to continue

ith contraceptive precautions for at least 3 months postprocedure and ma

resume “unprotected” sexual intercourse only after there is conﬁ

rmation of

atisfactor

tubal occlusion (e.

., b

x-ra

sterosalpin

ram)

the Operat

on: Interval Preferred (Level B)

herever

ossible, tubal occlusion should be

erformed at an a

riate

nterval followin

pre

nanc

. Sterilization can be performed in the post -

artum period (combined with cesarean section or via minilaparotom

) or

https://t.me/med1917

12. Minimizin

the Risk of Sterilization Failure 117

posta

ortion. However, t

is perio

is associate

wit

er rates o

ure

ret

e woman [38,39], an

ese

actors s

e incorporate

into t

e counse

ocumentation prior to t

e proce

ure. In terms o

postpartum steri

ization, sa

pingectomy an

ie c

ave simi

ar rates o

ure (7.5 an

8.8 per 1000, respective

) [10,38]

election of Technique: Laparoscop

Preferred ove

aparotomy (Level B)

ach combination of sterilization method and

atient characteristics has

speciﬁ

c advantages, disadvantages, and individualized failure rates. This infor-

mation should be conve

ed durin

the counselin

process. A metaanal

sis [40]

and large population study [41] have shown no signiﬁ

iff

in f

rate or ma

or operative morbidit

between minilaparotom

and laparoscop

methods of sterilization. However, la

arosco

ic methods have lower minor

operative morbidit

and are preferred for interval sterilizations, as the

offer

obvious advanta

es in terms of shorter operative time, same-da

hospital

dischar

e, and shorter convalescence period. Ultimatel

, as h

steroscopic

terilization becomes more widespread and established worldwide we envisa

this will eventuall

become the preferred sterilization method of choice in the

next 2 to 5

ears

elect

on of Techn

que: Mod

ed Pomero

at Cesarean

ection (Level B)

A modiﬁ

ed Pomeroy procedure rather than Filshie clip application may

e pre

era

or postpartum steri

ization per

orme

y mini

aparotomy or at

e time o

cesarean section, as t

s to

ower

ure rates [10,38,42],

oug

proce

ures are equa

y popu

ar c

oices wit

surgeons [43]

elect

on of Techn

que: F

lsh

e Cl

p Ster

zat

on Is

referred Method (Level B)

wo small randomized controlled trials

[

44,45

]

and observational studies

[12,46] have shown the Filshie clip to have the lowest failure rate for interval

terilization failure, and it has therefore been recommended b

the RCOG [1]

as the preferred method at laparoscopic tubal occlusion (Table 12.2). Rin

methods have also been recommended b

the RCOG and appear to have con

traceptive efﬁ

cacy equal to that of the Filshie clip. However, ring methods tend

to be technically more difﬁ

cult to apply to the fallopian tubes and have gradu-

all

become less popular in UK clinical practice

https://t.me/med1917

18 R. Varma and J.K. Gu

Operat

ve Techn

que for F

lsh

e Cl

p (Levels C and GPP

)

dent

Correct Isthm

c Port

on of Tub

are s

e ta

en to ensure t

at t

e Fi

ie c

ip is app

to t

e optima

idisthmic tubal site (1 cm to 3 cm from the uterine cornu) and that this

tructure not

e mista

or “steri

ization” o

an a

jacent structure, suc

e roun

igament or a

peritoneum

etween t

e roun

igament an

ube [47].

orrectly Al

gn Cl

p and Ensure Cl

p and Tube are Flattened

e Fi

ie c

ip s

e app

in a manner to: comp

ete

encapsu

ate

e tu

e an

umen,

lly

wit

e upper

aw compresse

e com

pletely ﬂ

attened, and have its end adequately secured under the latch, (which

“locks” the clip jaw, see Figure 12.3). The clip should ﬂ

atte

the

hole

tube

portion within the clip without leaving any unﬂ

atte

tubal

“

uckles

”

out transectin

e tu

e. Fina

lly

, t

e c

ip s

sit perpen

icu

ar to t

axis o

e tu

e [47],

aci

itate

stretc

e ist

mic portion wit

e placed on the antimesenteric aspect of the tube.

void Clip Overclosure (Technique and Usin

Serviced Clip Applicator)

xcessive forceful clip applicator overclosure (Figure 12.3) or underclo-

ure may

to tu

transection an

sequent steri

ization

ure t

roug

luminal regeneration (i.e., tubal ﬁ

stu

a or recana

ization) or incomp

ete tu

cclusion [47]

Wide Length of Upper

Clip Jaw Under Latch

Latch for Upper

Jaw

Latch Clip Jaw

Tubal Lumen

Hinge

Correct Closure of Clip

Locked Clip Under Latch

Flattened Upper Jaw

Complete Tubal Lumen Occlusion

Underclosure of Clip

Narrow Length of Upper

Clip Jaw Under Latch

Locked Clip Under Latch

Rounded/Blowed Upper Jaw

Incomplete Tubal Lumen Occlusion

Caused by Operator Fault

ure 12.3. Filshie clip under-closure due to operator fault. Despite the clip appearin

ocked, on closer inspection the upper jaw of the clip will be noted to be incompletel

com

ressed, rounded rather than flattened, and the end insufficientl

secured under the under

he latch for the upper

aw. Most causes of clip underclosure are due to operator fault.

https://t.me/med1917

12. Minimizin

the Risk of Sterilization Failure 119

pre

isposin

actor to improper c

osure is a “

” Fi

ie c

ip app

ica-

tor. T

is is rare,

owever, as it is a

requirement t

evice app

icators

e we

maintaine

equate

to ensure optimum

unction. In

e case o

e Fi

ie c

ip,

e manu

acturer (Femcare, UK, www.

emcare.

co.u

) an

e Me

ica

Devices A

enc

(MDA) stron

gly

recommen

at a

e Fi

ie c

ip app

icators

e service

rea

uste

east once a

ear

or a

ter every 100 proce

ures. Furt

ermore, a c

osing c

ing gauge

e use

prior to every steri

ization proce

ure to ensure t

at t

e app

cator

unctions correct

. T

ere is on

1 pu

case o

steri

ization,

proposes Fi

ie c

ip un

erc

osure as t

e most

y mec

anism o

teri

ization

ure. T

ere

ore, t

is cause o

ure s

e consi

ere

rare

[

]

Appl

Onl

1 Clip to Each Tub

ying 2 mec

anica

ips a

jacent to eac

er on t

e tu

oes not

ecrease t

ure rate

ut may even increase it i

ey are app

too c

ose

toget

er [47,49–51]

Do Not Fa

l to Systemat

cally Check Pos

on of Cl

p on Tube (Take Image

)

ollowin

clip application, there should be a s

stematic checkin

pro-

cedu

ect

uctu

bot

des

tube

been satisfactoril

occluded, and this procedure should be documented.

Althou

h this process is not a le

al requirement in the United Kin

dom, we

eco

ing c

inica

otograp

s or operative vi

eos o

e steri

ize

structures, i

enti

ying t

em as

opian tu

es. However, p

oto-

graphs may be unhelpful in conﬁ

dently excluding other negligent

auses o

incomp

ete tu

occ

usion, e.g., protru

ing

nuc

e o

e, ina

equate

ing o

ip jaws, c

ip un

erc

osure, or tu

ransection (partia

or comp

ete).

e presence o

a secon

operating surgeon

or counterc

ing. A

ecent stu

y invo

ving 1094 steri

izations

rom 1988 to 1989 s

owe

at registrars

a 1.3%

ure rate, consu

tants

a 1.9%

ure

ate, an

consu

tants an

registrars per

orming t

e proce

ure

together had a 0.7% failure rate [37]. A medical witness to conﬁ

e steri

ization proce

ure is a

ega

requirement in some countries

Recogn

ze That True Method Fa

lure Is Extremel

Rare

here is evidence that anatomical tubal patency can occur following a cor

rectly undertaken sterilization (true method failure); this occurrence has been

reported following correctly applied Filshie clips in 3 cases of Filshie clip

failure (Table 12.2) [53] and is implied to have occurred in the 29 of 73 cor

rect

y app

ip steri

ization

ures reporte

y an o

servationa

stu

https://t.me/med1917

20 R. Varma and J.K. Gu

12]. However, persistin

anatomica

patenc

oes not necessari

imp

teri

ization

ure, as tu

patenc

rates o

1%–2% at 3 mont

s an

16% at

ears

ave

een note

owin

correct

app

ation, wit

ctua

pregnancy occurrence o

1%–2% over t

is time perio

[22]. Even so,

true method failure is rare and difﬁ

cult to prove; nonetheless, three possible

anisms o

true met

ure are su

este

. A partia

y nonocc

segment o

umen

orme

wit

e c

ip. T

is tu

“

nuc

e,” wit

a patent

umen, can exist wit

the completely ﬂ

attened tube portion inside the clip, identiﬁ

y at microscopy

. Preexisting uterotu

structura

norma

ities. T

ese a

norma

ities

e accessory

opian tu

e, uterine

ys [54], an

utero-

tubal ﬁ

stulas.

3. Mec

anica

ure o

e Fi

ie c

ip. Manu

acturers

or t

e Fi

ave not reporte

spontaneous mec

anica

ure as a possi

or steri

ization

ure, an

is concurs wit

an a

sence o

suc

ases in t

iterature. Nevert

ess, t

ere remains at

east

eoretica

possi

ity o

mec

anica

materia

ure, an

manu

acturers suc

as Femcare o

er an examination o

e Fi

ie c

ips

steri

ization to exc

e t

e possi

ity o

ure mec

ism (Dr Marcus Fi

ie, C

Executive, Femcare UK, persona

ommunication, June 2007

)

Operator Exper

ence and Tra

Leve

s C an

GPP

)

mproper app

ication o

occ

usive

evices

y inexperience

surgeons

requent

y reporte

in cases o

steri

ization

ure [16,55,56].

e CREST stu

y s

owe

ure rates o

7.1 to 78.0 per 1000

or t

e Hu

ip an

0 to 42.5 per 1000

or t

e si

icone ring—a

epen

ent on t

e operating

enters surveye

[10]. Hig

ure rates were more common in centers

orming

ewer annua

proce

ures. T

e RCOG

as recommen

at train-

es per

orm at

east 25 supervise

aparoscopic tu

occ

usions

ore operat

ng wit

out supervision [1]

ollow-up Requ

red If Uncerta

ubal Occlus

on (Level GPP)

ollowin

a complicated sterilization,

ood clinical practice (rather than a

al requirement) dictates testin

of tubal patenc

[16,57–60]. However, a

https://t.me/med1917

12. Minimizin

the Risk of Sterilization Failure 121

ative

e spi

poststeri

ization

sterosa

ram (HSG)

oes not com

ete

prec

e t

e possi

pre

nanc

at a

ater sta

e [61]

Other Issues: Clip Migration and Dropped “Lost”

lsh

e Cl

s (Level C)

ood clinical practice dictates that proof of tubal occlusion (x-ra

HSG,

tubal dye insufﬂ

ation, or histology of salpingectomy) should be undertaken

once missing clips are identiﬁ

ed, not only when examining failed sterilization

cases, but also at laparoscop

or laparotom

for other reasons [47,62]. However,

missin

clips do not necessaril

indicate failed application or imminent pre

nanc

failure, as over time there is a tendenc

for clips to mi

rate and even be

expelled without resultin

in clinical morbidit

[12,45,63–71]. There are no

reports of clip migration leading to sterilization failures [63]. It is estimated

that more than 25% of women will experience a migration of 1 or more Filshie

clips [63]. The tissue between the Filshie clip jaws normally undergoes avas

cular necrosis and ﬁ

brosis, leaving two healed stumps, which tend to separate,

permitting c

isp

acement

ilshie clips may be inadvertently dropped during laparoscopic steriliza

tion. If possible, the clip should be laparoscopically removed upon completion

of the sterilization

rocedure. However, if the cli

is irretrievable, either o

or closed, it should be left. Performing a laparotomy would subject the woman

to greater operative morbidity risk than leaving the lost clip in the abdomen.

To date, there have been no reports of an

serious morbidit

or mortalit

consequent to a lost clip. Women should be informed of the lost clip and reas

ured accordingly [47]

onclus

on and Further Research

verall, the level of evidence supportin

screenin

or preventative

measures to reduce the risk of sterilization failure remains

oor. There a

ears

to be a propensit

for ne

ent rather than nonne

ent sterilization failures.

However, this can be veriﬁ

ed only by establishment of a national register of

failed sterilizations (as recommended b

the RCOG [1]) that have been sub

ected to s

stematic inquir

to establish the mechanism of failure. Like other

conﬁ

dential inquiries, such a registry could identify areas of substandard care

that could be used as an impetus to improve research and medical trainin

terilization procedures and help desi

n effective clinical risk-prevention

trategies. The introduction of an operative checklist or proforma, similar to

the preoperative counselin

checklist recommended b

the RCOG [1] and used

in another stud

[72], ma

result in reduced numbers of ne

entl

performed

ste

riliz

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eferen

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ilization in an outpatient settin

. F

ertil

teril

2004;82:196–199

6. Kerin JF, Cari

nan CS, Cher D. The safet

and effectiveness of a new h

steroscopic

method for permanent birth control: results of the ﬁ

rst Essure pbc clinical study.

ust

stet G

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. 2001;41:364–370.

7. Cooper JM, Carignan CS, C

er D, Kerin JF. Microinsert nonincisiona

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teri

ization.

stet G

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8. Du

y S, Mars

F, Rogerson L, et a

. Fema

e steri

isation: a co

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ESSURE versus

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isation.

ste

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9. Varma R, Gupta JK. Failed sterilisation: evidence-based review and medico-legal

ramiﬁ

cations.

bste

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10. Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of

pregnancy after tubal sterilization: ﬁ

ndings from the US Collaborative Review of

terilization. A

bstet Gynecol

1996;174:1161–1168.

1. Trussell J, Guilbert E, Hedle

A. Sterilization failure, sterilization reversal, and

pre

nanc

ter steri

ization reversa

in Que

ec.

stet G

neco

. 2003;101:677

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2. Kovacs GT, Krins AJ. Fema

e steri

isations wit

ie c

ips: w

at is t

e ris

ure?

A retrospective survey o

30,000 app

ications.

am P

Repro

Hea

are.

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3. Peterson HB, Xia Z, Hug

es JM, Wi

cox LS, Ty

or LR, Trusse

J. T

e ris

ectopic

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ter tu

steri

ization. US Co

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eld AJ. The Filshie clip for female sterilization: a review of world experience.

bstet

ynecol

2000;182:485–489

5. Stovall TG, Lin

FW, O’Kelle

KR, Coleman SA. Gross and histolo

ic examination

of tubal li

ation failures in a residenc

trainin

pro

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61–465.

https://t.me/med1917

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