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11. Complications in H
y
steroscopic Surger
y
10
3
O
ccasiona
lly
t
h
ese simp
l
e measures
f
ai
l
to contro
l
h
emorr
h
a
g
e. T
h
is ma
y
occur i
f
resection
h
as
b
een carrie
d
out too
d
eep into t
h
e m
y
ometrium an
d
a
p
l
exus o
f
vesse
l
s opene
d
. In t
h
is case
hy
sterectom
y
,
l
i
g
ation, or u
l
trasoun
d-
gui
d
e
d
em
b
o
l
ization o
f
t
h
e anterior
b
ranc
h
es o
f
t
h
e interna
l
i
l
iac arteries may
b
e necessar
y
.
Less signifi
cant bleeding may be caused by tearing the cervix with the
tenacu
l
um. T
h
is can usua
ll
y
b
e manage
d
b
y
d
irect pressure (a sponge-
h
o
ld
ing
f
orceps is use
f
u
l
), or occasiona
ll
y a suture wi
ll
b
e require
d
. Latera
l
tears o
f
the cervix may produce signifi
cant bleeding and may also lead to excessive
a
b
sorption o
f
t
h
e
d
istension me
d
ium
.
Ad
hesi
o
n F
o
rm
a
ti
on
I
ntrauterine a
dh
esions are particu
l
ar
l
y common a
f
ter myomectomies
when 2 fi
broids are situated on opposing uterine walls. In these cases the
myomectomy is
b
est per
f
orme
d
in stages to prevent a
dh
esion
f
ormation. T
h
e
insertion o
f
a copper intrauterine
d
evice an
d
a
d
ministration o
f
estrogen mini
-
mize a
dh
esion
f
ormation
f
o
ll
owing resection, a
dh
esio
l
ysis, or
d
ivision o
f
a
s
ep
t
um.
C
onclus
i
on
T
his cha
p
ter is an evaluation of the different methods used to decrease the
risk of complications in h
y
steroscopic sur
g
er
y
. We have focused on the pre-
vention of those complications that are related to the basic principles of h
y
s-
teroscopic surgery, rather than providing a discourse on specifi
c o
p
erative
com
p
lications
.
D
espite the tremendous advances in this area of
gy
necolo
g
ical sur
g
er
y
, and
the appropriate emphasis on trainin
g
, accreditation, and critical appraisal of
new techniques, there is a surprisin
g
lack of consensus on even the most basic
techniques. Due to lack of qualit
y
research to determine the safest approaches,
we have been unable to
g
ive an
y
didactic opinions; instead, we offer a critical
account of current practices, and look forward to the time when we can
g
ive
more defi
nitive answers. Minimal access surgery has now proved its superior-
it
y
over conventional open sur
g
er
y
in a ran
g
e of operations; it is now time to
rmly establish the acceptable and safest methods for performing these opera-
tions, particularly in the fi
e
l
d
o
f
e
n
do
m
et
ri
a
l
ab
l
at
i
o
n
.
W
e have attempted to
g
ive as comprehensive an overview of the equip-
ment currentl
y
available as possible. There have been excitin
g
developments
in this area, notabl
y
in improvin
g
the safet
y
aspects of these potentiall
y
dan
-
gerous devices. Good-quality trials to confi
rm clinically the theoretical advan-
tages t
h
ese instruments possess are awaite
d
.
https://t.me/med1917

04 P. McGur
g
an and P. O’Donovan
ey Po
i
nts for Cl
i
n
i
cal Pract
i
c
e
Gener
al
Appropriate case se
l
ection is vita
l
.
P
h
ysica
l
an
d
psyc
h
o
l
ogica
l
patient preparation are equa
ll
y
i
mportant.
Confi
dence in surgery depends on appropriate training and the use
of
qua
l
ity equipment wit
h
w
h
ic
h
t
h
e surgeon an
d
t
h
eater sta
ff
are
f
ami
l
iar
.
Hy
steroscop
i
c Surger
y
Beware the diffi
cult cervical dilation; in our experience, the degree
o
f force re
q
uired is
p
ro
p
ortional to the com
p
lication rate
.
Visualizin
g
the endometrial cavit
y
before and after “blind” endome
-
trial ablation techni
q
ues is recommended
.
Select the distension media to suit the
p
rocedure and the
p
atient;
always monitor fl
ow rates and fl
uid balance.
If the uterine cavit
y
collapses, this is uterine perforation until proven
otherwise. Have a low threshold for investi
g
atin
g
iatro
g
enic trauma
if this occurs in o
p
erative
p
rocedures.
e
f
erences
1. Overton C, Har
g
reaves J, Maresh M. A national surve
y
of the complications of
endometrial destruction techniques for menstrual disorders: the MISTLETOE stud
y
.
Minima
lly
Invasive Sur
g
ica
l
Tec
h
niques—Laser, En
d
ot
h
erma
l
or En
d
oresection.
B
r J O
b
stet G
y
naeco
l
.
7;
10
4:
13
5
1
–
13
5
9
.
2. Roya
l
Co
ll
ege o
f
O
b
stetricians an
d
Gynaeco
l
ogists.
R
eport o
f
t
h
e RCOG Wor
k
in
g
P
art
y
on Training in G
y
naeco
l
ogica
l
En
d
oscopic Surger
y
. Lon
d
on: Roya
l
Co
ll
ege o
f
O
bstetricians and Gynaecologists Press; 1994.
3. Propst AM, Liberman RF, Harlow BL, Ginsburg ES. Complications of hysteroscopic
surgery: predicting patients at risk.
bstet Gynecol. 2000
;
9
6
:517–520
.
4. Ro
y
al Colle
g
e of Obstetricians and G
y
naecolo
g
ists.
R
e
p
ort o
f
the Audit Committee’s
Working Group on Communication Standards Gynaecology: Surgical Procedures.
London: Ro
y
al Colle
g
e of Obstetricians and G
y
naecolo
g
ists Press; 1995.
5. Pre-operative en
d
ometria
l
t
h
innin
g
a
g
ents
b
e
f
ore en
d
ometria
l
d
estruction
f
or
h
eav
y
m
enstrua
l
bl
ee
d
in
g
. Coc
h
rane Data
b
ase S
y
st Rev.
2002
;
3.
6. Asc
h
R, Stu
dd
J. Progress in repro
d
uctive me
d
icine. In: Nez
h
at et a
l
., e
d
s. New Yor
k
:
P
ant
h
eon Pu
bl
is
h
ing; 1998:57–85
.
https://t.me/med1917

11. Complications in H
y
steroscopic Surger
y
10
5
7. Loffer FD. Preliminar
y
experience with the VersaPoint bipolar resectoscope usin
g
a vaporizin
g
e
l
ectro
d
e in a sa
l
ine
d
isten
d
in
g
me
d
ium. J Am Assoc G
y
neco
l
Laparosc.
2000
;7:4
98
–5
02
.
8. Xia E, Feng L, Duan H. Com
b
ination o
f
h
ysteroscopy an
d
l
aparoscopy in gyneco-
l
ogic operation: an ana
l
ysis o
f
65 case
s
.
C
h
in Me
d
J
.
1998;111
:
1001
–
1003
.
9. Crane JM, Hea
l
ey S. Use o
f
misoprosto
l
b
e
f
ore
h
ysteroscopy: a systematic review.
J Obstet Gynaecol Can. 200
6;
28:373–379
.
10. Hulka J, Peterson H, Phillips J, Surrey M. Operative hysteroscopy. AAGL 1993 mem-
bership surve
y
.
J
.
A
.
A
.
G
.L
.
1995;2:133–13
6.
11. Mana
g
er D, Gerson JI, Wallweiner D, et al. Pulmonar
y
oedema and coa
g
ulopath
y
d
ue to H
y
skon. Anesth Anal
g
.
989;68:686–687
.
12. Kim AH, Keltz MD, et al. Dilutional h
y
ponatraemia durin
g
h
y
steroscopic m
y
omec-
t
om
y
wit
h
sor
b
ito
l
-mannito
l
d
istension me
d
ia. J Am Assoc G
y
neco
l
Laparosc
.
5;
2
:
23
7–
2
4
2.
13. O’Connor H. How to avoi
d
comp
l
ications at
h
ysteroscopic surgery. In: Bonnar J, e
d
.
Recent A
d
vances in O
b
stetrics an
d
G
y
naeco
l
og
y
.
2
0t
h
e
d
. Lon
d
on: C
h
urc
h
i
ll
Living
-
stone
;
199
7:
13
4–
1
45.
14. Allweiner D, et al. Addition of ethanol to the distension medium in surgical hyster-
oscopy as a screening test to prevent “fl
u
i
d
o
v
e
rl
oad.
”
eburtshilfe Frauenheilkd.
1996;56:462–469.
15. Hamou J, Fr
y
man R, McLucas B, Garr
y
R. A uterine distension s
y
stem to prevent
fl
uid intravasation during hysteroscopic surgery.
G
y
neco
l
En
d
osc
.
1996;5:131–136
.
ui
d
moni-
t
oring gui
d
e
l
ines. T
h
e a
d
h
oc committee on
h
ysteroscopic training gui
d
e
l
ines o
f
t
h
e
American Association o
f
Gyneco
l
ogic Laparoscopists.
J
Am Assoc G
y
neco
l
Laparosc.
2
000
;
7:1
6
7–1
6
8
.
https://t.me/med1917

2. Minimizin
g
the Risk o
f
teriliz
a
ti
o
n F
a
il
u
re
:
An
vidence-Based Approach
R
a
j
esh Varm
a
J
anesh K. Gupt
a
F
emale sterilization is one of the commonest procedures performed world
-
w
i
d
e. In 1999 aroun
d
50,000
f
ema
l
e steri
l
izations were per
f
orme
d
in Eng
l
an
d
i
n the National Health Service (NHS) and charitable sectors [1]. The procedure
i
s performed on mainly healthy women at their request, and the intention is
t
o occlude each fallopian tube. This ma
y
be achieved throu
g
h tubal sur
g
ical
e
xcision, application of a mechanical device, or electrocautery coagulation
Table 12.1). Where resources permit, the preferred and most widely estab
-
l
ished technique is laparoscopic tubal occlusion, which has, moreover, replaced
t
he earlier technique of performing female sterilization via minilaparotomy.
I
n t
h
e Unite
d
King
d
om, t
h
e Roya
l
Co
ll
ege o
f
O
b
stetricians an
d
Gynaeco
l
ogists
RCOG) recommends that laparoscopic sterilization be performed using either
F
ilshie clip or ring [1]. Tubal excision and separation and related techniques
e.g., Pomeroy procedure) are preferred if sterilization is performed at cesar
-
e
an delivery.
H
ysteroscopic sterilization may be considered a nonincisional, nonsurgi
-
c
al form of permanent contraception and is a promising alternative to lapa-
r
osco
p
ic tubal occlusion. The
p
rocedure involves the insertion of a small,
fl
exible titanium microinsert into each of the fallopian tubes through the
c
ervix using a gui
d
ewire an
d
a
h
ysteroscope (Essure, Conceptus Inc.,
M
ountain View, Ca
l
i
f
). T
h
e proce
d
ure is usua
ll
y per
f
orme
d
un
d
er
l
oca
l
anes
-
th
esia an
d
/or intravenous se
d
ation. A
l
t
h
oug
h
h
ysteroscopic steri
l
ization is
l
icensed in the United Kingdom, the National Institute for Clinical Excellence
NICE) consi
d
ers it to sti
ll
b
e un
d
er eva
l
uation an
d
h
as state
d
t
h
at it s
h
ou
ld
be performed only in accordance with specifi
c NICE guidance, particularly on
p
atient consent and coordinated follow-up [2]. This is mainly because there is
insuffi
cient evidence on long-term effi
cacy (single case report of failure [3] and
t
u
b
a
l
per
f
oration [4]) an
d
sa
f
ety o
f
h
ysteroscopic steri
l
ization, wit
h
t
h
e manu
-
f
acturer reporting 99.8% e
ff
ectiveness at preventing pregnancy at 2-year
f
o
ll
ow-up (
h
ttp://www.essure.co.u
k
) [5–7]. Furt
h
ermore, t
h
ere are no pu
b
-
l
is
h
e
d
ran
d
omize
d
contro
ll
e
d
tria
l
s comparing Essure
d
irect
l
y wit
h
common
ly
u
se
d
f
ema
l
e tu
b
a
l
occ
l
usion met
h
o
d
s [8]
.
https://t.me/med1917

12. Minimizin
g
the Risk of Sterilization Failure 107
ates of Ster
i
l
i
zat
i
on Fa
i
lure
C
once
p
tion that occurs after sterilization is termed sterilization failure and
can happen several
y
ears after the procedure. Publications have reported dif
-
ferences in sterilization failure rates
,
even with the same sterilization method.
S
uch variation is due to differences in the characteristics of the women under-
g
oin
g
sterilization; operator experience; operatin
g
center workload; steriliza
-
tion method chosen; and time interval to resumin
g
sexual activit
y
, and its
frequenc
y
, poststerilization [9].
T
he two lar
g
est studies that have examined failed sterilization have
reported the 10-
y
ear cumulative probabilit
y
of pre
g
nanc
y
to be 18.5 per 1000
procedures (US CREST stud
y
) [10] and 8 per 1000 procedures (Canada) [11].
The reason for the lower sterilization failure rate in the Canadian stud
y
com-
pared to the US CREST stud
y
ma
y
be predominant use of the Filshie clip and
incorporation of nonteachin
g
hospitals in the Canadian data set. However,
both studies were also signifi
cant in the following aspects:
. Utilizin
g
the superior and preferred life-table anal
y
sis method
cumulative probabilit
y
of pre
g
nanc
y
at serial time intervals since
s
terilization) for reportin
g
sterilization failure, rather than the less
a
ccurate crude failure or Pearl index outcomes that were re
p
orted
by
previous studies
.
T
ab
le 12
.
1
.
Female Sur
g
ical Sterilization Techniques
Method Techni
q
ues Comments
Ligating tube with Pomero
y
Preferred option at minilaparotom
y
,
partial or complete Fimbriectom
y
but laparoscopic salpingectom
y
i
s
tu
b
a
l
excision Sa
l
pingectom
y
an a
l
ternativ
e
Mechanical occlusion Filshie clip Less o
f
the tube is dama
g
ed,
of the tubal lumen Hulka-Clemens clip increasin
g
the chance of
Fa
l
ope ring reversi
b
i
l
it
y
Si
l
astic rin
g
Coagulation-induced Unipolar diatherm
y
Not recommended as the
f
irst-lin
e
tu
b
a
l
c
l
osure Bipo
l
ar
d
iat
h
erm
y
met
h
o
d
in t
h
e Unite
d
King
d
om
by
t
h
e RC
OG
H
y
steroscopic tu
b
a
l
Expan
d
ing meta
l
tu
b
a
l
License
d
in t
h
e Unite
d
King
d
om an
d
occ
l
usion micro-insert im
pl
ant un
d
er eva
l
uation
(Essure) Guidance
f
or usa
g
e in accordanc
e
wi
th
NI
CE
Virtuall
y
no possibilit
y
o
f
reversal
C
ontrace
p
tive
p
recautions to continu
e
f
or at least 3 months
p
ost
p
rocedur
e
and x-ra
y
HSG con
f
irmation o
f
tuba
l
o
cc
lu
si
on
https://t.me/med1917

08 R. Varma and J.K. Gu
p
ta
2
. O
b
tainin
g
f
o
ll
ow-up
d
ata
f
or at
l
east 5 to 15
y
ears
f
o
ll
owin
g
t
h
e
ste
ri
l
iz
at
i
o
n
Th
is concept o
f
cumu
l
ative ris
k
o
f
pre
g
nanc
y
is particu
l
ar
ly
important
f
or
th
ose women steri
l
ize
d
at a
y
oun
g
a
g
e (w
h
o wi
ll
b
e expose
d
to a ris
k
o
f
pre
g-
n
anc
y
f
or a
g
reater time perio
d
) an
d
f
or t
h
ose w
h
o
h
ave
b
een steri
l
ize
d
by
methods of low short- and long-term effi
cacy (because such methods, over
c
ertain time
f
rames, wi
ll
acquire a
g
reater percenta
g
e o
f
tota
l
f
ai
l
ures t
h
an
o
t
h
er more e
ff
ective met
h
o
d
s
).
B
ot
h
US an
d
Cana
d
ian
d
ata-set stu
d
ies [10,11] va
l
i
d
ate
d
t
h
is conce
p
t o
f
c
umu
l
ative ris
k
o
f
pre
g
nanc
y
. In t
h
e Cana
d
ian
d
ata set, t
h
e cumu
l
ative pro
b-
ab
i
l
it
y
o
f
pre
g
nanc
y
increase
d
f
rom 0.3% at 1
y
ear to 0.7%
by
5
y
ears an
d
0.9%
b
y 15 years [11]. T
h
is progression is
d
epicte
d
in Figure 12.1. It is t
h
ere
f
ore
i
mportant to quote women a 10-year ris
k
o
f
steri
l
ization
f
ai
l
ure, in
d
ivi
d
ua
l
ize
d
t
o eac
h
met
h
o
d
an
d
patient a
g
e, w
h
en counse
l
in
g
t
h
em
f
or t
h
e steri
l
ization
p
roce
d
ure,
b
earin
g
in min
d
t
h
at as
l
on
g
as a woman is
f
erti
l
e an
d
sexua
lly
a
ctive, s
h
e ma
y
continue to
b
e at ris
k
f
or steri
l
ization
f
ai
l
ure.T
h
e RCOG
h
as
r
ecommen
d
e
d
a 10-
y
ear steri
l
ization
f
ai
l
ure rate o
f
2–3 per 1000 proce
d
ures
b
e use
d
f
or t
h
e Fi
l
s
h
ie c
l
ip met
h
o
d
. However, t
h
is rate is
d
rawn pre
d
ominant
ly
f
rom a retrospective questionnaire stu
dy
, o
f
5-
y
ear
f
o
ll
ow-up, wit
h
an exa
g-
g
erate
d
d
enominator [12]. Given t
h
is in
f
ormation, an
d
consi
d
ering t
h
e ot
h
er
r
eporte
d
Fi
l
s
h
ie c
l
ip stu
d
ies (Ta
bl
e 12.2), 2–3 per 1000 ris
k
is more
l
i
k
e
l
y to
correspond to the fi
rst year or even annual noncumulated absolute risk of
s
teri
l
ization
f
ai
l
ure
.
Cumulative
Probability of
Pregnancy
% of Cases
1.5
Steep
Gradient
510
Years Since Sterilization
15
Initial
Non-occulusion
Predominates
Constant Rate of Tubal
Recannalization and Fistula
Formation, Combined with
Ovulatory Dysfunctional
Decline
Shallow Gradient
Age < 30
Age > 35
1.0
0.5
i
g
ure 12.1. Clinicopatholo
g
ical mechanisms proposed in sterilization failure based on
C
anadian data set
[
11
].
https://t.me/med1917

12. Minimizin
g
the Risk of Sterilization Failure 109
T
ab
le 12
.
2
.
Filshie Cli
p
: Re
p
orted Sterilization Failure Rate
s
Peri
od
D
a
t
a
Is Collected Sterilizations Sterilization T
y
pe o
f
Stud
y
From Performed Method Outcome Stud
y
Peterson, US 1978–1986 10,685; Various Overa
ll
, 18.5 per Prospectiv
e
Co
ll
a
b
orative Fi
l
s
h
ie c
l
i
p
met
h
o
d
s 1000 over 10 co
h
ort
Review o
f
was not Hulka
y
ears multicenter
Steri
l
ization use
d
, as it spring c
l
ip Hu
lk
a, 36.5 pe
r
CREST
)
[10] was not
(
1595
)
1000
l
icense
d
in Si
l
icone Si
l
icone ru
bb
e
r
t
h
e Unite
d
ru
bb
er
b
an
d
b
an
d
, 17.7 pe
r
States unti
l
(3329) 1000
1996
[
14
]
Trusse
ll
[11] 1980–1999 311,960 Main
l
y 8 per 1000 Retrospectiv
e
laparoscopic (2496
f
ailures) multicenter
Fi
l
s
h
ie c
l
i
p
Kovacs [12] 1994–1998 30,000 A
ll
Fi
l
s
h
ie 2.4 per 1000 Retrospectiv
e
(estimate) (73
f
ailures)* multicenter
Filshie [46] 1982–1992 First 202 All Filshie 2.3
p
er 1000 Case serie
s
res
p
onders (1 failure at
from a series 6 months
)
o
f 4
3
4
Birdsall [37] 1988–1989 1094 Mainl
y
12 per 1000 at Case serie
s
la
p
arosco
p
ic 12 months
†
Filshie cli
p
Sokal [45] 1984–1990 2746 Filshie clips 1.7 per 1000
f
or Randomized
vs rings (2 in
b
ot
h
ring an
d
contro
ll
e
d
eac
h
group Fi
l
s
h
ie c
l
ip
became
g
roups at
pre
g
nant) 12 months
Domini
k
[44] 1984–1990 2126 Fi
l
s
h
ie c
l
ips At 12 mont
h
s: Ran
d
omize
d
vs Hulka 1.1 per 1000
f
or controlled
c
l
ips (11 Fi
l
s
h
ie c
l
ip; 6.9 tria
l
pregnancies per 1000
f
o
r
occurre
d
: Hu
lk
a c
l
ip
9 Hu
lk
a, At 24 mont
h
s:
2 Filshie) 9.7 per 1000
f
or
Fi
l
s
h
ie c
l
ip; 28.
1
per 1000
f
o
r
Hu
lk
a c
l
ip
* O
f
the 73
f
ailures noted in the Kovacs stud
y
, 14 cases were due to operator error, 29 were properl
y
app
lied cli
p
s, and 30 cases had unknown reason
f
or
f
ailure
.
† In the Birdsall stud
y
, registrars had a 1.3%
f
ailure rate and consultants had a 1.9%
f
ailure rate, and when
b
oth a consultant and registrar per
f
ormed the procedure, the
f
ailure rate was 0.7%. Eighty-six percent
(6/7) of failed sterilizations were due to operator error (wron
g
structure, initial nonocclusion).
https://t.me/med1917

10 R. Varma and J.K. Gu
p
ta
ey Factors (Exclud
i
ng Operator Error) Ident
i
f
i
ed to
Alter Cumulative Probabilit
y
of Pregnanc
y
T
he failure rate for each sterilization method tends to stabilize over the
l
ong term (Figure 12.2) and may thus be represented as a constant lifetime risk
o
f sterilization failure (1 in 200 is
q
uoted for the Filshie cli
p
[1]). However, a
m
ore precise estimate would also be based on the patient’s a
g
e at sterilization
a
nd the subsequent number of fertile years during which the patient is at risk
o
f pre
g
nanc
y
. The Canadian data set showed that sterilization of
y
oun
g
women
30
y
ears of a
g
e) compared to older women
(
35
y
ears of a
g
e) was associated
w
it
h
an overa
ll
increase
d
a
b
so
l
ute ris
k
o
f
pregnancy a
f
ter steri
l
ization (1.5%
v
s 0.4%), an
d
t
h
at t
h
is cumu
l
ative ris
k
sta
b
i
l
ize
d
l
ater in t
h
e younger age
-
g
roup [11]. T
h
is statistic is
d
epicte
d
in Figure 12.1
.
Mu
l
tivariate regression ana
l
ysis o
f
t
h
e CREST stu
d
y [10] s
h
owe
d
t
h
at
t
he following factors were associated with an increased risk of sterilization
f
ai
l
ure:
. Sterilization method used (see Figure 12.2). Most effective were post
-
partum partial salpingectomy and laparoscopic unipolar coagula
-
tion at 7.5 pregnancies per 1000 procedures, but laparoscopic
spring-clip application had the highest risk of failure at 36.5 preg
-
nancies per 1000 procedures (Table 12.2)
.
2
. Age at steri
l
ization. T
h
e pro
b
a
b
i
l
ity o
f
f
ai
l
ure
f
or women steri
l
ize
d
at ages
<
2
8 years is greater than that for women sterilized at ages
>
3
4 years for all methods of sterilization except interval partial
salpingectomy.
3. Race or ethnicity. Black non-Hispanic women were at signifi
cantly
greater risk for sterilization failure than were white non-Hispanic
w
o
m
e
n
.
4. Study site. Substantial differences in procedure-specifi
c failure rates
between sites were observed, likely representing variation in opera
-
tor experience, requirements to teach
j
uniors, and volume of steril
-
ization operations.
Notably, the US CREST study showed no statistically signifi
cant associations
between risk of sterilization failure and history of pelvic infl
ammatory disease,
h
istory of previous abdominal or pelvic surgery, or presence of any adhesions
r
ecorded at sterilization, although these factors have been assumed empiricall
y
b
y practitioners to affect the risk of sterilization failure.
Ster
i
l
i
zat
i
on Fa
i
lure and Subsequent Intrauter
i
ne or
ctop
i
c Pregnanc
y
O
verall, for all sterilization methods, studies have shown that ectopic pre
g-
n
anc
y
ma
y
occur in 4.3%–76.0% of failed sterilizations [1]. The relative risk of
i
ntrauterine to ectopic pre
g
nanc
y
occurrence in failed sterilization varies
https://t.me/med1917

12. Minimizin
g
the Risk of Sterilization Failure 111
accor
d
in
g
to t
h
e steri
l
ization met
h
o
d
an
d
time interva
l
f
rom t
h
e steri
l
ization
proce
d
ure. Women w
h
o
h
ave
b
een steri
l
ize
d
h
ave a consi
d
era
bly
l
ower
a
b
so
l
ute ris
k
o
f
an ectopic pre
g
nanc
y
compare
d
to nonsteri
l
ize
d
f
erti
l
e
women (as sterilization protects a
g
ainst both intrauterine and ectopic pre
g
nan-
cies); however, should pre
g
nanc
y
occur, the relative risk of it bein
g
ectopic
rather than intrauterine is hi
g
her in pre
g
nant women who have been sterilized.
Women should be counseled about such risks when decidin
g
the method o
f
ste
riliz
at
i
o
n
.
Cumulative Risk of Pregnancy per 1000 Sterilization Procedures
Y
ears
S
ince
Steri
l
iz
a
ti
o
n
Bipolar
3
4
5
6
8
9
2
.3
4
.6
6.7
1
3.1
16.
5
18.3
20.7
23.3
2
4.
8
0.
7
2.3
2.3
2.3
2
.
3
2.3
2.3
2.3
7
.5
5.9
7
.6
8.3
9
1
0
1
0
1
3
6.1
6.1
7
.
7
1
8
.
2
23
.
8
2
9.1
3
0.
7
3
1
.7
3
1
.7
3
1
.7
3
1
.7
34
3
6.
5
0.6
3
.
9
4.
6
5.
4
6
.
3
6.3
6.3
6.3
7.5
7
.
5
2.5
2.5
2.5
2.5
2
.
5
2
.
5
2
.
5
2.5
2.5
2.5
B
a
n
d
C
li
p
ostpartum
salpingectomy
Fi
l
s
h
ie C
l
ip
Estimat
e
O
n
ly
)
0
5
10
20
25
3
0
35
4
0
234567891
0
Y
e
a
rs S
i
nce Ster
i
l
i
z
a
t
ion
umulat
i
ve R
i
sk of Pregnancy
ipola
r
ni
p
o
l
ar
Silicone Band
u
lk
a
Salpingectomy
ilshi
e
F
i
gure 12.2
.
Cumulative risk o
f
pregnancy by method extracted
f
rom US CREST study [10]
an
d
Fi
l
s
h
ie c
l
ip stu
d
ies [12,14]
d
epicte
d
in ta
bl
e an
d
grap
h
ica
ll
y.
https://t.me/med1917

12 R. Varma and J.K. Gu
p
ta
Th
ere were 47 ectopic pre
g
nancies in t
h
e 10,685 steri
l
ize
d
women in t
h
e
U
S CREST stu
dy
, w
h
ic
h
equates to a 10-
y
ear cumu
l
ative pro
b
a
b
i
l
it
y
o
f
ectopic
p
re
g
nanc
y
f
or a
ll
steri
l
ization met
h
o
d
s com
b
ine
d
o
f
7.3 per 1000 proce
d
ures
13]. Women steri
l
ize
d
b
y
b
ipo
l
ar tu
b
a
l
coagu
l
ation
b
e
f
ore t
h
e age o
f
30 years
h
a
d
a pro
b
a
b
i
l
it
y
o
f
ectopic pre
g
nanc
y
t
h
at was 27 times as
h
i
gh
as t
h
at amon
g
w
omen o
f
simi
l
ar a
g
e w
h
o un
d
erwent postpartum partia
l
sa
l
pin
g
ectom
y
(31.9
v
s 1.2 ectopic pregnancies per 1000 proce
d
ures) [13].
C
lass
i
f
i
cat
i
on of Causes of Ster
i
l
i
zat
i
on
ailures: The Role of O
p
erator Error
Negl
i
gent Mechan
i
sm)
The mechanism of sterilization failure should be identifi
ed through a sys-
t
ematic assessment of fallopian tube histolo
gy
, x-ra
y
h
y
sterosalpin
g
o
g
raph
y
,
a
nd direct pelvic visual inspection. Neither of the ma
j
or observational studies
o
n sterilization failure reported on the underl
y
in
g
mechanism of sterilization
failure [10,11]. Our systematic review identifi
ed only 81 cases in the world lit-
erature where the mechanism of sterilization failure had been confi
rmed by
s
uch s
y
stematic methodolo
gy
[9]
.
Sterilization failure may be classifi
ed as arising from negligent or non-
n
e
g
li
g
ent mechanisms, which ma
y
be dependent or independent of the steri
-
l
ization method utilized
(
Table 12.3
)
. If the mechanism of failure is due to
t
ubal nonocclusion or wron
g
-structure sterilization, these are considered
negligent mechanisms, whereas spontaneous tubal recanalization or fi
stu
l
a
f
ormation mechanisms of failure are considered nonne
g
li
g
ent
.
Several studies have shown operator error to represent a signifi
cant
(
if not
t
he ma
j
or) cause of sterilization failure. One summative review showed that
th
e overa
ll
10-
y
ear
f
ai
l
ure rate
f
or wor
ld
wi
d
e Fi
l
s
h
ie c
l
ip steri
l
izations was
0.56% in 10,000 women but fell signifi
cantly to 0.2% when cases caused by
o
perator error were excluded [14]. A questionnaire-based stud
y
examinin
g
F
ilshie cli
p
use in Australia showed that of the 73 sterilization failures from
30,000
p
rocedures, 14 were due to o
p
erator error, 30 were due to unknown
r
easons, and 29 occurred in the presence of a “properl
y
applied clip” [12].
A
nother stud
y
, which incorporated participants of the US CREST stud
y
,
r
eported that all 20 sterilization failures usin
g
sprin
g
clip and silicone rubber
b
and arose from im
p
ro
p
er a
pp
lication of the occlusive devices [15,16]. Of the
8
1 steri
l
ization
f
ai
l
ures reporte
d
in our s
y
stematic review o
f
pu
bl
is
h
e
d
l
itera
-
t
ure [9], 57 cases were due to operator error (wron
g
structure “sterilized” and
initial tubal nonocclusion), and 24 were not due to operator error (fi
stu
l
a
f
o
r
-
m
ation or recanalization). We have recentl
y
submitted an anal
y
sis of 131 cases
o
f sterilization failure, incorporatin
g
our s
y
stematic review, where 88 were
n
e
g
li
g
ent and 43 were nonne
g
li
g
ent sterilization failures [17]
.
M
echanical tubal occlusive methods have lower rates of tubo
p
eritoneal
stula formation than coagulation-based techniques [17–20]. This may be
b
ecause mechanical occlusion methods destro
y
much less tube (approximatel
y
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