Female sterilization and refertilization

Anneloes N.J. Huijgens *, Ce line M.J.G. Lardenoije, Helen J.M.M. Mertens

Department of Gynecology and Obstetrics, Orbis Medical Center, Dr. H. van der Hoffplein 1, 6162 BG Sittard-Geleen, The Netherlands
1. Introduction
Female sterilization is a common method of contraception
worldwide. In the Netherlands, more than 10,000 sterilizations
are performed each year [1]. Surgical techniques to occlude tubal
patency include the application of a mechanical device, tubal
electro-coagulation, and tubal excision, with or without separa-
tion. In Western countries, laparoscopic tubal occlusion is the most
common surgical method for sterilization [1].
Data regarding the effectiveness and regret of sterilization are
limited. While sterilization at the time of a cesarean section (CS)
eliminates the need for additional surgery, it is known to be less
effective due to oedematous and friable fallopian tubes in the early
postpartum period [2], and it should be noted that this timing
for deciding on denitive contraception is associated with higher
rates of regret [3]. In this study, we analyzed data reported for
sterilization and refertilization in the south of the Netherlands
during the past decade.
The sterilization techniques used in the Netherlands are the
Filshie clip, the Falope ring, bipolar electrocoagulation, and the
Pomeroy, Irving, and Uchida techniques [1]. Bipolar electrocoa-
gulation, the Filshie clip and the Falope ring are mostly applied and
usually performed by laparoscopy. The Pomeroy, Irving, and
Uchida methods are mostly performed by laparotomy; the Irving
method may also be accomplished by laparoscopy. Hysteroscopic
sterilization procedures have been introduced recently, but these
techniques were not performed in this cohort and, therefore, will
not be discussed.
2. Materials and methods
This study included all patients who underwent surgical tubal
sterilization for contraception between 2002 and 2011 in the Orbis
Medical Center (OMC), as well as all patients who underwent a
refertilization between 2002 and 2012 in the OMC.
The OMC is an independent teaching hospital in the south of the
Netherlands. All data were analyzed retrospectively. The follow-up
lasted until 2012.
European Journal of Obstetrics & Gynecology and Reproductive Biology 175 (2014) 8286
A R T I C L E I N F O
Article history:
Received 18 July 2013
Received in revised form 10 January 2014
Accepted 23 January 2014
Keywords:
Sterilization
Refertilization
Sterilization failure
Complications
A B S T R A C T
Objective: To analyze data on sterilization and refertilization procedures that took place at Orbis Medical
Center in Sittard, a hospital in the south of the Netherlands.
Study design: Retrospective cohort study of surgical tubal sterilizations performed on 966 patients for
contraception between 2002 and 2011, and of 19 patients who underwent refertilization between 2002
and 2012. The main outcome measures were complications and failure rates of sterilization, motives for
refertilization and pregnancy rates after refertilization. The t test and nonparametric tests were used to
determine differences between groups and proportions.
Results: Between 2002 and 2011, the number of sterilizations declined. Almost all the patients (99.8%)
underwent laparoscopic sterilization. The most common method of sterilization used Filshie clips, and
was used in 99.7% of the women. The median age at the time of sterilization was 37 years. The failure rate
was 0.3%. All procedures were uneventful. The number of refertilizations during this time period also
declined. The median time between sterilization and refertilization was 65 months. Patients who
underwent refertilization were signicantly younger at time of sterilization than patients who did not
(p < 0.001). After refertilization, 12 patients (63.2%) became pregnant.
Conclusions: The complication and failure rates of laparoscopic sterilization are low. The number of
laparoscopic sterilizations and the number of refertilizations are both declining. Still, refertilization is a
safe procedure and gives a signicant chance of becoming pregnant.
2014 Elsevier Ireland Ltd. All rights reserved.
* Corresponding author. Tel.: +31 88 4597787; fax: +31 88 4597463.
E-mail address: anneloeshuijgens@gmail.com (Anneloes N.J. Huijgens).
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and
Reproductive Biology
j ou r nal h o mepag e: w ww. el sevi er . co m / l ocat e/ ej og r b
0301-2115/$ see front matter 2014 Elsevier Ireland Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ejogrb.2014.01.026
2.1. Sterilization
At the OMC, Filshie clips were used for tubal occlusion. The
Filshie clip is made of titanium and silicone rubber with a diameter
of 3 mm. It is bent around the Fallopian tube by an applicator. The
rubber expands to keep the lumen blocked as tubal necrosis occurs.
The clips need to be placed straight on the complete diameter of
the midisthmic part of the fallopian tube [1,4,5]. The clips were
placed during laparoscopic surgery or during a CS. Occasionally, in
case of doubt or incorrect positioning, a second clip was placed. If
the clip could not be placed on the complete diameter of the tube,
or if the tube was bleeding after the attempted placement, bipolar
coagulation was performed.
2.2. Refertilization
Each patient and her partner desiring refertilization under-
went investigation and examination, including male and female
fertility tests and a psychological examination. Refertilization
was performed by laparotomy. Reanastomosis was achieved
by suturing, using suture size 6/0 or 8/0. All refertilization
procedures were performed by the same gynecologist. After
surgery, tubal patency was not routinely checked.
2.3. Statistical analysis
Statistics were performed using IBM SPSS statistics 19. The t test
and nonparametric tests, including x
2
test and Fishers exact test,
were used to determine differences between groups and propor-
tions. A p-value < 0.05 was considered to be statistically signi-
cant.
3. Results
3.1. Sterilization
Between 2002 and 2011, 966 patients underwent tubal
sterilization. Of all the patients, 964 women (99.8%) were sterilized
by laparoscopy and two women (0.2%) were sterilized at the time
of CS. The Filshie clip method was used in 963 women (99.7%),
while bipolar coagulation was used in three women (0.3%) because
of thick hemorrhagic tubes. The mean age (SD) of the patients at
the time of laparoscopic sterilization was 36.4 5.4 years (median
age was 37 years). The mean age (SD) of the patients sterilized at the
time of CS was 36.0 1.4 years (median age was 36 years). Mean age
did not signicantly differ between the two groups or over the course
of the time period for which this study was performed (Fig. 1). After
sterilization, the mean time (SD) of follow-up was 7.1 2.8 years
(median follow-up time was 7.6 years).
The number of sterilizations decreased signicantly through
the years. In 2002, there were 162 patients who underwent
sterilization. From 2003 on, there was a rapid decline, with only 56
patients undergoing sterilization in 2011 (Fig. 2).
3.2. Failure
Overall, three patients (0.3%) became pregnant after steriliza-
tion. They were all sterilized by laparoscopic tubal occlusion using
Filshie clips. Each procedure was performed by a different
gynecologist. All three sterilization procedures were uneventful.
The rst patient was sterilized in 2009 and was 40 years old at
the time of sterilization. Sixteen months later, she became
pregnant. She decided to continue the pregnancy and delivered
at term. Afterwards, her partner chose to be sterilized.
The second patient was sterilized in 2008 and she was 35 years
old at the time of sterilization. Sixteen months later, she became
pregnant. She decided to abort in the 7th week. At the same
time, laparoscopic resterilization was performed by two gyne-
cologists. It was determined that the right tube was not
completely enclosed by the clip, but the left tube was completely
enclosed. New Filshie clips were placed on both tubes. After-
wards, hysterosalpingography (HSG) showed that both tubes
were occluded.
The third woman was sterilized in 2009, when she was 33. Six
weeks later, she became pregnant and decided to abort. At the
same time, laparoscopic resterilization was performed. The right
tube turned out to be completely enclosed by the clip. The left clip,
on the other hand, was located just next to the tube. A second clip
was placed on the correct location. After this, an extra Filshie clip
was placed on both tubes. After the procedure, HSG was performed
to check the occlusion of the tubes. Again, there was a possibility
that the left tube was still open. Therefore, the partner of the
patient chose to be sterilized.
3.3. Refertilization
Between 2002 and 2012, 19 patients underwent refertilization.
Overall, 17 patients (89%) were sterilized by Filshie clips and two
patients (11%) by Falope rings. All procedures were uneventful. The
mean time (SD) between sterilization and refertilization was
6.2 4.0 years (median time was 5.4 years). Most women regretted
the sterilization because of a new, childless relationship (n = 14, 74%).
Other reasons for regret were religious (n = 1, 5%), death of a child
(n = 1, 5%), or unknown (n = 3, 16%).
year
2011 2010 2009 2008 2007 2006 2005 2004 2003 2002
A
g
e

a
t

s
t
e
r
i
l
i
z
a
t
i
o
n

t
h
r
o
u
g
h

t
h
e

y
e
a
r
s
60
50
40
30
20
10
428 892
785
717
601
602
354
366
452
342
343
415
234
187
190
217
112
5
Fig. 1. Age at sterilization during the years 20022011. Boxplot of age at sterilization during 20022011, demonstrating that mean age at sterilization did not signicantly
differ through the years.
A.N.J. Huijgens et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 175 (2014) 8286 83
After refertilization, the mean follow-up time (SD) was
7.7 3.4 years (median follow-up time 8.7 was years). During
follow-up, 12 patients (63%) became pregnant, while seven (37%) had
not yet been able to. Of the 12 pregnant women, nine (75%) delivered
at term at least once (which corresponds to 47% of the total cohort),
two (25%) experienced only miscarriages, and one (8%) had an ectopic
pregnancy. The method of sterilization did not inuence the
pregnancy rate or birth rate (NS).
The mean age (SD) at sterilization of the patients who
underwent refertilization was 27.0 4.1 years (median age was
27.0 years). Patients who asked for refertilization were signicantly
younger at the time of sterilization than patients who did not request
refertilization (p < 0.001) (Fig. 3).
The number of refertilizations decreased during the past
decade: ve patients (26%) in 2002, four patients (21%) in 2003,
ve patients (26%) in 2004, one patient (5%) in 2005, one (5%) in
2008, one (5%) in 2011, and two patients (11%) in 2012 (Fig. 4).
year
2011 2010 2009 2008 2007 2006 2005 2004 2003 2002
N
u
m
b
e
r

o
f

s
t
e
r
i
l
i
z
a
t
i
o
n
s
180
160
140
120
100
80
60
40
20
0
Fig. 2. Number of sterilizations per year. Graph of the number of sterilizations per
year during 20022011, demonstrating a rapid decline in the number of procedures
after 2003.
refertilization
no yes
A
g
e

a
t

s
t
e
r
i
l
i
z
a
t
i
o
n
50
40
30
20
10
234
969
187
190
217
428
892
112
785
5
1.012
Fig. 3. Age at which patients underwent sterilization for both those who either did
or did not have refertilization performed. Boxplot of the age at which patients
underwent sterilization and then did or did not have refertilization performed,
demonstrating that patients who underwent refertilization were signicantly
younger at the time of sterilization than patients who did not ask for refertilization
(p < 0.001).
Fig. 4. Number of refertilizations per year. Graph of the number of refertilizations per year during 20022012, showing a rapid decline in the number of procedures after 2004.
A.N.J. Huijgens et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 175 (2014) 8286 84
4. Comments
4.1. Sterilization
In the Netherlands, tubal sterilization is a laparoscopic surgical
procedure, except for immediate postpartum sterilization per-
formed during a CS [1,5]. Filshie clips are preferred for laparoscopic
or laparotomic tubal occlusion because, while they have similar
failure rates, there is a higher rate of minor morbidity (OR: 2.15;
95% CI: 1.22, 3.78) and of technical difculties (OR: 3.87; 95% CI:
1.90, 7.89) for tubal ring sterilization versus clip sterilization [68].
For laparotomic sterilization at the time of the CS, Filshie clips were
preferred because they are easier to apply and have equal failure
rates compared to the Pomeroy technique (p = 0.03), as conrmed
by Kohaut et al. [9] and Madari et al. [10]. This is in conict with the
study of Rodriguez et al. [11], which shows decreased efcacy of
the clip compared with partial salpingectomy in the postpartum
population. However, the conclusion of this article is based on
limited data. Moreover, the quality of this review is under
discussion [12].
In the last decade, we have seen a decline in sterilization rates
and refertilization rates at the OMC. This trend has been shown in
the rest of the Netherlands as well. The decline is probably due to
good alternative methods of contraception and changes in
compensation by health insurance [1].
4.2. Failure rate
At one year post-sterilization, the risk of pregnancy for women
sterilized by Filshie clips is 1.12.5 per 1000 women, and for
bipolar electrocoagulation and Falope ring, failure rates are 2.3 per
1000 women and 2.55.9 per 1000 women, respectively [1,5,7].
Failure rates for the Filshie clip and the Pomeroy technique are
similar [4]. At the OMC, the failure rate (0.3%) was lower than the
failure rates reported in previous analyses.
Several indirect factors are thought to predispose a patient to
failure of the sterilization procedure. Incomplete tubal occlusion
may result in pregnancy (surgeon failure). Complete or partial
tubal transection may be due to improper use of a clip and luminal
regeneration. Incorrect application of the occlusive devices by
inexperienced surgeons is a common factor in sterilization failure
[8].
Tubal patency can also occur despite correctly applied
sterilization. Tubal patency rates of 12% at three months and
16% at ve years, with a 12% occurrence of pregnancy, are seen
following correctly applied devices. Spontaneous tubal lumen
regeneration (method failure) might occur because of tubo-
peritoneal stula formation or reanastomosis and recanalization
[8]. The exact etiology of tubal lumen regeneration has never been
reported. Younger age and longer periods of time since surgery
favor sterilization failure. Pre-existing gynecological pathology can
also result in a predisposition for sterilization failure [8].
The CREST study, which was a large, prospective multicenter
observational study, identied 143 failures of sterilization (1.3%).
The cumulative 10-year probabilities of pregnancy were highest
after the clip sterilization (36.5 per 1000 procedures), and lowest
after unipolar coagulation (7.5 per 1000 procedures) and
postpartum partial salpingectomy (7.5 per 1000 procedures).
The Filshie clip was not included in that study [13].
4.3. Complications
At the OMC, the risk of complications was very low, and
corresponded with the risks reported in the literature. Complica-
tions result from the sterilization technique (i.e. laparoscopy and
laparotomy), the method of sterilization, or the anesthesia [1].
While the risk of complications after laparoscopic sterilization is
low (15 per 1000 women), wound infection, hematoma and
perforation of the uterus, bladder, or intestine occur in 0.41% of all
procedures. Major complications are related to general anesthesia,
sepsis, and hemorrhage. Severe sepsis generally results from
unrecognized thermal bowel injury during unipolar coagulation.
Myocardial infarction and pulmonary embolus also contribute to
perioperative mortality [5]. Mortality due to sterilization is
extremely rare. U.S. mortality rates of tubal sterilization are 14
deaths per 100,000 procedures, and are primarily due to
hypoventilation and cardiopulmonary arrest during general
anesthesia. Sterilization in the postpartum period has a greater
risk for complications due to the indications for which the CS was
performed and due to an increased risk of thrombo-embolic
complications [5,14,16].
As reported in the literature, each sterilization method has its
own complications. For the Pomeroy method, the most common
complication is slippage of the suture ligatures with retraction of
the tube. This risk is minimized by placement of two sutures and
exerting traction only on the distal suture. For the Irving and the
Uchida methods, the most common complication is bleeding.
Retraction of the distal segment can occur, but can be prevented by
placing traction on the distal segment, or by placing a suture
around the distal stump and attaching it to the serosa before
closure of the serosa is completed. In the banding procedures
(Falope ring), complications are seen during the tubal transaction if
the tube is drawn into the inner cylinder too quickly and the bands
are placed on the proximal and distal tubal segments. Large tubes
require a modication in technique to assure complete occlusion.
Of all Filshie clips, 625% become detached and eventually encased
in dense adhesions. Rarely, migration results in organ penetration,
pain, or other morbidities [5]. Both the Falope ring and the Filshie
clip can cause bleeding because of injury to the tubes (5 in 1000
procedures). Less than 1 in 1000 procedures results in infection,
since this is more common in extended procedures, in the presence
of the pre-existent pathogens in the genital tract, and when there is
a lot of tissue destruction during the procedure causing substantial
amounts of necrosis [1].
4.4. Refertilization
Overall, regret after sterilization is seen in approximately 3
25% of women, but only 12% of all women who have undergone
sterilization seek reversal [5]. In our cohort, 19 patients underwent
sterilization reversal during the last decade. These patients were
signicantly younger at the time of sterilization than patients who
did not seek reversal (p < 0.001). The main reason was the desire to
have a mutual child with a new partner.
This is supported by worldwide reported analysis, showing that
the main reason for regret is a new relationship or increased age.
Women 30 years of age and younger at the time of sterilization had
an increased probability of expressing regret during follow-up
interviews within 14 years after the procedure [1,3,1416]. Other
common factors associated with regret are religious, socioeco-
nomic, and educational backgrounds, and unpredictable life
events, such as the death of a child [5,17]. Sterilization during
the postpartum period is associated with higher rates of regret. The
cumulative probability of regret during the postpartum period is
16.117.8% over 14 years after sterilization [3]. Parity, once
considered important in determining eligibility for sterilization,
does not correlate with sterilization regret and should not be a
reason to deny the procedure [18,19].
At the OMC, after refertilization, 63% of the patients became
pregnant and 47% delivered at term. This is lower than reported by
Schippert et al., who observed a pregnancy rate of 73.0% with a
delivery rate of 50.6% [15]. This discrepancy may be explained by
A.N.J. Huijgens et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 175 (2014) 8286 85
the small cohort size in our study and the short time of follow-up
for some of the patients. However, pregnancy rates of only 3555%
have also been reported previously. For example, Kim et al.
reported a pregnancy rate of 54.8% after microsurgical reversal in a
cohort of 1118 patients [8,20].
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