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Female sterilization and refertilization

Anneloes N.J. Huijgens*, Celine 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

arelimited. 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 definitive 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 aremostly 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

thesetechniques 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.

TheOMC 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 analyzedata on sterilization and refertilization proceduresthat took place atOrbisMedical

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 between2002 and2011, and of 19 patients whounderwent refertilization between2002and 2012. Themainoutcomemeasures were complications and failure rates of sterilization,motives for

refertilization andpregnancy rates after refertilization. The ttest 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 commonmethod of sterilization used Filshie clips, and

wasusedin 99.7% ofthewomen. Themedianageat thetime ofsterilizationwas37 years.Thefailure 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 significantly 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 significant 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 andReproductive Biology

journal h omepage: www.elsev ier .co m/ locate/e jogrb

0301-2115/$ see front matter 2014 Elsevier Ireland Ltd. All rights reserved.

http://dx.doi.org/10.1016/j.ejogrb.2014.01.026

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2.1. Sterilization

At the OMC, Filshie clips were used for tubal occlusion. The

Filshie clip is made of titanium and silicone rubber with adiameter

of 3 mm. It is bent around the Fallopian tube by an applicator. The

rubber expands to keep the lumen blocked as tubalnecrosis 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

Statisticswereperformedusing IBM SPSS statistics19. The t test

and nonparametric tests, including x2 test and Fishers exact test,

were used to determine differences between groups and propor-

tions. A p-value

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After refertilization, the mean follow-up time (SD) was7.7 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 influence 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 significantly

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: five patients (26%) in 2002, four patients (21%) in 2003,

five 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).

year2011201020092008200720062005200420032002

Number

ofsterilizations

180

160

140

120

100

80

60

40

20

0

Fig. 2. Number of sterilizations per year. Graph of the number of sterilizations per

yearduring20022011,demonstrating a rapid decline in the number ofprocedures

after 2003.

refertilizationnoyes

Ageatsterilization

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 whoeither 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 significantly

younger at the time of sterilization than patients whodid not ask for refertilization

(p

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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 difficulties (OR: 3.87; 95% CI:

1.90, 7.89) for tubal ring sterilization versus clip sterilization [68].

For laparotomic sterilization at the time of theCS, Filshie clipswere

preferred because they are easier to apply and have equal failure

rates compared to the Pomeroy technique (p = 0.03), as confirmed

byKohaut et al. [9] andMadari et al. [10]. This is in conflict with the

study of Rodriguez et al. [11], which shows decreased efficacy 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 incompensation 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 partialtubal 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 five 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 fistula 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, identified 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 theuterus, 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 preventedby

placing traction on the distal segment, or by placing a suture

around the distal stump and attaching it to the serosa beforeclosure of the serosa is completed. In the banding procedures

(Falope ring), complicationsare seenduring 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 modification 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 thepresence

of thepre-existentpathogens in the genital tract, andwhen 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

significantly younger at the time of sterilization than patients who

didnot seek reversal (p

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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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