Fertility control

DOI: 10.1111/j.1471-0528.2012.03292.x
www.bjog.org

Complications of hysteroscopic Essure

sterilisation: report on 4306 procedures
performed in a single centre
B Povedano,a JE Arjona,a E Velasco,a JA Monserrat,a J Lorente,a C Castelo-Brancob
a
Department of Obstetrics and Gynaecology, Reina Sofa University Hospital, Cordoba, Spain b Institute Clinic of Gynaecology, Obstetrics
and Neonatology, Faculty of Medicine, University of Barcelona, Hospital Clinic-Institut dInvestigacions Biome`diques August Pi i Sunyer
(IDIBAPS), Barcelona, Spain
Correspondence: Dr C Castelo-Branco, Institut Clnic de Ginecologia, Obstetrcia i Neonatologa, Hospital Clnic, Villarroel 170, 08036
Barcelona, Spain. Email castelobranco@ub.edu

Accepted 15 January 2012. Published Online 23 February 2012.

Objective To analyse the short-, medium- and long-term

complications in women undergoing hysteroscopic tubal

sterilisation with the Essure device.
Design Retrospective 7-year study.
Setting Office hysteroscopic unit in a teaching hospital.
Sample A total of 4306 women whoe underwent the Essure

sterilisation procedure from 2003 to 2010.

Methods Data on the success of the procedure and complications

arising from outpatient hysteroscopic sterilisation using the

Essure system were collected from consecutive women
undergoing the procedure over a 7-year period.
Main outcome measures Placement rate, successful bilateral

tubal occlusion, perioperative adverse events, early postoperative

(during the first 3 months of follow-up) and late complications
(after the initial 3 months of follow-up).

Results A total of 4108 (96.8%) women completed the standard

3-month follow-up protocol. Only 534 (13%) women had
undergone the procedure within the previous year. There were
115 (out of 4306; 2.7%) recorded complications, none of which
resulted in the need for hospitalisation or discharge later than
2 hours after the procedure. Vasovagal syncope was the most
frequently encountered adverse event, occurring in 85 (2.0%) of
4306 cases. In 19 cases, one device was expelled, with most
expulsions (14 out of 19) being detected before or during the
3-month follow-up.
Conclusions Outpatient hysteroscopic sterilisation using the

Essure system is safe, with a low rate of complications.

Keywords Adverse events, complications, Essure

hysteroscopic

tubal sterilisation.

Please cite this paper as: Povedano B, Arjona J, Velasco E, Monserrat J, Lorente J, Castelo-Branco C. Complications of hysteroscopic Essure sterilisation:
report on 4306 procedures performed in a single centre. BJOG 2012;119:795799.

Introduction
Hysteroscopic sterilisation using Essure (Conceptus,
Mountain View, CA, USA) has been used increasingly
throughout the world, especially within the European
Union, after the technology was introduced in 2001. Compared with classic laparoscopic sterilisation techniques
(bipolar coagulation, Hulka clips, Filshie clips and silicone
rings), hysteroscopic sterilisation can be performed with
less surgical time in an outpatient clinic setting, without
the need for surgical incisions or general anaesthesia, and
with superior patient tolerance and patient satisfaction.14
However, the ability to complete the procedure is generally

lower than traditional laparoscopic approaches. The transcervical route of accessing the fallopian tubes requires proficiency in outpatient hysteroscopy as well as familiarity
with the Essure technique. Failure to satisfactorily insert
the devices into the fallopian tubes varies from 88 to
98%,1,4,5 although successful placement appears to be
improving as experience amongst gynaecologists increases
in conjunction with continued improvements in Essure
technology.6
To date, complications associated with the Essure procedure are thought to be uncommon, and are minor when
present.7 On the other hand, complications with laparoscopy, although rare, can be serious, including organ or

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Povedano et al.

vascular injury and problems arising from general anaesthesia.8,9 Possible adverse events with the Essure procedure
are related either to the general hysteroscopic approach or
the specific Essure placement technique. Complications
such as fluid overload and electrolyte disturbances are unusual, as the distending media for Essure sterilisation is saline solution, and the operating time on average decreases
to around 8 minutes, with experience.10,11 Uterine and cervical trauma is rare, as the procedure is completed with
small-diameter continuous-flow hysteroscopes. In a phaseII study, 7% of women reported an adverse event, of which
vasovagal syncope was the most prevalent, followed by
device expulsion, perforation and unsatisfactory placement.5 Pain during and after the procedure, bleeding and
dyspareunia have also been described.5 Persistent pain has
been reported, but is unusual and, if present, raises the
possibility of tubal perforation by the device, which may
affect around 12% of procedures.12,13 Migration to the
cavity can also occur without tubal perforation.14 Confirmatory radiological testing with abdominal X-ray, transvaginal ultrasound (TVU) or hysterosalpingogram (HSG),
according to local protocols, is mandatory to establish
satisfactory device placement and/or tubal occlusion. Early
expulsion of a device from the tube and uterine cavity is
usually diagnosed at this time, but if this takes place after
the 3-month follow-up test it may remain undetected,
leaving the patient at risk of an unwanted pregnancy.15
There is a need for more data regarding the feasibility
and safety of hysteroscopic sterilisation. We therefore
undertook a study to analyse the practicality and short-,
medium- and long-term complications of hysteroscopic
tubal sterilisation using the Essure permanent birth control system.

Methods
All women attending the Andalusia Health Service in
Cordoba requesting permanent birth control, and who
underwent hysteroscopic sterilisation with the Essure
system at the Reina Sofa University Hospital between
March 2003 and June 2010 were identified. A total of
4306 women were included in this study carried out
from March 2003 to June 2010. The inclusion criteria
for hysteroscopic sterilisation were women aged 18
45 years desiring permanent birth control and able to
comprehend and sign written consent, attend the 3permanent birth control, and who underwent hysteroscopic
sterilisation with the Essmonth follow-up and use contraception until then. Women were excluded if they had
abnormal uterine bleeding, active pelvic inflammatory
disease or uncertainty about their desire to end their
fertility. All procedures were carried out or supervised by
four gynaecologists (B.P., E.V., J.M. and J.L.) experienced

796

in the Essure technique. Of the 4306 procedures, 1683

were performed by resident gynaecologists and 293 were
performed by external training gynaecologists.
The procedures were scheduled to be performed in the
follicular phase of the menstrual cycle, unless women
were taking oral contraceptives, in which case they were
advised to take their pills continuously for at least a
month prior to the intervention. All women received
premedication with oral ibuprofen and 10 mg of diazepam 1 hour before the procedure. Of the sample, 472
women received paracervical anaesthesia (mepivacaine
cloridrate 3%, 7.2 ml) because they found routine gynaecological examination painful, had a tight cervical os or
were anxious.1 A vaginoscopic approach to hysteroscopy
was adopted routinely, and the Essure microinserts were
placed through the 5F working channel of a 5-mm, continuous-flow, 30 hysteroscope (Karl Storz Endoscopia,
Barcelona, Spain), using a saline distension medium.
Placement was performed according to the manufacturers instructions. Placement was considered to be optimal when between one and eight coils remained visible
in the uterine cavity. After insertion, the women consulted and completed an oral questionnaire defining their
pain experience as none, mild (less than menses), moderate (similar to menses) or severe (more than menses).
All women who underwent Essure placement were discharged home on the same day of the procedure.
Women were advised to use an alternative contraceptive
method until a simple pelvic X-ray examination was performed at least 3 months after the insertion. Placement was
considered satisfactory when both devices appeared to be
within the tubal lumen, had symmetrical appearance, ends
that looked opposite one another and when the distance
between the intrauterine ends was not >4 cm. If the position of the devices were not clear in the pelvic X-ray a
TVU was performed with recourse to HSG if the ultrasound was equivocal (i.e. if the transversal section of the
uterus did not show both devices at the uterotubal junction). In addition, HSG was performed when the placement
was not satisfactory (more than eight or less than one coils
remaining visible by hysteroscopy, insertion only in one
tube or highly difficult procedure). On confirmation of
adequate placement at the 3-month follow-up visit,
women were advised to rely on the Essure system for
contraception.
Adverse events were recorded at the time of the procedure, at the 3-month follow-up and at each gynaecological
check-up. The telephone number of the unit was given to
all the women, who were advised to report any complication. All general practitioners and general gynaecologists in
the healthcare reference area were advised to report and
refer the subject in the case of complications being detected
in Essure users.

2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology 2012 RCOG

Complications of Essure sterilisation

Results
The mean age of the sample was 36 years, ranging from 19
to 49 years, with 1306 women aged 4049 years, 2687 aged
3039 years, 315 aged 2029 years and three women who
were <20 years old. Of the 4306 women undergoing hysteroscopic Essure sterilisation, 4242 (98.5%) were successfully completed, of which 4075 were successfully sited at
one attempt (96%), without the need for a second-stage
procedure at a later date. A total of 4108 (96.8%) women
complied with the 3-month radiological follow-up. The
majority of women had follow-up beyond 1 year, with only
534 cases having had the procedure within the previous
year (Figure 1). The rate of successful bilateral obstruction
(including unilateral occlusion in women with only one
tube) was 99.7% (4095/4108). One or both tubes remained
patent in 13 women (0.3%), representing a 3.1:1000 failure
rate (Figure 2).
A total of seven women (0.16%), three before and four
after the 3-month follow-up, became pregnant. The pregnancy rate after assessment for satisfactory placement was
0.09%. In one subject who became pregnant 32 months after
the procedure, the 3-month control pelvic X-ray and vaginal
ultrasound scan suggested that the devices were well placed,
and the HSG performed after delivery showed an apparent
bilateral occlusion. However, laparoscopy demonstrated a
unilateral tubal perforation.
The most frequent perioperative complication was vasovagal syncope, occurring in 85 women (1.9%). Of 19 device
expulsions (0.4%), 14 occurred during the early postoperative period; in 13 women another device was placed, and
in two other women the expulsion was incomplete, and in
these cases the coils trailing into the cavity were cut. Subsequent HSG demonstrated correct bilateral tubal obstruction. In three cases the devices were erroneously placed in

4306 Patients

4242 (98.5%)
Successful insertion

42 one tube
(Salpinguectomy or
unicornuate uterus)

4108 (96.8%)
3 months
radiology*
4095 (99.6%)
success
obstructions

4200 both tubes

64 (1.5%)
no insertion

29 no insertion
one tube

35 no insertion
both tubes

134 (3.2%) lost

to follow up

13 (0.3%)
unsuccessful
obstructions

Figure 2. Flow chart of the trial process (success/failed insertion and

obstructions with Essure). *Abdominal X-ray, transvaginal ultrasound
and/or hysterosalpinogram.

the myometrium (0.06%). In two other cases, asymptomatic migrations into the abdominal cavity (0.04%) were
detected, as were two cases of pelvic inflammatory disease
(0.04%). Both women with abdominal migration of one
device underwent another placement, retaining the
migrated devices in the abdominal cavity. Longer term
complications included one woman who suffered persistent
abdominal pain (0.02%) and one women with tubal perforation (0.02%). Two allergies to nickel were noted. The
first case was a woman with a history of atopy, who presented shortly after the procedure with papular urticaria
and erythema, and in whom the symptoms disappeared
after the subsequent removal of both devices. The other
case was a woman referred with a history of persistent genital pruritus 1 year after the placement who decided to
remove the devices.
In 3568 women (82.8%), the perioperative pain was considered non-existent or mild, which was managed with oral nonsteroidal anti-inflammatory drugs (NSAIDS). Moderate pain
was reported by 513 (11.9%) women, and severe pain was
reported by 155 women (3.5%). In 70 cases (1.5%) pain was
not recorded at all. One subject experienced persistent
abdominal pain that did not disappear with NSAIDS. As the
pain remained after the removal of the devices, a prophylactic
appendicectomy and cholecystectomy was performed, but the
pain continued to persist. This woman is currently receiving
treatment with antidepressant drugs.

Discussion
Figure 1. Length of follow-up of women undergoing Essure
sterilisation.

This study has demonstrated Essure hysteroscopic sterilisation to be a successful and safe procedure. No adverse

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Povedano et al.

events identified were associated with serious long-term

medical problems. Indeed 75% of complications were
minor, self-limiting episodes of vasovagal syncope, a phenomenon associated with any form of uterine instrumentation, and not specific to the Essure procedure.
Interestingly, a higher incidence of vasovagal syncope was
observed in interventions performed by gynaecologists with
a shorter learning curve.1 Techniques aimed at reducing
the incidence of vasovagal syncope include performing the
procedure with smaller diameter instruments (avoiding the
use of the outflow channel) and reducing the intrauterine
pressure provided by the perfusion pump to 90 mmHg on
the appearance of vasovagal symptoms, although there is
no evidence to support these manoeuvres at present.
No serious sequelae arose from the abnormal placement
of the device. Among the 19 device expulsions recorded,
another device was placed in 13 of the women, and
3 months later the HSG performed to assess the location of
the device demonstrated secondary bilateral tube obstructions. In two other cases, the expulsion was partially
towards the endometrial cavity, and the coils seen in the
cavity were cut, showing a correct bilateral obstruction on
HSG. In the two cases of cavity migration a new device
was placed without the removal of the migrated devices.
Both patients remain asymptomatic, without pain, infection
symptoms or gastrointestinal symptoms. Nickel allergies
affect 17% of women,16 representing 721 cases of expected
nickel allergies in 4242 placements. Nonetheless, in this series only two women presented with an allergy to nickel.
This low incidence could be explained by the very low proportion of nickel in the devices, and thus allergy symptoms
only develop in a very small number of patients who are
extremely sensitive to this element. Pelvic inflammatory
disease is uncommon after hysteroscopy. Only two cases of
pelvic inflammatory disease were observed in this series,
both of which resolved after treatment with endovenous
antibiotics. Our results are in agreement with those
described by others. In a prospective study including 1952
surgical hysteroscopies, only 18 endometritis and 12 urinary tract infections, but no cases of pelvic inflammatory
disease, were observed.17 Another recent study reported
two cases (79%) of pelvic inflammatory disease after 253
diagnostic hysteroscopies.18 Therefore, prophylactic antibiotic treatment prior to the Essure procedure is not
recommended.
Our series supports the contention that Essure hysteroscopic sterilisation is acceptable, with <5% of women considering the pain experienced during the procedure as
severe, and is effective at preventing pregnancy, with only
seven pregnancies reported in over 4000 procedures. Of
these seven procedures that resulted in pregnancy, three
women did not comply with the follow-up protocol and
became pregnant prior to confirmatory radiological testing.

798

Of the four true method failures (i.e. women who became

pregnant after apparently successful procedures), one case
is of note as it occurred over 3 years after the procedure.
An HSG at 3 months had shown an apparent bilateral
occlusion. The woman decided to continue with the pregnancy, and after delivery laparoscopy showed a right tubal
perforation.19 This highlights the need for long-term data
regarding the effectiveness of Essure sterilisation in preventing pregnancy so as to better aid the counselling and
informed consenting of our patients.
Our series is the largest to date evaluating the feasibility,
safety and effectiveness of Essure hysteroscopic sterilisation. We identified all women undergoing the procedure.
However, the incidence of adverse events post-operatively
may be an underestimate as we relied upon self-reporting.
However, we did emphasise the importance of reporting
any complications to our unit via telephone, and complications were enquired about at each consultation. Moreover,
healthcare professionals in primary care and peripheral centres were encouraged to report any adverse events presumed to have arisen from the procedure. We relied upon
pelvic X-ray examination to confirm the adequacy of sterilisation, although the accuracy of pelvic X-ray has been
questioned compared with TVU or HSG.20 Whereas it is
likely that some complications may have remained undetected, we believe that it is unlikely that any major adverse
events, such as pelvic inflammatory disease or pregnancy,
occurred without our knowledge.
In conclusion, our results, the largest series by far to
date, support existing data demonstrating that outpatient
clinic tubal hysteroscopic sterilisation with Essure is feasible, successful and safe.

Disclosure of interests
The authors have received expenses from Conceptus (the
manufacturer of Essure) to attend scientific meetings and
congresses.

Contribution to authorship
BP was involved in the conception and design of the study,
performed procedures, managed the inclusion and followup of participants, collected and analysed data, and
approved the final version of the article. JEA was involved
in the conception and design of the study, performed procedures, managed the inclusion and follow-up of participants,
collected and analyses data, and approved the final version
of the article. EV performed procedures, managed the inclusion and follow-up of participants, collected data and
approved the final version of the article. JAM performed
procedures, managed the inclusion and follow-up of participants, collected data and approved the final version of the
article. JL performed procedures, collected data, reviewed
the article and approved the final version. CC-B was

2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology 2012 RCOG

Complications of Essure sterilisation

involved in the conception and design of the study, performed statistical analyses, performed the final analysis of
the data, drafted and revised the article for important intellectual content, and approved the final version.

Details of ethics approval

The study was performed in a regular practice, and all the
women demonstrated comprehension after the explanation
of the procedure and signed a written consent that emphasised the irreversibility of the procedure, and included
the possibility of failure to achieve sterilisation at first
attempt. IRB Reina Sofia University Hospital. January
2003.

Funding
None to declare. j

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