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Complications of hysteroscopic Essure

sterilisation: report on 4306 procedures

performed in a single centreB 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 d Investigacions Biomediques 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 [email protected]

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.

DesignRetrospective 7-year study.

SettingOffice hysteroscopic unit in a teaching hospital.

Sample A total of 4306 women whoe underwent the Essure

sterilisation procedure from 2003 to 2010.

MethodsData 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 measuresPlacement 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).

ResultsA 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.

KeywordsAdverse 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 EuropeanUnion, after the technology was introduced in 2001. Com-

pared 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 trans-

cervical route of accessing the fallopian tubes requires pro-

ficiency in outpatient hysteroscopy as well as familiarity

with the Essure technique. Failure to satisfactorily insert

the devices into the fallopian tubes varies from 88 to98%,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 pro-

cedure are thought to be uncommon, and are minor when

present.7 On the other hand, complications with laparo-

scopy, although rare, can be serious, including organ or

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

795

DOI: 10.1111/j.1471-0528.2012.03292.x

www.bjog.orgFertility control


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vascular injury and problems arising from general anaesthe-

sia.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 unu-

sual, as the distending media for Essure sterilisation is sal-

ine solution, and the operating time on average decreases

to around 8 minutes, with experience.10,11 Uterine and cer-

vical trauma is rare, as the procedure is completed with

small-diameter continuous-flow hysteroscopes. In a phase-

II study, 7% of women reported an adverse event, of which

vasovagal syncope was the most prevalent, followed by

device expulsion, perforation and unsatisfactory place-

ment.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 Confir-

matory radiological testing with abdominal X-ray, trans-vaginal 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 con-

trol 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 tocomprehend and sign written consent, attend the 3per-

manent birth control, and who underwent hysteroscopic

sterilisation with the Essmonth follow-up and use contra-

ception 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

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 diaze-

pam 1 hour before the procedure. Of the sample, 472

women received paracervical anaesthesia (mepivacaine

cloridrate 3%, 7.2 ml) because they found routine gynae-

cological 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, con-

tinuous-flow, 30 hysteroscope (Karl Storz Endoscopia,

Barcelona, Spain), using a saline distension medium.

Placement was performed according to the manufac-

turers instructions. Placement was considered to be opti-mal when between one and eight coils remained visible

in the uterine cavity. After insertion, the women con-

sulted and completed an oral questionnaire defining their

pain experience as none, mild (less than menses), moder-

ate (similar to menses) or severe (more than menses).

All women who underwent Essure placement were dis-

charged 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 per-

formed 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 posi-

tion of the devices were not clear in the pelvic X-ray a

TVU was performed with recourse to HSG if the ultra-

sound was equivocal (i.e. if the transversal section of the

uterus did not show both devices at the uterotubal junc-

tion). 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 proce-

dure, 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 complica-

tion. 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.

Povedanoet al.

796 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology 2012 RCOG


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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


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events identified were associated with serious long-term

medical problems. Indeed 75% of complications were

minor, self-limiting episodes of vasovagal syncope, a phe-

nomenon associated with any form of uterine instrumenta-

tion, 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 obstruc-

tions. In two other cases, the expulsion was partiallytowards 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 ser-

ies only two women presented with an allergy to nickel.

This low incidence could be explained by the very low pro-

portion 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 uri-

nary 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 anti-

biotic treatment prior to the Essure procedure is not

recommended.Our series supports the contention that Essure hystero-

scopic sterilisation is acceptable, with


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involved in the conception and design of the study, per-

formed statistical analyses, performed the final analysis of

the data, drafted and revised the article for important intel-

lectual content, and approved the final version.

Details of ethics approvalThe 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 em-

phasised the irreversibility of the procedure, and included

the possibility of failure to achieve sterilisation at first

attempt. IRB Reina Sofia University Hospital. January

2003.

FundingNone to declare.j

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Complications of Essure sterilisation

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