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Review Article

Management of Complications Encountered With Essure


Hysteroscopic Sterilization: A Systematic Review
Marisa R. Adelman, MD*, Mark W. Dassel, MD, and Howard T. Sharp, MD
From the Department of Obstetrics and Gynecology, University of Utah, Salt Lake City (all authors).

ABSTRACT Essure hysteroscopic sterilization has been US Food and Drug Administrationapproved in the United States since 2002.
Complications associated with the Essure device include improper placement (malpositioning), unintended pregnancy,
pain, infection, and nickel allergy. The rarity of complications, compounded by underreporting, makes it difficult to determine
best practices insofar as management. This systematic review synthesizes the national and global experience with management of Essure-related complications and suggests treatment options when data allow. Journal of Minimally Invasive Gynecology (2014) 21, 733743 2014 AAGL. All rights reserved.
Keywords:

DISCUSS

Chronic pain; Complication; Essure; Hysteroscopic sterilization; Malposition

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Essure (Bayer AG, Leverkusen, Germany) is a hysteroscopic sterilization procedure in which a dynamically expanding micro-insert is placed in the proximal section of
the fallopian tube. The insert is composed of an inner stainless steel coil and an outer expanding coil of nitinol, which is
a nickel and titanium alloy. The inner coil houses polyethylene terephthalate fibers, which induce localized tissue
ingrowth, resulting in tubal occlusion (Fig. 1). Optimal
placement is defined as 3 to 8 mm of the proximal device
visible at the ostium and is roughly equal to 3 to 8 visible
coils. This enables the reminder of the insert to span the
proximal isthmic portion of the tube. Satisfactory positioning allows for some deviation, with less than 50% of
the length of the inner coil located in the uterine cavity or
the inner coil being less than 30 mm from the uterine cornua,
as delineated by contrast material. Suboptimal placement
has been associated with expulsion and migration of the device [1]. Various methods of confirming tubal sterilization
Disclosures: None declared.
Corresponding author: Marisa R. Adelman, MD, Department of Obstetrics
and Gynecology, University of Utah, 30 N 1900 East, Ste 2B200, Salt Lake
City, UT 84132.
E-mail: marisa.adelman@hsc.utah.edu
Submitted February 27, 2014. Accepted for publication March 21, 2014.
Available at www.sciencedirect.com and www.jmig.org
1553-4650/$ - see front matter 2014 AAGL. All rights reserved.
http://dx.doi.org/10.1016/j.jmig.2014.03.019

are used worldwide, including pelvic radiography and ultrasound. In the United States, however, the US Food and Drug
Administration requires, and the American College of Obstetricians and Gynecologists recommends, confirmatory
hysterosalpingography at 3 months after placement of the
device. In the phase II study of the device, tubal occlusion
was achieved in 96% of women with successful bilateral
placement, with occlusion in 100% at 6 months. The 5year cumulative pregnancy rate is 2.6 per 1000 procedures
[2], and although this is evidence of a reliable and efficacious
method of sterilization, expulsion or migration of the device,
placement in the endometrium, perforation of the uterus or
fallopian tube, and pregnancy are rare events that do occur.
Failure to induce occlusion, and incorrect placement, can
have implications beyond that of unreliable contraception
alone. In addition to unintended pregnancy, uterine and tubal
perforation can result in chronic pain. Most pregnancies that
occur can be causally linked to patient noncompliance with
contraception or follow-up imaging, physician noncompliance with application of follow-up protocols, and misinterpretation of confirmatory imaging [3]. Complications
associated with correct positioning can also occur, including
infection and nickel allergy. Because of the relative rarity of
complications associated with Essure permanent sterilization, evidence-based strategies for management have been
lacking. The present review will serve as a summary of

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Journal of Minimally Invasive Gynecology, Vol 21, No 5, September/October 2014

Fig. 1
Essure micro-insert with radiologic markers. Reprinted with permission from Bayer AG.

complications, with focus on management strategies that


have been reported in the literature and recommendations
as to how management strategies should be applied.
PubMed, Scopus, Embase, and the Cochrane Library
were queried with the following search strategy: (Essure
AND [complications OR complication OR adverse]) OR
(Essure OR hysteroscopic OR transcervical OR endoscop*
OR microinsert OR nonincisional OR intrauterine) AND
(tubal OR tube OR tubes) AND (occlusion OR occlusions
OR sterilization OR sterilizations OR endometrial ablation OR endometrial ablations) AND (complications
OR complication OR adverse OR perforation OR perforat* OR pain OR malposition* OR bleeding OR hemorrhag* OR infection OR infections OR [bowel OR
intestin*]) AND ([injury or injuries] OR ectopic OR pregnancy OR pregnancies). Only English language articles
were considered.
Assessment of Evidence
The search generated 594 sources including clinical trials, systematic reviews, case series, and case reports. The
titles and abstracts were reviewed for relevance, and a full
text review of 107 articles was completed. Only English
language articles were included. There was a wide range
in level of evidence of the articles identified. Furthermore,
heterogeneity of the studies, lack of randomized trials, and
inherent rarity of the complications encountered precluded
reliable meta-analysis. The evidence judged to be informative is presented and forms the basis for recommendations
and conclusions.

Nickel Allergy
Allergic contact dermatitis from nickel hypersensitivity is
a type IV reaction, also known as delayed-type hypersensitivity, which results in cell-mediated T-cell activity.
Common manifestations of contact allergic reactions are
contact hypersensitivity, such as eczema, generalized dermatitis, and urticaria. Data from the North American Contact
Dermatitis Group, which has patch tested .25 000 individuals, show a steady increase in nickel sensitivity, from 14.5%
in 1992 to 18.8% in 2004, with a consistently higher percentage of women affected [4]. Several case reports and case
series have documented adverse events due to suspected
nickel hypersensitivity, some with confirmed sensitization
at skin patch testing and others with normal results.
Al-Safi et al [5] described a patient in whom generalized
pruritis developed in the absence of a visible rash, 3 days after an uncomplicated hysteroscopic sterilization procedure.
The patient was referred for skin patch testing, and was
found to be hypersensitive to nickel and nitinol. Hysteroscopic removal of the device was accomplished without difficulty 8 days after the initial procedure, and the symptoms
improved [5]. Bibas et al [6] described a patient who was
seen 3 months after microinsert placement, with a generalized erythematous maculopapular rash, localized to the genital and flexural areas. The delayed hypersensitivity reaction,
which results in acute erythema of the skin folds and genital
region, was initially described in the dermatology literature
as baboon syndrome. Topical corticosteroids, oral antihistamines, and systemic corticosteroids provided no relief.
Skin patch testing confirmed nickel hypersensitivity, and

Adelman et al.

Essure Complications

735

the implants were removed via salpingectomy. Improvement


was noted after 3 days, and complete resolution occurred
within 3 months. The authors postulated that the systemic reaction to the implants could be explained by corrosion of the
nitinol after implantation, resulting in release of nickel into
the blood, as has been observed with other nitinol-containing
implantable devises [6].
In a large retrospective review of .4000 patients who had
undergone successful micro-insert placement, 2 demonstrated allergy to nickel, with 1 experiencing urticaria and
erythema shortly after the procedure and the other with
persistent generalized pruritis 1 year after insertion. In
both women the symptoms resolved after removal of the
device [7].
Zurawin and Zurawin [8] reported a series of adverse
events due to suspected nickel hypersensitivity, identified
through the Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database is a reporting system mandated for post-market surveillance and thus
is a repository for complications and their management.
There were a total of 63 reports from 2001 through 2010,
of which 20 described patients who had undergone patch
testing. Thirteen patients tested positive, and 7 tested negative. Treatments and reported responses are given in
Table 1. Documented methods of removal included cornual
resection and laparoscopic salpingectomy, although it was
not consistently documented. The micro-inserts were
removed in 11 patients, only 2 of whom had documented
incomplete resolution of symptoms, 2 planned on undergoing removal, and 2 were managed conservatively with documented symptom resolution [8]. Although the MAUDE
database can be a useful repository of information, an important disclosure is that in addition to healthcare facilities and
healthcare professionals, the reports can be initiated by the
manufacturer or by patients and may therefore be subject
to duplication and inaccuracies.

Two studies addressed patch testing prospectively. In 1


study, 25 women with positive or negative results underwent
Essure micro-insert placement [9], and in the other all patients suspected of having a nickel allergy were tested preoperatively, followed by Essure micro-insert placement [10]. In
the second study, 5234 procedures were performed, and 45
women were suspected of having a nickel allergy. Forty
patients underwent patch testing, and 24 were found to be
positive. None of the women in either study experienced
allergic reactions, and none required device removal. This
suggests that a nickel allergy of the severity that requires
removal of the micro-inserts may be rare and that hypersensitivity is not necessarily manifested by a significant allergic
reaction. Thus, in women with symptoms, without obvious
alternative cause, it may be reasonable to remove the devices
if conservative management is ineffective. The level of evidence for this recommendation is IIB, and the grade of
recommendation is 1C, per the Grading of Recommendations, Assessment, Development, and Evaluation scheme.
There is no single method by which appropriately placed
devices may be removed; however, it seems reasonable to
attempt hysteroscopic removal before confirmation of bilateral occlusion at 3 months [1115]. If the patient desires
a concomitant sterilization procedure or is seen after
bilateral occlusion has been documented, a laparoscopic
approach may be indicated.
Universal patch testing before placement of Essure
micro-inserts is not cost-effective and is not recommended.
Although nickel sensitivity is common and disproportionately affects women, the actual reported incidence of sensitivity to Essure components is low, illustrating that positive
results of patch testing do not necessarily correlate well with
clinically significant reactions. However, in those women
suspected of having a nickel allergy preoperatively, patch
testing seems reasonable, and an alternative form of sterilization should be considered in those who test positive.
When a patient exhibits symptoms postoperatively, patch
testing should be performed to confirm sensitivity, and if results are positive, the threshold for removal should be low.

Table 1
Treatment and response in symptomatic women tested for nickel
hypersensitivity
Patch test positive

Patch test negative

Treatment

Treatment

Response/outcome

2 Removed
9 Removed 4 Complete
resolutions
3 Incomplete
Resolutions
1 Asymptomatic
1 Lost to follow-up
4 Retained 2 Awaiting removal 2 With
corticosteroids
1 Asymptomatic
1 Lost to follow-up
3 Unknown

Response/
outcome
2 Complete
resolutions

Malposition
Details of malpositioning are given in Table 2. Ninety
perforations and 33 malpositionings not otherwise specified
were reported in the MAUDE database and summarized in a
Table 2
Identified malpositioning of micro-inserts

1 Complete
resolution
1 Unknown
3 Unknown

Variable

No.

Perforation
Expulsion
Migration
Malpositioning not otherwise specified

166
186
14
54

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Journal of Minimally Invasive Gynecology, Vol 21, No 5, September/October 2014

review [16], and the remainder were presented as case reports, case series, retrospective reviews, or prospective trials
[1,7,13,1626]. Management of the malpositioning was
rarely reported but included 1 cornual resection [24], 3 hysteroscopic retrievals [11,12], 6 laparoscopic retrievals
[12,13,24,2729], 8 devices left in place (retention of
intraperitoneal device) [7,12,17,24,30], 1 spontaneous
vaginal expulsion [31], and 2 devices that could not be
removed hysteroscopically and therefore the visible intrauterine coils were trimmed [7]. Management of malpositioned devices is given in Table 3. Although hysteroscopic
retrieval was generally described as being easy and not
requiring excessive traction, 1 report in particular noted multiple unsuccessful attempts at removing the device using
graspers and failure to cut the trailing metal coils using scissors [21]. In 46 cases, another micro-insert was placed after
malposition was confirmed. In most cases, it was not specifically stated whether the original device was retrieved before
replacement, although when it was stated, it was more common with expulsions into the uterine cavity rather than the
peritoneal cavity. It is important to note that resistance and
difficult visualization were commonly cited in reports of
perforation and malposition. During the phase III trial, 13
of 14 expulsions into the endometrial cavity were thought
to be due to the device being located too proximal. At that
time, micro-inserts could not be removed as part of the protocol if they were misplaced. Manufacturer labeling now
allows for removal of the micro-insert if .18 coils are present in the cavity. Removal of proximally placed or clearly
misplaced devices may decrease the number of women
who are not able to rely on the devices for contraception
or who require additional procedures [1].
The expulsion rate in the Phase II clinical trial was 0.5%
[24], and in the Phase III trial was 2.9% [1]. Most expulsions
occur before confirmation of bilateral occlusion, and there is
only a single case report of expulsion after 3 months after
hysterosalpingography (HSG) [31]. In a series of 12 patients
undergoing Essure placement with concomitant endometrial
ablation, there was a single reported incidence of a dislodged
Essure micro-insert after removal of a NovaSure bipolar radiofrequency ablation device. Expulsion of the micro-insert
was identified at post-ablation hysteroscopy and was replaced immediately without difficulty [32].

Device migration into the abdominal cavity is rare, with


a reported incidence of 0.1% [33]. Although occlusion in
the Phase II trial was documented in 100% of correctly
placed micro-inserts at 6 months, there is a single report
of tubal patency continuing at 6 months, after correct placement had been confirmed at diagnostic laparoscopy [34].
The rate of uterine or tubal perforation was 2.6% in the
Phase II trial [24], and 0.9% in the Phase III trial [1]. In
many case reports, difficult insertion was associated with
subsequently identified malposition, and in particular,
perforation. Methods to improve successful placement rates
might include placement during the follicular phase or
pretreatment hormone therapy to improve visualization.
Use of nonsteroidal anti-inflammatory drugs preoperatively
could also be used to decrease tubal spasm, as is suggested
in much of the Essure outpatient feasibility literature
[1,7,17,20,23,24,3538].
Most reports documented an alternative means of sterilization, including replacement of the micro-insert, laparoscopic tubal ligation, and salpingectomy. When managing
the complication of micro-inert malposition, one must not
forget the original indication, and incorporate sterilization
into the plan. If perforation into the uterine wall is suspected,
with most of the coil within the cavity, hysteroscopic
removal and placement of a new device into the patent
tube is recommended. Similarly, if the device has been
completely expelled into the uterine cavity, it should be
removed, followed by placement of a second device. If uterine perforation is suspected, with most of the coil in the peritoneal cavity, laparoscopic removal with placement of an
occlusive device or salpingectomy is recommended. If complete expulsion into the peritoneal cavity is suspected and
the patient has no symptoms, the device can be left in place,
and another can be placed hysteroscopically. Laparoscopic
retrieval can be considered because serious complications
rarely occur (see Bowel Obstruction or Injury). Complete
expulsion can be confirmed by absence of the micro-insert in
the proper location as seen on a 3-dimensional ultrasound
scan or radiograph. In addition, in the case of concomitant
Essure device insertion and endometrial ablation, it may
be prudent to perform post-ablation hysteroscopy immediately after the procedure to ensure correct placement of the
micro-insert.
Bowel Obstruction or Injury

Table 3
Management of malpositioning
Variable

No.

Hysteroscopic retrieval
Hysteroscopic trimming
Replacement of micro-insert
Retention of intraperitoneal device
Laparoscopic retrieval
Cornual resection

3
2
46
8
6
1

Two case reports of bowel obstruction were identified in


the literature. In both cases, the patients had progressive
pain, nausea, vomiting, and abdominal distention. Radiologic imaging was suspicious for a small bowel obstruction,
and later review revealed that the micro-inserts were malpositioned or absent from their expected locations. Laparoscopy was performed in the first case and revealed a band
of adhesions attached to the perforated end of an Essure
coil, which tracked to the distal tip of the appendix, resulting
in a closed loop obstruction. The patient underwent lysis of

Adelman et al.

Essure Complications

adhesions, appendectomy, removal of the migrated Essure


microinsert, and left salpingectomy for sterilization [39].
In the second case, laparotomy was performed, and a metal
wire was observed traversing the mesentery, ensnaring a
loop of terminal ileum. The wire was identified as a stretched
Essure device, resulting in local perforation of the bowel
wall. The strangulating coil was removed, and an ileocecal
resection was performed. The right Essure device was noted
to be absent from the fallopian tube, and clips were applied
to the fallopian tubes bilaterally [40]. In both cases, the obstructions seem to have developed secondary to device
perforation or migration. As of February 2012, 2 bowel
injury cases were reported to the MAUDE database, 1 occurring with concomitant cryoablation and the other with
concomitant bipolar radiofrequency ablation [16].
The case reports illustrate the potential for significant
morbidity that can develop in the setting of device malpositioning and emphasize the importance of recognizing inappropriate positioning early postoperatively. When evaluating a
patient with a suspected bowel obstruction, attention should
be paid to whether the devices appear to be appropriately
positioned, and management should be guided by clinical
findings. Overall, bowel obstruction seems to be a rare
complication and has not been observed with proper device
placement.
Infection
There was a single case report of a tubo-ovarian abscess
3 years after micro-insert placement, and a single case report
of bilateral cornual abscesses after endometrial ablation after micro-insert placement 1 year previously. The tuboovarian abscess was identified during laparoscopy and was
found to be ruptured. Group A b-hemolytic streptococci
were isolated, and the patient ultimately required total
abdominal hysterectomy. Examination of the specimen revealed that the Essure micro-inserts were properly placed
in the fallopian tubes, and HSG 3 months after the procedure
had confirmed bilateral tubal occlusion. While it was not
clear that the Essure micro-inserts contributed to the
ascending infection, it did not prevent it, as is observed
with other forms of tubal sterilization [41]. In the case of
the bilateral cornual abscesses, the patient was seen 3 months
after a global endometrial ablation procedure. Diagnostic
laparoscopy was converted to laparotomy because of extensive adhesive disease, at which time abscess formation and
necrosis were noted from the intramural portion of the tubes.
The necrotic tissue and micro-inserts were removed along
with the remaining portions of the fallopian tubes. Haemophilus influenzae was isolated from the abscess [42]. In a
large retrospective series of .4000 patients, Povedano
et al [7] noted 2 pelvic inflammatory disease cases, both of
which resolved after treatment with intravenous antibiotics.
Infection after Essure micro-insert placement seems to be
rare, and when diagnosed shortly after insertion may
respond well to typical treatments for pelvic inflammatory

737

disease. If a patient is nonresponsive to antibiotic therapy


alone, evaluation for tubo-ovarian abscess formation and
operative management may be indicated. The level of evidence for this recommendation is III, and the grade of
recommendation is 1C. Although data are lacking, it should
be noted that a properly placed micro-insert in which occlusion has been documented may not prevent ascending infection, as has been demonstrated clinically with other methods
of tubal ligation.
Chronic Pain
Eleven cases of chronic pain after Essure micro-insert
placement were identified, as well as 2 retrospective reviews
of the MAUDE database. Details are given in Table 4. In 5
cases, malposition of the micro-insert was identified. Cornual
perforation with subserosal placement of the micro-insert
was noted in 3 cases, 2 of which specifically cited difficult
insertion. A cornual perforation was demonstrated at laparoscopy (Fig. 2A) and HSG (Fig. 2B). One of the devices was
removed hysteroscopically, 1 was removed laparoscopically
by unroofing the serosa and teasing the device out using
gentle traction, and the third was discovered during hysterectomy [28,30,43]. Two patients experienced prolonged
periods of pain, with lengthy evaluations. In both patients,
removal of the devices from the peritoneal cavity ultimately
required. One patient experienced pain for 3 years and
underwent laparoscopy before the micro-insert was eventually identified on a computed tomography (CT) scan, and
underwent subsequent removal via laparoscopy with intraoperative fluoroscopy [44]. Another patient experienced pain
for 4 years and underwent 1 laparoscopic and 3 laparotomy
procedures before several pieces of the micro-insert were
identified on a CT scan and removed via laparotomy with intraoperative fluoroscopy [27]. In all 5 patients with pain and
malpositioned devices the pain resolved postoperatively.
Eight cases of persistent pain were identified, which were
without evidence of perforation. These included 4 normal
ultrasound examinations, 3 normal hysteroscopic examinations, and 1 normal radiographic examination. A single radiograph suggested a perforation, which was not present at
laparoscopy. All of the patients underwent bilateral microinsert removal via either a hysteroscopic or laparoscopic

Table 4
Causes of chronic pain
Variable

No.

Perforation
Malpositioning not otherwise specified
Intraperitoneal device
Multiple micro-inserts
Concomitant endometrial ablation
No malpositioning identified

62
5
2
2
4
14

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Journal of Minimally Invasive Gynecology, Vol 21, No 5, September/October 2014

Fig. 2
(A) Cornual perforation demonstrated laparoscopically. (B) Hysterosalpingogram demonstrates left corneal perforation (arrow) and tubal patency (arrowheads). Lt 5 left; Rt 5 right. Reproduced with permission from Dr. John Thiel, MD, Provincial Academic Head of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan Regina, Saskatchewan.

approach. When completed laparoscopically, salpingectomy


was favored. Four of 7 patients experienced complete resolution of pain postoperatively [14,19,45,46], a fifth noted
improvement in progressive daily pain but with continued
intermittent abdominal pain [47], and the outcome in another
is unknown [22]. In the final patient, in whom the microinserts were thought to be correctly placed, chronic abdominal pain did not resolve after laparoscopic salpingectomy
and appendectomy [19].
In the Phase II clinical trial, 59% of participants reported
resolution of post-procedural pain within 1 day, 88% within
3 days, and 99% within 7 days. The remaining 2 patients reported resolution of pain within 14 days [24]. In a large retrospective review of .4000 patients who had undergone
successful micro-insert placement, only 1 reported persistent
pain [7].
Two retrospective reviews of the MAUDE database were
identified, 1 in 2009 and 1 in 2013. In 2009, there were 20
reports of persistent pain [3]. The causes of pain are given
in Table 4. In 2013, there were 217 reports of pain, ranging
from the time of insertion to years after the procedure. In 54
cases, perforation was discovered during evaluation. Pain
was reported in 47.5% of all reports submitted to the database [16].
Management of pain after micro-insert placement should
include a workup for perforation and other malpositioning,
in particular when resolution has not occurred within
2 weeks. Pelvic radiography or ultrasound should be the
initial imaging method, with HSG used for nondiagnostic
studies. Failure to identify a perforation can have longterm consequences, most notably chronic pain. When an
intraperitoneal micro-insert is suspected as the cause of
chronic pain, intraoperative fluoroscopy may be useful in
identifying the device as a whole or pieces that have detached, and may avert future operative interventions. This
is particularly helpful when the implant has been identified
on a radiograph, CT scan, or magnetic resonance image
but cannot be identified intraoperatively.

Unintended Pregnancy
A variety of reports present data on unintended pregnancy. Limited information is available, however, on how
pregnancy has been managed. There is 1 review in the
MAUDE database describing pregnancies reported as of
February 2012. There were 61 pregnancies, 29 of which
were ectopic. In 4 cases, pregnancy occurred within the first
3 months, and in 23, HSG had been completed, with evidence of bilateral occlusion [16]. It is clear that this is a gross
underestimation inasmuch as numerous reviews of reports to
the manufacturer have documented many more pregnancies
[2,3,16,4850]. Details are given in Table 5. In most cases,
the cause of pregnancy can be categorized as failure to complete post-procedure follow-up, failure to use appropriate
contraception before confirming occlusion, misinterpretation of confirmatory imaging, malpositioning of the device,
and pregnancy before placement. Noncompliance of the
physician and patient accounted for the largest percentage
of pregnancies in the literature, followed by misinterpretation of the imaging. The most common identifiable factor
was malposition, including expulsion, uterine perforation,
and tubal perforation. Luteal phase pregnancies also accounted for a large percentage of pregnancies within the first
3 months.
Table 5
Unintended pregnancy: reports to the manufacturer or MAUDE
database
Source

No. of recorded pregnancies

Kerin [49], 2005


Levy et al [2], 2007
Connor [3], 2009
Levy et al [50], 2011
Jost et al [48], 2013
Al-Safi et al [16], 2013

37 (location not indicated)


64 (location not indicated)
169 (4 ectopic)
748 (location not indicated)
54 (1 ectopic)
61 (29 ectopic)

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Essure Complications

739

image was either misinterpreted or the patient did not return


for follow-up [54]. Seven case reports were identified, accounting for 9 pregnancies [36,5560]. Details are given in
Table 7.
A single systematic review of pregnancies after hysteroscopic sterilization identified 22 articles involving Essure,
11 of which reported no pregnancies. The remaining 11
articles reported 102 pregnancies. Details of the reported
pregnancies are shown in Figure 3. Few pregnancies
occurred in women with confirmed bilateral tubal occlusion,
with the longest follow-up being 7 years [61].
With a large percentage of Essure device failures after
incomplete or failed confirmatory testing [53], the importance of tubal occlusion confirmation cannot be underemphasized. Although concomitant Essure placement and
endometrial ablation is safe [6264] and feasible for both
control of abnormal uterine bleeding and prevention of
pregnancy [64,65], the development of Asherman syndrome
related to endometrial ablation has made it difficult to
ensure tubal occlusion. In 2011 Detollenaere et al [66] found
HSG confirmatory testing to be inadequate in 25% of cases of
concurrent Essure placement and endometrial ablation. A
2007 analysis of 25 concomitant endometrial ablations and
Essure placements reported 21 patients with bilateral tubal
occlusion at HSG at 3-month confirmatory testing. Of the 4
other patients, 2 did not return for follow-up and 2 had failed
confirmatory testing due to cervical stenosis (at 3-month
HSG) and synechiae too severe to evaluate tubal patency (at
9-month HSG). The patient with cervical stenosis refused
further follow-up, and in the other patient proper placement

In a retrospective survey of pregnancies reported to


physicians in France as well as to the manufacturer, 58 pregnancies were identified. Eight full-term pregnancies, 9 miscarriages, 30 induced abortions (1 specifically because of
a genetic abnormality), and 1 ectopic pregnancy were
documented [48].
There have been several large prospective case series. Details are given in Table 6 [7,18,20,25,5154]. In 1 such case
series conducted in Spain, 3 pregnancies occurred after 1321
women underwent successful placement. Five-year data
were available for 1200 of those women. The effectiveness
was calculated at 99.75% [52], which was similar to an efficacy of 99.74% reported by the manufacturer in phase III
studies [1]. Three pregnancies were reported in a retrospective cohort of 294 successful procedures performed at the
Detroit Medical Center. Post-placement HSG was not documented in any of the 3 women because of patient noncompliance with the follow-up protocol. There was unilateral
absence of the device on ultrasound in all 3 patients, suggesting device expulsion or perforation. Two patients had term
deliveries, and the third had a first-trimester miscarriage
[25]. Twenty-two pregnancies were reported in a cohort of
women from Kaiser Permanente Northern Californian after
2621 successful placements. The 3 most common reasons
for failure were misinterpretation of the HSG, failure to
obtain an HSG, and pregnancy after the HSG showed nonreliance. The perfect-use device failure was estimated at 4.5%
of all failures [53]. Ten pregnancies were reported in the
Netherlands from 2002 through 2008, after approximately
6000 procedures had been performed. In several cases, the

Table 6
Unintended pregnancy, case series
Source

No. in cohort

Details

3
3

1615
294

Pinto et al [51], 2010


Veersema et al [54], 2010

1
10

391
6000

Andrade et al [18], 2012


Deraleau and Heinlein [53], 2012

3
22

544
2621

Povedano et al [7], 2012

4242

Rios-Castillo et al [52], 2013

1321

3 Occurred within 90 days (1 not using contraception)


3 Associated with unilateral absence
3 Failed to obtain HSG
1 Unknown cause
2 Associated with perforation
3 Associated with expulsion
3 Associated with unilateral placement
1 Occurred before placement
1 Unknown cause
3 Not described in detail
7 Associated with misinterpreted HSG
6 Associated with HSG showing nonreliance
5 Failed to obtain HSG
4 Not described in detail
3 Occurred within 90 days (1 not using contraception)
1 Associated with perforation
3 Not described in detail
2 Occurred before placement
1 Associated with migration

Arjona et al [20], 2008


Shavell et al [25], 2009

HSG 5 hysterosalpingogram.

No. of pregnancies

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Journal of Minimally Invasive Gynecology, Vol 21, No 5, September/October 2014

Table 7
Combined case reports of 9 unintended pregnancies

Collective sources

Details
(Combined)

Outcomes
(combined)

Duffy et al [56], 2005


3 Perforations 3 Full-term deliveries
Levie and Chudnoff [36],
2 Expulsions 3 Elective
2006
terminations
Hastings-Tolsma et al [57],
1 Unilateral
1 Spontaneous
2007
placement
miscarriage
Moses et al [59], 2008
Ory et al [60], 60
Ploteau and Lopes [55], 2009
Marcos Gonzalez [58], 2012

of the devices was confirmed at CT. No long-term pregnancy


data were available for this series [67]. Although confirmatory testing in the United States is HSG, other countries
have different requirements for confirmation of tubal occlusion. Studies from these countries have demonstrated no
difficulty with confirmatory testing using radiography or 3dimensional ultrasound and have reported no subsequent
pregnancies [68,69].
The Carotid Revascularization Endarterectomy vs Stenting Trial (CREST), which included data from .10 000
women, determined the cumulative risk of pregnancy to be
13.1 per 1000 procedures for all common methods of tubal

sterilization and included follow-up data for up to 14 years


[70]. The 5-year cumulative pregnancy rate of Essure hysteroscopic sterilization is 2.6 pregnancies per 1000 procedures
[2], which compares favorably.
There are insufficient data to guide treatment of pregnancy after hysteroscopic sterilization, although poor obstetric outcome does not seem to be associated with the presence
of micro-inserts. At present, there is no indication to terminate a pregnancy or to attempt removal of the device in the
context of pregnancy.
Although some may consider unintended pregnancy a
failure rather than a complication, it is important to keep
in mind that a large number of these failures are preventable or occur secondary to an aforementioned complication
such as malposition. The most effective treatment for unintended pregnancy after Essure hysteroscopic sterilization is
thus prevention. Adherence to strict follow-up protocols,
requiring contraception before placement or performing
the procedure in the follicular phase, providing effective
post-sterilization contraception, and recognizing that difficult insertion can be associated with malposition are all
ways of proactively preventing pregnancy.
Ectopic Pregnancy
There were 2 reports of ectopic pregnancy, one resulting in
tubal rupture and the other not definitively localized. In the
case of the tubal rupture, the patient underwent emergency

Fig. 3
Details of the Cleary et al. [61] systematic review of pregnancies after hysteroscopic sterilization.

Adelman et al.

Essure Complications

exploratory laparotomy, with identification of a left-sided


ectopic pregnancy and findings of appropriately placed
micro-inserts. The patient had previously undergone HSG,
which confirmed bilateral tubal occlusion. Repeat HSG
3 months after rupture of the ectopic pregnancy showed right
tubal patency [71]. In the second case, a patient had a pregnancy of undetermined location 4 years after hysteroscopic
tubal sterilization. A postoperative HSG had confirmed bilateral tubal occlusion, although .50% of the coils were within
the endometrial cavity, which does not meet the criteria set
forth by the manufacturer for satisfactory location. The patient underwent dilation and curettage and laparoscopic bilateral salpingectomy because she did not desire fertility. At
laparoscopy, there was no obvious tubal or adnexal disease,
although a left-sided tubal perforation was apparent. No chorionic villi or an implant site were identified in the pathology
specimen. When the b-human chorionic gonadotropin concentration continued to increase postoperatively, treatment
using methotrexate was successful [72].
Treatment of an ectopic pregnancy associated with previous Essure sterilization should focus on well-established
management protocols involving use of methotrexate and
surgical intervention, as well as prevention of future pregnancy. As with unintended intrauterine pregnancy, one
must consider that one or both of the micro-inserts is malpositioned or absent and take measures to ensure sterility, if
that is desired.
In conclusion, complications of Essure sterilization are
rare, and reports are therefore sparse. Although complications are reported to the MAUDE database and even to the
manufacturer directly, it is likely that complications are
grossly underreported. Owing to lack of randomized
controlled trials and reliance on large case series, the level
of evidence on which to base recommendations is level II
at best, with most cases being level III. With that in mind,
the following conclusions are presented:
 The most commonly reported complications of Essure
hysteroscopic sterilization are malpositioning, chronic
pain, unintended pregnancy, infection, and nickel allergy.
 Complications do not seem to occur in isolation, and
commonly involve uterine or tubal perforation, device
expulsion, and device migration.
 Failure to diagnose an improperly placed micro-insert can
have consequences beyond ineffective contraception, and
in rare cases can result in severe morbidity.
 A common reason for failing to diagnose a malpositioned
device is physician and patient noncompliance with
follow-up protocols.
 Pregnancy in the setting of properly placed devices is
often the result of noncompliance with post-procedural
contraception or pregnancy at the time of placement.
 If surgical removal is performed in a patient without
symptoms, all attempts should be made to remove the
entire device, using intraoperative fluoroscopy when
indicated.

741

 Management of complications should be individualized,


and when well-established protocols exist, as in the case
of ectopic pregnancy and pelvic inflammatory disease,
treatment should follow standard of care.
Acknowledgments
We thank Mary McFarland, Information and Technology
Consultant, Eccles Health Sciences Library, for invaluable
assistance in conducting the database searches.
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