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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.
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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
734
Fig. 1
Essure micro-insert with radiologic markers. Reprinted with permission from Bayer AG.
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
Table 1
Treatment and response in symptomatic women tested for nickel
hypersensitivity
Patch test positive
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
736
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].
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
Adelman et al.
Essure Complications
737
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
738
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.
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
Adelman et al.
Essure Complications
739
Table 6
Unintended pregnancy, case series
Source
No. in cohort
Details
3
3
1615
294
1
10
391
6000
3
22
544
2621
4242
1321
HSG 5 hysterosalpingogram.
No. of pregnancies
740
Table 7
Combined case reports of 9 unintended pregnancies
Collective sources
Details
(Combined)
Outcomes
(combined)
Fig. 3
Details of the Cleary et al. [61] systematic review of pregnancies after hysteroscopic sterilization.
Adelman et al.
Essure Complications
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