Review Article

cotem

D,lt Lak

d aninclulicattic rereatmts re

zation

ith o114

Essure (Bayer AG, Leverkusen, Germany) is a hystero-scopic steriliz

icrthe fallopian tube. The insert is composed of an inner stain-

a nickel and tylene terephtingrowth, resplacement isvisible at the

are used worldwide, includ

stetricians and Gynecolog

associated with correct positioning can also occur, includinginfection and nickel allergy. Because of the relative rarity ofcomplications associated with Essure permanent steriliza-

and Gynecology, University of Utah, 30 N 1900 East, Ste 2B200, Salt Lake

City, UT 84132.E-mail: marisa.adelman@hsc.utah.educoils. This enables the reminder of the insert to span theproximal isthmic portion of the tube. Satisfactory posi-tioning allows for some deviation, with less than 50% ofthe length of the inner coil located in the uterine cavity orthe inner coil being less than 30 mm from the uterine cornua,as delineated by contrast material. Suboptimal placementhas been associated with expulsion and migration of the de-vice [1]. Various methods of confirming tubal sterilization

method of sterilization, expulsion or migration of the device,placement in the endometrium, perforation of the uterus orfallopian tube, and pregnancy are rare events that do occur.

Failure to induce occlusion, and incorrect placement, canhave implications beyond that of unreliable contraceptionalone. In addition to unintended pregnancy, uterine and tubalperforation can result in chronic pain. Most pregnancies thatoccur can be causally linked to patient noncompliance withcontraception or follow-up imaging, physician noncom-pliance with application of follow-up protocols, and misin-terpretation of confirmatory imaging [3]. Complications

Disclosures: None declared.

Corresponding author: Marisa R. Adelman, MD, Department of ObstetricsSubmitted Februa

Available at www

1553-4650/$ - se

http://dx.doi.org/1itanium alloy. The inner coil houses polyeth-halate fibers, which induce localized tissueulting in tubal occlusion (Fig. 1). Optimaldefined as 3 to 8 mm of the proximal deviceostium and is roughly equal to 3 to 8 visible

device. In the phase II study of the device, tubal occlusionwas achieved in 96% of women with successful bilateralplacement, with occlusion in 100% at 6 months. The 5-year cumulative pregnancy rate is 2.6 per 1000 procedures[2], and although this is evidence of a reliable and efficaciousless steel coil and an outer expanding coil of nitinol, which is hysterosalpingography at 3 months after placement of thepanding m

ation procedure in which a dynamically ex-o-insert is placed in the proximal section of

sound. In the United StatesAdministration requires, ation, evidence-based stratelacking. The present revie

ry 27, 2014. Accepted for publication March 21, 2014.

.sciencedirect.com and www.jmig.org

e front matter 2014 AAGL. All rights reserved.0.1016/j.jmig.2014.03.019ing pelvic radiog, however, the USnd the Americanists recommendgies for managw will serveraphy and ultra-Food and DrugCollege of Ob-s, confirmatoryscanner in your smartphones app store or app marketplace.Management of Complications EnHysteroscopic Sterilization: A Sys

Marisa R. Adelman, MD*, Mark W. Dassel, MFrom the Department of Obstetrics and Gynecology, University of Utah, Sa

ABSTRACT Essure hysteroscopic sterilization has been US FooComplications associated with the Essure devicepain, infection, and nickel allergy. The rarity of compbest practices insofar as management. This systemament of Essure-related complications and suggests tcology (2014) 21, 733743 2014 AAGL. All righ

Keywords: Chronic pain; Complication; Essure; Hysteroscopic sterili

DISCUSS You can discuss this article with its authors and whttp://www.AAGL.org/jmig-21-5-JMIG-D-14-00untered With Essureatic Review

and Howard T. Sharp, MDe City (all authors).

d Drug Administrationapproved in the United States since 2002.de improper placement (malpositioning), unintended pregnancy,ions, compounded by underreporting, makes it difficult to determineview synthesizes the national and global experience with manage-ent options when data allow. Journal of Minimally Invasive Gyne-served.

; Malposition

ther AAGL members at

Use your Smartphoneto scan this QR codeand connect to thediscussion forum forthis article now*

* Download a free QR Code scanner by searching for QRement have beenas a summary of

om B

urnalcomplications, with focus on management strategies thathave been reported in the literature and recommendationsas to how management strategies should be applied.

Fig. 1

Essure micro-insert with radiologic markers. Reprinted with permission fr

734 JoPubMed, Scopus, Embase, and the Cochrane Librarywere queried with the following search strategy: (EssureAND [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 occlusionsOR sterilization OR sterilizations OR endometrial abla-tion OR endometrial ablations) AND (complicationsOR complication OR adverse OR perforation OR per-forat* OR pain OR malposition* OR bleeding OR he-morrhag* OR infection OR infections OR [bowel ORintestin*]) AND ([injury or injuries] OR ectopic OR preg-nancy OR pregnancies). Only English language articleswere considered.

Assessment of Evidence

The search generated 594 sources including clinical tri-als, systematic reviews, case series, and case reports. Thetitles and abstracts were reviewed for relevance, and a fulltext review of 107 articles was completed. Only Englishlanguage articles were included. There was a wide rangein level of evidence of the articles identified. Furthermore,heterogeneity of the studies, lack of randomized trials, andinherent rarity of the complications encountered precludedreliable meta-analysis. The evidence judged to be informa-tive is presented and forms the basis for recommendationsand conclusions.Nickel Allergy

Allergic contact dermatitis from nickel hypersensitivity is

ayer AG.

of Minimally Invasive Gynecology, Vol 21, No 5, September/October 2014a type IV reaction, also known as delayed-type hyper-sensitivity, which results in cell-mediated T-cell activity.Common manifestations of contact allergic reactions arecontact hypersensitivity, such as eczema, generalized derma-titis, and urticaria. Data from the North American ContactDermatitis Group, which has patch tested .25 000 individ-uals, show a steady increase in nickel sensitivity, from 14.5%in 1992 to 18.8% in 2004, with a consistently higher percent-age of women affected [4]. Several case reports and caseseries have documented adverse events due to suspectednickel hypersensitivity, some with confirmed sensitizationat skin patch testing and others with normal results.

Al-Safi et al [5] described a patient in whom generalizedpruritis developed in the absence of a visible rash, 3 days af-ter an uncomplicated hysteroscopic sterilization procedure.The patient was referred for skin patch testing, and wasfound to be hypersensitive to nickel and nitinol. Hystero-scopic removal of the device was accomplished without dif-ficulty 8 days after the initial procedure, and the symptomsimproved [5]. Bibas et al [6] described a patient who wasseen 3 months after microinsert placement, with a general-ized erythematous maculopapular rash, localized to the gen-ital and flexural areas. The delayed hypersensitivity reaction,which results in acute erythema of the skin folds and genitalregion, was initially described in the dermatology literatureas baboon syndrome. Topical corticosteroids, oral antihis-tamines, and systemic corticosteroids provided no relief.Skin patch testing confirmed nickel hypersensitivity, and

the implants were removed via salpingectomy. Improvementwas noted after 3 days, and complete resolution occurredwithin 3 months. The authors postulated that the systemic re-action to the implants could be explained by corrosion of thenitinol after implantation, resulting in release of nickel intothe blood, as has been observed with other nitinol-containingimplantable devises [6].

In a large retrospective review of.4000 patients who hadundergone successful micro-insert placement, 2 demon-strated allergy to nickel, with 1 experiencing urticaria anderythema shortly after the procedure and the other withpersistent generalized pruritis 1 year after insertion. Inboth women the symptoms resolved after removal of thedevice [7].

Zurawin and Zurawin [8] reported a series of adverseevents due to suspected nickel hypersensitivity, identifiedthrough the Manufacturer and User Facility Device Experi-

Two studies addressed patch testing prospectively. In 1study, 25 women with positive or negative results underwentEssure micro-insert placement [9], and in the other all pa-tients suspected of having a nickel allergy were tested preop-eratively, followed by Essure micro-insert placement [10]. Inthe second study, 5234 procedures were performed, and 45women were suspected of having a nickel allergy. Fortypatients underwent patch testing, and 24 were found to be

reaction. Thus, in women with symptoms, without obvious

Adelman et al. Essure Complications 735ence (MAUDE) database. The MAUDE database is a report-ing system mandated for post-market surveillance and thusis 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 patchtesting. Thirteen patients tested positive, and 7 tested nega-tive. Treatments and reported responses are given inTable 1. Documented methods of removal included cornualresection and laparoscopic salpingectomy, although it wasnot consistently documented. The micro-inserts wereremoved in 11 patients, only 2 of whom had documentedincomplete resolution of symptoms, 2 planned on undergo-ing removal, and 2 were managed conservatively with docu-mented symptom resolution [8]. Although the MAUDEdatabase can be a useful repository of information, an impor-tant disclosure is that in addition to healthcare facilities andhealthcare professionals, the reports can be initiated by themanufacturer or by patients and may therefore be subjectto duplication and inaccuracies.

Table 1

Treatment and response in symptomatic women tested for nickel

hypersensitivity

Patch test positive Patch test negative

Treatment Response/outcome Treatment

Response/

outcome

9 Removed 4 Complete

resolutions

3 Incomplete

Resolutions

1 Asymptomatic

1 Lost to follow-up

2 Removed 2 Complete

resolutions

4 Retained 2 Awaiting removal

1 Asymptomatic

2 With

corticosteroids

1 Complete

resolution1 Lost to follow-up 1 Unknown

3 Unknown 3 Unknownalternative cause, it may be reasonable to remove the devicesif conservative management is ineffective. The level of evi-dence for this recommendation is IIB, and the grade ofrecommendation is 1C, per the Grading of Recommenda-tions, Assessment, Development, and Evaluation scheme.There is no single method by which appropriately placeddevices may be removed; however, it seems reasonable toattempt hysteroscopic removal before confirmation of bilat-eral occlusion at 3 months [1115]. If the patient desiresa concomitant sterilization procedure or is seen afterbilateral occlusion has been documented, a laparoscopicapproach may be indicated.

Universal patch testing before placement of Essuremicro-inserts is not cost-effective and is not recommended.Although nickel sensitivity is common and disproportion-ately affects women, the actual reported incidence of sensi-tivity to Essure components is low, illustrating that positiveresults of patch testing do not necessarily correlate well withclinically significant reactions. However, in those womensuspected of having a nickel allergy preoperatively, patchtesting seems reasonable, and an alternative form of sterili-zation should be considered in those who test positive.When a patient exhibits symptoms postoperatively, patchtesting should be performed to confirm sensitivity, and if re-sults are positive, the threshold for removal should be low.

Malposition

Details of malpositioning are given in Table 2. Ninetyperforations and 33 malpositionings not otherwise specifiedwere reported in the MAUDE database and summarized in a

Table 2

Identified malpositioning of micro-inserts

Variable No.

Perforation 166

Expulsion 186positive. None of the women in either study experiencedallergic reactions, and none required device removal. Thissuggests that a nickel allergy of the severity that requiresremoval of the micro-inserts may be rare and that hypersen-sitivity is not necessarily manifested by a significant allergicMigration 14

Malpositioning not otherwise specified 54

review [16], and the remainder were presented as case re-ports, case series, retrospective reviews, or prospective trials[1,7,13,1626]. Management of the malpositioning wasrarely reported but included 1 cornual resection [24], 3 hys-teroscopic retrievals [11,12], 6 laparoscopic retrievals[12,13,24,2729], 8 devices left in place (retention ofintraperitoneal device) [7,12,17,24,30], 1 spontaneousvaginal expulsion [31], and 2 devices that could not beremoved hysteroscopically and therefore the visible intra-uterine coils were trimmed [7]. Management of malposi- subsequently identified malposition, and in particular,

736 Journaltioned devices is given in Table 3. Although hysteroscopicretrieval was generally described as being easy and notrequiring excessive traction, 1 report in particular noted mul-tiple unsuccessful attempts at removing the device usinggraspers and failure to cut the trailing metal coils using scis-sors [21]. In 46 cases, another micro-insert was placed aftermalposition was confirmed. In most cases, it was not specif-ically stated whether the original device was retrieved beforereplacement, although when it was stated, it was more com-mon with expulsions into the uterine cavity rather than theperitoneal cavity. It is important to note that resistance anddifficult visualization were commonly cited in reports ofperforation and malposition. During the phase III trial, 13of 14 expulsions into the endometrial cavity were thoughtto be due to the device being located too proximal. At thattime, micro-inserts could not be removed as part of the pro-tocol if they were misplaced. Manufacturer labeling nowallows for removal of the micro-insert if .18 coils are pre-sent in the cavity. Removal of proximally placed or clearlymisplaced devices may decrease the number of womenwho are not able to rely on the devices for contraceptionor 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 expulsionsoccur before confirmation of bilateral occlusion, and there isonly a single case report of expulsion after 3 months afterhysterosalpingography (HSG) [31]. In a series of 12 patientsundergoing Essure placement with concomitant endometrialablation, there was a single reported incidence of a dislodgedEssure micro-insert after removal of a NovaSure bipolar ra-diofrequency ablation device. Expulsion of the micro-insertwas identified at post-ablation hysteroscopy and was re-placed immediately without difficulty [32].

Table 3

Management of malpositioning

Variable No.

Hysteroscopic retrieval 3

Hysteroscopic trimming 2

Replacement of micro-insert 46

Retention of intraperitoneal device 8Laparoscopic retrieval 6

Cornual resection 1perforation. Methods to improve successful placement ratesmight include placement during the follicular phase orpretreatment hormone therapy to improve visualization.Use of nonsteroidal anti-inflammatory drugs preoperativelycould also be used to decrease tubal spasm, as is suggestedin much of the Essure outpatient feasibility literature[1,7,17,20,23,24,3538].

Most reports documented an alternative means of sterili-zation, including replacement of the micro-insert, laparo-scopic tubal ligation, and salpingectomy. When managingthe complication of micro-inert malposition, one must notforget the original indication, and incorporate sterilizationinto the plan. If perforation into the uterine wall is suspected,with most of the coil within the cavity, hysteroscopicremoval and placement of a new device into the patenttube is recommended. Similarly, if the device has beencompletely expelled into the uterine cavity, it should beremoved, followed by placement of a second device. If uter-ine perforation is suspected, with most of the coil in the peri-toneal cavity, laparoscopic removal with placement of anocclusive device or salpingectomy is recommended. If com-plete expulsion into the peritoneal cavity is suspected andthe patient has no symptoms, the device can be left in place,and another can be placed hysteroscopically. Laparoscopicretrieval can be considered because serious complicationsrarely occur (see Bowel Obstruction or Injury). Completeexpulsion can be confirmed by absence of the micro-insert inthe proper location as seen on a 3-dimensional ultrasoundscan or radiograph. In addition, in the case of concomitantEssure device insertion and endometrial ablation, it maybe prudent to perform post-ablation hysteroscopy immedi-ately after the procedure to ensure correct placement of themicro-insert.

Bowel Obstruction or Injury

Two case reports of bowel obstruction were identified inthe literature. In both cases, the patients had progressivepain, nausea, vomiting, and abdominal distention. Radio-logic imaging was suspicious for a small bowel obstruction,and later review revealed that the micro-inserts were malpo-sitioned or absent from their expected locations. Laparos-copy was performed in the first case and revealed a bandof adhesions attached to the perforated end of an EssureDevice migration into the abdominal cavity is rare, witha reported incidence of 0.1% [33]. Although occlusion inthe Phase II trial was documented in 100% of correctlyplaced micro-inserts at 6 months, there is a single reportof tubal patency continuing at 6 months, after correct place-ment had been confirmed at diagnostic laparoscopy [34].The rate of uterine or tubal perforation was 2.6% in thePhase II trial [24], and 0.9% in the Phase III trial [1]. Inmany case reports, difficult insertion was associated with

of Minimally Invasive Gynecology, Vol 21, No 5, September/October 2014coil, which tracked to the distal tip of the appendix, resultingin a closed loop obstruction. The patient underwent lysis of

disease. If a patient is nonresponsive to antibiotic therapyalone, evaluation for tubo-ovarian abscess formation andoperative management may be indicated. The level of evi-dence for this recommendation is III, and the grade ofrecommendation is 1C. Although data are lacking, it shouldbe noted that a properly placed micro-insert in which occlu-sion has been documented may not prevent ascending infec-tion, as has been demonstrated clinically with other methodsof tubal ligation.

737There was a single case report of a tubo-ovarian abscess3 years after micro-insert placement, and a single case reportof bilateral cornual abscesses after endometrial ablation af-ter micro-insert placement 1 year previously. The tubo-ovarian abscess was identified during laparoscopy and wasfound to be ruptured. Group A b-hemolytic streptococciwere isolated, and the patient ultimately required totalabdominal hysterectomy. Examination of the specimen re-vealed that the Essure micro-inserts were properly placedin the fallopian tubes, and HSG 3 months after the procedurehad confirmed bilateral tubal occlusion. While it was notclear that the Essure micro-inserts contributed to theascending infection, it did not prevent it, as is observedwith other forms of tubal sterilization [41]. In the case ofthe bilateral cornual abscesses, the patient was seen 3monthsafter a global endometrial ablation procedure. Diagnosticlaparoscopy was converted to laparotomy because of exten-sive adhesive disease, at which time abscess formation andnecrosis were noted from the intramural portion of the tubes.The necrotic tissue and micro-inserts were removed alongwith the remaining portions of the fallopian tubes. Haemo-philus influenzae was isolated from the abscess [42]. In alarge retrospective series of .4000 patients, Povedanoet al [7] noted 2 pelvic inflammatory disease cases, both ofwhich resolved after treatment with intravenous antibiotics.

Infection after Essure micro-insert placement seems to beadhesions, appendectomy, removal of the migrated Essuremicroinsert, and left salpingectomy for sterilization [39].In the second case, laparotomy was performed, and a metalwire was observed traversing the mesentery, ensnaring aloop of terminal ileum. Thewire was identified as a stretchedEssure device, resulting in local perforation of the bowelwall. The strangulating coil was removed, and an ileocecalresection was performed. The right Essure device was notedto be absent from the fallopian tube, and clips were appliedto the fallopian tubes bilaterally [40]. In both cases, the ob-structions seem to have developed secondary to deviceperforation or migration. As of February 2012, 2 bowelinjury cases were reported to the MAUDE database, 1 occur-ring with concomitant cryoablation and the other withconcomitant bipolar radiofrequency ablation [16].

The case reports illustrate the potential for significantmorbidity that can develop in the setting of device malposi-tioning and emphasize the importance of recognizing inappro-priate positioning early postoperatively. When evaluating apatient with a suspected bowel obstruction, attention shouldbe paid to whether the devices appear to be appropriatelypositioned, and management should be guided by clinicalfindings. Overall, bowel obstruction seems to be a rarecomplication and has not been observed with proper deviceplacement.

Infection

Adelman et al. Essure Complicationsrare, and when diagnosed shortly after insertion mayrespond well to typical treatments for pelvic inflammatoryTable 4

Causes of chronic pain

Variable No.

Perforation 62

Malpositioning not otherwise specified 5

Intraperitoneal device 2

Multiple micro-inserts 2Chronic Pain

Eleven cases of chronic pain after Essure micro-insertplacement were identified, as well as 2 retrospective reviewsof the MAUDE database. Details are given in Table 4. In 5cases, malposition of the micro-insert was identified. Cornualperforation with subserosal placement of the micro-insertwas noted in 3 cases, 2 of which specifically cited difficultinsertion. A cornual perforation was demonstrated at laparos-copy (Fig. 2A) and HSG (Fig. 2B). One of the devices wasremoved hysteroscopically, 1 was removed laparoscopicallyby unroofing the serosa and teasing the device out usinggentle traction, and the third was discovered during hysterec-tomy [28,30,43]. Two patients experienced prolongedperiods of pain, with lengthy evaluations. In both patients,removal of the devices from the peritoneal cavity ultimatelyrequired. One patient experienced pain for 3 years andunderwent laparoscopy before the micro-insert was eventu-ally identified on a computed tomography (CT) scan, andunderwent subsequent removal via laparoscopy with intrao-perative fluoroscopy [44]. Another patient experienced painfor 4 years and underwent 1 laparoscopic and 3 laparotomyprocedures before several pieces of the micro-insert wereidentified on a CT scan and removed via laparotomy with in-traoperative fluoroscopy [27]. In all 5 patients with pain andmalpositioned devices the pain resolved postoperatively.

Eight cases of persistent pain were identified, which werewithout evidence of perforation. These included 4 normalultrasound examinations, 3 normal hysteroscopic examina-tions, and 1 normal radiographic examination. A single radio-graph suggested a perforation, which was not present atlaparoscopy. All of the patients underwent bilateral micro-insert removal via either a hysteroscopic or laparoscopicConcomitant endometrial ablation 4

No malpositioning identified 14

gogram demonstrates left corneal perforation (arrow) and tubal patency (arrow-

hiel, MD, Provincial Academic Head of Obstetrics, Gynecology and Reproduc-

738 Journal of Minimally Invasive Gynecology, Vol 21, No 5, September/October 2014approach. When completed laparoscopically, salpingectomywas favored. Four of 7 patients experienced complete resolu-tion of pain postoperatively [14,19,45,46], a fifth notedimprovement in progressive daily pain but with continuedintermittent abdominal pain [47], and the outcome in anotheris unknown [22]. In the final patient, in whom the micro-inserts were thought to be correctly placed, chronic abdom-inal pain did not resolve after laparoscopic salpingectomyand appendectomy [19].

In the Phase II clinical trial, 59% of participants reportedresolution of post-procedural pain within 1 day, 88% within3 days, and 99% within 7 days. The remaining 2 patients re-ported resolution of pain within 14 days [24]. In a large retro-spective review of .4000 patients who had undergonesuccessful micro-insert placement, only 1 reported persistentpain [7].

Two retrospective reviews of the MAUDE database wereidentified, 1 in 2009 and 1 in 2013. In 2009, there were 20reports of persistent pain [3]. The causes of pain are givenin Table 4. In 2013, there were 217 reports of pain, ranging

Fig. 2

(A) Cornual perforation demonstrated laparoscopically. (B) Hysterosalpin

heads). Lt5 left; Rt5 right. Reproduced with permission from Dr. John T

tive Sciences, University of Saskatchewan Regina, Saskatchewan.from the time of insertion to years after the procedure. In 54cases, perforation was discovered during evaluation. Painwas reported in 47.5% of all reports submitted to the data-base [16].

Management of pain after micro-insert placement shouldinclude a workup for perforation and other malpositioning,in particular when resolution has not occurred within2 weeks. Pelvic radiography or ultrasound should be theinitial imaging method, with HSG used for nondiagnosticstudies. Failure to identify a perforation can have long-term consequences, most notably chronic pain. When anintraperitoneal micro-insert is suspected as the cause ofchronic pain, intraoperative fluoroscopy may be useful inidentifying the device as a whole or pieces that have de-tached, and may avert future operative interventions. Thisis particularly helpful when the implant has been identifiedon a radiograph, CT scan, or magnetic resonance imagebut cannot be identified intraoperatively.Unintended Pregnancy

A variety of reports present data on unintended preg-nancy. Limited information is available, however, on howpregnancy has been managed. There is 1 review in theMAUDE database describing pregnancies reported as ofFebruary 2012. There were 61 pregnancies, 29 of whichwere ectopic. In 4 cases, pregnancy occurred within the first3 months, and in 23, HSG had been completed, with evi-dence of bilateral occlusion [16]. It is clear that this is a grossunderestimation inasmuch as numerous reviews of reports tothe 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 com-plete post-procedure follow-up, failure to use appropriatecontraception before confirming occlusion, misinterpreta-tion of confirmatory imaging, malpositioning of the device,and pregnancy before placement. Noncompliance of thephysician and patient accounted for the largest percentageof pregnancies in the literature, followed by misinterpreta-tion of the imaging. The most common identifiable factor

was malposition, including expulsion, uterine perforation,and tubal perforation. Luteal phase pregnancies also ac-counted for a large percentage of pregnancies within the first3 months.

Table 5

Unintended pregnancy: reports to the manufacturer or MAUDE

database

Source No. of recorded pregnancies

Kerin [49], 2005 37 (location not indicated)

Levy et al [2], 2007 64 (location not indicated)

Connor [3], 2009 169 (4 ectopic)

Levy et al [50], 2011 748 (location not indicated)

Jost et al [48], 2013 54 (1 ectopic)

Al-Safi et al [16], 2013 61 (29 ectopic)

In a retrospective survey of pregnancies reported tophysicians in France as well as to the manufacturer, 58 preg-nancies were identified. Eight full-term pregnancies, 9 mis-carriages, 30 induced abortions (1 specifically because ofa genetic abnormality), and 1 ectopic pregnancy weredocumented [48].

There have been several large prospective case series. De-tails are given in Table 6 [7,18,20,25,5154]. In 1 such caseseries conducted in Spain, 3 pregnancies occurred after 1321women underwent successful placement. Five-year datawere available for 1200 of those women. The effectivenesswas calculated at 99.75% [52], which was similar to an effi-cacy of 99.74% reported by the manufacturer in phase IIIstudies [1]. Three pregnancies were reported in a retrospec-tive cohort of 294 successful procedures performed at theDetroit Medical Center. Post-placement HSG was not docu-mented in any of the 3 women because of patient noncompli-ance with the follow-up protocol. There was unilateralabsence of the device on ultrasound in all 3 patients, suggest-ing device expulsion or perforation. Two patients had termdeliveries, and the third had a first-trimester miscarriage[25]. Twenty-two pregnancies were reported in a cohort ofwomen from Kaiser Permanente Northern Californian after

image was either misinterpreted or the patient did not returnfor follow-up [54]. Seven case reports were identified, ac-counting for 9 pregnancies [36,5560]. Details are given inTable 7.

A single systematic review of pregnancies after hystero-scopic sterilization identified 22 articles involving Essure,11 of which reported no pregnancies. The remaining 11articles reported 102 pregnancies. Details of the reportedpregnancies are shown in Figure 3. Few pregnanciesoccurred in women with confirmed bilateral tubal occlusion,with the longest follow-up being 7 years [61].

With a large percentage of Essure device failures afterincomplete or failed confirmatory testing [53], the impor-tance of tubal occlusion confirmation cannot be underem-phasized. Although concomitant Essure placement andendometrial ablation is safe [6264] and feasible for bothcontrol of abnormal uterine bleeding and prevention ofpregnancy [64,65], the development of Asherman syndromerelated to endometrial ablation has made it difficult toensure tubal occlusion. In 2011 Detollenaere et al [66] foundHSG confirmatory testing to be inadequate in 25% of cases ofconcurrent Essure placement and endometrial ablation. A2007 analysis of 25 concomitant endometrial ablations and

No. in

1615

294

391

6000

544

2621

4242

1321

Adelman et al. Essure Complications 7392621 successful placements. The 3 most common reasonsfor failure were misinterpretation of the HSG, failure toobtain an HSG, and pregnancy after the HSG showed nonre-liance. The perfect-use device failure was estimated at 4.5%of all failures [53]. Ten pregnancies were reported in theNetherlands from 2002 through 2008, after approximately6000 procedures had been performed. In several cases, the

Table 6

Unintended pregnancy, case series

Source No. of pregnancies

Arjona et al [20], 2008 3

Shavell et al [25], 2009 3

Pinto et al [51], 2010 1

Veersema et al [54], 2010 10

Andrade et al [18], 2012 3

Deraleau and Heinlein [53], 2012 22

Povedano et al [7], 2012 7

Rios-Castillo et al [52], 2013 3HSG 5 hysterosalpingogram.Essure placements reported 21 patients with bilateral tubalocclusion at HSG at 3-month confirmatory testing. Of the 4other patients, 2 did not return for follow-up and 2 had failedconfirmatory testing due to cervical stenosis (at 3-monthHSG) and synechiae too severe to evaluate tubal patency (at9-month HSG). The patient with cervical stenosis refusedfurther follow-up, and in the other patient proper placement

cohort Details

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

of the devices was confirmed at CT. No long-term pregnancydata were available for this series [67]. Although confirma-tory testing in the United States is HSG, other countrieshave different requirements for confirmation of tubal occlu-sion. Studies from these countries have demonstrated nodifficulty with confirmatory testing using radiography or 3-dimensional ultrasound and have reported no subsequentpregnancies [68,69].

The Carotid Revascularization Endarterectomy vs Stent-ing Trial (CREST), which included data from .10 000

sterilization and included follow-up data for up to 14 years[70]. The 5-year cumulative pregnancy rate of Essure hyster-oscopic sterilization is 2.6 pregnancies per 1000 procedures[2], which compares favorably.

There are insufficient data to guide treatment of preg-nancy after hysteroscopic sterilization, although poor obstet-ric outcome does not seem to be associated with the presenceof micro-inserts. At present, there is no indication to termi-nate a pregnancy or to attempt removal of the device in thecontext of pregnancy.

Although some may consider unintended pregnancy afailure rather than a complication, it is important to keepin mind that a large number of these failures are prevent-able or occur secondary to an aforementioned complicationsuch as malposition. The most effective treatment for unin-tended pregnancy after Essure hysteroscopic sterilization isthus prevention. Adherence to strict follow-up protocols,requiring contraception before placement or performingthe procedure in the follicular phase, providing effectivepost-sterilization contraception, and recognizing that diffi-cult insertion can be associated with malposition are allways of proactively preventing pregnancy.

Ectopic Pregnancy

Therewere 2 reports of ectopic pregnancy, one resulting in

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],

2006

2 Expulsions 3 Elective

terminations

Hastings-Tolsma et al [57],

2007

1 Unilateral

placement

1 Spontaneous

miscarriage

Moses et al [59], 2008

Ory et al [60], 60

Ploteau and Lopes [55], 2009

Marcos Gonzalez [58], 2012

steros

740 Journal of Minimally Invasive Gynecology, Vol 21, No 5, September/October 2014women, determined the cumulative risk of pregnancy to be13.1 per 1000 procedures for all common methods of tubal

Fig. 3

Details of the Cleary et al. [61] systematic review of pregnancies after hytubal rupture and the other not definitively localized. In thecase of the tubal rupture, the patient underwent emergency

copic sterilization.

ysis of adverse events with Essure hysteroscopic sterilization reportedexploratory laparotomy, with identification of a left-sidedectopic pregnancy and findings of appropriately placedmicro-inserts. The patient had previously undergone HSG,which confirmed bilateral tubal occlusion. Repeat HSG3 months after rupture of the ectopic pregnancy showed righttubal patency [71]. In the second case, a patient had a preg-nancy of undetermined location 4 years after hysteroscopictubal sterilization. A postoperative HSG had confirmed bilat-eral tubal occlusion, although.50% of the coils were withinthe endometrial cavity, which does not meet the criteria setforth by the manufacturer for satisfactory location. The pa-tient underwent dilation and curettage and laparoscopic bilat-eral salpingectomy because she did not desire fertility. Atlaparoscopy, there was no obvious tubal or adnexal disease,although a left-sided tubal perforation was apparent. No cho-rionic villi or an implant site were identified in the pathologyspecimen. When the b-human chorionic gonadotropin con-centration continued to increase postoperatively, treatmentusing methotrexate was successful [72].

Treatment of an ectopic pregnancy associated with previ-ous Essure sterilization should focus on well-establishedmanagement protocols involving use of methotrexate andsurgical intervention, as well as prevention of future preg-nancy. As with unintended intrauterine pregnancy, onemust consider that one or both of the micro-inserts is malpo-sitioned or absent and take measures to ensure sterility, ifthat is desired.

In conclusion, complications of Essure sterilization arerare, and reports are therefore sparse. Although complica-tions are reported to the MAUDE database and even to themanufacturer directly, it is likely that complications aregrossly underreported. Owing to lack of randomizedcontrolled trials and reliance on large case series, the levelof evidence on which to base recommendations is level IIat best, with most cases being level III. With that in mind,the following conclusions are presented:

The most commonly reported complications of Essurehysteroscopic sterilization are malpositioning, chronicpain, unintended pregnancy, infection, and nickel allergy.

Complications do not seem to occur in isolation, andcommonly involve uterine or tubal perforation, deviceexpulsion, and device migration.

Failure to diagnose an improperly placed micro-insert canhave consequences beyond ineffective contraception, andin rare cases can result in severe morbidity.

A common reason for failing to diagnose a malpositioneddevice is physician and patient noncompliance withfollow-up protocols.

Pregnancy in the setting of properly placed devices isoften the result of noncompliance with post-proceduralcontraception or pregnancy at the time of placement.

If surgical removal is performed in a patient withoutsymptoms, all attempts should be made to remove the

Adelman et al. Essure Complicationsentire device, using intraoperative fluoroscopy whenindicated.to the manufacturer and user facility device experience database.

J Minim Invasive Gynecol. 2013;20:825829.

17. Andersson S, Eriksson S, Mints M. Hysteroscopic female sterilization

with Essure in an outpatient setting. Acta Obstet Gynecol Scand.

2009;88:743746.

18. Andrade C, Pinto RM, Nogueira-Martins N, Damasceno J, Pipa A, Management of complications should be individualized,and when well-established protocols exist, as in the caseof ectopic pregnancy and pelvic inflammatory disease,treatment should follow standard of care.

Acknowledgments

We thank Mary McFarland, Information and TechnologyConsultant, Eccles Health Sciences Library, for invaluableassistance in conducting the database searches.

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Management of Complications Encountered With Essure Hysteroscopic Sterilization: A Systematic ReviewAssessment of EvidenceNickel AllergyMalpositionBowel Obstruction or InjuryInfectionChronic PainUnintended PregnancyEctopic PregnancyAcknowledgmentsReferences