Essure Hysteroscopic Sterilization Research Articles

Essure removal for device-attributed symptoms: Quality of life evaluation before and after surgical removal

IntroductionIncreasing reports of adverse effects have raised concerns about the Essure hysteroscopic sterilization method. Women suffering alleged complications of the Essure device often seek surgical removal. This study evaluated the quality of life (QoL) and postoperative outcomes in women undergoing Essure removal. Material and methodsThis observational case series included 95 women. Removal was performed by laparoscopic salpingectomy-cornuectomy, or hysterectomy with bilateral salpingectomy. QoL was assessed preoperatively and three months postoperatively by SF-36 questionnaires [correlated physical health score (PCS) and mental health scores (MCS)]. Symptoms evolution was collected at three months, and complications at one month. ResultsSixty-four laparoscopic salpingectomy-cornuectomies, 33 laparoscopic hysterectomies, and eight vaginal hysterectomies were performed. Four intraoperative complications occurred (one conversion from cornuectomy to laparoscopic hysterectomy, one skin burn, two bladder injuries). Seven postoperative complications occurred (Clavien Dindo, grade 1 or 2). All components of the preoperative QoL scores were lower than those of the general population. PCS scores were lower preoperatively than postoperatively [37.6 versus 50.7; p<0.001]. MCS scores were lower preoperatively than postoperatively [29 versus 52.4; p<0.001]. 71% of patients showed an improvement of at least 10% in both PCS and MCS scores. Systemic and gynecologic symptoms were more frequent before than after surgery (98% versus 50%; p<0.001 and 77% versus 20%; p<0.001 respectively). ConclusionsPatients seeking Essure removal had an impaired preoperative QoL. They experienced a significant QoL improvement at three months post-operation. These findings will help clinicians to inform patients about their expected postoperative functional status and QoL.

Identification of inorganic particles resulting from degradation of ESSURE® implants: Study of 10 cases

ObjectiveApproximately 750,000 women worldwide have undergone ESSURE hysteroscopic sterilization since 2002. In 2015, an increase in adverse effects was noted, with gynaecological and systemic symptoms reported. Scanning electron microscopy (SEM) analysis of fallopian tube and uterine horn tissues and implants, after hysterectomy or salpingectomy, revealed the presence of inorganic particles resulting from implant degradation. Study designTen patients (age 42–53 years) were included in this study. Of these, eight patients had undergone hysterectomy and two patients had undergone salpingectomy. Mean exposure time was 85.5 months (standard deviation 26.8 months, range 34–105 months). Mineralogical analyses were performed on 13 tissue biopsies and four implants by SEM coupled with energy dispersive x-ray spectrometry. ResultsIn five of the 10 patients, tin particles were observed in fallopian tube or uterine horn tissues with inflammatory cell reactions. In the other five cases, iron, chromium, nickel or platinum particles were observed. For implants, major deterioration of the weld zone was observed with either destroyed appearance or the presence of an organic coating containing numerous particles. Discussion and conclusionAnalysis of the preclinical studies performed by the manufacturer suggests that degradation of the tin weld plays a major role in these adverse events, with increasing leaching and corrosion between 3 and 6 months for an intratubal insert that si designed to remain in an woman’s body for her entire life. For patients with gynaecological symptoms (e.g. pain, metrorragies) needing explantation, these findings raise the question of a causal relationship between tin particles from implant degradation and the inflammatory tissue response. For patients with systemic symptoms (e.g. blurred vision, headache, asthenia, myalgia), the hypothesis that these symptoms may be related to the formation of organotin (chemical compounds based on tin with hydrocarbon substituents) in the body has yet to be proven. Tin levels in blood have to be measured before and after explantation. To the authors’ knowledge, this is the first study to report significant degradation of the ESSURE implant weld, evidenced by the detection of tin particles in the uterine tissue of patients and comparison of the welding zone between unused and used implants.

Surgical Management for Removal of Essure Device

Video Objective To present two surgical cases of laparoscopic removal of Essure hysteroscopic sterilization device via salpingectomy with and without cornuectomy. Setting One 37-year-old woman with heavy menstrual bleeding, joint pain, and fatigue reported by rheumatology to have a nickel allergy who desired Essure removal and one 51-year-old woman with pelvic pain and multiple co-morbidities who desired Essure removal. Both patients underwent surgical management for the removal of Essure at an academic medical center. Interventions In this surgical video, we present two cases of women desiring Essure implant removal secondary to adverse effects from the device. The first case describes the step by step approach to removal of an intact Essure implant by laparoscopic salpingectomy. The second case describes an approach to removal of Essure by salpingectomy with cornuectomy which is particularly helpful when the endometrial cavity has been previously ablated as in second case, or if there was a complicated insertion with perforation. Additionally, we describe the Essure implant composition in detail, describing how intact removal is imperative as fracturing of the device may lead to further complications or adverse effects. Conclusion Laparoscopic salpingectomy with and without cornuectomy are safe and effective procedures for the intact removal of Essure and are feasible alternatives to hysterectomy for women who desire removal of Essure.

Use of Hysterosalpingo-Foam Sonography for Assessment of the Efficacy of Essure Hysteroscopic Sterilization.

Hysterosalpingo-foam sonography (HyFoSy) has been suggested to be a possible less invasive alternative to hysterosalpingography (HSG), which is the reference standard for confirmation of tubal occlusion after Essure (Bayer AG, Leverkusen, Germany) hysteroscopic sterilization. The purpose of our study was to evaluate the accuracy of HyFoSy compared to HSG for confirmation of tubal occlusion after Essure hysteroscopic sterilization. A prospective study included 90 patients who underwent Essure hysteroscopic sterilization. Twelve weeks after the sterilization, 2-dimensional transvaginal ultrasonography was performed to assess the microinsert position and was followed by HyFoSy and HSG for evaluation of tubal occlusion. Patients with patent fallopian tubes on HSG were scheduled for additional HSG procedures at 3-month intervals until tubal occlusion was documented. Of 90 enrolled patients, 86 patients with 170 fallopian tubes underwent the complete imaging protocol. Tubal occlusion was evaluated by HyFoSy as an index test and HSG as a reference standard. The accuracy of HyFoSy was 97.1% (95% confidence interval [CI], 93%-99%). The sensitivity and specificity were 100% (95% CI, 97%-100%) and 54.6% (95% CI, 23%-83%), whereas the positive and negative predictive values were 97.0% (95% CI, 93%-99%) and 100% (95% CI, 42%-100%), respectively. No long-term complications were reported for HyFoSy or HSG. Given that the concordance rate for tubal occlusion between HyFoSy and HSG was not 100%, an occluded fallopian tube on HyFoSy should be confirmed by HSG, which remains the reference standard for confirmation of tubal occlusion after Essure hysteroscopic sterilization.

Hysteroscopic Sterilization Device Follow-Up Rate: Hysterosalpingogram Versus Transvaginal Ultrasound

Study ObjectiveTo assess if follow-up confirmation testing 3 months after hysteroscopic sterilization with the Essure device (Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ) improved with recommendation for transvaginal ultrasound (TVUS) versus hysterosalpingogram (HSG). DesignRetrospective, observational case-controlled cohort study (Canadian Task Force classification II-2). SettingTwo-physician private practice in Evansville, Indiana. PatientsCompliance rates for a TVUS confirmation test on 100 women who underwent hysteroscopic sterilization compared with a previously published cohort of 1004 women who were scheduled to undergo an HSG confirmation test. InterventionAcquisition of 3-month confirmation testing after Essure hysteroscopic sterilization. Measurement and Main ResultsAll women who underwent Essure hysteroscopic sterilization with recommendation for TVUS confirmation testing between July 2015 and January 2017 were compared with a previously published cohort of 1004 patients with recommendation for HSG confirmation testing (HSG cohort). In addition, an HSG subgroup cohort (HSG subgroup) similar in size and closest chronology to the TVUS cohort was drawn from the original 1004 patients and analyzed for HSG follow-up. Records for all patients were reviewed for demographic, procedural, and confirmation testing and outcome data. One hundred patients were identified with successful Essure device placement and a recommendation for TVUS confirmation testing. Eighty-eight patients (88.0%) returned for TVUS at 3 months. In the HSG cohort 1004 successful Essure devices were placed, and 778 patients returned for the recommended HSG follow-up (77.5%). There was a significantly higher follow-up rate for TVUS compared with the HSG cohort (88.0% vs 77.5%, p = .008). In the HSG subgroup 184 patients were identified, and 133 patients presented for HSG follow-up (72.3%), indicating a significantly higher follow-up rate in the TVUS cohort (88.0% vs 72.3%, p = .001). No pregnancies after any confirmation testing were noted. ConclusionConfirmation testing with TVUS rather than HSG 3 months after Essure device placement results in increased patient compliance that may lead to improved patient outcomes with reduction of unintended pregnancy.

Essure Permanent Birth Control, Effectiveness and Safety: An Italian 11-Year Survey

Study ObjectiveTo describe safety, tolerability, and effectiveness results through a minimum 2-year follow-up of patients who underwent permanent sterilization with the Essure insert. DesignA retrospective multicenter study (Canadian Task Force classification II2). SettingSeven general hospitals and 4 clinical teaching centers in Italy. PatientsA total of 1968 women, mean age 39.5 years (range, 23–48 years) who underwent office hysteroscopic sterilization using the Essure insert between April 1, 2003, and December 30, 2014. InterventionThe women underwent office hysteroscopic bilateral Essure insert placement, with satisfactory device location and tube occlusion based on hysterosalpingography or hysterosalpingo-contrast sonography (HyCoSy). Measurements and Main ResultsPlacement rate, successful bilateral tubal occlusion, perioperative adverse events, early postoperative (during the first 3 months of follow-up), and late complications were evaluated. Satisfactory insertion was accomplished in 97.2% of women and, in 4, perforation and 1 expulsion were detected during hysterosalpingography. Three unintended pregnancies occurred before the 3-month confirmation test. Two pregnancies were reported among women relying on the Essure inserts. Postprocedure pain was minimal and brief; in 9 women, pelvic pain became intractable, necessitating removal of the devices via laparoscopy. On telephone interviews, overall satisfaction was rated as “very satisfied” by the majority of women (97.6%), and no long-term adverse events were reported. ConclusionThe findings from this extended Italian survey further support the effectiveness, tolerability, and satisfaction of Essure hysteroscopic sterilization when motivated women are selected and well informed of the potential risks of the device. Moreover, the results do not demonstrate an increased incidence of complications and pregnancies associated with long-term Essure use. Patients with a known hypersensitivity to nickel may be less suitable candidates for the Essure insert.

Improving Rates of Post-Essure Hysterosalpingography in an Urban Population Using Electronic Tracking Reminders

Study ObjectiveTo demonstrate the efficacy of electronic reminders for follow-up hysterosalpingography (HSG) after Essure hysteroscopic sterilization in an urban tertiary care hospital obstetrics and gynecology practice. DesignRetrospective cohort study (Canadian Task Force classification II-3). SettingObstetrics and gynecology practice at a university-affiliated urban tertiary care teaching hospital. PatientsTwo hundred and fifty patients who underwent Essure hysteroscopic sterilization between June 2011 and July 2014. InterventionImplementation of electronic reminders for the office staff. Measurements and Main ResultsTwo hundred and fifty of 259 patients (96.5%) underwent Essure hysteroscopic sterilization and successful placement of coils into bilateral Fallopian tubes. Among these 250 patients, 135 (54%) returned for HSG at 3 months post-Essure as advised at the time of procedure. The use of electronic reminders prompted another 45 patients (18%) to return for HSG, improving the total post-Essure follow-up rate to 72%. ConclusionElectronic reminders for the office staff of an urban tertiary care hospital's obstetrics and gynecology practice is an effective method for improving the rate of post-Essure HSG.

AAGL Advisory Statement: Essure Hysteroscopic Sterilization

AAGL Advisory Statement: Essure Hysteroscopic Sterilization

The Essure Hysteroscopic Sterilization: Initial Experience in Cardiff, UK – Does Prior Contraception Influence the Ease of Device Placement?

The Essure Hysteroscopic Sterilization: Initial Experience in Cardiff, UK – Does Prior Contraception Influence the Ease of Device Placement?

Analysis of Adverse Events With Essure Hysteroscopic Sterilization Reported to the Manufacturer and User Facility Device Experience Database

Study ObjectiveThe Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration–approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database. DesignRetrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III). SettingOnline retrospective review. PatientsOnline reports of patients who underwent Essure tubal sterilization. InterventionEssure tubal sterilization. Measurements and Main ResultsFour hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5%]) followed by delivery catheter malfunction (121 events [26.4%]). Poststerilization pregnancy was reported in 61 events (13.3%), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7%]), abnormal bleeding (44 events [9.6%]), and microinsert malposition (33 events [7.2%]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1%), of which 44 were hysterectomies. ConclusionSixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5%) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device.

Efficacy of Essure hysteroscopic sterilization – 5 years follow up of 1200 women

Objective: To assess the efficacy of the Essure hysteroscopic birth control device after 5 years follow up.Study design: Retrospective analysis of case series.Setting: Outpatient hysteroscopy facility in a large teaching hospital.Subjects: One-thousand three-hundred and twenty-one women who underwent hysteroscopic sterilization with Essure device (Conceptus, Inc., Mountain View, CA) between January 2003 and May 2005Intervention(s): Hysteroscopic tubal sterilization using Essure system.Main outcome measure: Efficacy/effectiveness, failure rate.Results: Satisfactory insertion was accomplished in the first attempt in 1166 women (97.16%). After the second attempt, successful insertion rate rise to 98.6%. (n = 31, 2.6%). Three pregnancies had been reported after 5 years follow up, which implies an overall absolute rate of 0.25%. This represents a Pearl index of 0.05 after 72 000 months of surveillance. All of them occurred in the first year of use of the microinsert. There has been no unintended pregnancy in the next 4 years.Conclusion(s): Essure has the lowest Pearl index never published being the most effective permanent birth control system to date. Unintended pregnancies tend to occur in the first year after the insertion, and can be avoided encouraging women to accomplish the protocol.

Essure Insert Expulsion After 3-Month Hysterosalpingogram Confirmation of Bilateral Tubal Occlusion and Bilateral Correct Placement: Case Report

Essure hysteroscopic sterilization is an effective permanent contraception option for women, with a 99.83% effectiveness rate. To date, more than 600,000 Essure procedures have been performed worldwide. This case report describes bilateral Essure insert placement, after which the left insert was subsequently expelled after hysterosalpingogram (HSG)–confirmed correct bilateral insert placement and bilateral tubal occlusion. Although insert expulsion has been reported before a 3-month post-procedure HSG, this is the first published report of expulsion after a confirmatory 3-month post-procedure HSG. Because there now exists documentation of Essure insert expulsion after a 3-month confirmatory HSG, physicians and patients should be informed of this rare occurrence. Further investigation into the causes of such an event is warranted.

Sublingual Nitroglycerin Spray for Treatment of Proximal Tubal Occlusion Secondary to Tubal Spasm during Essure® Hysteroscopic Sterilization

To assess the efficacy, safety, and success rate of using sublingual nitroglycerin spray (SLNTG) in failed placement of the Essure® hysteroscopic sterilization (EHS) device secondary to proximal tubal occlusion from suspected tubal spasm.

Case Report of Essure Microinsert Expulsion after 3 Month HSG Confirmation of Bilateral Tubal Occlusion and Bilateral Correct Placement

Presentation of a patient who underwent the Essure hysteroscopic sterilization procedure in the office and who subsequently experienced an expulsion of one micro-insert. The expulsion occurred after the 3 month confirmatory HSG showing correct placement of both micro-inserts and occluded tubes.

Venous Intravasation: A Potential Pitfall of Confirmatory Hysterosalpingogram Following Essure Hysteroscopic Sterilization.

Indications for hysterosalpingography (HSG) include evaluation of infertility, spontaneous abortions, postoperative evaluation of tubal ligation, pre-myomectomy evaluation, and more recently, evaluation of tubal occlusion after placement of the Essure Permanent Birth Control System. Here we report a case of venous intravasation during a routine post-Essure HSG, a phenomenon in which contrast transits from the uterine cavity, through the myometrium, and directly into draining pelvic veins. Venous intravasation is a potential pitfall in interpretation of HSGs.

A novel medical protocol to treat uterotubal spasm during Essure hysteroscopic sterilization: a pilot study

A novel medical protocol to treat uterotubal spasm during Essure hysteroscopic sterilization: a pilot study Hector O Chapa,1 Gonzalo Venegas21Women&#39;s Specialty Center, Dallas, TX, USA; 2Clinical Faculty, Department ObGyn Methodist Medical Center, Dallas, TX, USAObjective: To evaluate sublingual hyoscyamine (0.125 mg) as a uterotubal spasm reliever to increase successful bilateral, first-attempt Essure microinsert placement.Study design: Prospective cohort study as pilot clinical investigation of study medicine.Setting: An inner-city Dallas, TX obstetrics and gynecology office practice.Materials and methods: The study period was January 1, 2008 to July 1, 2010. Patients requesting sterilization were offered Essure under local anesthesia (office setting). Those declining were referred for operative laparoscopy. Patients accepting office sterilization were offered study participation. Study patients noted to have intraoperative uni/bilateral uterotubal spasms preventing cannulation were given one sublingual hyoscyamine (0.125 mg) tablet. Primary endpoint: spasm alleviation and successful tubal cannulation (bilaterally). Secondary endpoint: percentage of bilateral tubal occlusions documented by follow up hysterosalpingogram (12 weeks), and adverse events possibly related to medication.Results: Within the study period, 316 patients underwent office sterilization (local anesthesia); 21 had unilateral tubal spasm preventing cannulation (6%). Spasm was relieved in 17/21 (80%) after hyoscyamine, allowing for microinsert placement. The mean time from attempted cannulation to medication was 9 minutes (8.3&ndash;10.5 minutes), and the mean time for spasm resolution was 53 seconds (49&ndash;72 seconds). At follow-up confirmation testing, all 17 who were hyoscynamine responders were found to have bilateral tubal occlusion as well as proper microinsert location. The 4/21 hyoscyamine nonresponders underwent a second unilateral attempt 48&ndash;72 hours later. Fifty percent (n = 2) had successful placement, leaving two for alternative care. Rapid pulse was reported by 1/21 (4.7%) 5 minutes postmedication.Conclusion: Essure sterilization has a high bilateral, first-attempt success rate. Hyoscyamine may aid in spasm relief and increase single procedure, bilateral placement success rate further.Keywords: hysteroscopic sterilization, Essure, tubal spasm, hyoscyamine

Duration of Endometrial Preparation and Hysteroscopic Sterilization Placement Success

Objective: Previous research has demonstrated the value of endometrial preparation before hysteroscopic procedures. Duration of endometrial preparation prior to hysteroscopic sterilization has not yet been evaluated. The aim of our study is to evaluate the relationship between hormonal endometrial preparation duration and the placement success rate with Essure hysteroscopic sterilization. Study Design: An institutional review board (IRB) approved retrospective cohort study of all women who underwent hysteroscopic sterilization from August 2003 to April 2010 in an urban academic center in Chicago, Illinois was performed. Exclusion criteria included insufficient or incomplete data. Variables including Essure placement success, type and duration of endometrial preparation, demographic factors and hysterosalpingogram (HSG) occlusion rates were compared using chi-square and co-relational analyses. Results: Overall, the Essure placement success rate was 91.5% (226/247). Race, parity, body mass index (BMI), previous surgical history and type of hormonal endometrial preparation did not significantly affect the placement success rate. Women with endometrial preparation (n=216) were significantly more likely to experience successful placement compared to those with no preparation (n=31; p<.005). When comparing Essure placement success rates in patients with 30 days or less (n=49) compared to those that underwent more than 30 days of preparation (n=167), there was no significant effect of duration of hormonal endometrial preparation on placement success rate (p=0.518). Conclusion: This study supports the use of hormonal endometrial preparation prior to hysteroscopic sterilization and suggests that the duration of hormonal treatment does not affect the rate of successful Essure placement. Therefore, scheduling patients for Essure procedures within 30 days of initiating endometrial preparation is unlikely to deleteriously affect Essure placement success, but may instead lower costs and improve patient compliance. Further prospective studies are needed to validate these findings.

Outcome of Essure and Adiana Office Hysteroscopic Sterilization Procedures at an Academic Center

Outcome of Essure and Adiana Office Hysteroscopic Sterilization Procedures at an Academic Center

Analysis of Adverse Events Associated with Essure Hysteroscopic Sterilization Reported to the MAUDE Database, 2002-2011

Analysis of Adverse Events Associated with Essure Hysteroscopic Sterilization Reported to the MAUDE Database, 2002-2011

Analysis of adverse events associated with essure hysteroscopic sterilization reported to the maude database, 2002-2011

The Manufacturer and User Facility Device Experience (MAUDE) database may be useful for clinicians using a FDA (Food and Drug Administration) approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus, Inc.) using this database.