Laparoscopic Essure® Device Removal by En Bloc Salpingectomy-Cornuectomy with Intraoperative X-Ray Checking: A Retrospective Cohort Study.

STUDY OBJECTIVE: To evaluate the feasibility, efficacy, and morbidity of Essure® device removal via laparoscopic en bloc salpingectomy-cornuectomy resection (LSC) and the utility of confirmation of complete removal with an intraoperative X-ray of the removed specimen (IX-S). DESIGN: Retrospective observational cohort study. SETTING: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France. PATIENTS: Women who were not seeking future fertility seeking Essure® device removal by salpingectomy, between February 2017 and August 2018. INTERVENTIONS: All women underwent LSC. An IX-S was performed to confirm complete Essure® device removal. In the case of an unsatisfactory IX-S, an intraoperative pelvic X-ray control of the patient (IX-P) was performed. If IX-P diagnosed residual Essure® fragments, an additional resection was performed, and the removed tissue was checked by IX-S. MEASUREMENTS AND MAIN RESULTS: We included 72 women, and a total of 140 Essure® devices were removed. The IX-S confirmed complete Essure® device removal in 131 of 140 cases (93.6%) in 63 of 72 women (87.5%). Out of the 9 women with unsatisfactory IX-S, 6 had no residual Essure® fragments at IX-P, and Essure® device removal was considered complete. Three women had a persistent Essure® fragment at IX-P: an additional resection allowed complete removal in 2 cases and resulted in failure in 1 of 140 case (0.7%). There were 2 of 72 women (2.8%) intraoperative complications and 4 of 72 women (5.6%) postoperative grade 1 complications according to the Clavien-Dindo classification. CONCLUSION: Essure® device removal by LSC appears to be an effective and safe procedure. IX-S is a useful method to evaluate whether the removal of Essure® device is complete during an LSC procedure.

Clinical and histopathologic characteristics of patients undergoing surgical excision with Essure coils: Longitudinal experience at a women's specialty hospital.

The introduction of the Essure (Bayer AG, Leverkusen, Germany) device made possible a less invasive approach for patients desiring sterilization. Following FDA approval in 2002, problems were reported in some patients with these devices including most commonly pain. Labeling changes were mandated in 2016, and as of late 2018, the devices are no longer being sold in the United States. A comprehensive description of Pathologic findings in patients with these devices has not been reported. This study characterizes pathologic findings in patients undergoing surgery who had Essure in place, regardless of the indication for surgery. 137 cases were found, 126 of which had submitted tissue, 121 of which had fallopian tube(s) submitted. Duration for coils being in place was available for 104/137 patients (mean 48 months; median 43 months, range 0-166 months). Cases ranged from 2009 to 19, with a peak in cases noted in 2016. A chief complaint relating to the phrase "pelvic pain" was the most common, noted in 72/137 cases. Obliteration, defined as loss of the fallopian tube epithelium with filling of the lumen with fibrotic material, was noted in 33/121 cases. Inflammation was noted in 59/126 cases, 31/59 showed with giant cells, chronic inflammation (lymphocytes and/or plasma cells) in 37/59 cases, and acute inflammation 19/59 cases, with 14/19 showing eosinophils. Acute inflammation was noted in those with a shorter duration of coil implantation, while chronic inflammation, including giant cells, were noted across the span. This study has expanded knowledge of patients with removal of Essure coil devices.

Vaginal Hysterectomy with Salpingectomy for Essure Insert Removal.

STUDY OBJECTIVE: To evaluate the feasibility of an en-bloc salpingectomy at the time of vaginal hysterectomy for removal of Essure inserts. DESIGN: Prospective observational study (Canadian Task Force classification II-1). SETTING: Monocenter study at the Conception University Hospital Center, Marseille, France. PATIENTS: Women seeking removal of the Essure device and candidate for vaginal hysterectomy from January 1, 2017 to January 31, 2018. INTERVENTIONS: Patient underwent a total hysterectomy and bilateral salpingectomy by the vaginal route (VH-S) with en-bloc removal of each hemiuterus with the ipsilateral fallopian tube, thereby allowing for removal of the Essure inserts without fragmentation. MEASUREMENTS AND MAIN RESULTS: Twenty-six VH-S were performed. There was no converted case to laparoscopy or laparotomy because of issues regarding feasibility or complications. Removal of each hemiuterus with the ipsilateral tube as a single unit was feasible in all cases. There was 1 Clavien-Dindo grade 1 perioperative complication: a bladder injury that required 10days of urinary catheterization. There were 2 grade 2 postoperative complications: 1 case of metrorrhagia of a granuloma on the vaginal fundus that was treated with silver nitrate and 1 case of acute urinary retention that required urinary catheterization for 24hours. CONCLUSION: Performing a VH-S with en-bloc removal of the hemiuterus with the ipsilateral tube without fragmentation orsectioning of the Essure inserts appears to be feasible. The vaginal route can hence be an approach for women who undergo hysterectomy during Essure insert surgery removal.

Removal of Essure Sterilization Devices: A Retrospective Cohort Study in the Netherlands.

STUDY OBJECTIVE: To analyze short-term effectiveness and symptom resolution after surgical removal of Essure (Bayer AG, Leverkusen, Germany) sterilization devices. DESIGN: A single-center retrospective cohort study (Canadian Task Force classification III). SETTING: A large secondary care teaching hospital in the Netherlands. PATIENTS: All patients who underwent surgical removal of Essure devices between January 2009 and December 2015. INTERVENTIONS: Surgical removal of Essure devices was predominantly performed by laparoscopic surgery. In the majority of patients, Essure devices were removed by performing bilateral salpingectomy (66.6%). MEASUREMENTS AND MAIN RESULTS: Data regarding patient characteristics, symptoms, the insertion procedure, the removal procedure, results of the pathological assessment, and follow-up were extracted from patient files. A total of 93 patients had Essure devices removed in the selected period. The onset of symptoms after Essure sterilization was variable. The most frequently reported symptom was abdominal pain (69.9%) followed by lower back pain and fatigue. Most patients reported multiple symptoms; 39.8% of women reported complete relief of symptoms after removal surgery, whereas 15.1% did not notice any relief in symptoms. CONCLUSION: Six weeks after removal surgery, 39.8% of patients reported complete resolution of symptoms. Further research to reported symptoms after Essure sterilization and symptom resolution after removal surgery is necessary to inform both patients and gynecologists in order to make a well-considered decision about taking the risks of (major) surgery and the expected benefits of removal.

Two Surgical Techniques for Essure Device Ablation: The Hysteroscopic Way and the Laparoscopic Way by Salpingectomy with Tubal Interstitial Resection.

STUDY OBJECTIVE: To describe 2 different surgical techniques for Essure removal on the same patient: the hysteroscopic and laparoscopic techniques. DESIGN: An educational video approved by the local institutional review board (Canadian Task Force classification III). SETTING: A university hospital (University Hospital of Strasbourg, Strasbourg, France). PATIENT: A 46-year-old woman with many symptoms after Essure device implantation. An ultrasound found a right implant in the uterine cavity and a left intratubal implant. INTERVENTIONS: The first step was the hysteroscopic removal of the right implant. We viewed the 2 internal and external spirals, allowing the gripping of the whole device without risking any fragmentation or tubal lesion. The second step was bilateral salpingectomy with resection of the left interstitial tubal portion. We longitudinally incised the antimesial edge of the fallopian tube 2 to 3 cm from the tubal serous to the implant contact. A circumferential incision was performed at the uterine horn to circumscribe the interstitial tubal portion. The implant was released from the surrounding tissue. It was gently pulled to completely extract it and avoid spiral fragmentation. Then, we performed a bilateral total salpingectomy. An X-ray of the implants and pelvis was performed to ensure complete removal of the device. We made an X-stitch in the uterine horn to avoid the risk of fistula. CONCLUSION: More and more patients are asking for the removal of their implants. The surgical technique has to be adapted to the location of the implants and has to allow their complete removal to avoid leaving fragments that can cause the persistence of side effects.

A Pilot Study Comparing 2- and 3-dimensional Ultrasound Imaging for Confirmation of Essure Fallopian Tube Pregnancy Prevention Implants.

STUDY OBJECTIVE: To show the feasibility of 2-dimensional (2D) ultrasound (US) imaging compared with 3-dimensional (3D) US to identify the location of implants and assess if the classification developed by Simorre et al in 2016 was applicable to the 2 types of US imaging (i.e., 2D and 3D). DESIGN: A prospective study (Canadian Task Force classification II-2). SETTING: The department of obstetrics and gynecology in a teaching hospital. PATIENTS: One hundred fifty patients who had undergone hysteroscopic sterilization with Essure (Bayer Pharma AG Laboratory, Lyon, France) fallopian tube pregnancy prevention implants were invited by letter to participate in the study; 50 replied positively between January and August 2017. INTERVENTIONS: An initial 2D US was performed followed by 3D US reconstruction. The primary end point was to compare the identification of device placement with 2D and 3D US imaging procedures according to this new classification. Secondary considerations were to evaluate the difficulty of attaining images, the quality of implant curvature, the duration of each imaging procedure, and the number of images performed for each technique. MEASUREMENTS AND MAIN RESULTS: Ninety-six percent of tubal implants were observed via 3D US compared with 100% via 2D US. The mean time of 2D US was 14.64 seconds for the right fallopian tube and 15.25 seconds for the left fallopian tube compared with 25.11 seconds for the right and 31.57 seconds for the left fallopian tube in 3D US (p <.01). The mean number of image acquisitions per patient was 1.02 (±0.14 standard deviation) for 2D US compared with 1.37 (±0.64 standard deviation) for 3D US (p <.01). The sonographer had no difficulty performing 2D US in 88% of cases compared with 58% of 3D US cases. CONCLUSIONS: Two-dimensional ultrasound appears to be an acceptable alternative to 3D US. We propose a 2D classification for cross section device localization to facilitate image interpretation.

Hysteroscopic Placement of Platinum Microinsert in Patients With Hydrosalpinx Before In Vitro Fertilization and Embryo Transfer.

OBJECTIVE: To investigate the effectiveness of Tornado and Hilal (Cook Medical, Bloomington, IN) hysteroscopic proximal tubal occlusion (HPTO) for hydrosalpinx (HX) treatment before in vitro fertilization (IVF) and embryo transfer (ET) in patients with dense pelvic adhesions or low ovarian reserve. DESIGN: A retrospective study of patients treated between May 2014 and May 2016 (Canadian Task Force classification III). SETTING: A university-affiliated center. PATIENTS: One hundred fifty women with unilateral or bilateral HX who were not candidates for laparoscopic surgery. INTERVENTION: Tornado or Hilal HPTO before IVF-ET and/or frozen ET. MEASUREMENTS AND MAIN RESULTS: The main outcome was the cumulative live birth rate. Tornado or Hilal placement was successful for 143 (95.3%) patients. Of the 132 patients who underwent 204 ET cycles, 86 (65.2%) conceived, and 78 (59.1%) resulted in live births. The overall early and late miscarriage rates per clinical pregnancy were 12.8% and 1.1%, respectively. The ectopic pregnancy rate was 2.3%. No major complications occurred. CONCLUSION: Tornado or Hilal HPTO is an effective alternative for treating HX before IVF-ET/frozen ET in patients with dense pelvic adhesions or low ovarian reserve.

Accuracy of Ultrasonography in the Evaluation of Tubal Sterilization Microinsert Positioning: Systematic Review and Meta-analysis.

The current reference standard to check the position of a tubal sterilization microinsert device after its insertion is hysterosalpingography. The objective of this study was to evaluate the accuracy of 2-dimensional (2D) and 3-dimensional (3D) ultrasonography (US) in the positioning of the tubal sterilization microinsert for definitive contraception. We searched MEDLINE, Embase, Cochrane, and Scopus databases through October 2017. Selection criteria included studies that analyzed the accuracy of 2D or 3D US, or both, with respect to the positioning of the microinsert. Data were displayed as forest plots and a summary receiver operating characteristic curves. Values for sensitivity, specificity, and positive and negative likelihood ratios (LRs) were calculated. The pooled analysis produced sensitivity and specificity values for 2D US in the positioning of the microinsert of 0.88 (95% confidence interval [CI], 0.47-1.0) and 0.92 (95% CI, 0.88-0.95), respectively, with positive and negative LRs of 8.68 (95% CI, 1.63-46.1) and 0.35 (95% CI, 0.11-1.11), respectively. Three studies analyzed the performance of 3D US, showing sensitivity, specificity, and positive and negative LRs of 0.75 (95% CI, 0.35-0.97), 0.82 (95% CI, 0.77-0.87), 3.65 (95% CI, 2.31-5.75), and 0.46 (95% CI, 0.2-1.09). In conclusion, 2D and 3D US are methods that show good accuracy in tubal sterilization microinsert positioning.

One-step transvaginal three-dimensional hysterosalpingo-foam sonography (3D-HyFoSy) confirmation test for Essure® follow-up: a multicenter study.

OBJECTIVE: To evaluate, in patients who underwent Fallopian-tube sterilization by hysteroscopic insertion of an Essure® device, the feasibility and accuracy of three-dimensional (3D) transvaginal sonography (TVS) to check the position of the device and 3D hysterosalpingo-foam sonography (3D-HyFoSy) using contrast-enhanced gel foam to assess consequent tubal occlusion. METHODS: This was a prospective multicenter study conducted from June 2012 to July 2014 in four Italian centers, which included 50 women who underwent hysteroscopic Essure microinsert placement in a total of 95 Fallopian tubes. Placement of the microinserts was performed in an outpatient setting following standard procedure recommendations. All patients underwent transvaginal 3D-HyFoSy and hysterosalpingography (HSG) approximately 12-14 weeks after the procedure. The position of the devices was first checked on 3D-TVS and classified according to specific criteria (Positions A, B, C and D). Then, 3D-HyFoSy with ExEm® gel foam as the ultrasound contrast agent was performed to confirm tubal occlusion by the absence of contrast agent within the tubes and/or around the ovaries. To evaluate the feasibility of 3D-HyFoSy, consecutive volume acquisitions were performed while injecting the gel foam. After sonographic evaluation, women underwent HSG to assess the success of sterilization, as standard methodology. Side effects and pain evoked during and after 3D-HyFoSy and HSG were evaluated using a numeric pain rating scale. RESULTS: On 3D-TVS, 10 devices (10.5%) were in Position A, two (2.1%) in Position B, 59 (62.1%) in Position C and 24 (25.3%) in Position D. During 3D-HyFoSy, tubal occlusion was observed in 89 of 95 tubes (93.7%). In the six cases in which the passage of the contrast was observed, one device (16.7%) was in Position B, one device (16.7%) in Position D and four devices (66.7%) were found to lie in Position C. Tubal patency was confirmed at HSG with a concordance rate of 100%. The mean pain score associated with 3D-HyFoSy was significantly lower than that on HSG. CONCLUSIONS: 3D-TVS with HyFoSy allows accurate assessment of the position of Essure microinserts and tubal occlusion. It can be considered a safe, reliable, non-invasive alternative to HSG. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Safety and patients' satisfaction after hysteroscopic sterilisation.

The aim of this study was to understand the potential complications of the Essure® device as well as the factors influencing its onset and patient satisfaction. We present a 9-year descriptive prospective study that included 1068 patients. The device was placed in 1056 of them (98.8%); 894 had no pain or mild pain during the insertion and only 12 patients experienced pain greater than menstrual pain. The proportion of patients without pain was greater in the group that took NSAIDs or NSAIDs and BZD and the unmedicated group had the highest rate of severe pain (p = .00). In all, 161 of the 1064 patients who had the Essure® inserted reported having an adverse effect during the 3-months post-insertion (pelvic pain or discomfort). The mean score out of 10 attributed to this method was 9.06 (S = 1.11). We concluded that the Essure® shows a low rate of complications and users showed a high degree of satisfaction. Impact statement What is already known on this subject: There are few international publications on Essure®. When we conducted a search in PubMed for the term 'Essure', we obtained 221 publications. When we added the terms 'Essure and complications', we obtained 20 publications, and when we increased the restriction including 'satisfaction', we obtained seven; thus, the uniqueness of our study. What the results of this study add: We present a 9-year descriptive prospective study that included 1068 patients. The aim of this study was to understand the potential complications of the Essure® device (Bayer, Whippany, NJ), as well as factors that can influence its onset and the patient satisfaction. The device was placed in 1056 of the patients (98.8%); 894 had no pain or mild pain during the insertion and only 12 patients experienced pain greater than menstrual pain. The proportion of patients without pain was greater in the group that took NSAIDs or NSAIDs and BZD and the unmedicated group had the highest rate of severe pain (p=.00). What the implications are of these findings for clinical practice and/or further research: Our study shows a low rate of complications with Essure®, mild and transient in most cases, as well as a high degree satisfaction. Nevertheless, given the few published studies on this device, we believe that long-term follow-up is needed.

Laparoscopic Cornuectomy as a Technique for Removal of Essure Microinserts.

STUDY OBJECTIVE: The authors present a laparoscopic technique for complete removal of Essure microinserts (including nitinol coil and positron emission tomography fibers). DESIGN: Step-wise instruction using video. The study was granted a Research Ethics Board exemption because the Regina Qu'Appelle Health Region Research Ethics Board does not require ethics board approval for single case submissions. SETTING: Tertiary care hospital. PATIENTS: Patient requesting removal of Essure inserts because of post-placement discomfort. INTERVENTIONS: Recent concern regarding adverse outcomes (persistent pelvic pain, device malposition, nickel allergy) after Essure placement has led to a small percentage of women requesting removal of the coils. Laparoscopic salpingectomy and salpingostomy have been successfully used for removal. Hysteroscopic removal has been achieved up to 6 weeks after placement; however, because of the fibrosis-inducing mechanism of the inserts, there is theoretical concern regarding fragmentation or incomplete removal with a cut and pull approach. MEASUREMENTS AND MAIN RESULTS: The authors used a laparoscopic surgical approach for removal of the Essure microinserts "en bloc" by performing a salpingectomy and mini-resection of the uterine cornua to the level of the endometrium. This approach ensures complete extraction of the Essure microinserts. The surgery was completed in a tertiary care hospital operating theatre with standard laparoscopic and electrosurgical instruments using a 10-mm infraumbilical port and two 5-mm ports in the left lower quadrant. CONCLUSION: En bloc resection of the fallopian tubes, uterine cornua, and Essure microinserts is a feasible laparoscopic approach to ensure complete removal of Essure microinserts. This approach is technically straightforward and can be achieved with minimal blood loss.

Essure Removal for the Treatment of Device-Attributed Symptoms: An Expanded Case Series and Follow-up Survey.

STUDY OBJECTIVE: To evaluate perioperative outcomes and symptom resolution in women undergoing removal of the Essure device for device-attributed symptoms. DESIGN: Retrospective case series and follow-up patient survey (Canadian Task Force classification III). SETTING: Large academic medical center. PATIENTS: Fifty-two women who underwent laparoscopic or hysteroscopic Essure removal between 2012 and 2016. INTERVENTIONS: Women underwent one of four procedures: laparoscopic hysterectomy (LH) and bilateral salpingectomy (BS), laparoscopic BS and cornuectomy, laparoscopic Essure removal and BS, or hysteroscopic Essure removal and laparoscopic BS. MEASUREMENTS AND MAIN RESULTS: Fifty-two women who underwent Essure removal were asked to complete a survey regarding symptom resolution and quality of life following the procedure. Thirty-two women (61.5%) responded to the survey. Seventy-five percent (24/32) reported almost total or total improvement in quality of life, 56.3% (18/32) for sex life, 53.1% (17/32) for pelvic pain, and 65.6% (21/32) for daily activities. The majority of women reported some degree of improvement in all four domains queried (87.5%, 28/32). When asked about their symptoms in general, 31.3% (10/32) of women reported ongoing or worse symptoms after Essure removal. All procedures took approximately one hour (mean 65 min, SD 33 min), were associated with minimal blood loss (mean 31 mL, SD 17), and had no perioperative complications. CONCLUSION: Essure removal is a procedure that may be effective for treating most women with symptoms attributed to the device. Patients should be counseled that some symptoms may persist or even worsen following surgery.

Laparoscopic Removal of a Retroperitoneal Hysteroscopic Microinsert Using Fluoroscopy.

Perforation during placement of hysteroscopic microinserts for permanent sterilization occurs in approximately .9% to 2.6% of women undergoing the procedure. Most of the time perforation results in intraperitoneal placement of the hysteroscopic microinsert requiring laparoscopy or laparotomy for removal of the device. Herein we present a case of hysteroscopic microinsert perforation with subsequent retroperitoneal identification of the device. This is the first such case to our knowledge of retroperitoneal identification and retrieval of a perforated device that required real-time fluoroscopy during laparoscopy.

Utility of Three-Dimensional Ultrasonography to Assess the Position of Essure Tubal Occlusion Device and Its Complications.

BACKGROUND: To determine the utility of three-dimensional (3D) sonography to control the position of hysteroscopic sterilizing device compared to hysterosalpingography (HSG). METHODS: A prospective observational study was carried out on 139 patients who underwent hysteroscopic tubal occlusion method between February 2012 and May 2013. Patients underwent 3D ultrasound scan to control device positioning, and they also underwent HSG as an additional control method. Comparison between both methods was carried out. RESULTS: In all, 17 (12.2%) devices were inserted due to a hydrosalpinx and 122 (87.8%) due to sterilization purposes. In 124 (89.2%) cases, sonography correlated completely to HSG findings. Sonography-positive predictive value was 89.5% to detect correct device positioning. Just 4 (2.8%) patients did not present complete tubal occlusion 3 months after device insertion; one of them presented device expulsion, 2 of them presented previous hydrosalpinx (tubal occlusion was confirmed after 6 months), and the last case rejected to undergo further controls but device seem to be effective. CONCLUSIONS: 3D sonography seems to be effective for the control of sterilization device positioning, but it also detects insertion complications and device migration. Further studies would be required to assess our findings and the role of sonography in case of hydrosalpinx.

High miscarriage rate in women treated with Essure® for hydrosalpinx before embryo transfer: a systematic review and meta-analysis.

OBJECTIVES: Essure® has been tested as an alternative treatment for hydrosalpinx before embryo transfer (ET) in women undergoing assisted reproduction techniques. However, the persistence of a foreign body inside the uterine cavity might have a negative impact on the outcome of pregnancy. The present systematic review aimed at identifying, appraising and summarizing the available evidence regarding the effectiveness and safety of using Essure prior to ET for women with hydrosalpinx. METHODS: We searched for studies in PubMed, Scopus, CENTRAL, Web of Science and ClinicalTrials.gov and the reference lists of eligible studies. All studies including at least 10 women with hydrosalpinx who received Essure, any other intervention or no treatment prior to ET were considered eligible. Study selection, data extraction and evaluation of the risk of bias were performed independently by two authors. Study outcomes were miscarriage per clinical pregnancy, singleton preterm birth per singleton live birth and live birth/ongoing pregnancy and clinical pregnancy per ET. The pooled results for each outcome and intervention were summarized as proportions with their respective 95% CIs, using a random-effects model. RESULTS: Our electronic search of databases was performed on 7 November 2015, and 26 studies with 43 study arms were considered eligible: eight study arms evaluating Essure; seven assessing tubal aspiration; seven appraising effects of no treatment; 12 evaluating salpingectomy; two assessing tubal division; and seven evaluating tubal occlusion. When compared with women who had no intervention, women with Essure had a higher clinical pregnancy rate per ET (36% (95% CI, 0-43%) vs 13% (95% CI, 9-17%)). When compared with women who had other interventions, women with Essure had a higher miscarriage rate per clinical pregnancy (38% (95% CI, 27-49%) vs 15% (95% CI, 10-19%)). CONCLUSIONS: The available evidence suggests that, although Essure prior to ET in women with hydrosalpinx improves the chance of achieving a clinical pregnancy compared with no intervention, it is associated with a higher rate of miscarriage when compared with the other interventions. Although this evidence is based on observational studies, we believe that salpingectomy should be the first option for women who are eligible for videolaparoscopy. However, it is still premature to make recommendations for women who are not eligible for surgery, and randomized controlled trials are needed to clarify which is the best treatment alternative in such a scenario. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Techniques for the interruption of tubal patency for female sterilisation.

BACKGROUND: This is an update of a review that was first published in 2002. Female sterilisation is the most popular contraceptive method worldwide. Several techniques exist for interrupting the patency of fallopian tubes, including cutting and tying the tubes, damaging the tube using electric current, applying clips or silicone rubber rings, and blocking the tubes with chemicals or tubal inserts. OBJECTIVES: To compare the different tubal occlusion techniques in terms of major and minor morbidity, failure rates (pregnancies), technical failures and difficulties, and women's and surgeons' satisfaction. SEARCH METHODS: For the original review published in 2002 we searched MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL). For this 2015 update, we searched POPLINE, LILACS, PubMed and CENTRAL on 23 July 2015. We used the related articles feature of PubMed and searched reference lists of newly identified trials. SELECTION CRITERIA: All randomized controlled trials (RCTs) comparing different techniques for tubal sterilisation, irrespective of the route of fallopian tube access or the method of anaesthesia. DATA COLLECTION AND ANALYSIS: For the original review, two review authors independently selected studies, extracted data and assessed risk of bias. For this update, data extraction was performed by one author (TL) and checked by another (RK). We grouped trials according to the type of comparison evaluated. Results are reported as odds ratios (OR) or mean differences (MD) using fixed-effect methods, unless heterogeneity was high, in which case we used random-effects methods. MAIN RESULTS: We included 19 RCTs involving 13,209 women. Most studies concerned interval sterilisation; three RCTs involving 1632 women, concerned postpartum sterilisation. Comparisons included tubal rings versus clips (six RCTs, 4232 women); partial salpingectomy versus electrocoagulation (three RCTs, 2019 women); tubal rings versus electrocoagulation (two RCTs, 599 women); partial salpingectomy versus clips (four RCTs, 3627 women); clips versus electrocoagulation (two RCTs, 206 women); and Hulka versus Filshie clips (two RCTs, 2326 women). RCTs of clips versus electrocoagulation contributed no data to the review.One year after sterilisation, failure rates were low (< 5/1000) for all methods.There were no deaths reported with any method, and major morbidity related to the occlusion technique was rare.Minor morbidity was higher with the tubal ring than the clip (Peto OR 2.15, 95% CI 1.22 to 3.78; participants = 842; studies = 2; I² = 0%; high-quality evidence), as were technical failures (Peto OR 3.93, 95% CI 2.43 to 6.35; participants = 3476; studies = 3; I² = 0%; high-quality evidence).Major morbidity was significantly higher with the modified Pomeroy technique than electrocoagulation (Peto OR 2.87, 95% CI 1.13 to 7.25; participants = 1905; studies = 2; I² = 0%; low-quality evidence), as was postoperative pain (Peto OR 3.85, 95% CI 2.91 to 5.10; participants = 1905; studies = 2; I² = 0%; moderate-quality evidence).When tubal rings were compared with electrocoagulation, postoperative pain was reported significantly more frequently for tubal rings (OR 3.40, 95% CI 1.17 to 9.84; participants = 596; studies = 2; I² = 87%; low-quality evidence).When partial salpingectomy was compared with clips, there were no major morbidity events in either group (participants = 2198, studies = 1). The frequency of minor morbidity was low and not significantly different between groups (Peto OR 7.39, 95% CI 0.46 to 119.01; participants = 193; studies = 1, low-quality evidence). Although technical failure occurred more frequently with clips (Peto OR 0.18, 95% CI 0.08 to 0.40; participants = 2198; studies = 1; moderate-quality evidence); operative time was shorter with clips than partial salpingectomy (MD 4.26 minutes, 95% CI 3.65 to 4.86; participants = 2223; studies = 2; I² = 0%; high-quality evidence).We found little evidence concerning women's or surgeon's satisfaction. No RCTs compared tubal microinserts (hysteroscopic sterilisation) or chemical inserts (quinacrine) to other methods. AUTHORS' CONCLUSIONS: Tubal sterilisation by partial salpingectomy, electrocoagulation, or using clips or rings, is a safe and effective method of contraception. Failure rates at 12 months post-sterilisation and major morbidity are rare outcomes with any of these techniques. Minor complications and technical failures appear to be more common with rings than clips. Electrocoagulation may be associated with less postoperative pain than the modified Pomeroy or tubal ring methods. Further research should include RCTs (for effectiveness) and controlled observational studies (for adverse effects) on sterilisation by minimally-invasive methods, i.e. tubal inserts and quinacrine.

In Vitro Fertilization Outcomes After Placement of Essure Microinserts in Patients With Hydrosalpinges Who Previously Failed In Vitro Fertilization Treatment: A Multicenter Study.

STUDY OBJECTIVE: To investigate whether hysteroscopic proximal tubal occlusion with Essure microinserts (Conceptus Inc.; Bayer, AG, North Rhine-Westphalia, Germany) can improve pregnancy rates in patients with hydrosalpinges who had failed in vitro fertilization (IVF) treatment. DESIGN: A prospective cohort study. SETTING: University-affiliated tertiary centers. PATIENTS: Twenty-four consecutive women with hydrosalpinges who had failed IVF treatment were included. INTERVENTIONS: Hysteroscopic placement of Essure microinserts for hydrosalpinx blockage followed by IVF treatment. MEASUREMENTS AND MAIN RESULTS: Ongoing pregnancy and live birth rates were recorded. Of the 24 patients undergoing a total of 42 IVF cycles after Essure insertion, 18 (75% of patients and 42.8% of IVF cycle attempts) conceived and 16 delivered live births (66.6% of patients and 38.1% of IVF cycle attempts). CONCLUSION: Hysteroscopic proximal occlusion of hydrosalpinges with Essure microinserts is a valuable alternative to laparoscopic salpingectomy, resulting in reasonable pregnancy rates.

Confirmation Testing of Essure Microinserts in Unintended Pregnancies Using a 10-Year Retrospective Database.

STUDY OBJECTIVES: To examine the imaging modality used in cases of Essure failures and determine the cause of the unintended pregnancies (noncompliance to follow-up recommendations, misinterpretation of the imaging test, or device failure). DESIGN: Retrospective, single-center interventional cohort (Canadian Task Force classification II-2). SETTING: Tertiary level hospital. PATIENTS: Women who have had Essure placement and subsequent pregnancy. INTERVENTIONS: Coding data from the Regina General Hospital was examined for any pregnancy occurring after an Essure procedure. The hospital charts were then reviewed for data collection. A separate imaging database established over the same time frame was then reviewed to determine the imaging modality used in each case (transvaginal ultrasound [TVU], hysterosalpingogram [HSG], or none). Results of the imaging study were reviewed and the cause of the failure determined. MEASUREMENTS AND MAIN RESULTS: Twenty-four pregnancies in 25 women were identified after Essure procedures from January 1, 2003 to March 31, 2013. There were 4 in vitro fertilization pregnancies and 4 pregnancies where the woman had been instructed not to rely on the devices because of incomplete placement noted at time of the procedure. Therefore, 17 unintended pregnancies occurred of a total 2080 procedures performed. Examination of the imaging studies revealed that 11 were due to patient noncompliance (either early cessation of backup contraception or failure to go for confirmatory imaging), 5 due to misinterpretation of the imaging tests (3 HSG, 2 TVU), and 1 device failure. This reveals a cumulative failure rate of 6 of 2080 or .29% over 10 years with only .04% (1/2080) being device related. CONCLUSION: Essure sterilization is an effective means of permanent contraception with a device failure rate of only .04%. Most unintended pregnancies after the Essure procedure result from a failure to comply with follow-up recommendations, and strategies to improve compliance should be emphasized.

Technique for the Laparoscopic Removal of Essure Microinserts.

STUDY OBJECTIVE: To describe our technique for the laparoscopic removal of Essure microinserts (Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ). DESIGN: Step-by-step explanation of the procedure using video (Canadian Task Force classification III). SETTING: Hysteroscopic sterilization using tubal microinsert devices has generally been reported to be well tolerated in terms of procedure-related pain. Persistent pelvic pain requiring microinsert removal has been described in a few case reports and series and was estimated at 0.16% of cases (7 cases [49/4,274]) in a large retrospective study. Removal is usually performed at the patient's request and/or because of persistent pelvic pain unresponsive to other treatments with no other etiologies found. In general, the pain starts at the initial insertion and persists thereafter. Both laparoscopic and hysteroscopic removal approaches have been described in the few cases reported. INTERVENTIONS: In this video, we describe our technique for the surgical management of pelvic pain resulting from Essure microinserts. We performed laparoscopic removal of bilateral Essure microinserts in a 30-year-old G3P3 (Gravida 3 Para 3) with bilateral Essure devices placed 2 years before the procedure; hysterosalpingogram confirmed appropriate placement. The patient was suffering from bilateral sharp pelvic pain since insertion that was related to positional change and movements but unrelated to periods along with menorrhagia. A pelvic ultrasound showed a small intramural uterine leiomyoma. She failed a trial of treatment of her symptoms with a levonorgestrel intrauterine device. The patient requested removal of her Essure microinserts and endometrial ablation. She underwent laparoscopic bilateral Essure microinsert removal and bilateral salpingectomy along with hysteroscopic removal of the levonorgestrel intrauterine device and endometrial ablation. Her surgery was uneventful, and she was discharged the day of the surgery. Her symptoms resolved completely after the procedure. CONCLUSION: Laparoscopic removal of Essure microinserts in the context of persistent pelvic pain after insertion is a feasible and effective procedure and allows the avoidance of performing a hysterectomy when the patient declines this procedure. Sound knowledge of the Essure components and meticulous surgical technique are paramount for successful results.

Patient Outcomes Following Injury from Hysteroscopic Sterilization.

OBJECTIVE: We present clinical data on two patients who underwent hysteroscopic sterilization (HS) 11 years apart using the Essure® (Bayer Inc., Whippany, NJ) device. MATERIALS AND METHODS: Symptoms and resolution are described for symptomatic Essure® patients. RESULTS: Case 1 (G3P1) underwent HS in 2004 at age 21. Performed in a physician's office without anesthesia, HS involved placement of >2 Essure® devices which was followed by severe, unrelenting pelvic pain. Confirmatory hysterosalpingogram (HSG) three months after HS revealed five devices. Surgical costs for laparoscopic assisted vaginal hysterectomy (LAVH) were fully reimbursed by the device manufacturer seven months later. Case 2 (G8P4) underwent HS in 2015 at age 32. One year earlier, the patient's right fallopian tube was removed due to ectopic pregnancy. Essure® devices were placed bilaterally in a physician's office without anesthesia; HS was accompanied by sharp pelvic pain. The patient obtained HSG three weeks after HS due to constant discomfort. Bilateral tubal occlusion was verified, but abnormal device loop configuration suggesting myometrial penetration was noted on the right. At laparoscopy, the left Essure® device was excised intact but the right coil could not be located. Thus far, there has been no offer in Case 2 from the device manufacturer to offset medical expenses. CONCLUSIONS: While HS has been FDA approved for use in the United States since 2002, this is the first description of clinical sequela when FDA labeling for the Essure® procedure is ignored. These cases illustrate the importance of proper physician training in HS and underscore the need for improved tracking of Essure® associated symptoms.