Long-term patient satisfaction and removal rate after essure sterilization: a follow-up study.

BACKGROUND: The objective of our study was to assess the rate and causes for Essure® micro-insert system removal and patients' long term satisfaction rate with the procedure. METHODS: All patients who underwent Essure® hysteroscopic sterilization at our tertiary centre between years 2007 and 2018 were included in this follow-up study. A questionnaire was sent to all patients per standard mail. Patients who did not respond to questionnaires per mail, were called by phone. The satisfaction with the Essure® sterilization, as well as any additional procedures after the insertion or insertion-related complications were analysed. RESULTS: From the year 2007 to 2018, we performed 427 Essure® hysteroscopic sterilizations and of these, 329 patients responded to the questionnaire (response rate 77%). Ten patients (3%) had Essure® removal, two of them due to pain (0.6%). Patients were very satisfied with the procedure (9.5 on scale 0-10). Most patients (95.3%) would recommend the procedure to their friend. CONCLUSIONS: Essure® hysteroscopic sterilization is a procedure with a very high satisfaction rate and a very low removal rate due to sterilization-related complications. Trial registration Institutional review board of University medical centre Maribor approved the study, approval number UKC-MB-KME-73/19.

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.

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

STUDY OBJECTIVE: To 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). DESIGN: Retrospective, observational case-controlled cohort study (Canadian Task Force classification II-2). SETTING: Two-physician private practice in Evansville, Indiana. PATIENTS: Compliance 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. INTERVENTION: Acquisition of 3-month confirmation testing after Essure hysteroscopic sterilization. MEASUREMENT AND MAIN RESULTS: All 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. CONCLUSION: Confirmation 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.

Simulation for Training and Assessment in Hysteroscopy: A Systematic Review.

Hysteroscopy simulation complements conventional training on patients, yet evidence-based recommendations about its implementation and use are lacking. This systematic review analyzes and critically discusses hysteroscopy simulation literature published over the last 30 years. Systematic searches on PubMed, Embase, PsychINFO, ERIC, and the Cochrane Library produced 27 original articles published through 2017. Strategies based on different simulation models (e.g., animal organs, vegetables, synthetic uteri, virtual reality) were evaluated by users and appeared to facilitate learning. Observational studies have suggested a large impact on the knowledge and technical skills of novices for a wide range of hysteroscopic procedures, including for diagnosis, resection, and sterilization. Pretest/posttest studies show large improvements in performance time (6 studies; pooled effect size, 1.45; 95% confidence interval, 1.06-1.85) and overall performance scores (4 studies; pooled effect size, 3.19; 95% confidence interval, 1.45-4.94). Additionally, performance assessment on simulated models distinguishes novices from experts. Caution should be exercised because the available evidence largely originates from heterogeneous studies with weak designs, conducted in experimental settings with nonclinical participants (i.e., medical students). Moreover, neither clinical outcomes nor the clinical value of simulation-based assessment has been addressed. Hysteroscopy simulation may be supported ethically and pedagogically, but its role should be evaluated in pragmatic contexts, with robust interventional studies and broader competence-defining outcomes that include nontechnical skills.

Occurrence of Chronic Pelvic Pain, Abnormal Uterine Bleeding, and Hysterectomy Post-procedure among Women Who Have Undergone Female Sterilization Procedures: A Retrospective Claims Analysis of Commercially Insured Women in the US.

STUDY OBJECTIVE: To evaluate the frequency of chronic pelvic pain (CPP), abnormal uterine bleeding (AUB), and hysterectomy after hysteroscopic sterilization (HS) or laparoscopic sterilization (LS) in the United States. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Commercially insured women. PATIENTS: Women (aged 18-49 years) with claims for HS or LS from January 1, 2010 to December 31, 2012 were identified from the MarketScan Commercial database. Women were required to have 6 months of continuous coverage before (baseline) and 24 months after (follow-up) the procedure date. Women with ≥1 diagnosis for a pain condition (pain in pelvis/lower abdomen, low back pain, chronic headache, fibromyalgia) and/or AUB (excessive/frequent menstruation, irregular menstrual cycle, metorrhagia) during baseline were identified with International Classification of Diseases, Ninth Revision, Clinical Modification codes. INTERVENTIONS: HS/LS. MEASUREMENTS AND MAIN RESULTS: Outcome measurements were proportions of women with CPP, AUB, and hysterectomy during follow-up. Among the study population 10 224 women underwent HS, whereas 8051 underwent LS. During baseline 23.3% and 26.9% of women with HS and LS, respectively, had a pre-existing pain diagnosis. Among both HS and LS study cohorts, greater proportions of women with a pre-existing pain condition versus those without had CPP in the 24 months afterward (HS cohort: 19.8% vs 9.3%, p < .001; LS cohort: 23.8% vs 11.4%, p < .001). During baseline 11.7% and 6.4% of women with HS and LS, respectively, had pre-existing AUB. Among cohorts, greater proportions of women with pre-existing AUB versus those without had AUB in the 24 months afterward (HS cohort: 21.2% vs 7.3%, p < .001; LS cohort: 15.9% vs 6.4%, p < .001). Among women who underwent HS and LS, pre-existing pain and AUB were associated with higher rates of hysterectomy postprocedure. Multivariable regression results showed similar direction of findings. CONCLUSION: Among women who underwent HS and LS, pre-existing pain conditions and AUB were associated with higher rates of CPP and AUB postprocedure, respectively, and both pre-existing conditions were associated with a greater frequency of subsequent hysterectomy.

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

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

The feasibility, safety, and effectiveness of hysteroscopic sterilization compared with laparoscopic sterilization.

BACKGROUND: In contrast to conventional laparoscopic sterilization, newer hysteroscopic approaches avoid the need for hospital admission, general anesthesia, and prolonged recovery. However, there are concerns that the feasibility, safety, and efficacy of hysteroscopic sterilization may be lower than established laparoscopic sterilization. OBJECTIVE: We sought to evaluate the outcomes of hysteroscopic sterilization compared with laparoscopic sterilization in routine clinical practice in a comparative observational cohort study. STUDY DESIGN: This study was carried out at University of Birmingham, United Kingdom, National Health Service teaching hospital, office hysteroscopy clinics, and day-case hospital unit. In all, 1085 women underwent hysteroscopic sterilization and 2412 had laparoscopic sterilization. Hysteroscopic sterilization was carried out using the tubal implant permanent birth control system in the office setting and laparoscopic sterilization using the tubal ligation system as a day-case under general anesthesia. Outcome data were collected regarding feasibility (technical completion of the sterilization procedure, satisfactory radiological confirmation at 3 months-hysterosalpingogram or transvaginal pelvic ultrasound scan), safety events within 30 days of procedures, reoperations, and unintended pregnancies within 1 year of procedures. RESULTS: Hysteroscopic sterilization was successful in 992/1085 (91.4%; 95% confidence interval, 89.6-93.0%) at the first attempt. In comparison, bilateral tubal ligation was successfully performed in 2400/2412 (99.5%; 95% confidence interval, 99.2-99.8%) of patients who underwent laparoscopic sterilizations (odds ratio, 18.8; 95% confidence interval, 10.2-34.4). In all, 902/1085 (83.1%; 95% confidence interval, 80.8-85.2%) of successfully performed hysteroscopic procedures attended for radiological confirmation testing were considered satisfactory. The rate of adverse events within 30 days were similar: 2/1085 (0.2%) vs 3 (0.12%; 95% confidence interval, 0.04-0.36%). There were 3/1085 (0.3%; 95% confidence interval, 0.1-0.8%) unintended pregnancies after hysteroscopic sterilization compared with 5/2412 (0.2%; 95% confidence interval, 0.1-0.5%) laparoscopic sterilization (odds ratio, 1.3; 95% confidence interval, 0.3-5.6). Median length of follow-up for pregnancy outcome was 5 years. Hysteroscopic sterilization was associated with a higher risk of reoperation at 1 year compared to laparoscopic sterilization (odds ratio, 6.2; 95% confidence interval, 2.8-14.0) and the commonest reintervention was unilateral salpingectomy (12/22, 54.5%). CONCLUSION: Hysteroscopic sterilization has been introduced as a more convenient, office-based method of permanent fertility control. However, while the small risk of unintended pregnancy is comparable to conventional laparoscopic sterilization, women should also be counselled regarding its lower success rate in successfully completing the procedure and its higher rate of failed reoperation.

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.

Algorithm of Transvaginal Ultrasound and/or Hysterosalpingogram for Confirmation Testing at 3 Months after Essure Placement.

STUDY OBJECTIVE: To evaluate the algorithm of transvaginal ultrasound (TVU) and/or modified hysterosalpingogram (HSG) confirmation testing 3 months after Essure placement to determine if women can rely on the device for permanent birth control. DESIGN: Interim analysis of an ongoing 10-year, prospective, multicenter, nonrandomized, single-arm, international trial (Canadian Task Force classification II-2). SETTING: Twenty study centers in the United States (n = 12), Canada (n = 1), The Netherlands (n = 6), and Spain (n = 1). PATIENTS: Women undergoing the Essure procedure for permanent birth control. INTERVENTIONS: Based on the algorithm for confirmation testing, women with an uncomplicated Essure procedure underwent TVU as the confirmation test; modified HSG was used for women ineligible for TVU, when TVU findings were abnormal or inconclusive, or based on the physician's discretion. MEASUREMENTS AND MAIN RESULTS: Co-primary endpoints (intention-to-treat [ITT] population) were the reliance rate and the 1-year pregnancy rate. Safety evaluation was based on adverse events. Bilateral insert placement was attempted in 597 women (ITT population) and achieved in 582 of 597 (97.5%). A total of 547 women were told to rely on Essure for permanent birth control. Both co-primary endpoints met prespecified limits: based on Bayesian statistics, the reliance rate was 91.6% (547/597; 95% credible interval, 89.2%-93.6%) and the 1-year pregnancy rate .67% (95% credible interval, .16%-1.53%). Using the algorithm for confirmation testing, of 547 subjects told to rely on Essure, 470 (86%) underwent TVU alone, 30 (6%) had modified HSG alone, and 47 (9%) had TVU followed by modified HSG. Four women became pregnant after being told to rely on Essure. They all had confirmation testing with TVU alone, and each initially read incorrectly as optimal insert locations. In each case postpregnancy follow-up and root cause analysis revealed unsatisfactory insert locations, 2 of which were perforations. Most adverse events were mild and unrelated to Essure. CONCLUSION: The algorithm of TVU and/or modified HSG confirmation testing 3 months after Essure placement can determine that a woman can rely on the device for permanent birth control. The adverse events observed are consistent with the known safety profile of Essure. (clinicaltrials.gov: NCT01327105.).

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

STUDY OBJECTIVE: To describe safety, tolerability, and effectiveness results through a minimum 2-year follow-up of patients who underwent permanent sterilization with the Essure insert. DESIGN: A retrospective multicenter study (Canadian Task Force classification II2). SETTING: Seven general hospitals and 4 clinical teaching centers in Italy. PATIENTS: A 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. INTERVENTION: The 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 RESULTS: Placement 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. CONCLUSION: The 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.

Does Essure Cause Significant De Novo Pain? A Retrospective Review of Indications for Second Surgeries After Essure Placement.

STUDY OBJECTIVES: To examine the surgical indications and pathologic findings in patients undergoing a second surgery after placement of the Essure permanent birth control system to determine the role of Essure in developing new-onset pelvic pain. DESIGN: Retrospective cohort (Canadian Task Force classification II-2). SETTING: Tertiary-level hospital. PATIENTS: Women who have had Essure placement and subsequent second surgery. INTERVENTION: Charts from women undergoing pelvic surgery after Essure placement from June 2002 to June 2013 were reviewed and the indication for the procedure, surgical and pathologic findings noted. MEASUREMENTS AND MAIN RESULTS: Of 1430 patients, 62 (4.3%) had a second surgery after Essure placement, and 24 of these (1.6%) had a surgical indication not related to pain. The remaining 38 patients (2.7%) had either new-onset (n = 27) or worsening pre-existing pain (n = 11). In the new-onset pain group, 15 (1%) had surgical findings or pathology consistent with a painful gynecologic condition. In the remaining 12, 8 (0.5%) seemed to be related to some perforation or migration of the Essure device. In 4 patients (0.3%) with no other obvious cause for the new-onset pain, it was thus attributed to the Essure microinsert. CONCLUSION: Essure sterilization can be associated with new-onset pain or a worsening of a pre-existing painful gynecologic condition, although both are very rare. A careful and complete consent before placement and a thorough examination if pain does occur usually show some etiology for the pain other than the Essure insert.

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.

Incidence of opioid-managed pelvic pain after hysteroscopic sterilization versus laparoscopic sterilization, US 2005-2012.

OBJECTIVE: Compare incidence of opioid-managed pelvic pain within 12 months after hysteroscopic and laparoscopic sterilization. METHODS: Using administrative claims, we identified women aged 18-49 years without recent history of childbirth who underwent hysteroscopic or laparoscopic sterilization between 2005 and 2012. We defined the outcome as ≥2 diagnoses for pelvic pain and ≥2 prescription fills for opioids. We calculated adjusted hazard ratios (HR) using Cox models and propensity score methods (matching and inverse-probability-of-treatment-weighting [IPTW]). RESULTS: We identified 71,875 eligible women (hysteroscopic n = 26,927 [37.5%], laparoscopic n = 44,948 [62.5%]). Of those, 236 (0.88%) hysteroscopic patients and 420 (0.93%) laparoscopic patients experienced the outcome (crude HR = 0.97, 95%CI: [0.83, 1.14]). Adjusted analyses also yielded near-null results (matched HR = 1.08, 95%CI [0.90, 1.31]; IPTW HR = 0.97, 95%CI [0.80, 1.18]). While most sensitivity analyses generated results close to the null, hazard ratios estimated using propensity score matching ranged from 0.65 to 1.53. CONCLUSIONS: Among women without recent history of childbirth, we did not find compelling evidence of a clinically meaningful increase in the incidence of pelvic pain requiring opioids during the year after hysteroscopic sterilization. However, effects observed in sensitivity analyses may merit further investigation.

Essure hysteroscopic sterilization versus interval laparoscopic bilateral tubal ligation: a comparative effectiveness review.

A comparative effectiveness analysis was performed to examine the risks and benefits of laparoscopic bilateral tubal ligation compared with hysteroscopic sterilization using the Essure Permanent Birth Control System (Bayer HealthCare AG, Whippany, NJ). Existing evidence shows that both LBTL and Essure are safe and effective methods of female sterilization. Both have high rates of efficacy and low rates of complications although when complications do occur, those related to the Essure procedure are more likely to be minor in nature. The analysis was limited by the restricted number of studies involving head-to-head comparisons of the 2 approaches.

Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study.

OBJECTIVE: To describe safety, tolerability, and effectiveness results through 5 years of follow-up of a Phase III trial with Essure inserts. DESIGN: Multicenter, nonrandomized, single-arm international study (Canadian Task Force classification II-3). SETTING: Thirteen clinical study centers in the United States, Europe, and Australia. PATIENTS: A total of 518 previously fertile women seeking permanent contraception. INTERVENTION: The objective of the hysteroscopic sterilization procedure was bilateral Essure insert placement (ESS205 model) and tubal occlusion. Women with satisfactory device location and tube occlusion (based on modified hysterosalpingography [HSG]) were instructed to discontinue alternative contraception and to rely on Essure inserts for permanent contraception. MEASUREMENTS AND MAIN RESULTS: The primary endpoint for the Phase III study was the rate of pregnancies occurring during the first year of relying (i.e., HSG-confirmed occlusion) on the Essure inserts for permanent contraception (i.e., 12 months after HSG). For the full 5 years of follow-up (5 years total of relying on the Essure inserts for contraception), the endpoints of interest were safety, prevention of pregnancy, and satisfaction. No pregnancies were reported among women relying on the Essure inserts who completed the full 5 years of follow-up. As of December 5, 2007, 449 women with successful bilateral placement relying on the Essure inserts contributed a total 24 942 woman-months of follow-up for assessing effectiveness. Overall, the Essure inserts were generally well tolerated, with participant comfort rated as "good" to "excellent" by 99% of women (382 of 385) after 5 years of use. Similarly, overall satisfaction was rated as "somewhat" to "very satisfied" by 98% of women (376 of 384) after 5 years of use. The majority of adverse events reported during the 5 years of follow-up were rated as either "mild" or "moderate" in severity. Three severe events (abdominal pain with very heavy periods and irregular menstrual bleeding) were reported in 2 subjects during follow-up as being "possibly" related to the procedure or the inserts. CONCLUSION: The findings from extended follow-up of this Phase III trial with Essure inserts further support the effectiveness, tolerability, and satisfaction of this nonhormonal, nonincisional option for permanent contraception.

Incidence and risk factors for chronic pelvic pain after hysteroscopic sterilization.

STUDY OBJECTIVE: To investigate the incidence of and preoperative risk factors for developing pelvic pain after hysteroscopic sterilization using the Essure microinserts. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: University medical center. PATIENTS: A total of 458 patients who underwent hysteroscopic sterilization using Essure between January 1, 2005, and June 30, 2012. INTERVENTION: Hysteroscopic sterilization using Essure. MEASUREMENTS AND MAIN RESULTS: The incidence of acute pelvic pain after hysteroscopic sterilization was 8.1%, and of persistent pain at 3 months after the procedure was 4.2%. The range of presence of pain was 1 to 469 days (mean, 56 days). Of patients who developed chronic pelvic pain after the procedure, 75% reported it within 130 days of the procedure. Patients with previous diagnoses of any chronic pain (chronic pelvic pain, chronic low back pain, chronic headache, and fibromyalgia) were more likely to report both acute pain (odds ratio, 6.81; 95% confidence interval, 2.95-15.73) and chronic pain (odds ratio, 6.15; 95% confidence interval, 2.10-18.10) after hysteroscopic sterilization. CONCLUSIONS: Pelvic pain may develop after hysteroscopic sterilization. Patients with a diagnosis of preexisting chronic pain may be at increased risk of developing pelvic pain after the procedure. Fifty percent of new pelvic pain after Essure placement will resolve within 3 months.

Radiological assessment of placement of the hysteroscopically inserted Essure permanent birth control device.

Essure is a permanent birth control device that is inserted through the cervix by hysteroscopy. The device is placed in the fallopian tubes, where it causes occlusion by stimulating fibrosis. Patients can be followed up with plain-film X-rays, hysterosalpingography, and ultrasonography, although the devices can also be identified incidentally on CT and MRI. The follow-up of Essure is based on checking the criteria for appropriate positioning and correct functioning (tubal occlusion) and on diagnosing complications. The most common complications are perforation, migration (toward the uterine or peritoneal cavity), and occlusion failure. In hysterosalpingography, vascular intravasation is the most common cause of diagnostic error. Radiologists need to know how to recognize the device on different imaging techniques, how to check that it is correctly placed and functioning, and how to diagnose complications.

Management of complications encountered with Essure hysteroscopic sterilization: a systematic review.

Essure hysteroscopic sterilization has been US Food and Drug Administration-approved in the United States since 2002. Complications associated with the Essure device include improper placement (malpositioning), unintended pregnancy, pain, infection, and nickel allergy. The rarity of complications, compounded by underreporting, makes it difficult to determine best practices insofar as management. This systematic review synthesizes the national and global experience with management of Essure-related complications and suggests treatment options when data allow.

Hysteroscopic sterilization: 10-year retrospective analysis of worldwide pregnancy reports.

STUDY OBJECTIVE: To identify factors that might contribute to pregnancies reported after hysteroscopic sterilization worldwide. DESIGN: Retrospective review of commercial data compiled from the MAUDE database, medical literature, and manufacturer reports received during commercial distribution of hysteroscopic sterilization micro-inserts from 2001 through 2010 (Canadian Taskforce classification III descriptive study). MEASUREMENTS AND MAIN RESULTS: From 2001 through 2010, 497 305 hysteroscopic sterilization kits were distributed worldwide, and 748 pregnancies were reported, i.e., 0.15% of the estimated user population based on the number of distributed kits. The data were sufficient to enable analysis of 508 pregnancies for potential contributing factors and showed most to be associated with patient or physician noncompliance (n = 264) or misinterpreted confirmation tests (n = 212). Conceptions deemed to have occurred within 2 weeks of the procedure and therefore too early for detection were identified in 32 cases. CONCLUSION: Although there are limitations to the dataset and the study design is retrospective, it represents the largest body of cumulative hysteroscopic sterilization data available to date. Of the 748 pregnancies reported, it is apparent that some might have been prevented with greater patient and clinician attention to interim contraceptive use and counseling and with more rigorous evaluation and informed interpretation of the procedure confirmation tests. Although the estimated pregnancy rate based on such a dataset is likely an underestimation, it does suggest that the evaluable field performance of hysteroscopic sterilization micro-inserts is consistent with the labeled age-adjusted effectiveness of 99.74% at 5 years.