Essure Removal Research Articles

Dutch Nationwide Multicenter Prospective Cohort of Essure-related Symptomatology after Removal Surgery

Study objectiveEssure is a hysteroscopic sterilization device that has been used in the Netherlands since 2003. Essure has received a lot of publicity due to many reported symptoms associated with the device. Because of this, increasing numbers of patients requested surgical removal of Essure devices. There is still limited data available regarding the effect of removal surgery on reported symptoms and patient satisfaction. The aim of this study was to analyze the effect of Essure removal surgery on reported symptoms and quality of life. DesignMulticenter prospective study in the Netherlands. SettingSecondary non-teaching hospitals and secondary and tertiary teaching hospitals. PatientsPatients with Essure associated symptoms and a request for surgical removal of devices. InterventionsParticipants were asked to fill out questionnaires at their first clinic visit and 3 and 12 months after removal surgery. Questionnaires included questions regarding patient characteristics, symptoms and quality of life (SF-36). Clinicians also filled in 2 questionnaires, regarding peroperative findings, the removal surgery and post-operative recovery. Measurements and Main Results1248 patients in 32 hospitals were included in the period between May 2016 and April 2019. Mean age was 42.9 years (25-63 years). Most frequent reported symptoms were mood swings (72.4%), fatigue (71.8%), pain in hips, legs or groins (68.3%) and abdominal pain (62.3%). Essure was predominantly removed by laparoscopic salpingectomy (87.3%). Mean follow-up time was 17 months (± 10.8). 3 and 12 months after removal surgery all reported symptoms significantly improved. Quality of life improved significantly on all 9 domains. ConclusionEssure removal surgery was associated with improvement in reported symptoms and quality of life. Patients presenting with Essure related symptoms, should be offered Essure removal surgery, after considering the patient specific risks for surgery.

How to be sure of a complete removal of Essure® implant? A radiological study of Essure® microinserts

PurposeLaparoscopic cornuectomy, one of the most performed surgical techniques to remove Essure® implants, is associated with a risk of fragmentation of the device. We aimed to assess the diagnostic accuracy of the intraoperative radiograph of the removed Essure® microinserts compared with intraoperative inspection of the device. Study designIn this French retrospective cohort study including 66 patients, two experienced gynecologists and two residents evaluated the intraoperative radiograph in a blind manner. Diagnostic accuracy was calculated for each observer. ResultsThe global sensitivity and specificity for intraoperative radiograph to detect a residual fragment for both senior gynecologists and residents were, respectively 87.5 % (±3.3) and 80.0 % (+/12.2). Pooled positive (PPV) and negative predictive values (NPV) for intraoperative radiograph were respectively 99.2 % (±0.5) and 21.6 % (±6.4). There was a statistically significant difference in intraoperative radiograph analysis between senior gynecologists and residents (sensitivity: 91.4 %±0.8 vs 79.6 %±1.5, p = 0.02; specificity: 100% vs 50.0 %, p < 0.0001; PPV: 100 % vs 98.0 % ±0.1, p = 0.0007; NPV: 26.8 % ±1.8 vs 7.2 % ±0.5, p = 0.009).Sensitivity and specificity of the intraoperative inspection of the removal specimen was respectively 95.3 % and 100 % (PPV and NPV were, respectively 100 and 40 %).There were no statistically significant differences in diagnostic accuracy between intraoperative radiographs analysis and intraoperative inspection of the device for the senior gynecologists. ConclusionsIntraoperative radiograph of the removed Essure® implants analysis is a difficult skill needing specific training. Postoperative pelvic X-ray is still recommended in clinical practice after laparoscopic cornuectomy.

Essure removal surgery: Are preoperative transvaginal ultrasound and pelvic X-ray necessary?

ObjectiveThe objective of this study was twofold. (1) To investigate the predictive characteristics of transvaginal ultrasonography for hysteroscopy necessity in Essure removal surgery. (2) To investigate the additional predictive value of a preoperative pelvic radiograph to transvaginal ultrasonography for hysteroscopy necessity. Study DesignRetrospective cohort study, performed in an academic and a non-academic teaching hospital in the Netherlands. 71 women who underwent Essure removal surgery with a perioperative hysteroscopy and who had a preoperative pelvic X-ray and transvaginal ultrasound were included. Four experts first predicted hysteroscopy necessity based on transvaginal ultrasound description and secondly based on transvaginal ultrasound combined with the preoperative pelvic radiograph. Sensitivity, specificity, positive predictive value and negative predictive value of the predictive tests were calculated. ResultsBased on transvaginal ultrasound, the mean predictive characteristics for experts were: sensitivity 89.7% (range 66.7%–100%), specificity 37.4% (range 17.6%–67.7%), positive predictive value 18.8% (range 13.2%–29.5%) and negative predictive value 95.1% (range 86.1%–100%). After adding the pelvic radiograph to the transvaginal ultrasound descriptions, the results were: sensitivity 66.7% (range 53.3%–80%), specificity 72.6% (range 56%–97.3%), positive predictive value 23% (range 14.3%–26.9%) and negative predictive value 94.1 % (range 90.3%–98.4%). For three experts sensitivity decreased after adding the pelvic radiograph. For all experts specificity increased. ConclusionIt is difficult to preoperatively decide if the fourth marker of the Essure outer coil can be excised during hysteroscopy. The addition of pelvic radiography to transvaginal ultrasound is not beneficial. It is recommended to perform a hysteroscopy during Essure removal surgery.

Laparoscopic removal of Essure device techniques, perioperative findings and evaluation of patient's satisfaction: A case series

To evaluate perioperative outcomes and symptom resolution in women undergoing Essure removal. Single centre cohort study at a large University Teaching Hospital in the UK. Symptoms and Quality of life (QoL) were assessed using a standardised questionnaire administered at 6-months and up to 10-years following removal of Essure® devices. 61 women underwent surgical removal of Essure® devices representing 61/1087 (5.6%) of all women undergoing this hysteroscopic form of sterilization. Patients who had Essure® removal were more likely to have a previous caesarean section [38% vs 18%; OR 0.4, 95% CI 0.2-0.6; P <0.001]. The main indication for removal was pelvic pain (49/61, 80%). Removal was achieved by laparoscopic bilateral salpingectomy/cornuectomy (44/61,71%) or hysterectomy (17/61, 28%). At surgery, perforated device was seen in 4/61 (7%) cases. 26/61 (43%) of patients had concomitant pelvic pathology; 12/26 (46%) had fibrous adhesions, 8/26 (31%) endometriosis, 4/26 (15%) adenomyosis, and 2/26 (8%) had endometriosis and adenomyosis. 10 patients underwent further procedure following removal for ongoing symptoms. 55/61 women (90%) responded to the post removal symptom questionnaire. Most respondents to the quality of life survey 42/55 (76%) reported total or some improvement. 42/53 (79%) had total or some improvement in pelvic pain, 9/13 (69%) in mental health and 10/12 (83%) in bleeding. Surgical removal of Essure® devices appears to improve symptoms thought to be attributable to the presence of these uterine implants in most women. However, patients should be counselled that one in five women may experience persistent or even worsening symptoms.

Long-term quality of life after surgical Essure removal for device-attributed symptoms

ObjectiveTo analyze quality of life(QoL) and symptom resolution after surgical removal of Essure devices. MethodsSingle-center cohort study which included patients with Essure removal between February 2017 and March 2018. Surgery was performed in 65 patients by laparoscopy (Salpingectomy only or Hysterectomy). Questionnaires were used to assess QoL(SF-36), emotional disorders(HAD) and symptoms preoperatively, at 3 months and 4 years postoperatively. Results4(6,1%) and 16(24,6%) patients were lost of follow-up at three months and 4 years postoperatively respectively. Four(6,1%) intraoperative surgical complications occurred. During the three-months postoperative period, 3(4,6%) complications occurred: five Clavien Dindo Grade 1 complications (umbilical hematoma) and one Grade 2 complication (hyperthermia and digestive disorder requiring antibiotic therapy). Preoperative QoL scores were lower than those of general population. Scores were significantly improved at 3 months and 4 years postoperatively. At 4 years postoperatively, 17/49(34,7%) had a complete regression of symptoms, 21/49(42,8%) partial resolution and 11/49(22,4%) no improvement. 27/49(55,1%) patients made the connection between symptoms and ESSURE device after media coverage. 22/49(44,89 %) were influenced by media coverage in their decision of surgery. There was a higher percentage of patients with anxiety disorder before Essure removal than 4 years after [22/44 (50 %) versus 11/44 (25 %); p = 0.0045]. ConclusionEssure removal has a restorative role in terms of QoL in short and long-term. Patients should be informed about possibility of no improvement after surgery and surgical morbidity. Larger prospective cohort is needed to make a well-considered decision about risks of surgery compared with expected benefits.

7455 Long Term Outcomes after a Uterine-Sparing Approach to Essure Contraceptive Device Removal: A Case Series and Follow up Survey

<h3>Study Objective</h3> To analyze long-term effectiveness of a conservative, uterine-sparing approach to laparoscopic Essure contraceptive device removal. Specific outcomes of interest include patient satisfaction, symptom resolution and need for subsequent surgical intervention. <h3>Design</h3> Retrospective case series and follow up survey. <h3>Setting</h3> Large academic medical center. <h3>Patients or Participants</h3> Patients who underwent laparoscopic Essure removal without concomitant hysterectomy between January 2016 and December 2019. <h3>Interventions</h3> Patient underwent surgical removal of Essure device by laparoscopic salpingectomy or salpingostomy. Greater than 18 months after removal participants completed a survey assessing outcomes. <h3>Measurements and Main Results</h3> Twenty-nine patients underwent conservative Essure removal and there were 19 survey respondents, for a response rate of 65.5%. Among survey respondents, the mean length of time from Essure placement to removal was 56.7 months (range 5-117), and the mean length of time from removal to survey administration was 49.7 months (range 23-86). The most frequently reported symptom was pain (100%), followed by bleeding (52.6%), headache (42.1%), and dyspareunia (42.1%). The majority of patients underwent laparoscopic salpingectomy (79.3%); 3 patients (13.8%) underwent a combined hysteroscopic and laparoscopic approach, and 2 (6.9%) underwent laparoscopic cornuectomy. In reporting symptom improvement after Essure removal, 47.4% of patients reported total improvement, 36.8% reported almost total improvement, 5.3% reported some improvement, and 10.5% reported no improvement. The majority of patients (89.5%) reported satisfaction with their surgical results, and only 2 patients required subsequent surgical intervention for symptom management. <h3>Conclusion</h3> The majority of patients in our cohort reported almost total or total improvement in symptoms almost two years after Essure removal, with low rates of reintervention. A uterine-sparing approach to Essure removal, using laparoscopic and hysteroscopic modalities, may be a feasible and effective approach to addressing Essure-attributed symptoms.

8250 Two Approaches to Laparoscopic Removal of Essure® Coils: Salpingectomy and Cornuectomy

<h3>Study Objective</h3> To describe two uterine-sparing methods for laparoscopic Essure® coil removal. <h3>Design</h3> Demonstration of surgical steps involved in laparoscopic removal of Essure® coils. <h3>Setting</h3> University academic hospital. <h3>Patients or Participants</h3> The patient is a 39-year-old G1P1 with history of Essure® system sterilization presenting with chronic pelvic pain. <h3>Interventions</h3> Laparoscopic bilateral Essure® coil removal via bilateral salpingectomy and en bloc cornuectomy. <h3>Measurements and Main Results</h3> N/A. <h3>Conclusion</h3> Laparoscopic Essure® coil removal is a practical uterine-sparing option with no difference in perioperative outcomes between cornuectomy and salpingectomy alone.

Release of metal elements from the Essure implant: A prospective cohort study

Objective(s)The causal mechanistic relationships between Essure® and adverse effects are unclear, but corrosion in the in-vivo environment with release of metal ions may be suspected. Here we evaluated the concentrations of nickel (Ni), chromium (Cr) and tin (Sn) in the peritoneal fluid (PF) and in the fallopian tube (FT) during laparoscopic Essure® removal compared to a control group. Study designNi, Cr and Sn concentrations were determined in the PF and FT from two groups(group A: symptomatic patients with Essure®) vs group B (control group without Essure®) by Inductively Coupled Plasma Mass Spectrometry analysis. Correlation between metal elements concentrations and reported pre-operative symptoms was also investigated. ResultsThere were 131 patients in group A vs 92 control patients in group B. The concentrations of Cr and Ni in PF between both groups were significantly different (p < 0.0001) while there was no statistical difference for Sn (p = 0.58). There was also a significantly higher concentration in the FT for the 3 metal elements in group A than in group B (p < 0.0001). There were differential dynamics of the levels of metal elements based on the length of time between the placement and removal of Essure®. ConclusionsThere was a chronic exposure to metal elements in symptomatic patients with Essure® raising the question of the relationship between adverse effects and these potential toxic metals.

Could the anatomic location of Essure® device explain the impairment of quality of life?

Since health-related quality of life (HRQL) could improve after removal of Essure® (Bayer, Leverkusen, Germany) inserts in symptomatic patients, we aimed to assess whether such postoperative enhancement was linked to the anatomic placement of the device. Correct and incorrect placed Essure® (Bayer) were identified in the electronic database of the French cohort Ablimco (cohort of consenting patients with laparoscopic Essure® [Bayer] removal). HRQL, pain and heavy menstrual bleeding were evaluated after Essure® (Bayer) removal with validated quality of life questionnaires (Short Form12 Questionnaire, Visual Analogue Scale, French version of the McGill Pain Questionnaire and the pictorial blood assessment chart PBAC). Sixty-five patients were included in the study divided in two groups (group A with correct placement: 45 patients and group B with incorrect placement: 20 patients). HRQL and Pain Index were improved in both groups at 6 months post-surgery. There was not any statistically significant difference between group A and B. The PBAC score increased at 6 months postoperatively in group A and B without any statistically significant difference between them. Postoperative improvement of quality of life and pain index was similar whatever the position of the implant. This suggests that symptomatology and quality of life are not related to the anatomic location of the Essure® (Bayer) implants.

378 Toxic metal elements release from essure device in symptomatic patients: A prospective comparative cohort study

Introduction and aims of the study: Many patients with Essure® request the removal of these implants due to persistent non-symptomatic adverse effects. The pathophysiology remains unknown, but a corrosion in the in-vivo environment leading to metal ion release may be suspected. The implants consist of polyester fibers, nickel-titanium alloy and other metals including chromium and tin welding. The purpose of this study was to assess the concentrations of nickel, chromium and tin in peritoneal fluid and in the fallopian tube during laparoscopic removal of Essure® in comparison with a control group.

Quality of life and symptoms following laparoscopic essure removal: a prospective multicenter study

The objective of this study was to compare quality of life and symptoms before and after Essure removal. This multicenter, prospective study evaluated patient-reported quality of life and symptoms before and 4 months after laparoscopic Essure removal for device-attributed symptoms. Quality of life was measured using the validated Short Form-8 questionnaire for health-related quality of life. Symptoms were measured using a study-specific questionnaire. Essure removal was performed on 80 patients with device-attributed symptoms at 4 institutions between 2018 and 2020. The majority (n=53, 66.3%) underwent a laparoscopic hysterectomy and bilateral salpingectomy, and the remainder (n=27, 33.8%) underwent a laparoscopic bilateral salpingectomy alone. Indications for device removal were pain (n=73, 91.3%) and abnormal bleeding (n=42, 52.5%), in addition to several other patient-reported symptoms. 51 (63.8%) patients completed the postoperative questionnaire. Quality of life was significantly improved following Essure removal as measured by the physical and mental component summary scores (Table 1). Almost all symptoms were less commonly reported after Essure removal (Table 1). Subgroup analyses of patients who underwent a hysterectomy or a salpingectomy alone also demonstrated a significantly improved quality of life after the procedure. Symptoms were more likely to resolve following hysterectomy and salpingectomy compared to salpingectomy alone. Most patients (n=47/51, 92.2%) were satisfied with the results of their surgery. Patients undergoing laparoscopic Essure removal for device-attributed symptoms report improved quality of life and symptoms following the procedure. While the relationship between the Essure device and adverse symptoms remains unclear, Essure removal may benefit those experiencing adverse symptoms and is associated with high patient satisfaction.

Perioperative findings and complications in Essure® removal surgery

ObjectiveTo analyze perioperative findings and complications in surgical removal of Essure® microinserts. Study DesignA prospective cohort study of 274 patients who underwent surgical removal of Essure® microinserts. Outcomes of the surgical procedures and complications were entered into a digital case report form (CRF) by the surgeon and registered in an online database. Results were analyzed through IBM SPSS Statistics using descriptive statistical methods. ResultsDuring laparoscopic inspection in 15.4 % of fallopian tubes (n = 80) a chicken wing sign (the fallopian tube folding over the most distal part of the microinsert) was seen. Partial tubal perforation and total tubal perforation with migration of the microinsert out of the fallopian tube were seen in respectively 1.9 % (n = 10) and 0.2 % (n = 1) of cases. The microinserts were removed by laparoscopic tubotomy and extraction, followed by bilateral salpingectomy in 91.2 % of cases. In 7.3 % of cases (n = 20) a hysterectomy and bilateral salpingectomy was performed for additional indications than solely Essure® removal. Four microinserts were taken out entirely by means of hysteroscopy (1.5 %). We did not see major surgery related complications, however we found a risk of minor complications during or after surgery of respectively 1.6 % (n = 4) and 3.9 % (n = 10). ConclusionsDuring laparoscopic inspection, abnormalities were seen in 22.8 % (n = 119) of fallopian tubes, of which the chicken wing sign was the most common. Partial and total tubal perforation with migration of the microinsert were rare. The complication rate of Essure® removal surgery in our prospective study is low and complications are minor, without any major complication. However, while counseling patients with a request for surgical removal of Essure® microinserts, these results should be mentioned.

Robotic-assisted laparoscopic Essure removal: a novel surgical approach.

Primary objective was to evaluate safety and feasibility of robotic-assisted Essure removal while describing the procedure. Secondary objective was to assess improvement of symptoms post-operatively. The design was retrospective cohort study. Patients included were thosewho underwent robotic-assisted Essure removal between June, 2015 and December, 2020 for symptomatic relief. Interventions are robotic-assisted laparoscopic removal of Essure devices. A retrospective chart review was conducted. Phone survey of pain scores and quality-of-life ratings were performed. Twenty-one women underwent robotic-assisted removal of Essure devices. Two cases were excluded from analysis due to concomitant procedures. All devices were removed intact (19/19). The mean time from placement to removal was 5.3years. Safety and feasibility were demonstrated, mean operating time was 43.1 ± 12min, mean length of stay (LOS) was 11h, and no complications occurred. Mean pain scores (0-10) improved from 8.5 before surgery to 0.75 at 1 month after surgery (p < 0.005). Mean Quality-of-Life (QOL) scores (0-7) improved from 5.9 prior to surgery to 1.5 at 1 month after surgery (p < 0.005). To our knowledge, this is the first report of the use of robotic assistance for Essure removal. Robotic-assisted laparoscopic Essure removal appears safe, feasible, and potentially superior to other surgical approaches. Despite discontinuation of the device in 2018, Essure removal is likely to remain needed. Robotic-assisted laparoscopic Essure removal appears effective in treating pain and various other symptoms attributed to Essure devices.

Two Surgical Approaches to the Removal of the Essure Contraceptive Device

Study Objective We first review the Essure contraceptive device composition in order to aid in the understanding of proper removal. We present two safe and effective techniques for Essure removal and demonstrate the importance of individualizing and modifying the surgical approach based on intraoperative findings. Design Video presentation of techniques of Essure removal. Setting An ambulatory surgery center associated with an urban academic medical center. Patients or Participants Demonstration of presented techniques in a 35-year-old multiparous patient with bilateral Essure device in place for five years, complaining of pelvic pain and dyspareunia, desiring removal of the device. Interventions Laparoscopically, the Essure device was palpated in the right fallopian tube and a salpingostomy was created, revealing the Essure coils. The device was grasped and taking care to stabilize the proximal tube and avoid excess traction, the coils were extracted until all parts were accounted for. Attention was then turned to the left fallopian tube; the Essure device was not palpable and thus the decision was made to proceed with hysteroscopic removal. Hysteroscopically, the device was seen at the left tubal ostia and using grasping forceps the Essure device was removed from the tube. All components of the Essure device were accounted for and complete removal was ensured. Measurements and Main Results N/A Conclusion Successful removal of the Essure contraceptive device may be performed by a laparoscopic or hysteroscopic approach. The choice of technique may need to be modified based on surgical intraoperative findings. Therefore, familiarity with various surgical approaches in addition to knowledge of the structure of the Essure device is critical to ensure complete removal.

Potential release of toxic metal elements from Essure® device in symptomatic patients: First results of the French Ablimco cohort

ObjectiveMany patients with Essure® devices request the removal of these implants due to persistent adverse effects. The pathophysiology remains unknown, but a corrosion of the implants in the in-vivo environment leading to metal ion release may be suspected. The implants consist of polyester fibers, nickel-titanium alloy and other metals including chromium. The purpose of this study is to deliver the first results on the concentrations of nickel and chromium (two potential toxic metal elements) in peritoneal fluid and in the fallopian tube tissue during laparoscopic removal of Essure®. Study designIn this prospective observational study conducted in a French academic research hospital (University hospital of Lyon), nickel and chromium concentrations were determined in the fallopian tube tissue and peritoneal liquid from symptomatic patients with Essure® by Inductively Coupled Plasma Mass Spectrometry (ICP-MS) analysis in a PerkinElmer NexION 350. ResultsSignificant metal element concentrations were showed in the peritoneal fluid. There was also a differential concentration in the fallopian tube tissue with higher concentration close to the implant then lower at a distance from this implant. There was a correlation between the concentrations of the two metals. ConclusionThe presence of nickel and chromium in the fallopian tube tissue and the peritoneal fluid raises the question of a possible relationship between the symptoms attributed to Essure® implants and the dissemination of potential toxic metals due to galvanic corrosion of the devices.

Essure removal: comparison of two minimally invasive approaches

To study differences between robotic and laparoscopic approach in Essure device removal. Demonstration video of two different surgical approaches. Clinico San Carlos University Hospital in Madrid, Spain. A total of 737 Essure devices were implanted until June 2017 in Clinico San Carlos Hospital. Nineteen of them were removed. Fourteen (73.7%) were removed using the laparoscopic approach, 4 (21%) using the robotic approach, and 1 (5.3%) using hysteroscopy. We show two cases, one performed using the robotic approach and one using the laparoscopic approach. The first patient was 49 years old and the indication for Essure removal was nickel allergy. The second patient was 52 years old and she had chronic pelvic pain. We performed two cases of Essure device removal and bilateral salpingectomy operated using the laparoscopic and robotic approaches to compare both procedures. The first step was coagulation of the antimesenteric edge of the fallopian tube with bipolar forceps 2 cm from the uterine horn. The second step was cutting of the coagulated tissue and dissection to visualize the metallic spiral. The third step was pulling gently to extract one of the spirals of the device. The fourth step was salpingectomy and extraction of the proximal part of the Essure. After Essure removal and bilateral salpingectomy, we performed X-ray of the pelvis to ensure complete removal of the device in both patients. We recorded intraoperative and postoperative complications, total operative time and blood loss. We did not have intraoperative or postoperative complications in any of the surgical approaches. Total operative time was 30 minutes in the robotic surgery (total time in the operating room, 60 minutes) and 45 minutes in the laparoscopic approach (total time in the operating room, 65 minutes). Estimated blood loss was 10 mL in the robotic surgery and 25 mL in the laparoscopic surgery. Both patients were asymptomatic after 3 months of follow-up. The same results could be extrapolated to our series; we observed a median of total operating time of 45 minutes, no complications, length of stay of 2 days, and total resolution of symptoms after 3 months of follow-up. Our results are similar to the results reported by other authors who consider laparoscopic salpingectomy for removal of Essure inserts to be safe and feasible. Robotic and laparoscopic approaches allow complete removal of Essure devices in symptomatic patients without major complications. On the other hand, robotic surgery provides advantages to the surgeon, such as greater precision, elimination of tremor, three-dimensional visualization of surgical field, and ease of minimally invasive suturing. But robotic surgery has the disadvantages of increased cost and increased case time in some circumstances.

Symptom related to Essure® and evolution after removal: Outcomes of retrospective cohort

IntroductionThe number of requests for Essure removal has grown continually over recent years. The objective is to describe the symptoms reported after Essure sterilization, methods of removal and results. Material and methodsRetrospective and single-centre cohort (Regional university hospital of Lille, France) was conducted. All women, having consulted from December 2016 to February 2019 for symptoms related to Essure insertion, were included. All the symptoms were noted. A second group was created that included patients who underwent Essure removal to evaluate the benefits of surgery on these symptoms. ResultsThe study included 98 patients. Most frequent symptoms were musculoskeletal pain (75 %), asthenia (63 %) and pelvic pain (55 %). Fifty-nine patients (60 %) underwent surgery. Surgery appeared beneficial with reduction of symptoms in 60 % of these patients, complete resolution in 33 % and no reduction of symptoms in 7%. Many symptoms were relieved by surgery with an overall decline of 96 % in menorrhagia, 94 % in metrorrhagia and 93 % in dyspareunia. However, other symptoms were not relieved by surgery like 100 % of sleep disorders, 70 % of abdominal pain cases and 57 % of memory impairment cases. ConclusionSymptoms related to Essure insertion are numerous. Although surgery appears beneficial, some adverse effects remain. Therefore, a preoperative aetiologic assessment and information about risk of surgery failure are important.

Surgical removal of essure® micro inserts by vaginal hysterectomy or laparoscopic salpingectomy with cornuectomy: Case series and follow up survey about device-attributed symptoms resolution

IntroductionInserts Essure® were used as a definitive sterilization method from 2001 to 2017. They have been used for more than 750,000 procedures. Gynecological or extra gynaecological adverse events have been reported by patients.The objective of the study is to evaluate the resolution of symptoms attributed to Essure® micro-inserts after surgical removal. MethodsMonocentric retrospective study. Patients who had surgical removal of Essure® micro-inserts between January 2017 and April 2019 were included. The removal was performed by bilateral salpingectomy with cornuectomy by laparoscopy or vaginal hysterectomy. Symptoms were reported preoperatively, 4–8 weeks after withdrawal (early assessment) and 6–24 months after withdrawal (later assessment). ResultsNinety patients had a surgical removal of Essure® micro-inserts. Fifty-two vaginal hysterectomies and thirty-five laparoscopic salpingectomies were performed. The main symptoms reported are pelvic pain (70 %), fatigue (66.7 %) and heavy bleeding menstruations (53.3 %). One month after surgery, 46.7 % of patients have a major improvement of symptoms and 51.1 % a partial resolution. The major improvement rate is not significantly different between laparoscopic salpingectomy and vaginal hysterectomy (51.5 % versus 42.3 %) (p = 0.23). At 24 months, results improved with 83.3 % major improvement. ConclusionSurgical removal may be effective for treating most women with attributed device symptoms. Vaginal hysterectomy and laparoscopic salpingectomy with cornuectomy seem to have an equivalent rate for the resolution of extra-gynecological symptoms.

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.

Factors Associated with Negative Patient Experiences with Essure Sterilization

Study Objective:The objective of the study was to identify factors associated with negative patient experiences with Essure.Design:This was a retrospective cohort study and follow-up survey.Setting:The study was conducted in an academic setting.Patients:Patients included women who had an Essure placed between 2002 and 2017.Methods:The hospitals' database was queried to identify subjects and charts were reviewed to confirm medical information. Subjects were invited by mail, e-mail, or phone call to participate a survey regarding symptoms and satisfaction with Essure. A comparison was made between women who reported a negative experience with Essure versus those who did not. A multivariable logistic regression analysis was performed to identify subject or procedural characteristics associated with any negative experience with Essure sterilization.Results:Two hundred eighty-four women underwent Essure sterilization between 2002 and 2017, 42.3% of whom responded to the follow-up survey. Satisfaction with Essure was reported by 61.9% of respondents. Thirty-three percent of the respondents have undergone removal or desire removal of the device. The most frequent symptoms attributed to Essure were pelvic pain, dyspareunia, and vaginal bleeding. Forty-eight percent of the respondents were identified as having any negative experience with Essure. Factors associated with negative experiences with Essure included young age at placement (odds ratio [OR] 0.86; 95% confidence interval [CI] 0.79–0.94; P < .001), high gravidity (OR 1.39; 95% CI 1.14–1.71; P = .002), and absent history of abdominal surgery (OR 0.35; 95% CI 0.12–1.00; P = .049).Conclusion:Young age at placement, high gravidity, and absent history of abdominal surgery are factors associated with negative patient experiences following Essure sterilization. A negative experience with Essure is common, although dissatisfaction with the device is not always attributable to symptoms. This information could be considered when counseling women who plan removal of Essure.Implications Statement:Our study provides new follow-up data with respect to hysteroscopic sterilization. This research is the first to examine any cause for negative patient experiences with Essure. Understanding factors associated with negative patient experiences could improve patient counseling regarding the extent to which symptoms could be attributed to Essure as well as counseling women who want to undergo removal of the device. These factors could in turn prove to be predictors for successful resolution of symptoms after removal of Essure. Results of this study could also be used for developing future hysteroscopic sterilization techniques.