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.

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

OBJECTIVE: To analyze quality of life(QoL) and symptom resolution after surgical removal of Essure devices. METHODS: Single-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. RESULTS: 4(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]. CONCLUSION: Essure 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.

Circulating Tumor Cell Detection by Liquid Biopsy during Early-Stage Endometrial Cancer Surgery: A Pilot Study.

The recurrence of non-metastatic endometrial carcinoma (EC) (6 to 21%) might be due to disseminated tumor cells. This feasibility study investigated whether circulating tumor cells (CTCs) were detectable in blood samples from the peripheral and ovarian veins of 10 patients undergoing laparoscopic resection of stage I-II EC between July 2019 and September 2021. CTCs were detected using the CellSearch® system (i) preoperatively (T0) in peripheral blood, (ii) after ovary suspensory ligament pediculation in ovarian vein blood (T1), and (iii) before colpotomy in peripheral blood (T2). CTCs were detected only in ovarian vein samples in 8/10 patients. The CTC median number did not differ with patient age (37 (min-max: 0-91) in <70-year-old vs. 11 (0-65) in ≥70 year-old women, p = 0.59), tumor grade (15 (0-72) for grade 1 vs. 15 (0-91) for grade 2, p = 0.97), FIGO stage (72 (27-91) vs. 2 (0-65) vs. 3 (0-6]) for stage IA, B, and II, respectively; p = 0.08), and tumor size (40 (2-72) for size < 30 mm vs. 4 (0-91) for size ≥ 30 mm, p = 0.39). Estrogen receptor-positive CTCs and CTC clusters were identified. The prognostic and therapeutic values of CTCs released during EC surgery need to be determined.

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

INTRODUCTION: Increasing 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 METHODS: This 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. RESULTS: Sixty-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). CONCLUSIONS: Patients 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.

Are Adverse Events Attributed to Essure Associated With Nickel Sensitization?

BACKGROUND: Essure is an effective method for hysteroscopic sterilization. Reports of adverse effects, the underlying mechanisms of which are unknown, have increased in recent years. OBJECTIVE: The aim of the study was to determine whether there is a relationship between adverse events attributed to Essure and nickel sensitization. METHODS: Patients presenting alleged adverse reactions to Essure were referred for nickel patch testing before removal. Data regarding medical history of nickel sensitization and symptoms attributed to Essure were collected. Dimethylglyoxime spot tests were performed on the explanted Essure. There was a follow-up at 3 months to evaluate whether there is improvement of the symptoms after Essure removal. CONCLUSIONS: Nickel sensitization via the classic delayed hypersensitivity pathway did not seem to be responsible for adverse events attributed to Essure. Among systemic symptoms reported, extracutaneous symptoms had the highest prevalence. Systemic contact dermatitis to nickel could not be ruled out in one case.