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.

Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery. METHODS: A prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and < 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4-8 weeks and 11-13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation. RESULTS: Of the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22-4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia "usually or always" were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh). CONCLUSIONS: Bothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size.

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.

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.