Abstract
Objective:
Evaluate patient-reported symptoms and quality of life (QOL) before and after female sterilization device (Essure) removal.
Design:
Multicenter prospective study.
Setting:
Three academic institutions.
Population or Sample:
Patients with device-attributed symptoms undergoing Essure removal.
Methods:
Symptoms were measured using a study-specific questionnaire and Short Form-8 (divided into Physical and Mental Component Scores). Scores at 4 months postoperative were compared to baseline using a mixed effects logistic regression and linear mixed model. Subgroup analysis was performed for hysterectomy and uterine-preserving groups.
Main Outcome Measures:
Patient-reported symptoms and Short Form-8 4 months after Essure removal compared to baseline.
Results:
A total of 80 patients enrolled in the study and underwent Essure removal: 53 (66.3%) with laparoscopic hysterectomy and 27 (33.8%) with laparoscopic bilateral salpingectomy or bilateral cornuectomy. Fifty-one participants (63.8%) completed the 4-month postoperative questionnaire. Of the 17 device-attributed symptoms evaluated, participants reported clinically important improvement in 16 of the symptoms postoperatively. QOL improved significantly following device removal, with the Physical Component Score improving by 9.9 points (95% CI: 7.0–12.9) and the Mental Component Score by 13.8 points (95% CI: 10.4–17.2). QOL improved in both physical and mental score domains after device removal with no difference between hysterectomy and uterine-preserving groups (p = 0.83 and p = 0.06, respectively). Of the entire cohort, 92.2% (n = 47) were satisfied with their surgical results.
Conclusions:
Patients undergoing Essure removal for device-attributed symptoms report improved symptoms and QOL following surgery. Device removal may benefit those experiencing device-attributed symptoms and is associated with high patient satisfaction.
Keywords
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