Open-label, non-randomized, prospective observational postmarket surveillance study of two cohorts of subjects who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization.
Study subjects will be women who are seeking permanent contraception and who have elected to undergo either hysteroscopic sterilization (Essure System ESS305) or laparoscopic tubal sterilization. Candidates who meet the inclusion and exclusion criteria, are willing to participate in the study, and are able to provide Informed Consent will be eligible for the study. The sterilization procedure will proceed as it would if the subject were not in the trial. For subjects who elect to have hysteroscopic sterilization, 3 months following the placement procedure, the subject will be scheduled to return to the physician’s office or radiology facility for a confirmation test to evaluate Essure insert location and retention. Upon a satisfactory confirmation test, subject will be instructed to rely on Essure for contraception.
Follow-up contact will take place at 3 months (± 2weeks), 12 months (± 4 weeks), 24 months (± 4 weeks), and 36 months (-4 weeks, +1 week) post procedure. These visits will collect information that includes (but is not limited to) pelvic/ lower abdominal pain, bleeding, gynecological procedures, AEs, and concomitant medication use.