The proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after insertion of Essure System compared to the proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after laparoscopic tubal sterilization. Statistical analyses were exploratory and descriptive in nature and no confirmatory hypothesis testing was intended to be performed; p-values were to be interpreted as a metric for uncertainty (note: no analysis included in this final analysis provides p-values). Therefore, no adjustment for multiplicity was necessary. All endpoints and variables were analyzed by descriptive statistical methods.

Adjusted Full Analysis Set (AFAS): Among the PS (Propensity Score) confounder-adjusted population, a subject was included in the Adjusted FAS (AFAS) if both she and her PS-matched partner were included in the FAS.

Incidence of new onset or worsening abnormal bleeding events was based on AE reporting. If a potential bleeding AE was reported at a scheduled visit or if the subject spontaneously reports such an event to the site at some other time, the event was to be evaluated per standard AE assessment. If during the course of a scheduled PRO administration the subject indicated that she experienced abnormal bleeding that reached a preset threshold on the questionnaire, the investigator was alerted and instructed to investigate this finding in order to determine whether or not an AE occurred.

Adjusted Full Analysis Set (AFAS): Among the PS (Propensity Score) confounder-adjusted population, a subject was included in the Adjusted FAS (AFAS) if both she and her PS-matched partner were included in the FAS.

For potential allergic/hypersensitivity reactions, investigators were instructed that an evaluation was to be performed in subjects who presented with symptoms that could have possibly been related to an inflammatory reaction. After the evaluation of the subject was complete, regardless of the investigator's assessment as to whether or not a hypersensitivity/allergic reaction had occurred, all information was to be forwarded to the Adjudication Committee in a blinded fashion. Final determination of whether or not a hypersensitivity/allergic event had occurred was based on the determination of this committee.

Adjusted Full Analysis Set (AFAS): Among the PS (Propensity Score) confounder-adjusted population, a subject was included in the Adjusted FAS (AFAS) if both she and her PS-matched partner were included in the FAS.

Any subject presenting with symptoms indicating a potential autoimmune disorder was to be evaluated per standard medical practice. All effort was to be made to obtain records of any diagnostic workup conducted by outside physicians. NiLPT, chromium LPT, serum or plasma nickel level, and serum or plasma titanium level and serum inflammatory cytokines samples were also to be drawn by the study site. An appropriate human leukocyte antigen (HLA) panel was to be run on previously obtained baseline samples if sufficient sample existed.

After the evaluation of the subject was complete, all information was to be forwarded to the adjudication committee in a blinded fashion, regardless of investigator's assessment as to whether or not an autoimmune disorder existed. Final determination of whether or not an autoimmune disorder had occurred was based on the determination of this committee.

Adjusted Full Analysis Set (AFAS): Among the PS (Propensity Score) confounder-adjusted population, a subject was included in the Adjusted FAS (AFAS) if both she and her PS-matched partner were included in the FAS.

Adjusted Full Analysis Set (AFAS): Among the PS (Propensity Score) confounder-adjusted population, a subject was included in the Adjusted FAS (AFAS) if both she and her PS-matched partner were included in the FAS.