Gynecologic Surgery Following Permanent Sterilization: A Descriptive Analysis

    Basic Details
    Date Posted
    Thursday, July 23, 2020
    Status
    Complete
    Medical Product
    hysteroscopic sterilization
    Health Outcome(s)
    gynecologic surgery
    Description

    This request describes subsequent gynecological surgery among patients with hysteroscopic sterilization who had no subsequent tubal ligation, and additionally among patients with multiple hysteroscopic sterilization events and no subsequent tubal ligation. The request includes two reports:

    • Report 1, the main analysis, describes the number of patients who had hysteroscopic sterilization or laparoscopic tubal ligation followed by a subsequent gynecological surgery event.
    • Report 2, a sensitivity analysis, describes subsequent gynecological surgery among patients with hysteroscopic sterilization who had no subsequent tubal ligation, and additionally among patients with multiple hysteroscopic sterilization events and no subsequent tubal ligation.

    We distributed this request to 16 Sentinel Data Partners. The study period included data from January 1, 2008 to September 30, 2015. This request was distributed to Data Partners on October 10, 2017.
     

    Additional Details
    FDA Center
    CDRH
    Time Period
    January 1, 2008 - September 30, 2015
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    Females 21 to 50 years of age
    Data Sources
    Sentinel Distributed Database (SDD)