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)