Gynecologic Surgery Following Permanent Sterilization: A Descriptive Analysis

Project Title Gynecologic Surgery Following Permanent Sterilization: A Descriptive Analysis
Date Posted
Thursday, July 23, 2020
Project ID
cdrh_mpl1r_wp003
Status
Complete
Deliverables
Related Links
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.
 

Medical Product
hysteroscopic sterilization
Health Outcome
gynecologic surgery
Population / Cohort
Females 21 to 50 years of age
Time Period
January 1, 2008 - September 30, 2015
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDRH
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