Hysteroscopic sterilization with an essure: Post-approval studies and a future outlook

Erinma P. Ukoha, Kerry E. Drury, Shuai Xu, Jessica R. Walter*

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Introduction: Essure offers permanent sterilization via an officebased procedure. In 2015, patient-reported safety concerns led the FDA to re-investigate the device leading to a change in labeling and the initiation of a new post-marketing study. Methods: MEDLINE was queried using the following search terms: Essure; hysteroscopic sterilization; postmarket approval; efficacy. The quality of each study was rated using the Oxford Centre for Evidencebased Medicine Levels of Evidence rating scheme. A Grade 1 rating indicates the high quality data such as well-designed systematic reviews and randomized controlled trials (RCTs) while a Grade 5 rating indicates the weakest quality of evidence (e.g., expert opinion). Results: The search produced 231 unique references, of which 61 were considered relevant to the topic based on title and abstract. A total of 110,546 women were included with 23 non-randomized prospective studies, 21 single-arm retrospective cohort studies, three randomized control trials (RCTs), and three systematic reviews. The number of participants in each trial ranged from 18 to 71,875. Overall, the majority of studies (74%) were of Grade 4 or low quality case-series, cohort or case-control studies. Only 13% of studies were either Grade 1 or Grade 2. Conclusions: The available post-marketing data is not of ideal quality, but the evidence suggests that Essure is a safe and effective device. The controversy will likely continue until completion of the newly mandated post-marketing study.

Original languageEnglish (US)
Title of host publicationEssureal Journey
Subtitle of host publicationConcepts, Concerns and Considerations for Hysteroscopic Sterilization
PublisherNova Science Publishers, Inc.
Pages169-196
Number of pages28
ISBN (Electronic)9781536122213
ISBN (Print)9781536122046
StatePublished - Jan 1 2017

Keywords

  • Essure
  • Medical device safety
  • Post-marketing surveillance
  • Pre-market approval
  • U.S. food and drug administration

ASJC Scopus subject areas

  • Medicine(all)

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