Hysteroscopic sterilization with an essure: Public safety and premarket approval

Introduction: Essure, a first-in-class device approved in 2002 by the U.S. Food & Drug Administration (FDA), offers a minimally invasive means of permanent sterilization for women. Objective: Organize and present data pertaining to premarket approval and safety of hysteroscopic sterilization with Essure. Methods: The search strategy used to identify studies included in this chapter consisted of querying Medline for published reports on Essure as well as FDA regulatory filings. 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 seven were considered relevant to the topic based on the title and abstract. A total of 1,084 women were included in seven studies, all of which were nonrandomized prospective trials. The number of participants in each trial ranged from 14 to 518. Of the studies, four were multicenter and two were single-centered. Conclusions: The FDA designated Essure as a high-risk device requiring pre-market approval. Though Essure addresses a major unmet clinical need, the original PMA application was approved based on a small number of clinical studies with limited follow-up times and no comparator arms.