title: Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance.
abstract: In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.
authors.affiliation: Departments of Obstetrics and Gynecology, Radiology, and Dermatology, Northwestern University, and the Department of Radiology, University of Chicago Medical Center, Chicago, Illinois.
authors.forename: Jessica R
authors.initials: JR
authors.lastname: Walter
authors.forename: Comeron W
authors.initials: CW
authors.lastname: Ghobadi
authors.forename: Emily
authors.initials: E
authors.lastname: Hayman
authors.forename: Shuai
authors.initials: S
authors.lastname: Xu
mesh_terms: D005260:Female; D006291:Health Policy; D006801:Humans; D015907:Hysteroscopy / Q000009:adverse effects* / Q000295:instrumentation; D011356:Product Labeling; D011358:Product Surveillance, Postmarketing / Q000379:methods; D013245:Sterilization, Reproductive / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration