Essure’s approval and safety warnings
Медична ілюстрація встановлення трубних вставок Essure, Petr Kovář / Clinical illustration of placement of Essure tubal inserts, Petr Kovář; explanatory artwork, not a clinical photograph. Claims in the source’s promotional caption are not adopted. Credit: Petr Kovář MUDr. Havířov; CC BY-SA 4.0. https://creativecommons.org/licenses/by-sa/4.0 Source: https://commons.wikimedia.org/?curid=39105076
The FDA approved the Essure system for permanent contraception in the United States on 4 November 2002. It consisted of inserts placed in the fallopian tubes, rather than a hormonal arm implant. In 2016 the regulator required further safety research and stronger risk information, including a boxed warning and a patient decision checklist. Risks identified by the FDA included persistent pain, perforation and allergic reactions. Bayer stopped U.S. sales and distribution at the end of 2018; Essure should not be described as a currently available innovation.