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Safety and effectiveness of hysteroscopic sterilisation (Essure System) is an important and timely topic. Recent concerns, including 5093 adverse event reports related to Essure made to the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database prompted the FDA to reconvene its Obstetrics and Gynecology Devices Panel in September 2015 to evaluate the safety, effectiveness, and need for further postmarketing studies on Essure.1 Benefits of hysteroscopic sterilisation include no skin incision, probable avoidance of abdominal entry and general anaesthesia, and ability to perform the procedure in an office. Mao et al's2 observational cohort study uses an administrative database to compare selected outcomes after hysteroscopic and laparoscopic sterilisation and adds important data to this …
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.
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