The Food and Drug Administration said Monday that it will require German drug maker Bayer AG to undertake new safety studies on its permanent birth-control device Essure, after thousands of women complained about suffering complications from the controversial implant. The agency also plans to require a “black box” label warning about the device’s potentially serious side effects, plus a checklist for doctors to discuss potential risks with patients.
FDA to Require “Black Box” Warning, But Leaves Controversial Essure Implant on Market
