FDA Threatens Bayer with Penalties Over Contraceptive Device
April 10, 2018
(Bloomberg) – The U.S. Food and Drug Administration is threatening Bayer AG with civil and criminal penalties if it doesn’t better inform women about risks from one of the company’s contraceptive devices. Bayer’s device, Essure, is a permanent contraceptive developed by the German drugmaker as an alternative to surgical techniques like tying or severing the fallopian tubes. U.S. regulators found that some doctors weren’t always telling women about the Bayer’s device’s risks, which can include bleeding, pain and organ perforation.