FDA Threatens Bayer With Penalties Over Contraceptive Device

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, a move meant to signal the agency’s increasing oversight of health products already on the market.

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.

After noticing an increase in side ...