- FDA orders followup studies by Essure maker Bayer
- "Black box warning" mandated for packaging of implantable contraceptive device
- FDA reports 631 pregnancies among women with device, 294 of them pregnancy losses
(CNN)The U.S. Food and Drug Administration said it will require a new "black box warning" label for Essure, an implantable permanent contraceptive device. A black box warning in the labeling of products is "designed to call attention to serious or life-threatening risks," according to the FDA website.