FDA mandates new warnings, new data for Essure contraceptive device

Updated 10:01 AM ET, Tue March 1, 2016

(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.

Monday’s announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation.

Click here to read more: http://www.cnn.com/2016/02/29/health/fda-essure-birth-control-device/index.html

Congressman Says More than 300 Fetal Deaths Related to Essure Ahead of FDA Announcement

Rep. Mike Fitzpatrick (R-PA) on Wednesday presented new information raising questions about the safety of the permanent birth control device Essure, claiming the number of fetal deaths related to the device are far greater than what has been reported by the US Food and Drug Administration (FDA). - See more at: http://www.raps.org/Regulatory-Focus/News/2016/02/17/24349/Congressman-Says-More-than-300-Fetal-Deaths-Related-to-Essure-Ahead-of-FDA-Announcement/?utm_source=social&utm_medium=post&utm_campaign=RFnews#.dpuf