Essure labeling change
This article was originally published in The Gray Sheet
Executive Summary
Conceptus anticipates FDA will make a decision within six months on a Feb. 24 PMA supplemental filing for the non-incisional permanent birth control procedure. The new claim would extend Essure's effectiveness to four and five years of follow-up. To date, there have been no pregnancies in Conceptus' Phase II and pivotal trial enrollees...