What is the OUS labeling regarding global endometrial ablation with the micro-insert?
(OUS LABELING ONLY) Bench and clinical studies demonstrated that endometrial ablation of the uterus can be performed safely and effectively with the GYNECARE THERMACHOICE* Uterine Balloon System, the Hologic NovaSure** Endometrial Ablation System and the Boston Scientific Hydro ThermAblator*** immediately following Essure micro-insert placement. No specific studies have been conducted to evaluate Essure micro-insert expulsion or contraception rates following combined Essure and endometrial ablation procedures. There are no data evaluating the use of other GEA technologies with the Essure system. For complete information please refer to the Essure Instructions for Use.
