The Essure procedure is the first groundbreaking transcervical permanent birth control.
After nine years, the Essure commercial experience supports the clinical trial data and confirms Essure to be the gold standard in permanent birth control.
The Essure procedure went through several phases of clinical testing to evaluate the safety and efficacy of the Essure procedure and micro-inserts. The trials have showed an outstanding safety profile, very high device placement success, high patient tolerance, comfort and satisfaction.
Phase I: Peri and Pre-Hysterectomy Studies were performed in patients prior to their scheduled hysterectomy to evaluate the initial safety of the procedure and the mechanism of action of the Essure micro-inserts.
A Phase II Study was performed on 227 patients to gather safety and effectiveness data in the intended patient population as well as participant's tolerance of and recovery from the procedure and long-term safety and stability of the micro-inserts. >97 % of the patients rated the comfort with wearing the micro-inserts as “Good” to “Excellent”
The Pivotal Trial:
Study Overview:
In conjunction with the Phase II study, the Pivotal Trial was conducted to demonstrate the safety and effectiveness of the Essure Permanent Contraception and was designed as a multi-center, non-randomized, single-arm, international study of women seeking permanent contraception. The study results compared to findings in the U.S. Collaborative Review of Sterilization (CREST) study.
Study Endpoints:
518 patients were enrolled in the Pivotal Trial study and the primary endpoints of the Pivotal Trial were pregnancy prevention, safety of the placement procedure, and safety of long-term use. Secondary endpoints included patient satisfaction and bilateral placement rate.
Post Approval Study for Newly Trained Physicians
The Post Approval Study for Newly Trained Physicians was a prospective, multi-center, single-arm, non-randomized study intended to document the bilateral placement rate for newly trained physicians in the United States.
The primary endpoints for the study were:
- Rates of successful bilateral placement of the Essure System at first attempt, and;
- Identification of factors predictive of failure to achieve bilateral placement of the Essure System at first attempt.
As with all procedures, there are risks associated with the Essure procedure
To view a summary of the key risks and considerations of the Essure procedure, click here. Additionally, refer to the Patient Information Booklet, which contains a detailed discussion of the risks associated with an Essure procedure.
The prescribing Information, like any printed material, may become out of date over time. If you are a physician and have questions about the Essure procedure or the Patient Information Booklet, please call the Physician Consultation line at 877-ESSURE 2 (877-377-8732), prompt 3.