Essure: a review six years later.

Area of Science:

• Gynecology
• Minimally Invasive Surgery

Background:

• Hysteroscopic sterilization is increasingly adopted over laparoscopic methods.
• Essure hysteroscopic sterilization has demonstrated safety and efficacy post-FDA approval.

Purpose of the Study:

• To evaluate the real-world safety, effectiveness, and patient satisfaction of hysteroscopic sterilization.
• To identify and address challenges associated with hysteroscopic sterilization procedures and confirmation testing.

Main Methods:

• Review of U.S. and worldwide literature and clinical experience.
• Analysis of Essure's 5-year effectiveness rate and adverse events from clinical trials.
• Assessment of patient tolerance, placement success, and satisfaction in office settings.

Main Results:

• Essure exhibits a 5-year effectiveness rate of 99.8%, with most failures linked to protocol deviations.
• The procedure is well-tolerated, with high bilateral placement rates and patient satisfaction.
• Confirmation test compliance and technical issues are common; long-term side effects like pelvic pain are infrequent.

Conclusions:

• Hysteroscopic sterilization is a safe, effective, and well-tolerated procedure with high success rates.
• Adherence to protocol is key to minimizing unintended failures.
• While generally safe, practitioners must manage common technical and compliance issues, with further data needed for concomitant procedures.