OBJECTIVE: To assess the efficacy of the Essure hysteroscopic birth control device after 5 years follow up. STUDY DESIGN: Retrospective analysis of case series. SETTING: Outpatient hysteroscopy facility in a large teaching hospital. SUBJECTS: One-thousand three-hundred and twenty-one women who underwent hysteroscopic sterilization with Essure device (Conceptus, Inc., Mountain View, CA) between January 2003 and May 2005. INTERVENTION(S): Hysteroscopic tubal sterilization using Essure system. MAIN OUTCOME MEASURE: Efficacy/effectiveness, failure rate. RESULTS: Satisfactory insertion was accomplished in the first attempt in 1166 women (97.16%). After the second attempt, successful insertion rate rise to 98.6%. (n = 31, 2.6%). Three pregnancies had been reported after 5 years follow up, which implies an overall absolute rate of 0.25%. This represents a Pearl index of 0.05 after 72,000 months of surveillance. All of them occurred in the first year of use of the microinsert. There has been no unintended pregnancy in the next 4 years. CONCLUSION(S): Essure has the lowest Pearl index never published being the most effective permanent birth control system to date. Unintended pregnancies tend to occur in the first year after the insertion, and can be avoided encouraging women to accomplish the protocol.
OBJECTIVE: To assess the efficacy of the Essure hysteroscopic birth control device after 5 years follow up. STUDY DESIGN: Retrospective analysis of case series. SETTING:Outpatient hysteroscopy facility in a large teaching hospital. SUBJECTS: One-thousand three-hundred and twenty-one women who underwent hysteroscopic sterilization with Essure device (Conceptus, Inc., Mountain View, CA) between January 2003 and May 2005. INTERVENTION(S): Hysteroscopic tubal sterilization using Essure system. MAIN OUTCOME MEASURE: Efficacy/effectiveness, failure rate. RESULTS: Satisfactory insertion was accomplished in the first attempt in 1166 women (97.16%). After the second attempt, successful insertion rate rise to 98.6%. (n = 31, 2.6%). Three pregnancies had been reported after 5 years follow up, which implies an overall absolute rate of 0.25%. This represents a Pearl index of 0.05 after 72,000 months of surveillance. All of them occurred in the first year of use of the microinsert. There has been no unintended pregnancy in the next 4 years. CONCLUSION(S): Essure has the lowest Pearl index never published being the most effective permanent birth control system to date. Unintended pregnancies tend to occur in the first year after the insertion, and can be avoided encouraging women to accomplish the protocol.