The Adiana System for permanent contraception: safety and efficacy at 3 years.

STUDY OBJECTIVE: To evaluate the efficacy of the Adiana System for preventing pregnancy in women desiring permanent sterilization.

DESIGN: This study is a prospective, single-arm, multicenter, international trial. The primary endpoint was pregnancy prevention rate at 12 months. Pregnancy prevention rates at 24 and 36 months were also calculated (Canadian Task Force classification II-2).

SETTING: The study was conducted at 16 sites, 14 in the United States, 1 in Australia, and 1 in Mexico.

PATIENTS: A total of 645 women (intent-to-treat group).

INTERVENTION: Hysteroscopic placement of polymer matrix was attempted in all patients. Tubal occlusion confirmed by hysterosalpingography at 12 weeks. Ongoing monitoring for pregnancy over 36 months.

MEASUREMENTS AND MAIN RESULTS: There was a 95% bilateral matrix placement rate and 88.4% bilateral occlusion by hysterosalpingography, as previously reported. A total of 24 968 person-months of wearing were accrued. Pregnancy prevention rates were summarized with descriptive statistics by use of 95% two-sided confidence interval on the basis of life-table methods. Complete 36-month data were available for 481 subjects. During the first year, 6 pregnancies were reported. Three were determined to be the result of misinterpretation of hysterosalpingography results. The remaining 3 were attributed to method failure, as were the 3 pregnancies during the second year. No additional pregnancies occurred in year 3. The cumulative pregnancy prevention rates at 12, 24, and 36 months compare favorably with data from the Collaborative Review of Sterilization study and other published reports documenting efficacy of established permanent sterilization procedures.

CONCLUSIONS: These data demonstrate that the efficacy of the Adiana System for pregnancy prevention is similar to other permanent sterilization methods.