Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study.

OBJECTIVE To describe safety, tolerability, and effectiveness results through 5 years of follow-up of a Phase III trial with Essure inserts. DESIGN Multicenter, nonrandomized, single-arm international study (Canadian Task Force classification II-3). SETTING Thirteen clinical study centers in the United States, Europe, and Australia. PATIENTS A total of 518 previously fertile women seeking permanent contraception. INTERVENTION The objective of the hysteroscopic sterilization procedure was bilateral Essure insert placement (ESS205 model) and tubal occlusion. Women with satisfactory device location and tube occlusion (based on modified hysterosalpingography [HSG]) were instructed to discontinue alternative contraception and to rely on Essure inserts for permanent contraception. MEASUREMENTS AND MAIN RESULTS The primary endpoint for the Phase III study was the rate of pregnancies occurring during the first year of relying (i.e., HSG-confirmed occlusion) on the Essure inserts for permanent contraception (i.e., 12 months after HSG). For the full 5 years of follow-up (5 years total of relying on the Essure inserts for contraception), the endpoints of interest were safety, prevention of pregnancy, and satisfaction. No pregnancies were reported among women relying on the Essure inserts who completed the full 5 years of follow-up. As of December 5, 2007, 449 women with successful bilateral placement relying on the Essure inserts contributed a total 24 942 woman-months of follow-up for assessing effectiveness. Overall, the Essure inserts were generally well tolerated, with participant comfort rated as "good" to "excellent" by 99% of women (382 of 385) after 5 years of use. Similarly, overall satisfaction was rated as "somewhat" to "very satisfied" by 98% of women (376 of 384) after 5 years of use. The majority of adverse events reported during the 5 years of follow-up were rated as either "mild" or "moderate" in severity. Three severe events (abdominal pain with very heavy periods and irregular menstrual bleeding) were reported in 2 subjects during follow-up as being "possibly" related to the procedure or the inserts. CONCLUSION The findings from extended follow-up of this Phase III trial with Essure inserts further support the effectiveness, tolerability, and satisfaction of this nonhormonal, nonincisional option for permanent contraception.