Hysteroscopic sterilization: long-term safety and efficacy

Abstract

Introduction: The goal of the study was to assess the long-term safety and efficacy of hysteroscopic sterilization.Materials and Methods: The Essure micro-insert (Conceptus Inc., San Carlos, CA) was placed into the proximal segment of at least one fallopian tube lumen of 682 women in the prospective, multicenter, international Phase II and Pivotal clinical trials. Successful bilateral device placement was achieved in 643 (94%) women. After confirmation of tubal occlusion by hysterosalpingogram, they began relying on the micro-inserts for contraception. These women continue to be assessed at 1-, 2-, 3-, 4- and 5-year intervals.Results: As of December 16, 2004, 643 women contributed effectiveness time, 194 in the Phase II study and 449 in the Pivotal trial. In total, the 643 trial participants contributed 29357 months of follow-up time without pregnancy. The average duration of reliance on this method for permanent contraception was 52.9 months for Phase II subjects and 42.5 months for women in the Pivotal trial. To date, there have been no long-term adverse events found by the investigators to be directly related to the micro-insert or placement procedure.Conclusion: These findings indicate that this nonincisional method of hysteroscopic sterilization can be performed without general anesthesia and has acceptable long-term safety and contraceptive efficacy. Introduction: The goal of the study was to assess the long-term safety and efficacy of hysteroscopic sterilization. Materials and Methods: The Essure micro-insert (Conceptus Inc., San Carlos, CA) was placed into the proximal segment of at least one fallopian tube lumen of 682 women in the prospective, multicenter, international Phase II and Pivotal clinical trials. Successful bilateral device placement was achieved in 643 (94%) women. After confirmation of tubal occlusion by hysterosalpingogram, they began relying on the micro-inserts for contraception. These women continue to be assessed at 1-, 2-, 3-, 4- and 5-year intervals. Results: As of December 16, 2004, 643 women contributed effectiveness time, 194 in the Phase II study and 449 in the Pivotal trial. In total, the 643 trial participants contributed 29357 months of follow-up time without pregnancy. The average duration of reliance on this method for permanent contraception was 52.9 months for Phase II subjects and 42.5 months for women in the Pivotal trial. To date, there have been no long-term adverse events found by the investigators to be directly related to the micro-insert or placement procedure. Conclusion: These findings indicate that this nonincisional method of hysteroscopic sterilization can be performed without general anesthesia and has acceptable long-term safety and contraceptive efficacy.