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Essure Sterilization Safe, Effective at 5 Years


 

SAN FRANCISCO — Hysteroscopic sterilization with Essure microinserts appears safe and effective for at least 5 years after the procedure, according to a poster presented by John F. Kerin, M.D., at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Kerin of Flinders Medical Centre, Adelaide, Australia, and colleagues from the Selective Tubal Occlusion Procedure 2000 Investigators Group followed 643 women for up to 5 years after they underwent the procedure. All women had received bilateral placements of Ensure microinserts as part of phase II or phase III clinical trials sponsored by Conceptus Inc., the device's manufacturer.

Not a single pregnancy occurred in 29,357 woman-months of follow-up, Dr. Kerin reported. The age-adjusted cumulative bayesian effectiveness rate at 5 years was 99.74%.

Patient tolerance, comfort, and satisfaction were measured at seven or eight visits during the follow-up period.

At all visits, 99% of women rated their tolerance of Essure as “good” or “excellent,” 99% rated their comfort as “good” or “excellent,” and 97% rated their satisfaction as “satisfied” or “very satisfied.”

No women reported persistent pain or bleeding.

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