Essure’s Long-Term Safety, Efficacy Announced in Study

Bayer HealthCare announced results from a study that support previous findings on the effectiveness and safety of the Essure inserts and procedure for hysteroscopic sterilization. Findings from the study are published in The Journal of Minimally Invasive Gynecology.

Results from the prospective 5-year follow-up study tracked the initial cohort of women in the Phase 3 trial that led to the Food and Drug Administration (FDA) approval of Essure. The study enrolled previously fertile women aged 21–40 years old who were seeking permanent birth control, were in a monogamous relationship and were willing to use a temporary contraceptive method for the first three months following Essure insert placement. After the full 5-year follow-up, none of the 364 women relying on Essure reported any pregnancies. The study endpoints included safety and satisfaction, reliance on Essure for contraception and prevention of pregnancy.

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Essure inserts are permanently placed into a woman’s fallopian tubes and work with the body to form a natural barrier against sperm reaching the eggs. The inserts do not contain hormones.

Findings from the study support Essure as a safe and effective permanent contraception option for women when followed appropriately. The study also found that Essure inserts were generally well tolerated.

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