Phase III data on Essure for Contraception to be published- Bayer HealthCare

Bayer HealthCare announced that a study to be published online this week in The Journal of Minimally Invasive Gynecology reinforces findings from previous clinical studies that support the effectiveness and safety of the Essure inserts and procedure for hysteroscopic sterilization, or permanent birth control. The prospective five-year follow-up study followed the initial cohort of women in the Phase III clinical trial that led to the approval of Essure by the FDA in 2002.

Among the 364 women relying on Essure inserts who completed the full five years of follow-up, no pregnancies were reported. In addition, the Essure inserts were generally well tolerated. The study was designed to include five years of follow-up, one year of which was to be completed prior to a pre-marketing approval filing. The remaining four years of follow-up was completed as part of a post-approval study. For the full five years of follow-up (five years in total of relying on the Essure inserts for contraception) the end points of interest were safety and satisfaction, reliance on Essure for contraception and prevention of pregnancy. The five-year study evaluating long-term effectiveness was required by the FDA as part of the evaluation and approval of the Essure inserts.

The following severe events were reported as being possibly related to the Essure inserts or procedure: one woman with irregular menstrual bleeding, another woman with lower abdominal pain and very heavy periods, and a third woman with continuous bleeding. The latter two resulted in hysterectomy. Throughout the five-year study, pelvic pain was reported in no more than 7% of study participants at any visit.