Patient-Information-Booklet-ENG - Urogyn.org

Two separate studies of the safety and effectiveness of the Essure Permanent Birth Control Systemhave been conducted in women from the United States, Australia, and Europe. 2 The first studyinvolved approximately 200 women, and the second study involved approximately 500 women.The following has been demonstrated in these trials:No incisions are required 2• Unlike the incisional methods of tubal ligation, the Essure procedure does not require incisions.It also does not involve cutting, crushing, or burning of the fallopian tubes• Because there are no incisions, the Essure procedure does not cause scarsCan be performed without general anesthesia 2• The Essure procedure can be performed without general anesthesia. In the clinical trials ofEssure, general anesthesia was used rarelyEssure does not contain hormones 2• The Essure micro-inserts do not contain or release any hormonesEffective 2• In the first study, 192 women relied on Essure for contraception for 1 year, 177 relied on Essure forcontraception for 2 years, and 172 relied on Essure for contraception for 3 years. In the second study,434 women relied on Essure for contraception for 1 year, 403 relied on Essure for contraception for 2years and 21 for 3 years. None of the women who relied on Essure for contraception during the clinicaltrials became pregnant over the 1 to 3 years of follow-up. However, no method of contraception is100% effective, and there is a small chance that you can become pregnant. 3 Additional informationregarding the effectiveness of Essure and other methods of contraception is found in Tables 1 and 2.Rapid recovery 2• The procedure time to place the Essure micro-inserts averaged 35 minutes. Women weretypically discharged from the medical facility after waiting an additonal 45 minutes after theplacement procedure was complete• Almost all employed women who participated in the second Essure study resumed work in 24hours or less after the day of the procedure. Return to work was not evaluated in the first study• The majority of women returned to normal activities in 1 to 2 days• Almost all women rated their comfort as “good” to “excellent” within 1 week of the procedureHigh patient satisfaction 2• Women in the Pivotal Study consistently rated their overall satisfaction with the Essure microinsertsas very high5