Two separate studies of the safety and effectiveness of the Essure Permanent Birth Control System have been conducted in women from the United States, Australia, and Europe. The first study involved approximately 200 women, and the second study involved approximately 500 women. The following has been demonstrated in these trials:

No incisions are required

• 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 scars
  
  

Can be performed without general anesthesia

• The Essure procedure can be performed without general anesthesia. In the clinical trials of Essure, general anesthesia was used rarely
  
  

Ensure does not contain hormones

• The Essure micro-inserts do not contain or release any hormones
  
  

Effective

• In the first study, almost 200 women relied on Essure for contraception for 1 year, and more than 180 relied on Essure for contraception for 2 years. In the second study, 439 women relied on Essure for contraception for 1 year, and over 300 relied on Essure for contraception for 18 months. None of the women who relied on Essure for contraception during the clinical trials became pregnant over the 1 to 2 years of follow-up. However, no method of contraception is 100% effective, and there is a small chance that you can become pregnant. Additional information regarding the effectiveness of Essure and other methods of contraception is found in Tables 1 and 2.
  
  

Rapid recovery

• Women were typically discharged from the medical facility 45 minutes after the procedure
• Almost all employed women who participated in the second Essure study resumed work in 24 hours 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 procedure
  
  

High patient satisfaction

• Almost all women rated their satisfaction with Essure as “good” to “excellent” at all study visits after the 1-week visit