A Less Invasive Sterilization Option for Women
In November 2002, the US Food and Drug Administration (FDA) approved the first method of permanent sterilization for women that does not involve invasive surgery—a device called Essure. Essure is a small metallic implant that is placed into a woman’s fallopian tubes. Unlike other sterilization procedures for women, no incision or general anesthesia is required.
Female sterilization has traditionally been performed with a tubal ligation. This is a surgical procedure where the abdomen is entered and the fallopian tubes are cut and tied to keep eggs released from the ovaries from reaching the uterus.
How Does Essure Work?
A tool called a hysteroscope is inserted into the vagina and through the cervix, which allows the doctor to see inside of the uterus. The doctor then uses a thin tube to thread the Essure device through the vagina and then into the fallopian tube. This procedure is repeated to implant a second device into the other fallopian tube. The procedure causes pain in some women, but it is likely that pain is less than with other forms of permanent sterilization. Essure implants work by causing scar tissue to form over the implant. The scar tissue permanently blocks the fallopian tube and prevents fertilization of the egg by the sperm.
How Long Does It Take to Work?
Women must use an alternate birth control method for three months after the insertion of Essure implants, since it takes about that long for the scar tissue to grow. At the three-month point, the physician checks to make sure that the device has been properly placed and that the scar tissue has fully blocked the fallopian tubes. This is done with an injection of dye into the uterus followed by an x-ray. If implantation was successful, alternate contraception can be discontinued. In some cases, implantation is not successful. According to the FDA, one study showed implantation failure in about one in seven women.
Is It Effective?
The Essure procedure has undergone significant clinical testing in the United States, Europe, Australia, and Mexico. Data from clinical testing show that Essure was 99.80% effective in preventing pregnancy after three years of follow-up. Additionally, 92% of women who relied on Essure rated their long-term satisfaction with Essure as "somewhat satisfied" to "very satisfied" at three years of follow-up. However, women should be aware that pregnancies following sterilization can occur, even many years after the procedure. Additionally, pregnancies that do occur after sterilization are more likely to be ectopic pregnancies, which occur outside the uterus and can be life-threatening.
Is This the Right Procedure for You?
Before choosing Essure, be aware that the procedure is irreversible. Carefully evaluate issues, such as age and the possibility that you may want to have children in the future.
The FDA requires that the manufacturers of Essure, Conceptus, Inc, continue studying the women in the original clinical trials for five years to ensure that there are no long-term problems with the device.
US Food and Drug Administration
The Canadian Women's Health Network
The Society of Obstetricians and Gynaecologists of Canada
Clinical testing. Essure website. Available at: http://www.essure.com/Home/Understanding/ClinicalTesting/tabid/58/Default.aspx. Accessed August 4, 2008.
Duffy S, Marsh F, Rogerson L, Hudson H, Cooper K, Jack S, et al. Female sterilisation: a cohort controlled comparative study of ESSURE versus laparoscopic sterilisation. BJOG . 2005;112:1522-1528.
Essure System - P020014. US Food and Drug Administration website. Available at: http://www.fda.gov/cdrh/pdf2/p020014.html. Updated April 2003. Accessed August 4, 2008.
Female Sterilization (Essure). Planned Parenthood website. Available at: http://www.plannedparenthood.org/greater-iowa/female-sterilization-essure.htm. Accessed August 4, 2008.
Sterilization for men and women. American College of Obstetricians and Gynecologists website. Available at: http://www.acog.org/PUBLICATIONS/PATIENT_EDUCATION/BP011.CFM. Accessed August 4, 2008.
Last reviewed June 2008 by Ganson Purcell Jr., MD, FACOG, FACPE
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