Transcervical Sterilization
New Choice
The Essure method is an irreversible form of contraception that requires no incision and only a local anesthetic

By Kimberly A. Johnston, RN, EdD
May 22, 2004

Until recently, U.S. women seeking permanent methods of birth control had no other choice but to have a tubal ligation. Eleven million women aged 15 to 44 — 25% of this population — have undergone this surgical procedure,¹ making it the most common form of contraception among U.S. women, according to the national Centers for Disease Control and Prevention.

Tubal ligation is also the most common form of birth control in the world.² Every year, more than 700,000 women in the U.S. undergo the procedure. Tubal ligation is effective immediately in preventing pregnancy and can be done using local, general, or spinal anesthesia.

Although it has an effectiveness rate higher than 99%, it is an invasive surgical procedure with risks inherent to surgery and the use of anesthesia. And it is expensive for patients, costing an average of $1,200 to $2,500.³

This cost, however, is covered by Medicaid and some private health insurance policies.

The two most common procedures for performing a tubal ligation are the lap aroscopic procedure and the minilaparotomy. In the laparoscopic procedure, a laparoscope is inserted through a small incision near the navel to allow visualization of the fallopian tubes. Either an instrument is inserted through the laparoscope or another incision is made in the abdomen, through which the fallopian tubes are surgically closed.⁴

When tubal ligations are performed immediately after childbirth, as is most often the case, the procedure used is the minilaparotomy. In this procedure, only one incision is made in the patient’s abdomen, just above the pubic bone, to access the fallopian tubes.

More women complain of pain and cramping for a few days following a minilaparotomy than those who undergo the laparoscopic procedure.5 But either procedure can be done on an outpatient basis, and most women go home the same day the surgery is performed.⁴

Less invasive

In November 2002, the U.S. Food and Drug Administration approved a new method of permanent birth control that requires no incisions. The EssureAE method, developed by Conceptus, Inc., is a form of transcervical sterilization.6 Essure is the first and only FDA-approved transcervical sterilization method available to women in the U.S.

Transcervical sterilization differs from traditional tubal ligation in that it is an incision-free procedure in which a catheterlike instrument is guided through the cervix and uterus and then into the fallopian tubes (facing page, top illustration). The Essure method uses a small-diameter trans cervical access cath eter to place a mi cro insert (a soft, springlike coil made of polyester fibers and nickel titanium alloy) in each fallopian tube.

The microinsert has a stain less steel inner coil, a nitinol superelastic coil, and polyethylene fibers that are 0.8 mm long in a tightly wound configuration. Once in place, the outer coil expands to between 1.5 mm and 2 mm to anchor the microinsert (facing page, center image). Then tissue grows in and around it, blocking the fallopian tube^7,8 (facing page, bottom illustration.)

In clinical studies of women who had un dergone the Essure method, both fallopian tubes had closed in 96.5% of the women within three months and in 100% of the women within six months of the procedure.⁹

To determine whether occlusion of both fallopian tubes has occurred, a woman must undergo a hysterosalpingogram — an X-ray of the uterus and tubes using radiopaque dye¹— three months after the procedure. Since no incision is required with the Essure method, a local anesthetic may be used, unlike in a traditional tubal ligation, which typically requires that the patient undergo general anesthesia.

The Essure method is available to women for whom tubal ligation is contraindicated, such as those with medical conditions including obesity, previous abdominal surgeries, or allergies or reactions to general anesthesia. The procedure has the potential to cost less, since it can be performed in an outpatient clinic or physician’s office.

Some insurance companies provide coverage for the procedure, further reducing costs for patients.

Advantages, disadvantages

Although data are not available beyond two years, the one-year effectiveness rate of the Essure method has been shown to be 99.81% and the two-year effectiveness rate is 99.78%7 at preventing pregnancy.

Some disadvantages to the Essure method have been identified. Sterilization is not immediate; it takes several months for the fallopian tubes to become blocked with scar tissue. Therefore, women must use an alternate form of contraception for at least three months following the procedure. An intrauterine device (IUD) and intrauterine system (IUS) are the only forms of contraception that cannot be used during this time. Another concern is that it may take more than one attempt to place microinserts in the fallopian tubes. (Studies show that in 88% to 90% of women, placement is achieved on the first try.^10,11)

The procedure is not reversible, and surgery is required to remove the microinserts if that becomes necessary.

The Essure procedure has undergone extensive clinical testing in the U.S., Europe, and Australia. No pregnancies have been reported in two years of follow-up of more than 650 women who have undergone the procedure.¹²

Of the study participants who were employed, 92% resumed work within 24 hours of the procedure. Within one week of procedure, nearly all study participants rated their comfort level as “good” or “excellent,” and 98% of the women rated their long-term satisfaction with Essure as “good” or “excellent.”¹³

The future

While the Essure method is the only FDA-approved transcervical sterilization procedure now available for patient use, several other sterilization methods are in various stages of development.

> Adiana Inc., has developed a technology for permanent transcervical contraception using electrothermal energy.14 The system, which now is in clinical trials, uses a catheter to deliver 60 seconds of temperature-controlled radiofrequency energy to the fallopian tube. Then a porous implant is placed into the lesion left by the electrothermal energy. Over a few weeks, tissue grows into the implant and occludes the tubes. Adiana reported that of the first 100 women who had undergone the procedure in the EASE (evaluation of the Adiana system for sterilization) trial, the tubal implants were successfully placed on the first attempt. No pregnancies have been reported to date.14
> The use of two antibiotics, quinacrine and erythromycin, as sterilization drugs is also in pretrial status. The method for using each of the drugs is similar, in that the drug in pellet form is placed in the fallopian tubes to cause scarring and eventual occlusion of the tubes.1
> The intratubal ligation device, which is also in pretrial status, uses the transcervical method to place a ring over the fallopian tubes to create a mechanical blockage.1
> In addition, several transcervical methods of female sterilization are under investigation in Europe, including Ovabloc, P-block, the Hamou tubal plug, the Microsulis tubal occlusion method, and an intrauterine balloon.1 The intrauterine balloon works by inserting a tissue adhesive into the fallopian tubes.1

Transcervical sterilization could very well replace traditional tubal ligation as the most common sterilization method in the future.

The FDA’s approval of the Essure procedure is an important first step in the move toward a safe, effective, and economical method of transcervical sterilization.

On the horizon are even more options for women seeking a minimally invasive method of permanent contraception.

Kimberly A. Johnston, RN, EdD, is chairperson of the Department of Nursing at Kutztown University, Kutztown, Pa.

References

1. Farrington A. Permanent Contraception for Women in the United States. Association of Reproductive Health Professionals Website. Available at: www.arhp.org/healthcareproviders/onlinepublications/healthandsexuality/
permanentoptions/ PermanentOptionfor WomenintheUS.cfm. Accessed January 8, 2004.

2. Study demonstrates improvements with new coil catheter for Essure. Women’s Health Weekly. August 14, 2003:29-30.

3. Hatcher RA, Nelson AL, Zieman M, Darney PD, Creinin MD, Stosur HR. A Pocket Guide to Managing Contraception. 4th ed. Tiger, GA: Bridging the Gap Foundation; 2001.

4. Kolander CA, Ballard DJ, Chandler CK. Contemporary Women’s Health: Issues for Today and the Future. Boston, MA: McGraw-Hill Publishing; 1999.

5. The Boston Women’s Health Book Collective. Our Bodies, Ourselves. For the New Century. New York: Simon & Schuster; 1998.

6. Planned Parenthood Federation of America Inc. FDA approves innovative non-incision permanent birth control procedure for women. Available at: www.plannedparenthood.org/ about/pr/021105_birthcontrol.html. Accessed January 8, 2004.

7. Key milestone reached with Blue Cross/Blue Shield coverage of the Essure. Women’s Health Weekly. July 24, 2003:29-30.

8. Scalpel-free permanent contraception slashes recovery time. Health. 2003;17(1):105.

9. Cooper JM, Carignan CS, Cher D, Kerin JF. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102(1):59-67.

10. Essure [patient information booklet]. San Carlos, CA: Conceptus Inc.; 2003:10.

11. Rosen DMB. ANZJOG. 2004;44:62-64.

12. Minkin MJ, Hanlon T. New: Permanent birth control. Prevention. 2003;55(9):109.

13. Essure Permanent Birth Control: Clinical Testing. Available at: www.essure.com/consumer/c_clinical_testing.aspx. Conceptus, Inc., Website. Accessed January 8, 2004.

14. Adiana Inc. Reports Treatment of First 100 Women in EASE Transcervical Sterilization Trial. July 17, 2003. PR Newswire Association, Inc., Website. Available at: www.findarticles.com/ cf_dls/m4PRN/2003_July_17/105511185/p1/
article.jhtml. Accessed February 24, 2004.