Women who want permanent birth control now have a second option
Essure procedure offers noninvasive alternative to tubal ligation
American women now have a choice when it comes to permanent birth control: They can opt to undergo tubal ligation or choose the Essure transcervical sterilization procedure.
Essure, developed by San Carlos, CA-based Conceptus, is the first alternative to tubal ligation for women seeking permanent birth control in the United States. It is marketed in Australia, Europe, Singapore, and Canada. Unlike tubal ligation, which requires an abdominal incision and is typically done under general anesthesia, Essure requires no incisions and can be performed without general anesthesia. Cost of the Essure procedure is expected to be about the same as traditional tubal ligation, about $2,500.
The Essure method involves the use of a proprietary microinsert device and catheter delivery system for minimally invasive transcervical tubal access. The Food and Drug Administration (FDA) approved the sterilization procedure in November 2002. The agency expedited its review because of the potential benefit to couples seeking alternative means of sterilization.1 Conceptus, the manufacturer of Essure, expects to have the product available nationwide by March 2003. (Contraceptive Technology Update reported on the method in the February 2002 article, "Noninvasive female sterilization eyed," p. 15, and the October 2002 article, "Sterilization options may expand soon in U.S.," p. 111.)
Tubal sterilization is the most common method of contraception used in the United States; 11 million women ages 15-44 rely on the method for birth control.2 Half of the 700,000 annual bilateral tubal sterilizations are performed postpartum, and half are performed as ambulatory interval (unrelated in time to a pregnancy) procedures.2
"The No. 1 method used for pregnancy prevention in the U.S. is tubal ligation, and that is a fairly cumbersome procedure that involves surgery," observes Wayne Shields, president and chief executive officer of the Washington, DC-based Association of Reproductive Health Professionals (ARHP). "We are really encouraged to see a new method that accomplishes the same thing, is as effective, is safe, and doesn’t require surgery."
How does it work?
The Essure microinsert device measures 4 cm and consists of a stainless steel inner coil, a nickel titanium alloy outer coil, and polyethylene terephthalate (PET) fibers. The inner coil attaches the device to a guidewire used for placement in the fallopian tubes, while the outer coil anchors the microinsert in the fallopian tube. The PET fibers are a mesh between the two coils. (See the box on p. 3 for information on who may not use Essure.)
During the Essure procedure, the device is inserted through the cervix into the fallopian tubes through a catheter that covers the guidewire, from which the device is then released. The device promotes tissue growth in the fallopian tubes, that over a three-month period, provides tubal occlusion.
In clinical testing, the total procedure lasted about 35 minutes, with 15 minutes required to place the microinserts into the fallopian tubes. Most women were able to leave the treatment facility 45 minutes after the procedure. About 90% of women were able to resume work in 24 hours or less after the day of the procedure, with many women resuming normal physical activities the same day of the procedure.
Women must use another method of birth control for at least three months after the procedure is performed. At that time, a hysterosalpingogram evaluation is performed to make sure that both of the Essure microinserts are in the correct location and that both tubes have been blocked.
The FDA approval was based on data from two clinical trials involving more than 600 women who relied on the current Essure design for one to two years. Look for the U.S. data to be published in the first or second quarter of 2003, says Stan Van Gent, vice president of marketing for Conceptus.
In one clinical study, placement of the Essure implants in both fallopian tubes (bilateral placement) was achieved in 200 of 227 women. Follow-ing confirmation of placement after three months, 194 women began relying exclusively on the device to prevent pregnancy. Of those, 181 women have relied on the device for at least 24 months, and another 12 women have relied on the device for at least 12 months. To date, none of the women have reported pregnancy.1
In the second study, bilateral placement of the Essure implants was attempted in 518 women between ages 21 and 40. All women used an alternate form of contraception for the first three months. Following confirmation of proper placement, 449 women began relying on the device alone to prevent pregnancy. These women were then followed to see if any became pregnant or had any other adverse events. In this study, the FDA considered one-year data on 439 women and two-year data on 16 women. To date, none of these women have reported pregnancy.1
In the second study, physicians failed to achieve bilateral placement of the Essure implants at first attempt with 14% of patients in the study.1 Accord-ing to the FDA, Conceptus will conduct a post-approval study to document the placement failure rate with newly trained physicians and to identify factors associated with placement failure.
Because women will rely on the Essure device for permanent sterilization for many years after placement, Conceptus also is required to follow all study participants from both clinical studies for at least five years to evaluate long-term contraceptive effectiveness.
Check training options
A variety of training options will be available to help physicians receive education about the Essure procedure, says Van Gent. Conceptus will conduct one-day training sessions at multiple sites around the country; information about the training schedules will be available on the company’s web site, www.essure.com.
The sessions will cover indications, contraindications, risks, benefits, counseling, and the steps of the procedure. Physicians will be able to test their hysteroscopy skills and placement techniques on specially designed models, says Van Gent. Following the training session, company representatives will attend, on average, the physician’s first five placements and monitor the results of the first 10 cases via a voluntary fax reporting system.
Information about the Essure procedure will be included in ARHP’s accredited visiting faculty program in 2003 and 2004, says Shields. The sessions will include education about new contraceptive options, including the Essure method, and also will involve a nonaccredited hands-on practicum training session, he notes. ARHP will be developing centrally located centers of excellence for the visiting faculty program; check the ARHP web site, www.arhp.org, for specific sites.
While the Essure method may be different from tubal ligation, both are permanent forms of contraception, says Shields. Providers must follow the same steps of informed consent when counseling women on the Essure method.
"I think it is important for women to understand all of their options and to understand this new option, and how it works, and that it is permanent," he notes . "If women aren’t clear that it is permanent, then this is not the method for them."
References
1. Food and Drug Administration. FDA approves new female sterilization device. Press release. Nov. 4, 2002.
2. Westhoff C, Davis A. Tubal sterilization: Focus on the U.S. experience. Fertil Steril 2000; 73:913-922.
Resources
For more information on Essure, contact Conceptus, 1021 Howard Ave., San Carlos, CA 94070. Telephone: (650) 802-7240. Fax: (650) 610-8363. Web: www.essure.com or www.conceptus.com.
The Washington, DC-based Association of Reproductive Health Professionals (ARHP) has released an accredited issue of its monograph, Clinical Proceedings, on the topic of transcervical sterilization. The monograph is based on a December 2001 ARHP conference, Clinical Update on Trans- cervical Sterilization. Review the monograph on-line at ARHP’s web site, www.arhp.org. Click on "healthcare providers," and "online publications." Then click on "Clinical Proceedings," then the publication title, Clinical Update on Transcervical Sterilization. Up to 2.4 continuing medical education credits are available.
American women now have a choice when it comes to permanent birth control: They can opt to undergo tubal ligation or choose the Essure transcervical sterilization procedure.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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