A Food and Drug Administration (FDA) advisory committee has recommended approval for Essure, an alternative to tubal ligation, developed by Conceptus of San Carlos, CA. The committee recommended that Essure be approved once certain conditions are met, which include changes to the labeling and implementation of the company’s pre-existing plan to conduct post-marketing surveillance. While the committee’s recommendation is not binding, it moves the investigational device a step further in the development pipeline. (See "Noninvasive female sterilization eyed," Contraceptive Technology Update, February 2002, p. 15.)
The company is negotiating labeling with the FDA and awaiting its final decision, says Stan Van Gent, vice president of marketing for Conceptus.
A new alternative to tubal ligation could have a significant impact. Each year, more than 700,000 U.S. women opt for permanent surgical sterilization via tubal ligation.1 Half of these procedures are performed postpartum, and half are performed as ambulatory interval (unrelated in time to a pregnancy) procedures.1
Review the benefits
There are many women who can benefit from less invasive, permanent contraception, says Wayne Shields, president and chief executive officer of the Washington, DC-based Association of Reproductive Health Professionals (ARHP). The Essure method represents another option in contraceptive choices, he notes.
Transcervical sterilization provides a good alternative to tubal sterilization, according to the ARHP, which hosted a December 2001 conference on the subject.
Although considered safe, tubal sterilization carries some risks, according to the ARHP.
Compared with tubal sterilization, transcervical sterilization is an easier, faster, and less-invasive procedure, requires less anesthesia, and results in less pain and a shorter recovery period — all significant benefits to the woman, physician, and insurers, states the ARHP.
"If we have, now, a transcervical method that is well tested and is highly effective and safe to provide, one that can be provided without trespassing in the peritoneal cavity and that does not require general anesthesia, women in the U.S. should have access to that method," states Amy Pollack, MD, MPH, president of the New York City-based EngenderHealth, a not-for-profit family planning and reproductive health organization. Pollack testified before the FDA advisory committee prior to its decision on the method.
Although female sterilization using laparoscopic and minilap approaches most often are provided using local anesthesia in developing countries, they almost exclusively are performed in the United States using short-acting general anesthesia, states Pollack. Data from the CREST (U.S. Collaborative Review of Sterilization) studies cite the use of general anesthesia as a predictor of complications in women undergoing interval tubal sterilization, she observes.
The Essure method calls for a soft micro-insert to be placed in the fallopian tube through the cervix using a minimally invasive transcervical tubal access catheter. Once in place, the device is designed to elicit tissue growth in and around the micro-insert to form an occlusion in the fallopian tube. An Essure procedure does not require cutting or penetrating the abdomen and can be performed in a less-costly setting without general anesthesia. A woman is expected to return home about 45 minutes after the procedure is completed, according to the company.
After 12 weeks, the woman is examined post-placement to confirm satisfactory micro-insert location. During the period before the placement is verified, the woman must use alternative contraception.
Phase II and pivotal trials were conducted in the United States, Australia, and Europe. A total of 130 women were included in the Phase II trial, with 518 women in the pivotal trial. To date, there have been no reported pregnancies, according to Conceptus. The company plans to submit its research data for publication, says Van Gent.
In unpublished one-year follow-up data on patients from the method’s pivotal trial, 92% of patients who were employed returned to work in one day or less after the procedure day. Pivotal trial results also indicate that nearly 60% of patients were back to their regular physical activities within one day; and within two days, 77% had resumed regular activities.
The Essure method is available in Australia, Singapore, Canada, and several European markets. While the U.S. cost has yet to be determined, list price in Australia is about $600; in Europe, the list price is about $700.2
As with other methods of sterilization, the Essure method represents a form of permanent birth control. Provider counseling is key to avoid patient regret, states Shields.
The Washington, DC-based Association of Reproductive Health Professionals (ARHP) has published an 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 Transcervical Sterilization. Review the monograph on-line at ARHP’s web site, www.arhp.org. Click on "Publications," "Clinical Proceedings," then the publication title. Continuing education credits are available.
For more information on Conceptus, contact:
- Conceptus, 1021 Howard Ave., San Carlos, CA 94070. Telephone: (650) 802-7240. Fax: (650) 610-8363. Web: www.conceptus.com.
1. Westhoff C, Davis A. Tubal sterilization: Focus on the U.S. experience. Fertil Steril 2000; 73:913-922.
2. Association of Reproductive Health Professionals. Clinical update on transcervical sterilization. Clinical Proceedings May 2002; 10.