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Sterilization update: More options to come?
What percentage of women choose sterilization as their contraceptive option in your practice? Chances are it is a significant proportion. According to the National Center for Health Statistics, 17% of all women ages 15-44 rely on female sterilization for birth control.1 Along with the birth control pill, female sterilization has been one of the two leading methods in the United States since 1982.1
More providers are eyeing use of transcervical sterilization, which can be performed without an incision under local anesthesia, using a hysteroscope to locate the tubes. The Food and Drug Administration (FDA) approved Essure (Concep-tus; Mountain View, CA) in 2002 as the first transcervical sterilization option. In July 2007, the U.S. regulatory agency approved the third-generation Essure system. Health Canada followed suit in November 2007. The new generation includes changes to the delivery system that reduce the number of steps a physician is required to perform during a placement procedure.
In a multicenter Phase II trial of the original Essure system, successful bilateral microinsert placement was achieved in 88% of women. Correct device placement was confirmed in 97% of cases at three months. After 6,015 woman-months of exposure to intercourse, no pregnancies had been recorded.2
Providers may soon see another transcervical sterilization option. In December 2007, the FDA's Obstetrics and Gynecology Devices Advisory Panel recommended approvable status for the pre-market application for the Adiana Permanent Contraception, developed by Hologic of Bedford, MA. While the agency is not required to accept the panel's ruling, it traditionally follows the recommendations of such advisory panels. The approval was given contingent upon several conditions, including long-term follow up of current trial patients, a new post-approval study of new patients and physicians, and more specific labeling recommendations.
According to Ellen Sheets, MD, chief medical officer for Hologic, the FDA will conduct an audit of the clinical trial and manufacturing system at Adiana. It then will consider the results of the audit along with the panel's recommendation. At press time, news regarding FDA action was expected in February 2008.
The Essure procedure involves the use of a soft microinsert that is placed into the fallopian tubes through the cervix using a hysteroscope. Once in place, the device is designed to elicit tissue growth in and around the microinsert to form an occlusion or blockage in the tubes over a three-month time period. A hysterosalpingography must be performed after 12 weeks to determine tubal occlusion.
A major advantage of Essure's third generation system of is its ease of use, says Mark Levie, MD, director of the Department of Obstetrics & Gynecology and Women's Health at Montefiore Medical Center in New York City. With the new system, physicians now have easier visual markers to cue them about proper device placement, says Levie, who presented data on the Essure system at the November 2007 American Association of Gynecological Laparoscopists conference.3
There is no longer a need for the cumbersome movement of 10 counterclockwise turns to detach the device from the delivery catheter; this now occurs with the simple spin of a wheel on the handpiece," observes Levie. "Furthermore, the new system has a DryFlow introducer which prevents fluid from escaping through the operative channel, keeping the physician dry and the office clean."
Conceptus has developed resources available to new and experienced practitioners, says Kristen Sargent, a Conceptus spokeswoman. The company offers several resources for Essure practitioners, such hands-on training and demonstrations, and a web site, www.EssureMD.com, where providers can download training materials, procedure documents, and other information, she states.
The Adiana procedure can be performed utilizing local anesthesia in a physician's office. To perform the sterilization method, a catheter is positioned immediately inside the opening of the patient's fallopian tube using a hysteroscope. The catheter applies a low level of bipolar radiofrequency energy to remove a thin layer of cells inside the fallopian tube, then delivers an implantable, soft polymer matrix that remains within the prepared section of the tube. The procedure then is repeated on the other fallopian tube. A hysterosalpingogram is conducted at three months post-procedure to ensure the fallopian tubes are completely blocked and that the woman can begin relying on the method for permanent contraception.
Ted Anderson, MD, PhD, associate professor of obstetrics and gynecology at Vanderbilt University Medical Center and an investigator in Adiana's clinical trial, says the procedure is easy to learn, easy to perform, and well tolerated by patients.
In a multicenter prospective trial of the method, 604 women were enrolled, and 509 were brought to hysteroscopy after screening. A total of 499 women had attempted catheter placement, with bilateral success in 473 patients (94.8%). The observed one-year pregnancy prevention rate was 99.7%.4 Because the nonmetallic implant remains fully outside the uterine cavity, advantages over other systems may include easier insertion and future access to intracavitary diagnostic or therapeutic interventions, should they become necessary.4