The Food and Drug Administration’s (FDA) Obstetrics and Gynecology Devices Panel recommended this week that Essure, a nonsurgical alternative to tubal ligation sterilization be approved for sales. Essure works by placing a spring-like device in each fallopian tube, which then irritate the inner tube lining and prompt scar tissue formation – creating blockages that lead to sterilization. Manufactured by Conceptus, Inc., Essure was 99 percent effective in preventing pregnancies during clinical trials of 854 women. While general anesthesia and an abdominal incision are required with conventional sterilization in which the fallopian tubes are cut, tied or clasped shut, Essure placement requires only a catheter and local anesthesia. Most patients are discharged 45 minutes later. Cramps, pain and nausea are among the common side effects.
However, FDA advisers emphasize the importance of physician training to ensure proper insertion and operation. One study showed a 12 percent failure rate on the first implantation Ñ suggesting that the method may not work on all women, according to FDA engineer and chief of gynecologist devices Colin Pollard. The FDA panel also urged Conceptus to continue studies monitoring longer-term efficacy and effects.
FDA’s decision on Essure is expected in early 2003. The device is already approved for sale in Europe, Canada and Australia, where prices range from $500 to $800. US pricing has not been determined, Conceptus CEO Steven Bacich told Reuters Health.