Following a recommendation issued last July by its Obstetrics and Gynecology Devices Panel, the Food and Drug Administration (FDA) yesterday approved Essure, the first nonsurgical alternative to tubal ligation sterilization. A spring-like device placed in each fallopian tube, Essure irritates the inner tube lining and prompts scar tissue formation, creating blockages that after three months 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’s placement requires only a catheter and local anesthesia. Most patients are discharged 45 minutes later. Common side effects include cramps, pain and nausea. Conceptus will continue monitoring Essure’s longer-term efficacy and effects.
The manufacturer will commence physician training critical to the product’s proper insertion and operation as early as this weekend. Essure is expected to become available nationwide by March 2003 and will cost about $2,500, comparable to a tubal ligation. Each year, US women account for 700,000 of more than 180 million women globally who undergo sterilization.