FDA approves nonsurgical sterilization system: metallic coils deployed via hysteroscopy. (Procedure Considered Irreversible).

Women in the United States interested in sterilization now have a nonsurgical option that can be performed transcervically without general anesthesia or an incision.

Last month the Food and Drug Administration approved the Essure system, which features two soft metallic coils that are deployed via hysteroscopy into the proximal fallopian tubes.

Fibers laced through the inner coils stimulate a local fibrotic response in and around the coils, gradually occluding the tubes over 3 months. A transcervical tubal access catheter is also included in the system, which is being marketed by Conceptus Inc.

"Anyone who does diagnostic hysteroscopy will find learning the Essure procedure is not going to be difficult. They will just have to learn to orient themselves so they can easily approach the tube," said Dr. David J. Levine, who is a consultant to Conceptus.

"It is a little different than when you're looking around for uterine pathology. You, have to line yourself up to that tube so you can make the proper approach," added Dr. Levine, director of gynecologic laparoscopy and director of the Women's Diagnostic Center at St. Luke's Hospital, Chesterfield, Mo.

Dr. Levine said he expects that about 10% of women will not be able to have the coils implanted because of abnormal tubal anatomy, which will not be evident until the procedure is attempted.

Women should be counseled that the procedure is considered irreversible because it is far more difficult to reverse than a tubal ligation, probably requiring uterotubal reimplantation.