Five pregnancies reported in Essure's first year.(Gynecology)

SAN FRANCISCO -- Only five pregnancies have been reported in the first year of worldwide commercial experience with the Essure hysteroscopic sterilization device, and none resulted from devices that were placed properly, Andrew I. Brill, M.D., reported at the annual meeting of the American Association for Gynecologic Laparoscopists.

After the device was approved by the Food and Drug Adminsitration in 2002, Conceptus Inc. of San Carlos, Calif., shipped 9,000 units of Essure in the first year of commercial availability, said Dr. Brill, who is professor of ob.gyn., and director of gynecologic endoscopy at the University of Illinois, Chicago.

"Essure and other hysteroscopic sterilization methodologies are quickly becoming a standard option for patients seeking permanent sterilization and probably will become the norm, by my prediction, in 2 or 3 years," Dr. Brill said. "The effectiveness rate remains high in the commercial marketplace."

The rates of various adverse events reported in that first year were lower than those reported during the pivotal premarket clinical trials, but Dr. Brill acknowledged that the actual number of adverse events--and pregnancies--may be higher than the number voluntarily reported to the company by clinicians.

For example, the rate of expulsion of the Essure microinserts was 0.16% in commercial experience, compared with 2.9% in the clinical trials.

Tubal perforation was 0.31% in commercial experience and 1.1% in clinical trials.

Clinicians also reported that 0.97% of the insertion devices had bent tips, resulting in deployment difficulties.