Printer Friendly

Essure's first year results in only five pregnancies.

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 approval by the FDA in 2002, Conceptus Inc. of San Carlos, Calif., shipped 9,000 units of Essure in the first year of commercial availability, said Dr. Brill, 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.

Although Dr. Brill did acknowledge receiving consulting and grant support from several companies, including TAP Pharmaceuticals, Gynecare, SurgRx, Gyrus Medical, and ACMI, this list did not include Conceptus, which distributes Essure.
COPYRIGHT 2005 International Medical News Group
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Title Annotation:Women's Health
Author:Finn, Robert
Publication:Internal Medicine News
Article Type:Brief Article
Geographic Code:1USA
Date:Jan 15, 2005
Previous Article:Extended patch use delays bleeding by 54 days.
Next Article:Breast implants' link to connective tissue unclear.

Terms of use | Privacy policy | Copyright © 2019 Farlex, Inc. | Feedback | For webmasters