Essure birth control
This article was originally published in The Gray Sheet
Executive Summary
FDA's Obstetrics and Gynecology Devices Advisory panel will review one-year data on 400 patients treated with Conceptus' non-incisional permanent birth control device at its July 22-23 meeting. Submitted April 19, the Essure PMA was granted expedited review, and the device could be approved and on the market by the end of 2002, Conceptus notes (1"The Gray Sheet" March 25, 2002, p. 21). In clinical trials, the device has shown 100% effectiveness in preventing pregnancy, leading to a projected one-year efficacy rate of 99.8%, the firm reports...