FDA News

FDA Okeys Conceptus’ Third Generation Essure Permanent Birth Control System

(July 30, 2007)-- Conceptus  announced the approval of its third generation Essure permanent birth control system by the U.S. Food and Drug Administration (FDA). System modifications include changes to the delivery system that reduce the number of steps a physician is required to perform during a placement procedure.

In addition to the enhanced ease-of-use, hysteroscopic visualization of the implant and placement markers were significantly improved. A new DryFlow Introducer, which alleviates distension fluid loss, a major safety concern of hysteroscopists, is packaged with the product.

“We anticipate these physician-recommended changes will lead to a shorter learning curve for newly trained doctors and allow them to add the Essure procedure to their office practice services,” said Mark Sieczkarek, president and chief executive officer of Conceptus, Inc., developer of the Essure procedure. “We believe this will foster wider physician adoption, giving more women opportunity to select permanent birth control without the need to undergo tubal ligation and the risks associated with surgery.”

The Essure procedure remains the first and only FDA approved female sterilization procedure to have zero pregnancies in the clinical trials. To date, more than 130,000 Essure procedures have been performed worldwide.

In previous clinical studies, Essure patients returned to normal activity sooner and expressed a greater level of overall satisfaction when compared to tubal ligation. Because the Essure procedure does not require incisions, it can be performed in the comfort of a physician’s office in less than 15 minutes with a local anesthetic. Most women who get the Essure procedure are able to return to work or other activities the following day. It is also the only female birth control method that uses a test to confirm protection from pregnancy, providing women with peace of mind.

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