More Than 20 New Studies Show The Many Benefits Of Essure(R) Compared With Surgical Tubal Ligation

Main Category: Women's Health / Gynecology
Also Included In: Medical Devices / Diagnostics;  Pain / Anesthetics
Article Date: 08 Nov 2007 - 3:00 PDT

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Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the first and only non-incisional permanent birth control method available, reports that more than 20 new, independent studies show that the Essure® permanent birth control procedure has a very high success rate, a short physician learning curve and high patient satisfaction. Collectively, the data suggest that the Essure procedure can easily be done in a physician's office and does not require general anesthesia.

The new studies were conducted throughout Europe and were presented at the 16th Annual Conference of the European Society for Gynaecological Endoscopy (ESGE) last month in Slovenia. The conference was attended by more than 600 gynecologists from across Europe.

Unlike surgical tubal ligation, which involves cutting, clipping or burning the Fallopian tubes, the Essure procedure does not require any incisions and can be done in a physician's office under local anesthesia.

The largest of the studies, conducted by researchers in France, included 908 patients in seven facilities between January 2004 and June 2006. Nearly half (48 percent) of these patients required no analgesia, while the rest had local, spinal block, intravenous sedation or general anesthesia. The rate for successful placement was 96.6 percent. Researchers noted, "in the future, the hysteroscopic pathway will replace the laparoscopic route."

"The studies presented at ESGE's Annual Conference are further proof of the safety and efficacy of the Essure procedure. To date, more than 150,000 procedures have been performed worldwide," said Mark Sieczkarek, president and chief executive of Conceptus. "Our mission is to provide women with a safe and effective replacement to traditional tubal ligation, avoiding the risks associated with surgery and general anesthesia."

In another study, researchers in Portugal found that nearly 90 percent of patients in the 119-patient study reported high satisfaction with the Essure procedure and none reported post-procedure pain upon leaving the clinic. They noted the Essure procedure "can be safely performed with minimal patient discomfort in an office setting, with rapid recovery, high patient satisfaction and low rate of complications."

About the Essure® Procedure

The Essure procedure, approved by the FDA in 2002, is a permanent birth control procedure that replaces tubal ligation for women. In the comfort of a physician's office and in about 10 minutes, the soft micro-inserts are placed into the Fallopian tubes through the cervix eliminating the need for incisions. Once in place, the device is designed to elicit tissue growth in and around the micro-insert to form an occlusion or blockage in the Fallopian tubes.

The Essure confirmation test is performed three months after the procedure to confirm that the micro-inserts are in the correct location, the tubes are blocked and that the woman can discontinue temporary birth control. The Essure procedure is 99.80% effective with four years of follow-up and is the first and only FDA approved female sterilization procedure to have zero pregnancies in clinical trials.

About Conceptus

Conceptus, Inc. manufactures and markets the Essure Permanent Birth Control system, an innovative medical device and procedure designed to provide a non-incisional alternative to tubal ligation, which is currently the leading form of birth control worldwide. The availability of the Essure procedure in the U.S. is expected to open up a market currently occupied by incisional tubal ligation and vasectomy, which combined account for more than 1 million procedures annually.

Additional information about the Essure procedure is available at http://www.essure.com or by calling the Essure Information Center at 1-877-ESSURE1. Additional information about Conceptus is available at http://www.conceptus.com.