Conceptus(R) Announces 10-Year Commercial Data for Essure(R) at 40th AAGL Global Congress of Minimally Invasive Gynecology

Milestone Report Underscores the Essure Procedure's Proven Success is Standing the Test of Time


MOUNTAIN VIEW, Calif., Nov. 8, 2011 (GLOBE NEWSWIRE) -- Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the most effective non-surgical permanent birth control method available*, today released a new data report on Essure's 10-year commercial success at the 40th AAGL Global Congress of Minimally Invasive Gynecology in Hollywood, Florida, November 7-10, 2011.

This 10-year global study explores the commercial use of Essure by approximately 500,000 women. The new data tracks closely with Essure's clinical effectiveness rate of 99.8% based on four years of follow-up with zero pregnancies reported in clinical trials. 

"As the pioneer and market leader of hysteroscopic sterilization, we are pleased to be celebrating this milestone achievement for the Essure procedure at AAGL this year," said Mark Sieczkarek, president and chief executive officer of Conceptus. "Besides being the most effective form of permanent birth control, Essure is also the leading office-based method of female sterilization and offers patients a minimally-invasive procedure that takes less than 10 minutes with no incisions, no hormones and a short recovery period."

"Most patients have heard about tubal ligation or vasectomy. However, now that Essure has a decade of successfully proven commercial experience, it is time that more OB/GYNs and other healthcare professionals start recommending this safer, more convenient alternative to appropriate patients," said Barbara Levy, M.D., medical director for Conceptus.  

The AAGL Global Congress will feature more than 20 ground-breaking scientific communications on the Essure system from presenters around the world. Several of the presentations will favorably compare Essure to other forms of sterilization including laparoscopic tubal ligation, vasectomy, and a competitive hysteroscopic sterilization procedure. Among the presentations are:

  • Reported pregnancies after Essure® Hysteroscopic Sterilization: A Retrospective Analysis of Pregnancy Reports Worldwide: 2001-2010; Levy BS, Munro MG, Veersema S, Vleugels M.  Women's Health, Franciscan Health Systems, Federal Way, Washington; Department of Obstetrics & Gynecology, UCLA David Giffen School of Medicine, Los Angeles, CA; Department of Obstetrics & Gynecology, St. Antonius Hospital, Nieuwegein, Netherlands; Department of Obstetrics & Gynecology, Riverland Hospital Tiel, Tiel, Netherlands
  • A Comparative Study between Hysteroscopic (Essure) Versus Laparoscopic Sterilization: Patient Satisfaction; Perez C, Lopez G, Guillen C, Alvarez C, Jimenez JS, Munoz JL, Lorenzo E.  Department of Obstetrics & Gynecology, Madrid, Spain
  • Essure Versus Vasectomy: An analysis of Success, Complications, Pain, and Pregnancy; Smith KS, Gephart LF, Cooper J, Obstetrics & Gynecology, Howard University Hospital, Washington, DC
  •  Hysteroscopic Placement of the Essure Device in the Office-Setting; Levie M, Chudnoff S, Palmer S, To J. Montefiore Medical Center, Bronx, NY
  •  Impact of Experience on Essure Placement Rates; Levie M, Chudnoff S. Obstetrics & Gynecology and Women's Health, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY

As a long-standing contributor to AAGL, Conceptus will be an active participant in several conference activities that focus on the continuing education of residents and fellows. For example, the Company will participate in an office-based CME post-graduate course. At the Conceptus exhibitor booth, company representatives will celebrate the new 10-year commercial data results with an historical timeline of key Essure milestones, as well as provide visitors an opportunity to train on the Company's state-of-the-art EssureSim™ simulator that replicates the Essure procedure. The booth will also feature details on the Essurance™ Promise Program (Patient Reliance Warranty), the Essure FlexPay™ Plan, and Patient Education Systems digital program that facilitates patient awareness and education about office-based gynecological procedures. 

"This year's AAGL meeting marks the turning point for Essure after a decade of clinical excellence. We are positioned to expand awareness about Essure to both women who are done having children and the physicians who treat them," said Sieczkarek. "We share the vision with the members of AAGL to provide optimal patient care through minimally-invasive gynecology, and thank them for advancing Essure as a safe and effective office-based  method of permanent birth control."

About the Essure® Procedure

The Essure procedure, FDA approved since 2002, is the first permanent birth control method that can be performed in the comfort of a physician's office in less than 10 minutes (average hysteroscopic time) without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around and through the inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor is able to perform an Essure Confirmation Test to confirm that the inserts are properly placed and that the fallopian tubes are fully blocked, allowing the patient to rely upon Essure for permanent birth control.

The Essure procedure is covered by most insurance plans, and when it is performed in a doctor's office the cost to the patient may be as low as a simple co-pay. Essure has been proven and trusted by physicians since 2002, with more than 570,000 women worldwide having undergone the Essure procedure.

About Conceptus, Inc.

Conceptus, Inc. is a leader in the design, development and marketing of innovative solutions in women's healthcare. The Company manufactures and markets the Essure procedure. The Essure procedure is available in the United States, Europe, Australia, New Zealand, Canada, Mexico, Central and South America and the Middle East. The Company also promotes the GYNECARE THERMACHOICE® Uterine Balloon Therapy System by ETHICON™ Women's Health & Urology, a division of Ethicon, Inc., in U.S. OB/GYN physician offices.

Please visit www.essure.com for more information on the Essure procedure. Patients may call the Essure Information Center at 1-877-ESSURE-1 with questions or to find a physician in their area.

© 2011 Conceptus, Inc.—All rights reserved. Conceptus and Essure are trademarks or registered trademarks of Conceptus, Inc.

*Based on 4 years of clinical data

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