MOUNTAIN VIEW, Calif., Nov. 7, 2012 (GLOBE NEWSWIRE) -- Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the most effective permanent birth control method available1, will highlight the recent recommendation from a distinguished committee of OB/GYN leaders that hysteroscopic sterilization replace tubal ligation as best practice for female sterilization procedures during its participation at the 41st AAGL Global Congress of Minimally Invasive Gynecology in Las Vegas, Nevada, November 6-8, 2012.
The committee's opinion was recently published in a paper entitled "Best Practices for Female Sterilization in 2012 and Beyond" which appeared as a supplement in the October 2012 issue of OBG Management. The supplement was the result of a roundtable discussion by OB/GYN participants who reviewed 10-year clinical data and an extensive number of peer-reviewed studies on female sterilization.
The supplement emphasized that the hysteroscopic approach to sterilization yields many tangible and intangible advantages to patients, physicians, and the larger health care system. In addition, the lack of an incision, quick recovery, and ability to be performed in an office setting make this an excellent option for most patients. The supplement also highlighted that Essure is the most effective method of permanent birth control based on long-term data.
The supplement stated that while long-acting reversible contraception (LARC) may be an excellent option for women who desire future fertility, data from the LARC Guideline Development Group show that female sterilization is overall more effective than all LARC methods2. Female sterilization was also found to be more cost effective for patients seeking contraception that lasted longer than six years. Furthermore, LARC method use is associated with side effects, predominantly menstrual disturbances, which are among the major causes of discontinuation. Up to 43% of women discontinue IUD use at four years3.
Based on the data-driven evidence, the roundtable members concluded: "Our oath to minimize risk and maximize outcomes and reliability should shift the paradigm from laparoscopic and laparotomic toward hysteroscopic sterilization. The benefits to society as a whole are convincing. Hysteroscopic sterilization should be considered a best practice for physicians and their patients as we care for women in the 21st Century."
"We were pleased that the committee underscored the multiple advantages of hysteroscopic sterilization and thus advanced the discussion of making the Essure procedure the standard of care for permanent birth control," said D. Keith Grossman, president and chief executive officer of Conceptus. "As we enter the new era of value-driven healthcare in both the U.S. and abroad, it's critical that all constituencies including OB/GYNs and third party payers understand the benefits of the Essure procedure."
To access a copy of "Best Practices for Female Sterilization in 2012 and Beyond" published in OBG Management click http://www.conceptus.com/Documents/OBGMgmtOct2012.pdf. The roundtable received support from Conceptus.
Worldwide Scientific Researchers to Present Essure Communications at AAGL Congress
The 41st AAGL Global Congress will feature 19 Essure permanent birth control scientific communications presented by U.S. and international researchers. Studies include:
- Efficacy of Tubal Sterilization: Reported Pregnancies after Tubal Ligation and Essure® Hysteroscopic Sterilization – French Enquiry 2006-2010. H. Fernandez, P. Panel, C. Blein, L. Lamarsalle. JMIG 19(6)S19-S20.Nov 2012. The authors conclude: "This nationwide study of tubal sterilization showed that Essure has both greater efficacy and a lower rate of post sterilization regret than tubal ligation."
- Improved Hysterosalpingography (HSG) Compliance after Hysteroscopic Sterilization in a Clinic Population. S. Rizk, V. Shavell, A. Awonuga, M. Diamond, J. Berman.JMIG 19(6)S18.Nov 2012. The authors report: "Improved patient and provider counseling about the importance of post-hysteroscopic sterilization HSG to confirm tubal occlusion as well as implementation of a separate post-sterilization HSG consent form significantly increased HSG compliance in an inner city, clinic population."
- Hysteroscopic Sterilization under Intravenous Anesthesia Is a Safe Method for Women with Severe Cardiopathy and Contraindication to Outpatient Surgical Procedures. L. Gibran, T.M. Oliveira, A. Zanatta, J.A. JMIG 19(6)S163.Nov 2012. Dr. Gibran et al report that in two women with cardiopathy severe enough to preclude pregnancies: "Hysteroscopic Sterilization with the Essure® device under intravenously delivered anesthesia is a safe option for patients with severe cardiopathy who cannot tolerate ambulatory procedures."
Conceptus to Showcase Essure's 10-Year Anniversary of FDA Approval at AAGL Congress
Conceptus is celebrating the Essure procedure's 10-year anniversary of U.S. Food and Drug Administration (FDA) approval. Visitors to the Company's booth will have an opportunity to sign an historical timeline of key Essure milestones and train on the Company's state-of-the-art EssureSim™ simulator that replicates the Essure procedure. Other booth highlights include:
- Two presentations by Mark Levie, MD, "Best Practices for Female Sterilization in 2012 and Beyond."
- Two presentations by Cindy Basinski, MD, "Essure and GEA Safety: Maximizing Efficiency in the Office Setting."
- Information on recent label changes for the Essure procedure such as the removal of the nickel hypersensitivity contraindication and the safe and compatible use with all major global endometrial ablation (GEA) technology options including NovaSure®.
- Information on the inclusion of the Essure procedure in the women's preventive contraceptive services of the Patient Protection and Affordable Care Act of 2010 (ACA).
Conceptus will also participate in AAGL conference activities that focus on the continuing education of residents and fellows including:
- CME accredited post-graduate course on in-office hysteroscopy.
- A resident luncheon that will offer hysteroscopic sterilization training.
About the Essure® Procedure
The Essure procedure, FDA approved since 2002, is the only surgery-free and hormone-free 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 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 works with the inserts to form a natural barrier in the fallopian tubes to prevent sperm from reaching the egg. Three months after the Essure procedure, an Essure Confirmation Test is given to confirm that the inserts are in place and that the fallopian tubes are blocked, verifying that the patient can rely on Essure for permanent birth control.
The Essure procedure is 99.83% effective based on five years of follow up with zero pregnancies reported in clinical trials, making it the most effective permanent birth control available. Essure's 10-year commercial data tracks closely with its five-year clinical results, and Essure has been proven and trusted by physicians since 2002. The Essure procedure is covered in the U.S. by most public and private insurance plans and approximately 690,000 women worldwide have undergone the procedure.
About Conceptus®, Inc.
Conceptus, Inc. is the global leader in the development and commercialization of innovative device-based solutions in permanent birth control. The Company manufactures and markets the Essure Permanent Birth Control System.
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.
The Conceptus, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7961
1-Based on a comparison of five-year clinical data.
2-Mavranezouli I, Wilkinson C. Long-acting reversible contraceptives: not only effective, but also a cost-effective option for the National Health Service. J Fam Plann Reprod Health Care. 2006;32(1):3-5.
3-Moreau C, Bouyer J, Bajos N, Rodriguez G, Trussell J. Frequency of discontinuation of contraceptive use: results from a French population based cohort. Hum Reprod. 2009;24(6):1387-1392.
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