Healthcare Industry News: hysteroscope
News Release - August 1, 2007
Women Find Conceptus' Essure Permanent Birth Control Procedure Less Painful Than Tubal Ligation in a New StudyMore Women and Their Doctors Are Choosing the Incision-Free Replacement over Tubal Ligation.
MOUNTAIN VIEW, Calif.--(HSMN NewsFeed)--Conceptus, Inc. (NASDAQ:CPTS ) announces that a new independent study published in the May/June issue of Journal of the Society of Laparoendoscopic Surgeons found that the Essure® procedure is less painful than tubal ligation surgery for permanent birth control.
The study suggests the Essure hysteroscopic permanent birth control system is significantly less painful for women than traditional laparoscopic tubal ligation. The difference in pain between the two procedures demonstrates yet another reason why the Essure procedure is expected to become the preferred method of permanent birth control among women who have completed their child bearing.
"During the procedure, I had just a little bit of cramping, a lot like menstrual cramps, but it was very bearable," said Kelly(a), a recent Essure patient.
The study indicated that the average pain score immediately post-procedure was significantly lower among patients who underwent the transcervical Essure procedure than patients who underwent laparoscopic tubal ligation. At one week post-procedure none of the patients who underwent the Essure procedure reported any pain, while all of the tubal ligation patients were still experiencing mild to moderate pain. At four weeks post-procedure, women in the Essure procedure group continued to report no pain, while 35 percent of the tubal ligation group continued to report some pain, as reported in Patient Report of Pain Following Two Sterilization Procedures, conducted by Radha Syed, M.D., attending physician and gynecologic endoscopist at the Department of Obstetrics and Gynecology at Staten Island University Hospital.
"Hysteroscopic sterilization offers a minimally invasive, less painful option for women seeking permanent birth control," said Syed. "The procedure should be the gold standard for all women seeking permanent birth control."
In clinical studies, Essure patients returned to normal activity sooner and expressed a greater level of overall satisfaction when compared to tubal ligation. The procedure can be performed in the comfort of a physician's office in 13 minutes with only minimal anesthesia. The Essure procedure is the only female birth control method that uses a test to confirm protection from pregnancy, providing women with peace of mind.
"In addition to reduced pain, patients undergoing the Essure procedure do not require general anesthesia, thus avoiding the risks associated with surgeries such as tubal ligation," said Mark Sieczkarek, president and chief executive officer of Conceptus, Inc., developer of the Essure procedure. "The findings suggest that the procedure offers a higher standard of patient care than laparoscopic tubal ligation, and should be offered as the recommended option to all women seeking sterilization."
A copy of the full study is available by contacting Helen Phung at 310-577-7870 or firstname.lastname@example.org.
(a)Last name withheld for patient privacy.
About the Essure® Procedure
The Essure procedure, approved by the FDA in 2002, is a sterilization procedure that replaces tubal ligation for women. A soft micro-insert is placed into the Fallopian tubes through the cervix using a hysteroscope. 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, over three months. An Essure procedure does not require cutting into the body and can be performed in the doctor's office, a less costly procedure setting, with just a local anesthetic. A woman is able to leave the office about 45 minutes after the procedure is completed. 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 (based on four years of clinical study follow-up data). The probability of pregnancy in 1000 women at 4 years is only 2.0 as compared to 11.8 for surgical tubal ligation procedures studied in CREST.
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 www.essure.com or by calling the Essure Information Center at 1-877-ESSURE1. Additional information about Conceptus is available at www.conceptus.com or by calling 1-877-ESSURE2.
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. Discussions regarding Essure becoming the preferred method of permanent birth control, and other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking statements. Such differences may be based upon factors such as strategic planning decisions by management, re-allocation of internal resources, decisions by insurance companies, scientific advances by third parties, and introduction of competitive products, as well as those factors set forth in the Company's most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q, and other filings with the Securities and Exchange Commission.
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