Women Find Conceptus' Essure Permanent Birth Control Procedure Less Painful Than Tubal Ligation in a New Study.More Women and Their Doctors Are Choosing the Incision-Free Replacement over Tubal Tubal (t `bəl), in the Bible, son of Japheth. Ligation ligation /li·ga·tion/ (li-ga´shun) the application of a ligature.tubal ligation sterilization of the female by constricting, severing, or crushing the uterine tubes. . MOUNTAIN VIEW, Calif. -- Conceptus conceptus /con·cep·tus/ (-tus) the product of the union of oocyte and spermatozoon at any stage of development from fertilization until birth, including extraembryonic membranes as well as the embryo or fetus. , Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CPTS CPTS Certified Penetration Testing Specialist (network security) CPTS Comptroller Squadron CPTS Computer Program Test Specifications CPTS Catastrophe Personnel Tracking System CPTS Claims Procedure Training Specialist ) announces that a new independent study published in the May/June issue of Journal of the Society of Laparoendoscopic Surgeons found that the Essure([R]) 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 Laparoscopic A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen. Mentioned in: Obstetrical Emergencies 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 menstrual cramps Spasmodic dysmenorrhea Gynecology Painful cramps, spasms, lower abdominal discomfort, generally occurring on the first day of the menstrual period; the pain may extend to the low back, thighs, pelvis, and be accompanied by N&V, dizziness, , 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 gynecologic /gy·ne·co·log·ic/ (gi?ne-) (jin?e-kah-loj´ik) pertaining to the female reproductive tract or to gynecology. endoscopist endoscopist A health professional who performs endoscopic procedures. See Nurse endoscopist. at the Department of Obstetrics and Gynecology obstetrics and gynecology Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. at Staten Island University Hospital A major tertiary referral center on Staten Island, in New York City, Staten Island University Hospital (SIUH) is a three-campus, 785-bed hospital center founded in 1861 as the Samuel R. Smith Infirmary. It consists of the North Campus, South Campus, and Concord Campus. . "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 Anesthesia, General Definition General anesthesia is the induction of a state of unconsciousness with the absence of pain sensation over the entire body, through the administration of anesthetic drugs. , 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 hphung@fischerhealth.com. (a)Last name withheld for patient privacy. About the Essure([R]) Procedure The Essure procedure, approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in 2002, is a sterilization procedure that replaces tubal ligation for women. A soft micro-insert is placed into the Fallopian tubes Fallopian tubes The narrow ducts leading from a woman's ovaries to the uterus. After an egg is released from the ovary during ovulation, fertilization (the union of sperm and egg) normally occurs in 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. 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 vasectomy, male sterilization by surgical excision of the vas deferens, the thin duct that carries sperm cells from the testicles to the prostate and the penis. , 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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