Reimbursement Guide Essure Please See Additional Important Safety Information about Essure throughout Please See Additional Important Safety Information about Essure
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PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE THROUGHOUT PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON PAGES 2-5. WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device. IMPORTANT SAFETY INFORMATION
منابع مشابه
Efficacy, safety, and patient acceptability of the Essure™ procedure
The Essure™ system for permanent contraception was developed as a less invasive method of female sterilization. Placement of the Essure™ coil involves a hysteroscopic transcervical technique. This procedure can be done in a variety of settings and with a range of anesthetic options. More than eight years have passed since the US Food and Drug Administration approval of Essure™. Much research ha...
متن کاملAnalysis of surgeries performed after hysteroscopic sterilization as tabulated from 3,803 Essure patient experiences
OBJECTIVE Although previous research has suggested that risk for reoperation among hysteroscopic sterilization (HS) patients is more than ten times higher than for patients undergoing standard laparoscopic tubal ligation, little has been reported about these subsequent procedures. METHODS This descriptive cohort study used a confidential online questionnaire to gather data from women (n=3,803...
متن کاملEndometrial fluid associated with Essure implants placed before in vitro fertilization: Considerations for patient counseling and surgical management
Essure (Bayer) received approval from the U.S. Food and Drugs Administration as a permanent non-hormonal contraceptive implant in November 2002. While the use of Essure in the management of hydrosalpinx prior to in vitro fertilization (IVF) remains off-label, it has been used specifically for this purpose since at least 2007. Although most published reports on Essure placement before IVF have b...
متن کاملThe safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure pbc clinical study.
BACKGROUND Current methods of female surgical sterilisation require incisional surgery, general anaesthesia and a prolonged recovery time. We studied the safety and effectiveness of Essure pbc, a minimally invasive, transcervically placed micro-insert that occludes the Fallopian tubes, resulting in permanent female contraception. Device under study: The Essure pbc implant is a dynamically expan...
متن کاملHysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study.
OBJECTIVE To describe safety, tolerability, and effectiveness results through 5 years of follow-up of a Phase III trial with Essure inserts. DESIGN Multicenter, nonrandomized, single-arm international study (Canadian Task Force classification II-3). SETTING Thirteen clinical study centers in the United States, Europe, and Australia. PATIENTS A total of 518 previously fertile women seeking...
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تاریخ انتشار 2017