Hysteroscopic tubal sterilization: a systematic review of the Essure system.

OBJECTIVE: To update the evidence of the efficacy and safety of the Essure system. Female sterilization has undergone changes in the last decade. Besides laparoscopic tubal occlusion, the Essure system is now a viable option, with about 200,000 women sterilized using this method.
DESIGN: The review is based on the report of the Alberta Heritage Foundation for Medical Research and completed with systematic literature searches up to April 8, 2008.
SETTING: The Managed Uptake of Medical Methods program of the Finnish National Research and Development Center for Health and Welfare. PATIENT(S): Women over 30 years, who had been sterilized by the Essure method. INTERVENTION(S): Hysteroscopic tubal sterilization using Essure system. MAIN OUTCOME MEASURE(S): Efficacy/effectiveness, adverse events, costs. RESULT(S): Sterilization by Essure can be performed under local anesthesia or with oral analgesics in ambulatory settings. However, sterilization is not immediate and women must use additional contraception for 3 months until permanent tubal occlusion is verified by transvaginal ultrasound, hysterosalpingosonography, hysterosalpingography, or pelvic radiography. The evidence on efficacy and safety is mainly available from short follow-up case series but shows good efficacy and safety of the Essure system. Only a few small risks are associated with the procedure. Two economic studies, one of which implemented Essure as an in-office procedure, suggest that Essure could be more cost-effective than laparoscopic sterilization, but more information on the total cost is needed. CONCLUSION(S): The Essure system appears to be safe, permanent, irreversible, and a less invasive method of contraception compared with laparoscopic sterilization. Copyright (c) 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.