Essure: a review six years later.
Hysteroscopic sterilization is rapidly replacing interval laparoscopic sterilization. Six years after the Food and Drug Administration's approval of Essure hysteroscopic sterilization, U.S. and worldwide literature and clinical experience have confirmed the safety, effectiveness, and low rate of adverse events reported in clinical trials. Essure is highly successful, with a 5-year effectiveness rate of 99.8%, and review of the unintended failures reveals that most can be traced to protocol deviation. The procedure is well tolerated in the office, with high successful bilateral placement rates and high patient satisfaction. Compliance and technical issues with the 3-month confirmation test are prevalent. Clinical results are consistent with the Phase II and III clinical trials, and long-term changes such as pelvic pain and abnormal bleeding are infrequent. Concomitant endometrial ablation is feasible and effective; however, long-term data are needed. Practitioners will encounter these real-world issues as they increasingly perform this procedure, and suggestions for management are provided.
Connor
Viviane F
VF
Section of Minimally Invasive Gynecology, Cleveland Clinic Florida, Weston, Florida 33331, USA. connorv@ccf.org
D002986:Clinical Trials as Topic; D055356:Endometrial Ablation Techniques / Q000379:methods; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015907:Hysteroscopy / Q000379:methods*; D017060:Patient Satisfaction; D013246:Sterilization, Tubal / Q000295:instrumentation*