Essure: a review six years later.

Abstract:

: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.

authors

Connor VF

doi

10.1016/j.jmig.2009.02.009

subject

Has Abstract

pub_date

2009-05-01 00:00:00

pages

282-90

issue

3

eissn

1553-4650

issn

1553-4669

pii

S1553-4650(09)00115-0

journal_volume

16

pub_type

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