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BJOG. 2012 Jun;119(7):795-9. doi: 10.1111/j.1471-0528.2012.03292.x. Epub 2012 Feb 23.

Complications of hysteroscopic Essure(®) sterilisation: report on 4306 procedures performed in a single centre.

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1
Department of Obstetrics and Gynaecology, 'Reina Sofía' University Hospital, Córdoba, Spain.

Abstract

OBJECTIVE:

To analyse the short-, medium- and long-term complications in women undergoing hysteroscopic tubal sterilisation with the Essure(®) device.

DESIGN:

Retrospective 7-year study.

SETTING:

Office hysteroscopic unit in a teaching hospital.

SAMPLE:

A total of 4306 women whoe underwent the Essure(®) sterilisation procedure from 2003 to 2010.

METHODS:

Data on the success of the procedure and complications arising from outpatient hysteroscopic sterilisation using the Essure(®) system were collected from consecutive women undergoing the procedure over a 7-year period.

MAIN OUTCOME MEASURES:

Placement rate, successful bilateral tubal occlusion, perioperative adverse events, early postoperative (during the first 3 months of follow-up) and late complications (after the initial 3 months of follow-up).

RESULTS:

A total of 4108 (96.8%) women completed the standard 3-month follow-up protocol. Only 534 (13%) women had undergone the procedure within the previous year. There were 115 (out of 4306; 2.7%) recorded complications, none of which resulted in the need for hospitalisation or discharge later than 2 hours after the procedure. Vasovagal syncope was the most frequently encountered adverse event, occurring in 85 (2.0%) of 4306 cases. In 19 cases, one device was expelled, with most expulsions (14 out of 19) being detected before or during the 3-month follow-up.

CONCLUSIONS:

Outpatient hysteroscopic sterilisation using the Essure(®) system is safe, with a low rate of complications.

[Indexed for MEDLINE]
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