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FDA to Investigate Essure Contraceptive Device


FDA to Investigate Essure Contraceptive DeviceThe FDA reported recently that a review of its device adverse-event database (the Manufacturer and
User Facility Device Experience) found a significant increase in complaints regarding Essure.  Specifically,
it found 4150 Essure related reports between March 2013 and May 2015; opposed to, 943 reports for
the period spanning 2002 to 2013.

The most frequently cited complaints, by far, were related to heavier periods and other menstrual
irregularities.  Also cited were nickel allergy (941), device migration (482) and device breakage (259).
In issuing this report the FDA noted that it did not have conclusive “evidence in the literature indicating
any new or more widespread complications definitely associated with Essure occurring more than 5
years after Essure placement”.  The FDA’s Obstetrics and Gynecology Devices Panel has scheduled a
hearing to review the contraceptive device’s safety and effectiveness in September.


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