FDA Looking at Essure Birth Control Device Safety

From the WebMD Archives

June 25, 2015 -- The U.S. Food and Drug Administration on Wednesday announced that it would hold a public meeting to discuss the safety of the contraceptive device Essure.

Essure -- a small metal coil placed via catheter into the fallopian tubes -- is the only permanent birth control device approved for use in the United States. The device received approval in 2002, but over the years the FDA has been alerted to thousands of complaints from women who use the device.

Those complaints include abdominal pain, menstrual irregularities, headache, fatigue and weight fluctuations.

Complaints have also been received regarding "migration," breakage or malposition of the Essure device, the FDA said in a statement published on its website.

There have also been a small number of deaths of women potentially linked to Essure, the agency said, and five reports of fetal death after women became pregnant while using the contraceptive device.

The FDA has completed two studies reviewing "postmarket surveillance data," and now plans a public meeting of its Obstetrics and Gynecology Devices Panel on Sept. 24 to discuss the findings and help decide on "next steps" with regard to the device.

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