Thursday, September 24, 2015

F.D.A. Panel Weighs Complaints on Essure Contraceptive Implant - The New York Times

F.D.A. Panel Weighs Complaints on Essure Contraceptive Implant - The New York Times

SILVER SPRING, Md. — A panel of experts convened by the Food and Drug Administration weighed the evidence Thursday on a contraceptive device that has received thousands of complaints from women who say they were harmed by it.
The device, called Essure, is a small metal and polyester coil implanted into a woman’s fallopian tubes to make her permanently sterile. The F.D.A. approved Essure 13 years ago after a fast-track review process that prioritized the device because it offered the first alternative to surgical sterilization and promised a quick recovery.
But since then, allegations that the device has caused severe pain, perforations of fallopian tubes and possibly even death, and that it has failed to prevent pregnancy in some cases, have accumulated, and the agency decided to hold a daylong public meeting at its headquarters on Thursday to talk about them.

The large auditorium was unusually full, and the ordinarily dry scientific discussion was punctuated with emotional testimony by women who gave accounts of their experiences with Essure. Many spoke of health problems that surfaced after the device was implanted, and of odysseys through the health care system in search of diagnoses.
The panel of experts, which included gynecologists, obstetricians and other specialists, is not expected to vote on questions that would lead to action on the part of the agency, but the exercise will inform the agency’s view on the device as its tale continues to unfold.
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The device’s producer, Bayer HealthCare Pharmaceuticals, stands by it, saying its safety “is supported by more than a decade of science, with more than 10,000 women studied.” The company estimates that a million Essure devices have been distributed around the world, most of them in the United States.

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