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July 1, 2015

FDA clears alternate confirmation test for Bayer’s Essure contraceptive

The US Food and Drug Administration (FDA) has approved the use of transvaginal ultrasound (TVU) as an alternate confirmation test for Bayer HealthCare's Essure permanent birth control.

Bayer

The US Food and Drug Administration (FDA) has approved the use of transvaginal ultrasound (TVU) as an alternate confirmation test for Bayer HealthCare’s Essure permanent birth control.

The confirmation test is required three months after the Essure procedure to establish that the device is properly placed and the woman can depend on the procedure.

Women are being asked to use an alternate form of birth control to prevent pregnancy until she receives a confirmation from their doctor.

US Medical Affairs Women’s Health director Patricia Carney said: "TVU provides an additional method for physicians to check that the device is properly placed and a woman can rely on Essure for birth control.

"TVU is approved as a safe and effective confirmation test option for appropriate patients that can be performed in a physician’s office without an x-ray."

"TVU is approved as a safe and effective confirmation test option for appropriate patients that can be performed in a physician’s office without an x-ray and does not require use of contrast dye."

Designed to view a woman’s reproductive organs using sound waves emitted from a probe placed in the vagina, the TVU test can be used as an alternative confirmation test to modified hysterosalpingogram (HSG) in appropriate patients, with FDA approval.

HSG is an x-ray of the uterus and fallopian tubes after they have been filled with contrast dye.

A physician will advise which type of confirmation test is appropriate, and a HSG will have to be performed in case the physician failed to confirm acorrect Essure placement with TVU.

A non-hormonal permanent birth control option with a non-surgical procedure, Essure was originally approved by the FDA in 2002.

During the procedure, a soft and flexible Essure insert is permanently placed into each of a woman’s fallopian tube, to form a natural barrier that keeps sperm from reaching the eggs, preventing pregnancy.


Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer HealthCare AG.

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