FDA Approves Alternate Confirmation Test for Bayer's Permanent Birth Control Device

Whippany, N.J. -- Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved the use of transvaginal ultrasound (TVU) as an alternate confirmation test for Essure permanent birth control. A confirmation test must be given three months following the Essure procedure to confirm that the device is properly placed and the woman can rely on Essure for birth control. Until a woman receives such a confirmation from her doctor, she must use an alternate form of birth control to prevent pregnancy.

Originally approved by the FDA in 2002, Essure is a non-hormonal permanent birth control option with a non-surgical procedure. During the procedure, a doctor permanently places a soft, flexible Essure insert into each of a woman's fallopian tubes. These inserts work with a woman's body to form a natural barrier that keeps sperm from reaching the eggs, preventing pregnancy.

TVU is a test used to look at a woman's reproductive organs using sound waves emitted from a probe placed in the vagina. With this FDA approval, TVU can be used as an alternative confirmation test to modified hysterosalpingogram (HSG) in appropriate patients. 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 if the physician is unable to confirm correct Essure placement with TVU, an HSG will have to be performed.

Bayer and the FDA have agreed on the importance of a comprehensive training program for TVU which will begin in September with physicians who most frequently perform the Essure procedure. All physicians who offer Essure are expected to be trained and certified on the TVU confirmation test by mid-2016. Certification on TVU is required before a physician can offer this option to patients. Physicians should continue to use the HSG method as outlined in the Essure Instructions for Use until they have received training and certification on the use of TVU for Essure confirmation.

"We are very pleased that the FDA has approved the TVU confirmation test for Essure. 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," said Patricia Carney, MD, FACOG, director, US Medical Affairs, Women's Health. "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."