FDA Gives Greenlight For Alternative Essure Placement Test

July 1, 2015 — San Diego, CA

Bayer Healthcare has announced that the FDA approved using transvaginal ultrasound as an alternative test to confirm if the Essure device has been placed properly. Essure, a small metal coil inserted into a woman’s fallopian tubes, was approved in 2002, but has received more than 5,000 complaints to the FDA with side effects including pregnancy, pain, and even death.

The transvaginal ultrasound (TVU) is a secondary option to the current placement test for the Essure device: the hysterosalpingogram (HSG) test. The HSG is an x-ray test that looks inside of the uterus and fallopian tubes and the area surrounding them. The test involves transferring an iodine dye via the cervix into the uterus and fallopian tubes, in order to take the x-ray. Women have reported mild to severe cramping during the HSG test, and the insertion of the iodine into the cervix causes a strange, warm sensation.

The transvaginal ultrasound is a test in which sound waves emitted from a probe placed in the vagina check if Essure has been placed properly. This secondary test must be done on a woman with the Essure device to confirm the device is properly placed within three months of the procedure. It’s important to get this test done because until a woman receives confirmation from her doctor, she must use alternative birth control methods.

According to Bayer, all doctors who offer Essure are expected to be trained to perform the TVU confirmation test by mid-2016. They claim that the training will begin in September, the same month the FDA is scheduled to hold a public panel meeting to discuss the safety and effectiveness of Essure.

What does this mean for women suffering from Essure or considering having the procedure done? 

While it can be seen as a tiny bit of good news that there is a less invasive alternative to the highly painful HSG test, it does not change the fact that the FDA needs to make some serious decisions about this defective product. In addition, the information about this new TVU test doesn’t change the fact that the actual Essure device is ruining women’s lives. In the coming weeks, we hope to see some more detailed information about this TVU test. We will give you all the latest updates here.

If you or someone you love is suffering side effects from the Essure Implant, contact our Essure lawyers today, click the banner below to access the Essure Claim Evaluation form.

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