FDA OKs TVU as 2nd placement test for Bayer’s Essure

(Reuters) — Bayer (ETR:BAYN) said today that the FDA approved using transvaginal ultrasound as an alternate test to confirm if the company’s Essure permanent birth control device has been placed properly.

Essure is a small metal coil inserted into woman’s fallopian tubes. Since its FDA approval in 2002, women using the device have sent the safety watchdog more than 5,000 complaints, ranging from pain and menstrual problems to pregnancies and even deaths.

Some of the complaints related to the placement of the device.

In a transvaginal ultrasound, sound waves emitted from a probe placed in vagina help a physician check if Essure has been placed properly.

This test is an alternative to the generally-prescribed modified hysterosalpingogram test in which an X-ray of the uterus and fallopian tubes is used to check for proper device placement.

Women using Essure must do a test to confirm that the device is properly placed within 3 months of the procedure, using alternate birth control methods confirmation from a doctor, Bayer said today.

All physicians who offer Essure are expected to be trained to perform the TVU confirmation test by mid-2016, the company said.

The training will start in September, the same month the FDA is slated to hold a public panel meeting to discuss the safety and effectiveness of Essure.

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