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FDA approves TVU as alternative confirmation test for Bayer’s Essure birth control

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

Bayer

TVU is a test which uses sound waves to look into a woman’s reproductive organs. The sound waves are emitted via a probe placed in the vagina.

The FDA approval allows TVU to be used as an alternative to modified hysterosalpingogram (HSG) in appropriate patients.

US Medical Affairs Women’s Health director Patricia Carney said: "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.

"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."

A woman seeking birth control alternative can rely on Essure, which needs to pass a confirmation test three months after the procedure to guarantee about its proper placement.

The woman, however, will have to depend on alternate form of birth control to prevent pregnancy in the meantime.

Essure is a non-hormonal permanent birth control option which does not necessitate surgery.

The permanent process needs a doctor to place 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 which prevents the sperm from reaching the eggs, thereby ensuring birth control.

FDA and Bayer will offer a comprehensive training program to the physicians for the use of TVU from September.


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