Alternate Confirmation Test for Essure Gets Nod from FDA
Bayer HealthCare announced that the Food and Drug Administration (FDA) has approved an alternate confirmation test for Essure inserts, administered three months following the procedure for hysteroscopic sterilization.
Transvaginal ultrasound (TVU) can now be used as an alternative confirmation test to modified hysterosalpingogram (HSG) in appropriate patients. The physician will advise which type of confirmation test is appropriate and an HSG will need to be performed if the physician is unable to confirm correct Essure placement with TVU. All physicians who offer Essure will be expected to be trained and certified on the TVU confirmation test by mid-2016; certification on TVU is required prior to a physician offering this option to patients. Physicians are advised to continue using 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.
Essure inserts are non-hormonal and are permanently placed into a woman's fallopian tubes. They work with the body to form a natural barrier against sperm reaching the eggs.
For more information call (877) ESSURE1 or visit Essure.com.