U.S. FDA Approves Alternate Confirmation Test for Essure® Permanent Birth Control
WHIPPANY, N.J., July 1, 2015 /PRNewswire/ -- 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."
About Essure®
Indication
Essure® is permanent birth control that works with your body to create a natural barrier against pregnancy.
Important Safety Information
Essure is not right for you if you are uncertain about ending your fertility, can have only one insert placed, are or have been pregnant within the past 6 weeks, have had your tubes tied, have an active or recent pelvic infection, or have a known allergy to contrast dye.
Talk to your doctor if you are taking immunosuppressants.
WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test (3 months after the procedure) and your doctor tells you that you can rely on Essure for birth control. It can take longer than three months for Essure to be effective. Talk to your doctor about which method of birth control you should use during this period. Women using an intrauterine device need to switch to another method. If you rely on Essure for birth control before receiving confirmation from your doctor, you are at risk of getting pregnant.
WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control.
During the procedure: In clinical trials some women experienced mild to moderate pain (9.3%). Your doctor may be unable to place one or both Essure® inserts correctly. Although uncommon, part of an Essure insert may break off or puncture the fallopian tube requiring surgery to repair the puncture. Your doctor may recommend a local anesthetic. Ask your doctor about the risks associated with this type of anesthesia.
Immediately following the procedure: In clinical trials some women experienced mild to moderate pain (12.9%) and/or cramping (29.6%), vaginal bleeding (6.8%), and pelvic or back discomfort for a few days. Some women experienced nausea and/or vomiting (10.8%) or fainting. In rare instances, an Essure insert may be expelled from the body.
During the Essure Confirmation Test: You will be exposed to very low levels of radiation, as with most x-rays. In rare instances, women may experience spotting and/or infection.
Long-term Risks: There are rare reports of chronic pelvic pain in women who have had Essure. In rare instances, an Essure insert may migrate through the fallopian tubes and may require surgery. No birth control method is 100% effective. Women who have Essure are more likely to have an ectopic pregnancy (pregnancy outside the uterus) if they get pregnant. This can be life-threatening. The Essure insert is made of materials that include a nickel-titanium alloy. Patients who are allergic to nickel may have an allergic reaction to the inserts. Symptoms include rash, itching and hives.
The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old.
Essure does not protect against HIV or other sexually transmitted diseases.
Talk to your doctor about Essure and whether it is right for you.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
Forward-Looking Statements
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer Web site at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
The Bayer Cross, Bayer and Essure are registered trademarks of Bayer.
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SOURCE Bayer HealthCare Pharmaceuticals, Inc.
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