FDA Advisory Panel Provides Advice for the Continued Safe and Appropriate Use of Essure® Permanent Birth Control

WHIPPANY, N.J., Sept. 24, 2015 /PRNewswire/ -- Today the U.S. Food and Drug Administration's Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee discussed considerations to help ensure the continued safe and appropriate use of Essure^® permanent birth control. At the meeting, Bayer presented safety and efficacy data on Essure, as well as information on the need for permanent birth control options. There was agreement among the Panel members that Essure is an important contraceptive option, and the Panel provided input and guidance for the FDA and Bayer to consider.

"There's a need for safe and effective options for permanent birth control for women who have decided they've completed their families and that's what Essure can provide for appropriate patients. Bayer stands by the positive benefit-risk profile of Essure, and we look forward to working closely with the FDA as it considers the Panel's advice," said Dario Mirski, M.D., vice president and head of U.S. medical affairs at Bayer. "Bayer's highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure. We thank the women who shared their personal experiences at the meeting, and we continue to be committed to maintaining an open dialogue with any patient who has questions or concerns about Essure." 

FDA convened the meeting in order to seek expert scientific and clinical opinion on the benefits and risks of Essure. The Panel was asked to evaluate currently available scientific data pertaining to the safety and effectiveness of Essure, including its safe and appropriate use.

Based on information presented during this meeting, the Advisory Panel discussed a number of considerations including patient education and counseling; training and certification of physicians; post-procedural patient management; and clinical research. 

Since there is a high percentage of women who use permanent birth control, it is critical that they have access to a wide range of safe and effective birth control options to fit their needs. 

The safety and efficacy of Essure is supported by more than a decade of research and development and real world clinical experience. Essure has been studied in more than 10,000 women since it was first developed.

The counseling that women receive from their physicians when considering Essure as their permanent birth control choice is critical for the safe and appropriate use of the device. Physicians should counsel their patients on the risks of Essure; the permanency of the procedure; the importance of the three-month confirmation test to verify that the inserts can be relied upon to prevent pregnancy; and the need to use an alternate contraceptive method until a satisfactory Essure confirmation test is documented. Bayer includes extensive information on counseling patients in its physician training program and on its website.

Bayer also conducts rigorous training with physicians across the U.S. to help them use Essure safely and appropriately. In addition, Bayer provides ongoing support and conducts continuous outreach to physicians to learn more about their use of Essure and to answer their questions.

Essure Permanent Birth Control
Essure was approved by the FDA in 2002 as a permanent birth control option for women who have completed their families. The Essure procedure is 99.83 percent effective based on five-year clinical study data, making it one of the most effective methods of permanent birth control available.

The safety profile of Essure, well-established from clinical trials, observational research and post-marketing reporting, supports a product that offers women a safe, viable option for permanent birth control.

Bayer takes all adverse events very seriously. Bayer continuously collects and analyzes all adverse event data it receives and works closely with the FDA in monitoring the safety profile of Essure. For women who experience adverse events following an Essure procedure, the support and follow up care they receive is critical. The first step a patient should take is to talk with her physician. A dedicated consumer support line is also available at 1-877-ESSURE1  (1-877-377-8731). Women with questions about the Essure procedure can call and speak directly with a registered nurse.

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, suspect you are pregnant 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.

Tell your doctor if you are taking immunosuppressants or think you may have a nickel allergy.

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. For some women, it can take longer than three months for Essure to be effective, requiring a repeat confirmation test at 6 months. 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. In rare cases, part of an Essure insert may break off or it may puncture the fallopian tube requiring surgery to repair. If breakage occurs, your doctor may remove the piece or let it leave your body during your period. 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. You should arrange to have someone take you home after the procedure. 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 reports of chronic pelvic pain in women possibly related to Essure. An Essure insert may migrate into the lower abdomen and pelvis and may require surgery for removal. 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.

Click here for Essure Instructions for Use | Click here for Essure Patient Information Brochure

Talk to your doctor about Essure and whether it is right for you.

About Bayer HealthCare Pharmaceuticals
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 Pharmaceuticals Inc. 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.

BAYER, the Bayer Cross and Essure are registered trademarks of Bayer.              

Forward-Looking Statement
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 website 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.

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SOURCE Bayer HealthCare Pharmaceuticals