WHIPPANY, N.J., May 1, 2015 /PRNewswire/ -- Bayer HealthCare announced today that a study published online this week in The Journal of Minimally Invasive Gynecology reinforces findings from previous clinical studies that support the effectiveness and safety of the Essure® inserts and procedure for hysteroscopic sterilization, or permanent birth control. The prospective five-year follow-up study followed the initial cohort of women in the Phase III clinical trial that led to the approval of Essure® by the U.S. Food and Drug Administration in 2002.
The study enrolled previously fertile women 21 to 40 years of age who were seeking permanent contraception, were engaged in a monogamous relationship, and were willing to use a temporary contraceptive method for the first three months following Essure insert placement. Among the 364 women relying on Essure inserts who completed the full five years of follow-up, no pregnancies were reported. In addition, the Essure inserts were generally well tolerated.
'Female sterilization is the second most common form of contraception in the United States and Essure, as the only available hysteroscopic approach, does not require incisions and represents an important contraceptive option for women who have completed their families,' said John E. Nichols, Jr., MD, FACOG, Medical/Laboratory Director, Piedmont Reproductive Endocrinology Group, Greenville, SC, and study investigator. 'The results of this study, which are consistent with other published literature on Essure, document the extended five-year effectiveness, safety, and tolerability of Essure inserts.'
The Phase III study was designed to include five years of follow-up, one year of which was to be completed prior to a pre-marketing approval filing. The remaining four years of follow-up was completed as part of a post-approval study. For the full five years of follow-up (five years in total of relying on the Essure inserts for contraception) the end points of interest were safety and satisfaction, reliance on Essure for contraception and prevention of pregnancy. The five-year study evaluating long-term effectiveness was required by the FDA as part of the evaluation and approval of the Essure inserts.
The following severe events were reported as being possibly related to the Essure inserts or procedure: one woman with irregular menstrual bleeding, another woman with lower abdominal pain and very heavy periods, and a third woman with continuous bleeding. The latter two resulted in hysterectomy.
Throughout the five-year study, pelvic pain was reported in no more than 7% of study participants at any visit. Women with pre-existing chronic pain were excluded from participation and no study participants reported persistent pelvic pain of any kind at the 3-, 4-, and 5-year follow-up visits.
'Essure is supported by more than a decade of science and real world clinical experience,' said Edio Zampaglione, MD, Vice President, U.S. Medical Affairs, Women's Healthcare and Neurology. 'Bayer is strongly committed to providing access to a wide range of safe and effective contraceptive options for women, and we look forward to continued research on Essure.'
Essure is a safe and effective permanent birth control option for women when health care providers and patients follow the Instructions for Use. Most of the side effects that have been reported about Essure are known and included in the Instructions for Use.
Bayer takes all adverse events 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 health professional. Patient support is also available from Bayer by dialing 1-888-84BAYER or by email at firstname.lastname@example.org.
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.
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