WHIPPANY, N.J., May 8, 215 /PRNewswire/ -- In response to a May 4, 215 story in The New York Times about Essure® permanent birth control, Bayer submitted the following letter to the editor, which The New York Times refused to publish in its entirety:
To the Editor:
Re: "Long-Term Data on Complications Adds to Criticism of Contraceptive Implant" (May 4, 215), Roni Rabin mischaracterizes a recently published long term study on Essure. This well-designed, well-executed study reinforces the safety and efficacy of the device and the procedure. The side effects reported are consistent with numerous other scientific studies and the Instructions for Use on Essure – which the FDA approved in 22 and then reevaluated in 213.
Women deserve access to a wide range of contraceptive options, and Essure is an important non-surgical and non-hormonal option for women who have completed their families and want permanent birth control. However, no medical device, procedure, or even drug is completely free of side effects.
That's why the importance of the conversation between patients and their doctors cannot be overstated. Health professionals must appropriately counsel their patients about Essure, and women who experience any issues should immediately contact their OBGYN.
Moreover, while social media is a valuable tool for patient support, it should never be used as a substitute for medical advice from an experienced, board certified physician. Bayer has reached out to many women on social media who have said they've experienced problems with Essure, and we encourage any woman who has concerns to contact us at uswomenshealth@bayer.com or 1-888-84BAYER so we can help her get the support she needs.
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 (1.8%) 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 1% 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 letter to editor of The New York Times regarding recent story about Essure® permanent birth control