Statement from Bayer concerning Essure - wave3.com-Louisville News, Weather & Sports

Statement from Bayer concerning Essure

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At Bayer, our mission is to create medicines and devices that help people.  We have great sympathy for anyone who is experiencing pain, regardless of the cause. We have also read the stories from women who are sharing their personal experiences with Essure. These stories, while compelling, are not representative of the hundreds of thousands of women who have relied on Essure since its FDA approval in 2002.

As the manufacturer of this product, we have a responsibility to share the facts about Essure:

  • Most of the adverse events that have been reported recently about Essure are known and have been in the Essure product label. This has been confirmed by the FDA which found that "[a]lthough there is evidence of complications, as there are with all medical devices, overall results from [a five year safety] study did not demonstrate any new safety problems or an increased incidence of problems already known. (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ucm371014.htm)
  • Essure has more than a decade of research and development in addition to a decade of real world experience.  More than 750,000 devices have been sold worldwide.  Essure has been shown to be highly efficacious (99.83% based on a 5 year study) and the safety profile has been documented through clinical trials. The American College of Obstetricians and Gynecologists (ACOG) has recognized that "hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk."
  • More than 600,000 tubal legation procedures are performed in the United States each year.  We stand by the benefit-risk profile of Essure as an important option available to women who want permanent contraception.

No form of contraception is without risk, should be considered appropriate for every woman or is considered 100 percent effective. It is important that women discuss the risks and benefits of any birth control option with their physicians.

Indication

Essure is a permanent birth control procedure that works with your body to create a natural barrier against pregnancy.

 

Important Safety Information

 

WARNING: You must continue to use another form of birth control until you have your Essure

Confirmation Test and your doctor tells you that you can rely on Essure for birth control.

  • You can rely on Essure for birth control only after your doctor has reviewed your Essure Confirmation Test results. Your doctor will confirm that the inserts are properly placed and both of your fallopian tubes are blocked. If you rely on Essure for birth control before having your Essure Confirmation Test, you are at risk of getting pregnant.
  • Talk to your doctor about which method of birth control you should use for the 3 months after the procedure. Some women can remain on their current birth control. Other women, such as those using an intrauterine device or contraceptive (IUD or IUC), will need to switch to another method.
  • It can take longer than three months for the Essure procedure to be effective. In rare cases, it has taken up to 6 months. Make sure to continue using an alternate form of birth control up until your doctor has reviewed your Essure Confirmation Test results and confirmed that you can rely on Essure for birth control.

WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control. The younger a woman is when she chooses to end her fertility, the more likely she is to regret her choice later.

During the procedure: You may experience mild to moderate pain, your doctor may be unable to place one or both Essure inserts correctly, part of an Essure insert may break off or puncture the fallopian tube requiring surgery to repair the puncture, or your body may absorb a large amount of the salt water solution. Your doctor may recommend a local anesthesia which numbs the cervix. Ask your doctor about the risks associated with this type of anesthesia.

Immediately following the procedure: You may experience mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days. Some women experience nausea and/or vomiting 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 into the lower abdomen and pelvis. It may be necessary to surgically remove the migrated device if the patient is experiencing an adverse event.  No birth control method is 100% effective. If you do become pregnant after Essure, the risks to you, the fetus, the pregnancy and childbirth are unknown. Women who have the Essure procedure are more likely to have an ectopic pregnancy if they get pregnant. Ectopic pregnancy is when the pregnancy occurs outside of the uterus. Ectopic pregnancies can be very serious or life-threatening. If you have the NovaSure® procedure, a procedure that removes the lining of the uterus to lighten or stop menstrual bleeding, after the Essure procedure, your risk of pregnancy may increase. 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.

Unknown Risks: The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old. The safety and effectiveness of reversing the Essure procedure, of in vitro fertilization (IVF) after the procedure, or to you and your fetus if you get pregnant after the procedure are not known.

Adverse Events: During the procedure, the most common problem reported was mild to moderate pain (9.3%).  Some of the women in the study reported moderate pain (12.9%) and/or cramping (29.6%) on the day of the procedure. A smaller percentage of women reported nausea/vomiting (10.8%) and vaginal bleeding (6.8%).

Essure inserts do not protect against HIV or other sexually transmitted diseases.

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