On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. Health care providers can implant Essure for up to one year from the date the device was purchased.
Women who have been using Essure successfully to prevent pregnancy can continue to do so. Those with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take.
On this page:
- What is Essure?
- What are the Benefits and Risks of Essure?
- Required Patient-Doctor Discussion Checklist for Essure
- Can Essure be Removed?
- Report Problems with Essure to the FDA
- Ongoing Clinical Study for Essure
Essure is a permanently implanted birth control device for women (female sterilization). Essure is made by Bayer and was approved by the FDA in 2002. Implantation of Essure does not require a surgical incision. In the procedure, a health care provider places flexible inserts through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs and prevents conception.
You are encouraged to discuss all available sterilization and birth control options and carefully consider the benefits and risks of each, with your health care provider before deciding on the method that is right for you. Read a comparison of Essure and other forms of birth control in Bayer's product labeling.
Essure is not appropriate for all women of child-bearing age, but it may be appropriate for those women who:
- do not want any more children
- want a permanent form of birth control
- seek a sterilization procedure that does not require an incision or general anesthesia. Some doctors may use a local (numbing) anesthetic to reduce potential discomfort during the procedure.
- want a permanent birth control method that does not involve hormones
Women considering Essure should be aware that the device is not immediately effective in preventing pregnancy. Also, about 8 percent of (or 8 out of 100) women who get Essure are not able to rely on the device for birth control.
If you are considering Essure as a permanent birth control method, you must use another form of birth control to prevent pregnancy until you have a confirmation test given by your health care provider. At three months after Essure placement, it is important you see your doctor for a pelvic imaging confirmation test to verify that Essure is placed correctly to prevent pregnancy.
The FDA continues to monitor the safety of Essure to ensure that its benefits continue to outweigh its risks. Learn more about the benefits and risks of Essure.
In 2016, the FDA approved important labeling changes for Essure to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. This included a boxed warning and a patient decision checklist to help ensure that women are informed about the device's benefits and risks. In April 2018, the FDA required that Essure only be sold to health care providers who share with patients and sign Bayer's Patient-Doctor Discussion Checklist in the Patient Information booklet. The FDA approved this safety measure to ensure that the device meets our standards for a reasonable assurance of safety and effectiveness.
Essure is a permanent form of birth control and is not intended to be removed. If Essure needs to be removed, a surgical procedure may require use of general anesthesia. Device removal has its own risks. You should discuss the benefits and risks of any operation or procedure with your health care provider before deciding on the best option for you. Learn more about the FDA's latest review of reports about device removal.
If you have been using Essure successfully to prevent pregnancy you can continue to do so. If you suspect that you may have problems related to Essure, such as persistent pain, you should consult with your doctor right away.
Patients and health care professionals are encouraged to submit a voluntary report about any problems experienced with Essure through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
In February 2016, the FDA ordered Bayer, the company that makes Essure, to conduct a postmarket surveillance ("522") study to gather more data about Essure's benefits and risks. To learn more about this study, you or your health care provider may visit the Essure 522 webpage or find information provided by Bayer at ClinicalTrials.gov (NCT number): NCT03127722.