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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 are encouraged to discuss all available sterilization and birth control options and carefully consider the benefits and risks of each, with their health care provider before deciding on the method that is right for them.
The FDA remains committed to learning more about Essure's risks and communicating publicly about significant findings even after the device is no longer on the market. Benefits and risks associated with Essure are described below.
- Essure is intended to provide women with permanent birth control. Essure is inserted through the vagina and cervix into the fallopian tubes. The procedure does not require a surgical incision.
- Essure inserts do not contain or release hormones.
- Essure insertion is typically performed in a doctor's office and does not require general anesthesia.
Short-term risks to women with Essure as reported in clinical trials include:
- Mild to moderate pain during and immediately following the Essure placement procedure.
- Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort immediately after the procedure.
Longer-term risks to women with Essure as reported in clinical trials include:
- Abdominal, pelvic, or back pain
- Tear or hole (perforation) of the uterus or fallopian tubes
- Unintended pregnancy
- Allergy or hypersensitivity reactions
- Essure inserts unexpectedly moved to the abdominal or pelvic cavity
- If a patient and health care provider decide to remove Essure, another surgery may be required.
Other reactions included in medical device reports submitted to the FDA include:
- Feeling tired (fatigue)
- Weight changes
- Hair loss
- Mood changes, including depression
It is important for women considering Essure to know that based on clinical studies, approximately 8 percent of women who undergo attempts at Essure placement are not able to rely on the device for birth control.
While scientific evidence shows that Essure is an effective means of permanent contraception when health care providers and patients follow the appropriate instructions for use, no form of birth control is 100 percent effective. Data shows that after 5 years from the date a woman has Essure placed successfully, she has less than a 1 percent chance of getting pregnant.
All pregnancies carry some risk to women and their fetus. The risks to women and their fetus if pregnancy occurs after Essure placement are unknown. While successful pregnancies with healthy deliveries have been reported with Essure devices in place, neonatal or pregnancy complications have also been reported. Also, the FDA has received reports of pregnancy losses in women who became pregnant following Essure placement. If a woman becomes pregnant with Essure, there may be a risk for the pregnancy to occur outside of the uterus (ectopic pregnancy), which may result in serious complications.