Essure Benefits and Risks
On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. Health care providers could implant Essure up to one year from the date the device was purchased. As of December 31, 2019, all unused Essure units should have been returned to Bayer and are no longer available for implantation. Women who have been using Essure successfully to prevent pregnancy can and should continue to do so. The FDA remains committed to collecting long-term safety information in women who have received the device.
Women seeking contraception are encouraged to discuss all other available 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.
What is Essure?
Essure is a permanently implanted birth control device for women (female sterilization). Implantation of Essure did not require a surgical incision. In the procedure, a health care provider would place 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.
The information provided below describes the benefits and risks associated with Essure as included in the most recent labeling.
Benefits of Essure
- Intended to provide women with permanent birth control.
- Inserted through the vagina and cervix into the fallopian tubes.
- The procedure did not require a surgical incision.
- Essure inserts do not contain or release hormones.
- Insertion was typically performed in a doctor's office and did not require general anesthesia.
Risks of Essure
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 with 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.
Pregnancy Risks Related to Essure
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 show that after 5 years from the date a woman has Essure placed successfully, she has less than a 1 percent (1%) 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.