What is Essure?

Essure is a permanently implanted birth control device for women (female sterilization). Implantation of Essure does 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.

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. Women who have been using Essure successfully to prevent pregnancy can and should continue to do so. Postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency. We will continue to communicate publicly about new findings.

Essure should no longer be available for implantation. Women seeking contraception are encouraged to discuss all other availablebirth 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 information provided below describes the benefits and risks associated with Essure as included in the current labeling.

Benefits of Essure

• 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.

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:

• Headache
• 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.

Ongoing Clinical Study for Essure

The FDA continues to collect long-term safety information following the discontinuation of sales and distribution of Essure to better evaluate its safety profile when used in the real world. This includes ensuring that Bayer continues to meet its mandated postmarket study obligations for Essure beyond 2019.

• 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. As of December 31, 2019, enrollment for this study has ended. The FDA will post the interim study results once the enrollment data are analyzed and the next report is reviewed. Follow-up of patients in the study is ongoing. The FDA believes clinical data from this postmarket study will help patients, health care providers, and the agency better understand certain patient complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation. To learn more about this study, please visit the Essure 522 webpage or find information provided by Bayer at ClinicalTrials.gov (NCT number): NCT03127722.
• Bayer has two ongoing post-approval studies. Both ongoing studies are conditions of approval for premarket application supplements in support of labeling modifications. Details on the study protocols, status and interim results are posted on the Post-Approval Study Status web page.

The FDA will continue providing updates on our ongoing postmarket evaluation of Essure to patients and health care providers.