Medical Devices

Essure Benefits and Risks

Medical devices and procedures may have certain benefits and risks. Benefits and risks associated with Essure are described below.

Benefits

  • 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.

Essure is the only currently marketed, FDA-approved non-incisional sterilization device for women who want permanent birth control in the United States. To read a comparison of Essure and other forms of birth control, you may refer to the product labeling.

Risks

Short-term risks to patients reported in clinical trials include:

  • During the Essure placement procedure and immediately following, some patients may experience mild to moderate pain.
  • Immediately following the procedure, some patients may also experience cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort.

Long-term risks to patients reported in clinical trials include:

  • Unintended pregnancy
  • Abdominal, pelvic or back pain
  • Perforation of the uterus or fallopian tubes
  • Inserts found in the abdominal or pelvic cavity

Other reactions included in medical device reports submitted to the FDA include:

  • Headache
  • Fatigue
  • Weight changes
  • Hair loss
  • Mood changes, including depression
  • Allergy or hypersensitivity reactions
  • Joint or muscle pain
  • Muscle weakness

While scientific evidence shows that Essure is an effective means of sterilization when health care providers and patients follow the appropriate instructions for use, no form of birth control is 100 percent effective. Based on currently available data, the chance of unintended pregnancy for women who have Essure successfully placed and demonstrated tubal occlusion on a post-implant study is less than 1 percent at 5 years.

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. The FDA will continue to monitor the safety of this device to ensure that its benefits of continue to outweigh its risks.

For additional information on the benefits and risks of Essure, refer to the current product labeling.

Page Last Updated: 11/18/2016
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