Medical devices and procedures may have certain benefits and risks. 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.
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.
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, dizziness, pelvic or back discomfort.
Long-term risks to patients reported in clinical trials include:
- Unintended pregnancy
- Pelvic pain
- Perforation of the uterus or fallopian tubes
- Migration of Essure inserts through the fallopian tubes or uterus into the lower abdomen and pelvis
Other reactions following Essure placement not reported in clinical trials but included in medical device reports submitted to the FDA include:
- Allergy or hypersensitivity reactions
- Joint or muscle pain
- Muscle weakness
- Excessive fatigue
- Hair loss
- Weight changes
- Mood changes
- Persistent fever
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 is less than 1 percent.
The risks to women and their fetus if pregnancy occurs after Essure placement are unknown. However, the FDA has received reports of pregnancy losses in women who became pregnant following Essure placement. Women who have had the Essure placement procedure are more likely to have a pregnancy outside the uterus (ectopic pregnancy) than women who have not had the Essure placement procedure. At present, clinical studies and individual cases of Essure sterilization failure reported in the scientific literature have not demonstrated an increased risk of neonatal or pregnancy complications when pregnancy is in the uterus following Essure placement. The FDA will continue to monitor the safety of Essure to make certain that its benefits of providing women with this sterilization procedure continue to outweigh its risks.
For additional information on the benefits and risks of Essure, refer to the current product labeling. The FDA intends to require that a boxed warning and patient decision checklist be included in Essure labeling to describe the risks associated with the device to facilitate informed decision-making. FDA believes that a boxed warning and patient checklist will help to better communicate the risks associated with permanent hysteroscopically-placed tubal implants to patient and physicians.