The U.S. Food and Drug Administration describes Essure as a medical device that is intended to provide women permanent birth control.

Essure is inserted and permanently placed into a women’s fallopian tubes, through the vagina and cervix, by a medical practitioner. This insertion works by creating a barrier that keeps sperm from reaching an egg and does not require a surgical incision.

Some benefits described is that the insertion does not release or contain any hormones and does not require general anesthesia. However, although there are some benefits to using the permanent contraceptive, there are several adverse health effects and Essure birth control complications.

Essure Birth Control Complications

Some short-term risks, described by the FDA, is that immediately after Essure insertion some patients experience some mild to moderate pain. In addition, the FDA asserts that some patients may also experience “cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort.”

There are other Essure birth control complications which includes long-term adverse effects and risks as reported in patient clinical trials. Some of these risks include perforation of the uterus or fallopian tubes, inserts found in the pelvic or abdominal cavity, abdominal or back pain and unintended pregnancy.

There are also other Essure birth control complications that have been reported to the FDA in medical device reports. These complications include weight changes, hair loss, fatigue, headache, mood changes like depression, muscle or joint pain, hypersensitivity reactions or allergies, and muscle weakness.

The U.S. Food and Drug Administration further reports that although risks to the fetus and pregnant women are unknown following pregnancy even with an Essure insertion, “neonatal or pregnancy complications have also been reported.”

The FDA reports that it had “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.”

In 2015, the FDA issued a black box warning, its most serious warning, due to serious adverse effects and Essure birth control complications occurring and being reported. Purportedly, after receiving thousands of serious adverse effects event statements and accounts, the FDA called a panel hearing in September 2015.

The agency accounted additional studies, and during the meeting it instructed the medical device’s manufacturer, Bayer, to conduct investigation studies about Essure’s advantages and health risks.

Although the agency did not ban the medical device, it had proposed additional advisories. Some of these stated that more training was required of physicians, women with hypersensitivity to nickel should not use Essure, and women with autoimmune disorders should not use Essure, as they are at more risk for Essure birth control complications.

Essure describes some additional warnings for women and conditions that would prevent Essure from being the right birth control contraception for them.

According to their website, they state that some conditions would be women who have one or both fallopian tubes closed or obstructed, women who have had their “tubes tied,” those that have suspected or known cancer of the female reproductive organs, women suspected of being pregnant, and those that have unexplained vaginal bleeding.