According to the U.S. Food and Drug Administration, or FDA, Essure is intended to provide women with a permanent form of birth control. Essure is implanted through the vagina and cervix and is then implanted into the fallopian tubes.

The procedure does not require a surgical incision. Essure is typically implanted in a doctor’s office and does not require anesthesia does not have its inserts release or contain any hormones.

According to the FDA, moreover, “Essure is the only currently marketed, FDA-approved non-incisional sterilization device for women who want permanent birth control in the United States.”

There are some risks involved, however, and Essure medical complications that may result in being implanted with the permanent contraceptive.

According to the FDA, some short-term risks for patients have been reported in clinical trials. The FDA maintains that immediately following the procedure, some patients experienced mild to moderate pain. Additionally, some patients, immediately following the procedure, “experienced cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort.”

According to the FDA, moreover, there are other Essure medical complications that result in long-term risks. These are reported in clinical trails and in thousands of adverse event reports submitted to the FDA.

Some Essure medical complications reported include unintended pregnancy, abdominal, pelvic or back pain, perforation of the uterus or fallopian tubes, and migration of implants to elsewhere in the abdominal or pelvic cavity.

According to the FDA, moreover, that are other Essure medical complications that have been reported to the FDA through medical device reports. These Essure medical complications include the following: headache, fatigue, weight changes, hair loss, mood changes, allergy or hypersensitivity reactions, joint or muscle pain, and muscle weakness.

The FDA says it 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 occur outside of the uterus (ectopic pregnancy), which may result in serious complications.”

According to a Washington Post article, more than 750,000 Essure devices have been sold worldwide. Bayer reports that sales continue to grow. However, “device insertion fails anywhere from 4 to 12 percent of the time, making actual usage unclear,” the article states.

Additionally, the FDA has received more than 16,000 adverse-event reports about Essure. Among the reports, are nearly 9,000 surgical removals of the medical device primarily by hysterectomy. A former FDA analyst, according to the Washington Post, says of this report that “that’s a lot of surgeries for a device that’s considered minimally invasive.”

In 2015, the FDA held a hearing on the device. The hearing later resulted in the addition of a “boxed warning” of the possible Essure medical complications that may come about.

According to the Washington Post, moreover, “Black box warnings, as they’re commonly called, are among the strongest action the FDA takes to warn the public about potential dangers of a drug or device, and they are exceedingly rare for devices…”