Reports of Essure medical complications have led to thousands of legal claims against Bayer.

Essure was intended and functions to provide women with a permanent form of birth control. The Essure medical device is made up of two flexible coils made of metal and polyester. Each of these coils is implanted in a woman’s fallopian tubes.

Over the next few months, tissue begins to develop around the metal coils, thereby blocking conception. Essure patients must be evaluated by their doctor about three months after implantation to confirm that the implants are preventing conception.

The implantation of Essure is performed at a doctor’s office and does not require any anesthesia. The medical device does not contain or release any hormones.

According to the U.S. Food and Drug Administration, “Essure is the only currently marketred, FDA-approved non-incisional sterilization device for women who want permanent birth control in the United States.”

Reports of Essure Medical Complications

However, Essure has been blamed for many reported Essure medical complications.

According to adverse event reports submitted to the FDA, immediately after a woman becomes implanted with the device, she can experience anything from mild to moderate pain. The FDA says that some reported Essure medical complications include “cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort.”

There are also additional long-term Essure medical complications that have also said to result from a woman becoming implanted with the Essure medical device. According to the FDA, some of these long-term Essure medical complications include the following: unintended pregnancy, pain in the abdomen, pelvis or back, and perforation of the uterus or fallopian tubes. Some Essure implants have migrated out of place and were found elsewhere in the abdominal or pelvic cavity.

Additional Essure medical complications reported following the insertion of the permanent birth control device include headache, fatigue, weight changes, hair loss, mood changes, allergy or hypersensitivity reactions, joint or muscle pain, and muscle weakness.

Essure, as a permanent non-hormonal birth control was approved by the FDA in 2002. However, Essure was approved through a faster approval process because it provided an alternative to surgical sterilization and provided women a faster recovery time after its implantation.

But since that approval, thousands of women who have been implanted with the device and have suffered from Essure medical complications alleged that the device was approved for market sale prematurely, before it had been adequately evaluated for safety and efficacy.

Hundreds of thousands of women have been implanted with the Essure medical device. More than 4,500 adverse event reports have been filed with the FDA alleging Essure medical complications that have resulted. Since then, Bayer has faced a wave of litigation from Essure patients who say they were never given fair warning about the potential complications that could result from their use of Essure.