The Essure FDA warning issued in September 2016 was a step in the right direction, but does not go far enough to prevent complications related to the device, critics claim. Many women continue to be implanted with the device, and many negative side effects continue to be reported.

What is Essure?

Essure is a permanent sterilization device that can be implanted in a woman who wishes to avoid traditional tubal ligation surgery. The procedure to implant Essure is done in a physician’s office and does not require the healing time that a surgery does.

The physician inserts a small metal coil device into each fallopian tube by inserting a placement device through the vagina. Once the coils are in place, the body mounts an inflammatory response to the foreign material.

Scar tissue then forms around the coils and blocks the fallopian tubes, preventing sperm from reaching the eggs, therefore preventing pregnancy.

While this device has been safe and effective for many women, there are also tens of thousands of women who have reported complications from the device.

Details of the Essure FDA Warning

The Essure FDA warning came after the FDA had convened its Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to review data surrounding the safety of the device following many adverse event reports filed over the device.

The panel also discussed the device’s effectiveness in preventing pregnancy and heard from women who had the device implanted and suffered complications.

The agency decided it would issue an Essure FDA warning after learning that, among other problems, 4 patients had died as a result of the device, 15 pregnancies were lost and 631 unintended pregnancies occurred while women were implanted with the permanent birth control device.

The FDA required the manufacturer of Essure, Bayer, to implement a post-market surveillance study so that more safety and efficacy-related information could be obtained about the device. Periodic updates will be released as the study progresses.

In issuing its Essure FDA warning, the agency also issued a document providing official guidance to the medical community and issued a patient decision checklist that physicians can use to go over the risks and benefits of Essure with interested patients.

The issued FDA warning also includes black box labeling for the product. Pharmaceuticals and medical devices that carry a black box warning have the most strict warning available for the most potentially dangerous products and devices.

Critics of the FDA’s actions believe that the agency did not do enough to ensure the safety of women who have been implanted with Essure and those who are considering implantation.

They state that the patient decision checklist is not required for the physician to review, the study is taking a very long time and will not be able to help women in the interim, and a black box warning is not sufficient based on the severe complications that can result from the use of the device.

Many advocates calling for stricter actions hope that the device is eventually recalled, but feel a bit of hope that the Essure FDA warning is potentially a step in the right direction.