Risks and Benefits of Essure to be Weighed by FDA Panel

The permanent female sterilization device Essure will be on the agenda at the September 24 U.S. Food and Drug Administration’s hearing of the OB/Gyn Device Panel.

The committee plans to discuss the risks and benefits of the Essure System, manufactured by Bayer HealthCare. The Essure system, known as permanent birth control without surgery, was originally approved by the FDA in 2002, and consists of a delivery system and nickel-containing permanent implants. Two metal coils are inserted through the vagina, and implanted within each fallopian tube, where they stimulate the formation of scar tissue resulting in a tubal occlusion and sterilization of the woman.

Essure was approved through the FDA’s Pre-Market Approval (PMA) process, which tests the device for safety and effectiveness prior to FDA approval for marketing. Because the device has undergone scientific and regulatory review, federal law protects the manufacturer against liability.

Essure Side Effects

Many women have become frustrated by the lack of information they were given about the side effects they believe they experienced from the implant of Essure.  Bayer markets Essure as an effective, affordable and convenient means of birth control, but since obtaining approval, harmful side effects associated with the use of Essure exist, including:

• Severe joint pain
• Recurrent, debilitating headaches
• Weight gain
• Chronic fatigue
• Hair loss
• Heavy, painful, and irregular menstrual bleeding
• Premature births in women who became pregnant while implanted with Essure
• Power Morcellation used to remove the Essure device has resulted in fragments of nickel spread throughout the abdominal and pelvic cavity
• Death

These same women have found further frustration when they find that Bayer, the manufacturer of the Essure device, is federally protected from lawsuits. These patients and patient advocates continue their mission to have Essure pulled of the market and have the federal preemption laws changed.

Women or other interested persons may present data, information, or views, orally or in writing on their experiences with the Essure Device. These submission must be made prior to September 4, 2015 in order to be included in the September 24^th FDA Meeting. More information about how to submit information can be found on the FDA website.

We will continue to monitor the results of the FDA meeting on September 24^th.