Essure birth control is a permanent, non-surgical sterilization procedure for women that was approved by the FDA in 2002.

Coils made of stainless steel are on the inside, and a nickel alloy are on the outside, which are covered in small fibers to produce a fibrotic reaction when inserted into the fallopian tubes.

After three months of the body reacting by producing tissue growth, the fallopian tubes are blocked, forming a barrier between sperm and eggs.

However, not only have thousands of women reported serious injuries from Essure, but also there is compelling evidence that the FDA and manufacturer Bayer may have hidden potential Essure complications from the public and the medical community.

A letter written as a plea to open an investigation and possible congressional hearing regarding FDA oversight of Essure birth control reads almost like a novel, telling of deception, greed and the fox guarding the hen house.

Essure Problems, an advocacy group of women who experienced side effects of Essure, teamed up with a legal expert to write this letter to Congressman Jason Chaffetz. The following summarizes the content of the letter that can be viewed in its entirety on Legal Reader.

Tens of thousands of women who trusted that Essure was safe have claim they have suffered serious Essure complications, including, but not limited to:

• Debilitating pain in the ovaries or uterus
• Headaches
• Irregular bleeding
• Allergic reaction
• Nausea
• Flu-like symptoms
• Joint pain
• Muscle weakness
• Miscarriages
• Ectopic pregnancies

How Did Essure Pass FDA Testing?

According to women injured by the device, Essure clinical trials were flawed because they followed too few women for too short a time. When the FDA concluded that Essure was 97% successful after one year, that claim was based on incomplete data.

Although 926 women enrolled in the study, 181 chose not to have Essure done. Only 85% of the women who actually had Essure were followed up at one year, and only 25% were followed up at two years.

Despite the allegedly flawed clinical trials, Essure bith control received “fast track approval” from the FDA.

What is even more interesting is that during the time Essure birth control was being tested, a senior vice president from Essure’s parent company was on the FDA advisory committee that oversaw Essure’s clinical studies.

Cindy Domecus served as Senior Vice-President of Clinical Research/Regulatory Affairs at Conceptus from May 1944 to December 2003, owned company stock and was heavily involved in the development of Essure. She also was a member of the Obstetrics and Gynecology Device Panel of the Medical Device Advisory Committee from March 1995 to January 2001.

The FDA committee, made up of several former colleagues of Cindy, granted Essure “fast track approval” and gave it “expedited review status.”

According NASDAQ documents, Essure’s parent company, Conceptus, was struggling financially at the time and admitted in papers filed with the SEC in June 2002 that:

“Essure is our only product and we are wholly dependent on it. Essure may be unsuccessful, which would harm our business and force us to curtail or cease operations. We will need FDA approval before commercializing Essure in the U.S and clinical trials of Essure for that purpose are still ongoing.”

Critics claim the FDA and Conceptus released Essure to the public knowing it was not adequately tested, and the political and financial twists behind its accelerated release are more twisted than the Essure coils themselves.

Essure Allegedly Omitted Nickel Allergy Warning

Conceptus allegedly talked the FDA into leaving out a label that would have warned people with hypersensitivity to nickel to undergo a skin test to assess hypersensitivity prior to proceeding with Essure implantation.

This apparently gave Essure a big advantage over a competitive product that followed the rules and kept the nickel warning on its label.

FDA Records, Response Lack Integrity, Group Claims

Despite knowing of tens of thousands of complaints since as early as 2010, the FDA has done nothing in response, according to the advocacy group. Its own database was found to be in great error, reporting only five fetal deaths when the actual number was 303, they claim.

The FDA ordered Bayer, which bought Conceptus in 2013, to conduct new clinical trials on Essure .The advocates felt that asking– it asked the manufacturer to test its own product was a definite conflict of interest. They fear more women will be placed at risk for this allegedly dangerous device if this demand issued in February 2016 comes to fruition.

In summary, the advocates stated that the public trusts the FDA to be a watchdog on their behalf and not to be in the wallets of pharmaceutical companies. They felt this trust was betrayed in the fast-tracking of Essure birth control.

If you or someone you know has received Essure birth control, you could be eligible to participate in a class action lawsuit for compensation for a wide range of debilitating side effects of Essure that were not disclosed to you that you are now experiencing.