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

Tiny coils made of stainless steel on the inside, but a nickel alloy on the outside, 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 scar tissue growth, the fallopian tubes are blocked, forming a physical barrier between sperm and eggs.

Bayer now owns Essure, which was first created and marketed by Conceptus.

Promoted as a non-surgical, permanent method of birth control that requires no anesthesia and no down time, Essure became a popular birth control option for busy women who liked the sound of the fast, easy and safe alternative that they were told “works with our body to prevent pregnancy.”

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

Tens of thousands of women who trusted the Essure contraceptive device was safe have suffered serious complications, including, but not limited to:

• Debilitating pain in the ovaries or uterus
• Headaches
• Irregular bleeding
• Nausea
• Flu-like symptoms
• Joint pain
• Muscle weakness

Incomplete Data with the FDA

Critics say 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 the Essure contraceptive device implanted were followed up at one year, and only 25% were followed up at two years.

Nickel, PET Plastic Can Cause Harm

Before launching the Essure contraceptive device, Conceptus 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 gave Essure a big advantage over a competitive product that followed the rules and kept the nickel warning on its label.

PET fibers are plasticizers used in a variety of commercial products. Plasticizers work well when used as stain or water repellants on certain materials, but PET fibers will break down when exposed to heat and over time.

As PET fibers degrade, they release a toxin called acetaldehyde, which is a byproduct in the metabolism of alcohol and the main cause of liver damage in alcoholics. Acetaldehyde also is a cancer-causing by-product of wood smoke and other heat-induced reactions.

The Essure contraceptive device’s PET fibers can break down and release antimony, a semi-metallic chemical element that is toxic when applied topically. Over time, leaching antimony can cause a variety of problems from heart issues to cell death similar to arsenic poisoning.

Both plasticizer compounds have been proven to seep into drinking water from plastic bottles exposed to temperatures above 65 degrees. These chemicals rest inside the fallopian tubes, enveloping the Essure birth control coils, where the temperature is 98-plus degrees.

FDA Adverse Events Reports

The FDA reported 5,093 adverse event reports from November 2002 through May 2015.

The agency also found 20,000 complaints made by women through Facebook and Twitter accounts, reported ABC News.

The FDA has seen a “dramatic increase” in adverse events that have been reported in the last two years.

If you have received this implanted birth control without knowing the risks, you could be eligible to participate in a class action lawsuit.