Many women are plaintiffs in a mass tort Essure side effects lawsuit filed in a California Superior Court.

The Essure permanent birth control system has been marketed as a quick and easy alternative to surgical sterilization that offers irreversible results with no down time.

Two small metal and fiber coils are inserted into the fallopian tubes, which are reached through the vagina. Over the course of three months, scar tissue grows around the coils, blocking the fallopian tubes to stop impregnation.

More than 750,000 women have been implanted with Essure, and thousands say they have suffered Essure side effects that have adversely affected their lives.

Essure Side Effects Lawsuit Addresses Alleged Cover-up of Adverse Events

A company called Conceptus sought and gained FDA approval for the Essure medical device. Conceptus was bought by Bayer in 2013.

The FDA approved Essure in 2002 based on studies of only 745 clinical trial patients for a maximum of 24 months. Longer-term responses to the inserts and the ability of the devices to stay in place were not known.

“The FDA advised Conceptus of these facts and emphasized their special significance with respect to the risk of ectopic pregnancies, putting Conceptus on clear notice that the company’s duty to vigilantly monitor and report the real world clinical experience with the device was paramount,” according to this Essure lawsuit.

Conceptus allegedly “falsified the records of patients who participated in clinical trials.” For instance, when one Essure patient reported unusual pain, the Conceptus representative allegedly recorded no pain.

Conceptus allegedly failed to meet its post-approval obligations under federal law ─ including duties to report adverse events to the FDA, monitor the product after pre-market approval and report to the FDA any adverse health consequences or complaints, and to truthfully advertise Essure.

According to the Essure side effects lawsuit, “The FDA inspector specifically advised Defendants that any instances of the device migrating to, perforating, or penetrating areas in the body outside of the fallopian tubes constituted a malfunction and should be reported. In response, the Quality Manager at Conceptus told the inspector that they did not consider an Essure device falling out of the fallopian tube because of a perforation to be a device malfunction.”

Essure Problems Blamed on Materials, Design Flaws

Women implanted with Essure have reported fatigue, rashes, headaches, heavy periods, cramping, ectopic pregnancies, painful intercourse and debilitating joint pain. Other women have experienced device migration or perforation of the fallopian tubes, causing excruciating pain and necessitating surgical removal of the devices. Some women have needed to undergo a hysterectomy to rid themselves of the device’s side effects.

According to the Essure side effects lawsuit, the failures that Conceptus allegedly knew could occur with the birth control device include:

• The stainless steel used in Essure is passivated, which means it is chemically treated to make it less reactive. The material used in Essure can become unpassivated, which leads to rusting and degrading

• Essure permanent birth control coils contain nickel. The Centers for Disease Control and Prevention estimates that between 10 and 20% of the population is allergic to nickel.

• The metals in Essure permanent birth control can degrade due to high nickel ion release, which increases the risk of metal poisoning in patients.

• The plastic used in the surfacing of the coils is made of PET plastic, which is known to degrade and leach toxins when it reaches a temperature of 85 degrees. When it releases these toxins into the human body, the plastic can cause chronic inflammation and possible autoimmune responses.

If you or someone you love has suffered injury from an Essure device, you may be eligible to file an Essure lawsuit of your own.

This Essure Side Effects Lawsuit is Case No. 3:17-cv-01987-SBA in the Superior Court of the State of California, County of Alameda.