Essure is a permanent form of birth control that is non-surgically implanted into the cervix. The device was developed by a subsidiary of Bayer AG, Conceptus Inc., and was approved by the FDA for use in the United States in 2002. Due its lack of hospital stays, no need for anesthesia, and economic benefits, Essure soon became a leading choice of sterilization for many women.
It works by doctors placing small and flexible inserts into the fallopian tubes which induce inflammation, causing a benign ingrowth. Once in place, the growth continues over three months, which results in a blockage in the fallopian tubes to prevent the sperm from reaching the egg. After the initial three months have passed, a procedure called a hysterosalpingogram is performed to confirm the tubes are completely blocked and that Essure is functioning as intended.
In 2013, Essure made headlines in the United States when women complained of severe side effects which led to the medical device having to be surgically removed. The complaints were so numerous that two years later the FDA admitted to an investigation into the medical device and reported over 5,000 complaints from women who had the device implanted. This included seven reported deaths allegedly due to the device with many additional side effects, including failure of the device, improper placement, and improper insertion.
The dangers are so great that a website has been set up for women to register their issues after the medical device was implanted as well as share their complications. They include:
The FDA has ordered Bayer to conduct post marketing studies of the safety and efficacy of the device, however, the results of the study will not be available for some time.
Although no recall has been issued, the FDA has issued a black box warning for the device which is the most severe warning a device can receive before being taken off the market. Lawsuits have already begun in several states alleging that Bayer did not properly warn the public of the dangers associated with Essure and knew their medical device was more dangerous than they let on. Initially, Bayer was successful in getting Essure lawsuits dismissed, but after several rulings, this defense is no longer working for the company. Essure lawsuits around the country are shaping up and in some states like California, the lawsuits are being coordinated in an effort obtain a speedy resolution.
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.