In 2002, the FDA approved Essure, a contraceptive device that was intended to provide women with a non-surgical method of sterilization. A small metal coil, Essure is implanted in the fallopian tube to cause scarring that prevents pregnancy. Shortly after the device came on the market, the manufacturer, Bayer Pharmaceuticals, began to receive wide reports of severe complications in patients. In response, the FDA required that a warning “Black Box” label be printed on the box of the device. Doctors were also given a checklist of known risks to discuss with patients. But from metal allergies to device migrations into the pelvis and abdomen, the Essure device continued to have devastating consequences for patients nationwide. Even now, sales of this device won’t officially stop until the end of the year. Whether you’re considering Essure or worry you might have an injury from the device, here’s what you need to know about this controversy and pursuing justice in Indiana.
Failure to Warn About Essure Risks
From 2002-2017, tens of thousands of adverse events related to Essure were reported to the FDA. Some sources like the New York Times claim over 27,000 events were reported. These included abnormal bleeding and device migration that are known to have resulted in or contributed to many deaths. At least 9,000 of these cases resulted in the surgical removal of Essure, in many cases through a partial or full hysterectomy. One patient told the Washington Post about how she had a known allergy to the metal nickel, but because her doctor never asked, she had the device implanted anyway.
Throughout the almost two decades these incidents occurred, the FDA maintained most of the time that the device was safe for “most women.” The Black Box warning on the label that indicated “some women” had experienced these adverse events wasn’t required or added until 2016, a full 14 years after Essure had started affecting lives.
Symptoms of Essure Injury or Migration
Common symptoms of an Essure migration or other Essure complication include:
- Enduring pelvic pain
- Changes to your normal menstrual cycle (how long, how heavy the bleeding)
- Increased urinary tract infection or yeast infection
- Severe bloating
- Metallic taste in mouth
- Mood swings or depression
- Twitches and spasms in muscles
- Numbness in the thighs, pelvis, and face
- Blood clots
Patients have completed their own lists of symptoms and formed online communities to support each other through these challenges and their negative outcomes.
Filing an Essure Class-Action Claim in Indiana
Cline Farrell Christie & Lee is part of the group of advocates in Indiana representing the rights of patients injured by Essure. The specific claims and evidence against Bayer vary case-by-case, and include negligence, fraud and misrepresentation. Bayer failed to monitor and test Essure, to properly analyze the risks of Essure, and did not exercise reasonable care in quality control or manufacturing. There’s also the question of whether or not the doctor who recommended or implanted Essure was properly trained or certified. For all these reasons, if you are a Hoosier woman who suffered injury by Essure, or your loved one wrongfully died due to Essure, we want to start by listening to your story and serve as your advocates. Contact us today for a free consultation.