Baron & Budd can help you explore your potential legal options if you have suffered harm after using the device. Please call 866-750-3386 or complete our contact form to learn more and see if you qualify to file a lawsuit for Essure complications.
How the Essure Device Works
The Essure device is inserted into a patient’s fallopian tubes by a doctor. Over about a three-month period, scar tissue begins to form around the device, blocking sperm from being able to fertilize a woman’s eggs. After three months, the doctor performs a follow-up examination to confirm that the woman is no longer able to become pregnant. This test involves the injection of a dye into the uterus and then an x-ray to confirm the devices are in place and the fallopian tubes are blocked.
What’s the Problem?
Recent news articles have highlighted severe complications that have been linked to Essure. For example, a National Public Radio website article from July 2015 reported the story of a woman who experienced several different symptoms after her Essure device was inserted in 2010. These included fatigue, abdominal pain, migraine headaches and hair loss, among others.
An October 2015 article in The New York Timescovered the suffering experienced by a woman who was still having problems six years after using Essure in 2008. Not only did she go through painful menstruation, intercourse also led to extreme discomfort. She ultimately had a hysterectomy last year. After the procedure, her doctor told her that the Essure device had migrated into her uterus and become surrounded by scar tissue.
What Can You Do About It?
Essure was granted “premarket approval” by the FDA in 2002, which, in theory, is supposed to protect Bayer from any lawsuits involving health complications associated with the device. However, just because a company’s product is granted premarket approval, that does not automatically mean it will be shielded from legal action.
The pharmaceutical giant has been accused of improper behavior associated with the manufacture of Essure. For example, it has been alleged that Bayer manufactured the device at an unlicensed facility, used non-conforming materials when manufacturing the Essure, and also tried to conceal negative reports regarding Essure from the FDA. If these allegations are proven true, that could render Essure’s premarket approval invalid.