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Thousands of women believed that the Essure birth control device was a safe and effective alternative to having surgical sterilization. So, when complaints were starting to be filed, nobody really understood how serious the situation would get. Now, 16 years after the device was approved for use, Bayer is facing thousands of lawsuits demanding justice. If you were injured after being implanted with the device, you might be entitled to seek compensation through an Essure side effects lawsuit.
Thousands of Women Suffer Injury
Nearly 30,000 adverse event reports were received by the FDA between 2002, when the device was first approved for sale, and 2017. According to the New York Times, reports ranged from hair and tooth loss to chronic pain, miscarriages, severe bleeding and even death. Yet, Bayer maintained that the benefits of the device outweighed the risks.
But some women who received the device only to undergo surgical procedures to remove it, or to repair or remove body parts that had been damaged by the device, say the risks far outweigh any benefits. Especially when research shows that women who are implanted with the device instead of undergoing surgical sterilization are 10 times more likely to have to undergo unplanned surgeries because of the side effects and complications of the device.
In 2016, the FDA issued a Black Box Warning for Essure on the product label to warn of the risks of the device including that the coils could puncture through the fallopian tubes, puncture through the uterus, and travel or migrate to elsewhere in the body, including the pelvic cavity and abdomen.
Warnings and Restrictions Are Not Enough
But still, women who were harmed by the device continued to push for Essure to be withdrawn from the market. Instead, the FDA issued a sales restriction that limited sales of the device to only medical facilities that agreed to share an information booklet with patients and get a signature from patients saying they understood the risks and warnings of the device.
But this was not good enough for the tens of thousands of women who turned to the internet to voice their pain, dissatisfaction and concern over Essure side effects and complications. These women did what Bayer and the FDA refused to do. They put the health and welfare of all women first, and they kept pushing for market withdrawal saying the device posed serious health hazards to women who received it.
Victory for Women
Bayer announced in July 2018 that it would stop selling and distributing the Essure permanent birth control device in the United States, the only country was still selling the device. By this time, more than 16,000 lawsuits had been filed against the pharmaceutical giant seeking justice for Essure injuries and compensation for their losses. Cases have been filed in state courts across the country, and many have been moved to federal courts. Now, Bayer will have to stand in front of a judge and jury and explain why they failed to warn women of the risks and dangers of the device, why they kept the device on the market in the U.S. while pulling it from other countries, and why sales and profits were more important than the lives and the health of women seeking a birth control solution.
If you or a woman you love has suffered serious injury from the Essure device, contact us today. We have been fighting for the rights of those harmed by medical devices for decades, and we will fight for you.