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If you have been hearing about the controversy surrounding the Essure permanent birth control device, you may be wondering what’s going on. From injuries and dangers to its efficacy at preventing pregnancy, Essure has been associated with devastating and debilitating adverse events and complications that have prompted thousands of women to seek justice. If you or a woman you love suffered a severe Essure injury, you may be eligible to file an Essure complications lawsuit.
Truth: Thousands of women have complained about serious side effects and complications after receiving the Essure device
Essure was approved for use in the United States in 2002 by the FDA. Since then, upwards of 30,000 complaints and adverse event reports have been reported, including:
- Uterine perforation
- Removal of the fallopian tubes due to severe complications
- Perforation of the fallopian tubes
- Pain and heavy bleeding
- Infant death
- Hysterectomy due to complications
- Device breakage and migration
- Depression and thoughts of suicide
- Debilitating fatigue
- Brain fog or cognitive issues
- Abnormal weight gain
Truth: Essure Has a Black Box Warning
The FDA held a panel review of Essure and sorted through more than 20,000 complaints of severe complications from Essure posted online in forums, Facebook groups, and other forms of social media. This and other investigations into the device led the FDA to issue a requirement for Essure to carry a Black Box warning on the label for organ perforation, device migration, and chronic pain.
Truth: the FDA restricted Sales of the Device
In April 2018, the FDA issued a sales restriction limiting sales to only medical practices that agreed to give patients a booklet on the risks and complications of the device, as well as an acknowledgment form that patients sign stating they understand the risks and complications they may experience if they get the device. But women who were implanted with the device and suffered serious injuries and adverse events said the warning on the label wasn’t enough. These women’s health advocates were pushing to have the device pulled from the market.
Lie: Essure will continue to be sold in the U.S.
While the company refused to acknowledge the tens of thousands of complaints against Essure, Bayer announced in July 2018 that it would pull Essure from the market and not distribute or sell the device in the United States after December 2018. While most affected women saw this as a major victory, more needs to be done.
Women or the families of women who suffered serious injuries, had to undergo unplanned surgeries, had to have their fallopian tubes or uterus removed, and those who have been left in chronic pain with debilitating fatigue may be entitled to seek justice and compensation from Bayer. Product manufacturers have a high duty to ensure their products are safe before they are sold on the market. When they fail this duty, those injured by the product may be entitled to hold the manufacturer liable for the injuries and losses they suffered due to that product.
If you suffered a severe Essure injury and you want justice, contact us now. We have been fighting for patients’ rights for decades, and we will fight for you. Contact us today to learn more.