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Women across the country have some celebrating to do. The Essure birth control device made by Bayer will be removed from U.S. shelves at the end of the year. The pharma giant’s decision to pull the controversial device comes after more than 16,000 Essure birth control lawsuit were filed alleging the company failed to warn the medical community and patients about the risks and dangers of the device.
What is Essure
Initially touted as a safe and effective alternative to female sterilization Essure is a non-hormonal, non-surgical permanent contraceptive device approved by the FDA for use in the United States in 2002. Since that time, tens of thousands of complaints have been voiced and thousands of lawsuits filed on behalf of women who suffered serious injuries from the device.
Women have reported side effects, adverse events, and serious complications including:
- Uterine perforation
- Hysterectomy due to complications
- Perforation of the fallopian tubes
- Removal of the fallopian tubes due to severe complications
- Device breakage and migration
- Debilitating fatigue
- Pain and heavy bleeding
- Abnormal weight gain
- Brain fog or cognitive issues
- Depression and thoughts of suicide
- Infant death
Women chose Essure in part because it does not require surgery. But studies have shown that women who are implanted with Essure are TEN TIMES more likely to undergo operations than those who undergo surgical sterilization.
Essure is comprised of two nickel alloy coils that are inserted through the cervix into the fallopian tubes where an inflammatory response will cause enough scar tissue to form to block sperm effectively. The procedure to place Essure can be done in your doctor’s office without the need for general anesthesia.
Essure Sales Restriction
But so many complaints were filed about the device that the FDA issued a sales restriction in April 2018. This restriction requires medical practices that offer the device to provide patients with a booklet that details the side effects and potential complications that have been associated with the device. Then physicians must review a three-page consent form with their patients and have them sign that they understand the potential risks and complications of the device.
Essure Will Not Be Sold in the US After 2018
But Essure victims did not give up and continued to demand that the Food and Drug Administration remove the device from the market. After all, Bayer stopped sales and distribution of Essure in Canada, England, Brazil, and France. In fact, the United States is the only place where the device is still sold.
Bayer announced it would stop selling the Essure birth control device in the U.S. at the end of 2018. However, the company denied it made the decision to pull the device because of injuries, saying instead it was a business decision based on declining sales. But women who suffered injury and the families that love them will continue fighting to hold Bayer responsible for the thousands of injuries that have been reported.
Any woman who suffered injury after receiving the Essure birth control device may be entitled to seek compensation for those injuries. Speak to a highly-qualified medical device injury attorney to learn more.