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Essure Birth Control Defective Product Lawsuit Filed
Santa Clara, CA: Bayer is facing a defective products lawsuit alleging its Essure birth control coil causes painful and serious complications requiring surgery to remove the product.
Filed by April Norman of Connecticut, the lawsuit asserts that Norman suffered severe complications including painful bleeding, blood clots, hair loss, discomfort during sex and depression after Essure coils were implanted during the sterilization procedure.
A permanent form of birth control, Essure requires an outpatient procedure that involves a doctor inserting bendable coils into the fallopian tubes. This process causes scar tissue to form around the coils over several months, which is supposed to block the tubes and prevent pregnancy.
Norman contends that as a result of the complications she suffered from the Essure implant, she had to undergo a hysterectomy to remove the birth control device.
According to the complaint, Norman first underwent the Essure procedure in March 2012, and less than a year later required a hysterectomy for its removal.
Between the date the sterilization procedure was approved by the Food and Drug Administration (FDA) in November 2002, and May 31, 2015, the FDA received more than 5,000 adverse Essure event reports.
The lawsuit alleges that Bayer aggressively marketed Essure to physicians without providing the proper training, and withheld information about the risk of Essure complications from the FDA, doctors and women.
"The only way Plaintiff' implanting physician would have been aware of the adverse events or additional warnings would have been for Defendants to report the adverse events or warnings to the FDA,"the lawsuit states. "Had Defendants properly warned or reported the adverse events to the FDA as required under federal law, the warnings would have reached Plaintiff' implanting physician in time to prevent Plaintiff' injuries."
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Last updated on Mar-21-16
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