Essure Procedure Lawsuit Alleges Complications Resulted in Hysterectomy for Coil Removal

Bayer faces a new product liability lawsuit from a Connecticut woman who alleges she suffered severe complications from an Essure procedure, indicating that she had to undergo a hysterectomy to remove the birth control device.

The complaint (PDF) was filed by April Norman in the U.S. District Court for the District of Connecticut on February 16, indicating that she experienced painful bleeding, blood clot, hair loss, discomfort during sex and depression after Essure coils were implanted during the sterilization procedure.

Norman indicates that she first underwent the Essure procedure in March 2012, and indicates she required a hysterectomy for Essure coil removal less than a year later.

The case joins a growing number of Essure procedure lawsuits filed in recent months, alleging that Bayer aggressively marketed the device to physicians without providing the proper training, and withheld information about the risk of Essure complications from the FDA, doctors and women.

Between the date the sterilization procedure was approved by the FDA in November 2002, and May 31, 2015, the FDA received more than 5,000 adverse event reports involving Essure problems suffered by women nationwide.

“The only way Plaintiff’s 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’s implanting physician in time to prevent Plaintiff’s injuries.”

Essure is a permanent form of birth control, which is offered as an outpatient procedure where the doctor inserts 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.

Amid growing concerns about the potential Essure procedure risks, including allergic reactions, the device migrating out of position, perforating the fallopian tubes or causing other problems, the FDA held advisory panel meetings last year to review the safety of the device and whether an Essure recall should be issued to protect women.

Earlier this week, the FDA announced that the device will remain on the market, but stronger Essure warnings will be placed in a prominent boxed warning on the label, to ensure women are informed about the potential risks. The federal regulatory agency is also requiring Bayer to conduct additional studies to better understand the safety of the birth control coils, which many plaintiffs in the recently filed lawsuits allege should have been performed before the sterilization procedure was ever marketed to women and physicians.