An Arizona woman is suing Bayer Pharmaceuticals Inc. and its related companies over problems she says she suffered from the Essure birth control device.

Plaintiff Christine B. says she was implanted with the Essure device in July 2013. She says that after receiving the implant, she suffered from several Essure problems including “migraines, severe abdominal, ovarian and pelvic pain, sharp, stabbing pain, pain during intercourse, heavy bleeding, emotional pain and mental anguish.”

In addition, she says that her Essure reversal required a total hysterectomy in January 2015.

The Essure device is designed to be a substitute for surgical sterilization as a method of permanent birth control. It consists of a small metal coil that is implanted within the recipient’s fallopian tubes in an outpatient procedure.

After implantation, the presence of the implant stimulates the growth of scar tissue around it, eventually closing off the fallopian tube and preventing the passage of ova from the ovaries to the uterus. Essure implants are intended to remain in place for the life of the recipient.

Part of Christine’s Essure lawsuit is an attack on the FDA’s approval process for Essure, alleging failure on Bayer’s part to satisfy FDA requirements. Christine says that Bayer was supposed to report annually on the status of 745 women who received Essure implants as part of the clinical trials required for FDA approval.

However, she says, Bayer failed to report certain Essure problems to the FDA, including eight separate instances of perforations associated with Essure. She argues these and other alleged failures on Bayer’s part made Essure an “adulterated” device that could not lawfully qualify for FDA approval.

Elsewhere in the Essure lawsuit, Christine questions the training that Bayer provided for the physician who implanted her Essure device. She says that though the physician was trained on implanting Essure, he received no training for Essure reversal in the event the device should migrate or cause other problems.

Christine also implicates Bayer’s distribution plan for Essure kits. The plan allegedly required physicians to purchase two Essure kits per month. Christine argues this plan was unreasonably dangerous because it compelled the purchasing physician to implant at least two Essure devices per month, at the expense of patient safety and health.

The Essure Lawsuit is filed in the U.S. District Court for the Northern District of California.

Other Essure Lawsuits

Christine is one of thousands of women in the U.S. who report Essure problems. The FDA has received over 5,000 adverse event reports related to the Essure device since first approving it for use in 2002. Women have reported experiencing pain, abnormal bleeding, unintended pregnancies, and perforation of organs after having been implanted with the Essure device. Based on those reports, the FDA has begun to reevaluate the safety and efficacy of Essure.

Another set of Essure lawsuits is underway in a federal court in Philadelphia. Five different actions with claims similar to Christine’s have been consolidated in a single court. One Essure reversal required a hysterectomy after her implants migrated into her uterus.

Plaintiffs in those cases are trying to work around a 2008 Supreme Court opinion holding that medical devices approved by the FDA are shielded from state products liability laws. Like Christine, the plaintiffs in the Philadelphia actions argue that Essure’s FDA approval was invalid due to Bayer’s alleged deception and failure to comply with FDA requirements in the approval process.