An Essure lawsuit has been filed by nearly 100 women against Bayer Essure Inc. and its related companies alleging the Essure birth control device caused each of the women serious personal injury.

The Essure lawsuit was filed by the women who stated that the activities of the manufacturer were inappropriate after the device had gone to the market, leading Essure patients to suffer preventable injuries.

“This action rises from Defendants’ failures of their post-market responsibilities to monitor and warn about serious health risks that emerged after their permanent both control device, Essure, began to be sold in the United States,” the Essure lawsuit reads.

The Essure lawsuit goes on to state that only 745 women were included in the clinical trials that were used to support the device’s release onto the market. “When the FDA approved the device, the FDA was not aware that the device could cause serious health risks, such as perforation of the uterus, device migration or fracture, chronic pain, and prolonged bleeding, as well as ectopic pregnancies,” the claim states.

The plaintiffs allege that not only did the manufacturers of Essure not properly warn patients, healthcare providers were not warned either. “For example, Defendants failed to warn healthcare providers and consumers about roughly 16,000 complaints of serious injuries associated with its sure after the device was approved for sale,” the Essure lawsuit states.

The plaintiffs accuse Bayer of failing to report the serious injuries in a timely manner to the FDA, and this information later turned out to be the basis of the black box warning, the most serious kind of warning, that the FDA required to be placed on the product’s label. “If the Defendants had timely and adequately warned Plaintiffs’ healthcare providers and Plaintiffs of this new risk information, Plaintiffs’ injuries would have been avoided,” the plaintiffs state.

In addition to failing to report safety issues in a timely manner and failing to warn physicians and patients, the plaintiffs in this Essure lawsuit also accuse the birth control manufacturer of concealing “quality control problems that plague their manufacturing process and led to material flaws in the devices, which caused device failures in many patients.” The plaintiffs claim that the company continued to market the device as a safer alternative to other methods of permanent birth control.

The Essure lawsuit details the specific injuries suffered by each woman who is a plaintiff in the lawsuit. The injuries reported by the women include but are not limited to:

• Heavy bleeding
• Hysterectomy
• Perforation of organs
• Pain
• Blurred vision
• Depression
• Migration of the implant
• Pelvic pain
• Back pain
• Anxiety
• Forgetfulness
• Hair loss
• Large ovarian cysts
• Skin rash
• Abdominal pain
• Heavy menstrual cycles
• Fatty an enlarged liver
• Weight gain
• Autoimmune disorders
• Joint pain
• Painful intercourse
• Uterine fibroids
• Miscarriage

As a group, the plaintiffs have brought forth a number of allegations against Bayer including negligence, strict products liability, breach of express warranty, breach of implied warranty and fraud. They are requesting punitive damages and are seeking damages related to severe physical injuries, severe emotional distress, mental anguish, economic loss and other injuries. The plaintiffs are seeking a jury trial.

The Essure Lawsuit is Case No. 4:17-cv-01991-JAR, in the U.S. District Court for the Eastern District of Missouri.