A group of 98 women across the country have come together to file massive lawsuit in Missouri state court against pharmaceutical manufacturer Bayer.

The women all alleging serious Essure birth control complications and permanent injuries suffered as a result of being prescribed and implanted with the allegedly defective birth control device.

The Essure system is a unique non-surgical contraceptive device consisting of two metal coils that are implanted into a woman’s fallopian tubes.

The coils expand and are intended to elicit tissue growth that causes blockage of the tubes and thus prevents conception.

The first of its kind device was intended to be promoted as simple solution to permanent birth control needs and safer than all other permanent birth control options.

But at least 98 women who suffered Essure birth control complications disagree and challenge Bayer’s actions in promoting the device, saying the company downplayed the true safety risks of Essure.

According to the 191-page complaint submitted last week, Bayer “carefully manipulated its reports to the FDA and presented false and misleading information” about Essure birth control complications in order to guard sales.

Many of these women in the lawsuit contend that they suffered Essure birth control complications that included:

• Persistent pelvic pain or cramping
• Infection
• Device migration
• Perforation of organs
• Pregnancy
• Ectopic pregnancy
• Miscarriage
• Irregular bleeding
• Heavy metal toxicity
• Hypervolemia (fluid buildup in blood)

Some plaintiffs also allege their Essure birth control complications have required hospitalization, hysterectomy or surgical removal of the device.

FDA Evaluates Reported Essure Birth Control Complications

Initially, Conceptus, a subsidiary of Bayer, manufactured and marketed Essure.

The Food and Drug Administration (FDA) approved Essure in November 2002. It was approved through the Premarket Approval (PMA) process as a Class III device, generally the highest risk devices and subject to the highest level of regulatory control.

According to the FDA, “Over the past several years, the [agency] has been examining the growing number of reports of harm with Essure. The adverse events reported associated with the use of the Essure System include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure System failure, and, in some cases, incomplete patient follow-up have resulted in unintended pregnancies.”

On September 24, 2015, the FDA met with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, to hear expert scientific, clinical opinions as well as patients’ experiences regarding the benefits and risks of Essure.

On February 29, 2016, the agency released a press announcement recommending that sterilization devices, such as Essure, include a Black Box warning label, a label required for devices that potentially cause death or serious injury, explaining the possible side effects.

Harmed by Essure?

If you or a loved one has been injured by the implantable birth control device and suffered serious Essure birth control complications, you may have a case.  For more information about the legal process involved in taking part in an Essure lawsuit, contact a qualified personal injury attorney now for a free, no-obligation consultation.

The Essure Birth Control Complications Lawsuit is Case No. 4:16-cv-01192 in the Circuit Court of the City of St. Louis, State of Missouri.