An Essure birth control injury lawsuit has been filed by 104 plaintiffs, including some of the husbands of the women who have suffered from the permanent birth control implant.

Bayer Healthcare Pharmaceuticals, Inc. makes and markets Essure permanent birth control. Bayer bought out a company called Conceptus to obtain the rights to Essure back in 2013.

More than 750,000 women have received the Essure implant, which was marketed as a quick easy alternative to getting the fallopian tubes tied. Essure offered irreversible results with no down time because the procedure could be completed in the doctor’s office.

Essure consists of two metal and fiber coils that are inserted into the fallopian tubes through the vagina. The coils are designed to spur scar tissue growth, a “natural” way to block the eggs from being released by the fallopian tubes.

Essure Birth Control Injury Lawsuit Alleges Coverup

According to the Essure birth control injury lawsuit, the “Essure devices migrated, fractured, punctured internal organs, and/or caused other serious injuries.”

Bayer allegedly failed to comply with federal regulations and received citations from the FDA and the Department of Health for the following reasons:

• Neglecting to report and, in fact, actively concealed eight perforations by Essure coils
• Incorrectly including non-conforming materials to make Essure
• Neglecting to use pre-sterile and post-sterile cages
• Using an unlicensed facility to manufacture Essure
• Manufacturing the product for three years without proper license

These are just a few of the problems the FDA addressed with Bayer, which allegedly had:

• Not reported complaints of migration of the Essure coils
• Not reported that Essure had caused perforated bowels or that the coils had broken into pieces that migrated outside of the fallopian tubes
• Disclosed only 22 incidents of perforation even though Bayer had knowledge 144 perforations occurred
• Failed to profile a complete risk analysis for the Essure product
• Failed to recognize potential product quality issues
• Failed to disclose 16,047 complaints to the FDA as Medical Device Reports.
• Bayer also allegedly “concealed and altered the medical records of its own clinical trial participants to reflect favorable data.”

More specifically, plaintiffs allege Bayer modified the medical records to reflect less pain that was actually reported during Essure’s clinical trials and modified the birth dates of some participants to ensure certain age requirements were met.

Essure Birth Control Injury Lawsuit Points to Materials Used

Researchers believe several problems that women have experienced originate in the materials used to make the Essure coils. The stainless steel coils can become unpassivated over time. The coils contain nickel, which the body often attacks because of nickel allergies. The nitonol in the metal can degrade, increasing toxic metal ion levels in patients.

The plastic coating is made of polyethylene terephthalate (PET), which can be toxic to patients, cause chronic inflammation, and induce autoimmune responses.

The Essure birth control injury lawsuit also alleges that “PET fibers are also known endocrine disruptors.”

This means the PET fibers leach endocrine disrupting chemicals that can mimic or block a natural hormone, tricking the body into thinking a hormone has been released. At that point, the body can inappropriately activate the hormone’s receptor and cause hormonal responses that are supposed to only be activated by natural hormones.

The Essure Birth Control Injury Lawsuit is Case No. 2:18-cv-00037-JP in the U.S. District Court for the Eastern District of Pennsylvania.