Bayer Pharmaceuticals is facing a massive Essure lawsuit, filed by over 30 women alleging similar injuries.

The allegations surrounding the Essure problems ranged from pelvic pain to the complete device failure.

New Jersey plaintiff Krista R. is one of the numerous plaintiffs who is part of this collective suit, alleging similar Essure problems.

Krista had the Essure birth control implanted in December 2011, opting for  non-invasive female sterilization. She reportedly suffered no initial complications during the Essure implantation procedure.

However, Krista immediately started experiencing Essure problems after the procedure including “heavy and persistent bleeding, severe cramping, rashes, headache migraines, joint pain, chronic fatigue, anxiety, hair loss, pain during intercourse, loss of libido, and very painful menstrual cycles.” Before the device was implanted, Krista did not experience any of these conditions.

This lawsuit was filed not long after the FDA released a response over the concern of Essure side effects in February 2016. The FDA announced it would require Bayer to conduct a clinical study to properly evaluate the reported Essure problems such as “unplanned pregnancy, pelvic pain, and other symptoms.” These Essure side effects often required the patients to undergo surgery to remove the devices.

The massive concern also spurred the agency to require the Essure warning label to be updated, which will include a “black box” warning detailing the possible Essure problems that have been reported. Despite the severity of the Essure side effects reported, the FDA is still keeping it available on the marketplace because it is the only alternative available to tubal ligation.

Overview of Essure Problems

The Essure birth control product was approved by the FDA in 2002, originally marketed and produced by Conceptus. The Essure birth control product consists of a set of metal coils made of a nickel and titanium alloy, which are implanted directly into the fallopian tubes by a medical professional. After three months, the tissue will swell enough around the coils to block sperm  from reaching the eggs, thereby preventing fertilization.

Upon its release, the Essure birth control became one of the most popular methods of contraception and was considered a revolutionary breakthrough. The Essure birth control is the first contraceptive method that allows permanent female sterilization without surgical intervention.

Essure birth control was popular right out of the gate, with 750,000 women having the device implanted since its release in 2002. However there have been a number of severe Essure problems that caused the women pain, with some serious cases requring the devices to be surgically removed. The Essure side effects reported by patients include device breakage, hemorrhaging, and pelvic pain.

The plaintiffs in the Essure lawsuit state that both the original creator of the device, Conceptus Inc., and Bayer Pharmaceuticals had purposefully misled the FDA regarding Essure side effects. Further information is available at

The Essure Lawsuit Case No. 1622-CC00690, in the U.S. Circuit Court of the City of St. Louis, Missouri.