A couple from Texas has recently filed legal action against Bayer HealthCare, alleging that the permanent contraceptive had caused one of the women to undergo Essure hysterectomy.

The couple alleges that due to the complicated nature of the device complications, an Essure hysterectomy was necessary to improve the woman’s health and overall quality of life.

Plaintiffs April and Laverne T. conjointly filed this Essure lawsuit, alleging that April sustained chronic and life altering injuries caused by her Essure hysterectomy. Like numerous other women who opted for the permanent contraceptive, April had the Essure implanted to avoid a hysterectomy procedure.

Essure Birth Control Device

The Essure consists of two metal coils, one implanted into each fallopian tube, which causes the muscle to swell and block sperm to egg fertilization. Essure is currently the only non surgical option for female sterilization in the United States, and numerous women preferred the device over traditional hysterectomy due to its minimally invasive nature and short recovery period.

With these benefits in mind, April reportedly agreed to have the Essure coils implanted. She alleges she underwent the procedure on May 10, 2013, but began experiencing painful device complications not long after the Essure coils were implanted.

These side effects included pelvic pain, cramping, prolonged and heavy periods, fatigue, weight gain, and forgetfulness. According to the Essure lawsuit, these device complications got so bad that April was forced to undergo an Essure hysterectomy on Sept. 21, 2017, to remove the coils.

April and Laverne opted to file legal action against Bayer after discovering numerous other women reported similar complications.

Overview of Essure Device Complications

A hysterectomy may become necessary when the coils cause severe complications to the patient’s health, and removing the fallopian tubes is the best, or only way to resolve these problems. Since the coils are deep within the fallopian tubes, Essure hysterectomy is often necessary to safely remove the devices.

Since Essure’s release back in 2002, thousands of women have reported side effects and device complications ranging from cramping to serious health concerns like allergic reactions and ectopic pregnancies.

According to the Essure lawsuit, these injury reports spurred the FDA to issue a major label change to the permanent contraceptive on Feb. 29, 2016. This required patients to fill out a “Patient Decision Checklist” which explained the benefits and risks of the Essure device.

This checklist was mandated to ensure that patients understood the risks associated with the Essure contraceptive. The FDA mandated additional warnings on April 9, 2018, requiring the patient and implanting physician provide their signatures on the Patient Brochure for further assurance that they understood the risks.

However, even with these disclosures, this does not protect women from the potential of an Essure hysterectomy if their body does not respond well to the device. Moreover, these Essure complications were allegedly not disclosed to women for years, including the time when April had the device implanted.

April states she would not have agreed to have the permanent contraceptive implanted if she had known the risk of Essure hysterectomy.

In addition to failure to warn, April and Laverne are seeking damages for loss of consortium, alleging that their lives and marriage have been severely impacted by the Essure hysterectomy. This Essure lawsuit is Case No. 2:18-cv-03660-MSG, in the U.S. District Court for the Eastern District of Pennsylvania.