Bayer HealthCare has removed the Essure birth control system from the market after numerous women across the United States allegedly suffered serious Essure complications.

According to Bloomberg, Bayer stated they were ceasing sales of the Essure birth control after Dec. 31, 2018 due to decreasing sales. Some think it could be due to the numerous injury complaints and lawsuits filed by devastated women.

One of the most recent Essure lawsuits was filed by a woman from Rhode Island, alleging Bayer failed to warn her against the potential device complications associated with the permanent birth control device.

Plaintiff Kimberly B. had the Essure birth control device implanted on July 5, 2011, and was later confirmed to be properly in place.

However, Kimberly reportedly started suffering painful Essure complications not long after including heavy bleeding, painful intercourse, abnormal menstruation, bloating and severe abdominal pain.

Kimberly later learned of the problems reported with the Essure birth control device in the spring of 2018, and she says she had no way of discovering this information at an earlier time.

During this time, the FDA publicly called out the potential safety issues associated with the Essure birth control device. The FDA required Bayer to added a black box warning, patient decision checklists, and new clinical trials to evaluate the safety profile of the permanent contraceptive.

According to the Essure lawsuit, Kimberly had reviewed the patient brochure that had assured her it was safe and effective for permanent birth control. Instead, Kimberly reportedly suffered permanent injuries and has interfered with her ability to work.

Overview of Essure Complications

The Essure birth control device consists of two metal coils, which are each implanted into a fallopian tube. The metal coils spur inflammation in the surrounding tissue, which permanently blocks sperm to egg fertilization.

The Essure was the only non surgical female sterilization method available in the United States, and quickly became popular in the United States after it was released in 2002.

It is important to note that the Essure birth control device had been fast tracked through the FDA’s approval process, due to its unique benefit of being an alternative to traditional hysterectomy. However, it has been alleged the device was unreasonably dangerous for patients and the device should not have been released.

As of 2016, there have been over 10,000 Essure injury reports submitted to the FDA, which prompted the agency to order Bayer to conduct a seven year study on the device. The Essure birth control device has also been linked to 15 fetal deaths and four adult deaths, as well as hundreds of unwanted pregnancies.

One of the major issues associated with the Essure coils is that they may perforate the fallopian tubes and may migrated away from them. This can cause painful side effects ranging from cramping to ectopic pregnancies.

Even though these are very serious device complications, Kimberly claims Bayer failed to warn her and other patients. Kimberly states she would not have had the Essure birth control device implanted if she had known how devastating its side effects could be.

This Essure Lawsuit is Case No. 2:18-cv-05362-GJP, in the U.S. District Court of Eastern Pennsylvania.