Bayer HealthCare is facing a new Essure complications lawsuit from a Pennsylvania woman alleging serious device complications. The woman alleges Bayer HealthCare failed to disclose all potential adverse effects the Essure birth control device could induce, and opted to file the Essure complications lawsuit after discovering the company may have negligently marketing the device.

Plaintiff Linda D. alleges Bayer HealthCare had deliberately concealed vital product safety information in her Essure complications lawsuit, which caused her physician to believe it was safe.

The Essure birth control system consists of two nickel metal coils, each of which is implanted into a fallopian tube. After the coils are implanted, the surrounding tissue swells due to inflammation and settles around the coils. This ultimately prevents sperm to egg fertilization, and is the only form of non surgical female sterilization in the United States.

The Essure birth control device has become a popular choice for hundreds of thousands of women in the United States, with the device being very convenient and minimally invasive. In addition, Bayer HealthCare marketed the device as perfectly safe for human implantation and is a reliable method for women seeking alternatives to tubal ligation, according to the complaint.

Linda says her Essure birth control product was implanted on July 7, 2014, and she suffered no initial complications. However, alleges the plaintiff, not long after the Essure birth control coils were implanted, she developed permanent injuries.

The plaintiff says she opted to file this Essure complications lawsuit after discovering the defective nature of the permanent contraceptive on Feb. 29, 2016, alleging Bayer either knew or should have known about their product’s defective nature.

Overview of Essure Complications

The Essure birth control was approved by the FDA in 2002, and was originally manufactured and produced by Conceptus Inc. The product was later acquired by Bayer HealthCare, which is now responsible for marketing the benefits of the contraceptive and disclosing potential side effects.

Essure birth control was approved through the FDA’s fast track approval process, which means that the potential risks of the contraceptive may not have been properly evaluated before release, according to the Essure complications lawsuit. Consumer advocates have called for the Essure birth control to be removed from the market, arguing that the coils were not safe for human use.

Since Essure birth control entered the market, over 4,500 injury reports have been submitted to the FDA with complications including:

• Device Migration
• Hysterectomy
• Abdominal Pain
• Pelvic Pain
• Back Pain
• Bloating
• Weight Fluctuations
• Heavy or Unusual Menstruation Cycles
• Organ Perforation
• Ectopic Pregnancy (pregnancy that forms outside the uterus)

At all times relevant, Linda says that she and her physician were relying on the information provided by Bayer HealthCare.

Linda states she would not have agreed to have the Essure birth control device implanted, if she had known about the serious health risks it could cause. Linda further states the complications she suffered are permanent injuries, which will have an impact on the rest of her life.

This Essure Complications Lawsuit is Case No. 2:18-cv-01147-MAK in the U.S. District Court for the Eastern District of Pennsylvania.