Pennsylvania plaintiff Helen M. is suing Bayer Pharmaceuticals for allegedly causing her to suffer numerous complications and unplanned pregnancy. Helen claims that their permanent birth control device, Essure, failed and resulted in her becoming pregnant and her child forming birth defects.

Considering that the Essure birth control device is meant to permanently prevent women from becoming pregnant, the plaintiff would have no reason to believe she was in any danger of conceiving. This obviously was not the case, as a little over a year after the Essure was implanted, Helen gave birth to a child with several birth defects. Additionally, the plaintiff had to have the Essure explanted due to the painful complications it was causing to her fallopian tubes.

The plaintiff’s story begins when she had the Essure implanted on Feb. 27, 2012, wherein the device was placed into her fallopian tubes by a physician. Soon after the Essure implant procedure, Helen reportedly started experiencing fatigue, insomnia, pelvic pain, nausea, diminished brain functioning, numb limbs, headaches, and vision issues. Furthermore, Essure proved not to be effective in its express purpose, as she fell pregnant several months after the device was implanted, according to the Essure lawsuit.

Helen gave birth to her child on Aug. 16, 2013. The child now allegedly suffers from a number of serious birth defects, such as cardiac complications. Soon after going through the physically traumatizing event of childbirth, the plaintiff had to undergo a salpingectomy on Oct. 31, 2013, in order to have the Essure device surgically removed from her fallopian tubes. However, it is important to note that only one Essure coil was located and removed; the other was removed by a hysterectomy procedure.

The plaintiff is still dealing with the complications that came from such intense procedures, especially by the fact that they were conducted so close together. Helen claims that there were no warnings or indications on the Essure product’s label to warn her of any possible complications, especially unplanned pregnancies. She is now recovering from these surgeries and undergoing frequent medical exams, all while taking care of her young disabled child. Helen states that these injuries were completely avoidable, and demands compensation for her medical bills and any treatment her child may need.

Ultimately, Helen has decided to take Bayer Pharmaceuticals to court for failing to protect her against the defects of their Essure birth control product. Her lawyers state that the company had the civil responsibility of warning her and other Essure patients of all possible side effects and risks. Helen insists that she never would have chosen to use Essure if she had known about the possibility of it breaking apart and causing an unplanned pregnancy.

For being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous product, Helen is suing Bayer Pharmaceuticals. The charges include negligence, false advertising, concealing information, and misrepresenting a product.

This Essure Lawsuit is Case No. 2:14-cv-07315-JP, in the U.S. District Court for the Eastern District of Pennsylvania.

Overview of Essure Complications

Essure is a permanent form of birth control for women. It works by blocking the functions of the woman’s fallopian tubes. This device is made up of two coils that are directly inserted into the woman’s fallopian tubes, where it anchors and causes tissue growth in the insertion area, thus causing the desired blockage. The Essure coils are made up of either metal and polyester coils that are biologically safe for insertion; these coils are inserted through the vagina and uterus and are placed inside each fallopian tube. Basically, the Essure is meant to be a simple way to block conception in women that would pose no imposition on their everyday life.

Currently, Essure is the only non-surgical method of female sterilization and is advertised to be safer than surgically ligating the fallopian tubes. Essure was approved by the FDA in 2002 through the agency’s fast-track approval process because of the agency’s enthusiasm for an alternative to surgical sterilization. Women who receive Essure must be evaluated an approved by their doctors to receive it, and doctors must examine the patient three months after the Essure is implanted to be sure that the device is functioning as it should be.

Despite this, there have been numerous women who have reported suffering severe Essure complications after the device was inserted. Many of them assert that the Essure coils never should have been approved for market, and that Bayer did not take enough precautions to protect their consumers.