Bayer HealthCare is facing a growing number of product liability claims regarding the Essure birth control system, with a group of over 50 women filing legal action.

This group of women is filing a combined Essure lawsuit, alleging they experienced serious complications due to the adverse effects of the Essure birth control system.

These injury claims are joining over 1,500 other product liability claims filed against Bayer, alleging serious Essure complications. These women filed their Essure lawsuit in the U.S. District Court for the Eastern District of Pennsylvania, alleging the pharmaceutical giant either knew or should have known about the potential adverse effects the Essure birth control system.

The claimants allege this based on the number of injury reports submitted to the FDA, which were allegedly “manipulated” by Bayer to minimize the severity of the complications.

In addition, the women allege Bayer had taken various unethical measures to assure the Essure birth control system was approved to enter the United States market by concealing the serious side effects that appeared in clinical trials.

Overview of the Essure Birth Control System

The Essure birth control system was approved by the FDA in 2002, as the first non surgical female sterilization method. The Essure birth control system consists of two metals coils that are implanted into the woman’s fallopian tubes. This causes the surrounding tissue to grow, which blocks sperm to egg conception.

Compared to traditional hysterectomy, the Essure birth control system was much less invasive and provided a much faster recovery time for patients. Women flocked to the Essure birth control system because it could accomplish female sterilization, without the use of surgery.

However, there have been alarming allegations of serious injury and side effects, and that the device was not properly evaluated before being released into the market. This has allegedly resulted in numerous women sustaining injury and permanent damage to their reproductive systems, with stories spanning back to when the Essure birth control system was first released in 2002.

One of the women mentioned in the litigation is Keisha C., who had decided to have the Essure birth control system implant after having eight children. She was initially opting for tubal ligation but had quickly changed her mind upon learning about the Essure birth control system.

Keisha had reviewed an Essure brochure from Bayer, which described the contraceptive as “the most effective method of permanent birth control available.” However, Keisha alleges she experienced a variety of strange side effects after the implantation including her hair falling out in clumps and started experiencing allergic reactions to nickel.

According to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, there have been over 5,093 Essure injury reports submitted. Most of these reports came directly from the women experiencing adverse effects, with the FDA warning women and their physicians carefully evaluate the risks before getting the Essure birth control system implanted.

Stories like Keisha are not difficult to find, with several Facebook groups and other social media groups sharing their own accounts of the Essure birth control system. Women who opt for the Essure birth control system should undergo a checkup within three months of getting the device implanted, and should speak to their doctor if they experience any adverse effects.