The permanent birth control device known as Essure is the focus of a new lawsuit against Bayer HealthCare brought by a couple from Iowa. The wife allegedly suffered severe injuries as a result of using the device and claims that the pharmaceutical giant neglected to warn consumers of their product’s potentially dangerous side effects.
The Essure complications lawsuit was filed on July 15, 2016 after the wife suffered uterine perforation, hepatomegaly, and infection, each of which she maintains are connected to the defective nature of the Essure birth control device. The woman chose the Essure implantation after reviewing the promotions and discussing it with her physician. Her physician was unaware of the potential injuries she might suffer from the Essure device. The plaintiff says the complications were not listed on the products’ warning label, nor were any precautions or relevant studies provided by Bayer Healthcare.
Currently, the Essure method is the only non-surgical female sterilization method available for birth control. It was acquired by Bayer HealthCare shortly after its release in 2002. The device consists of two metal coils that are implanted into the woman’s fallopian tubes, eventually causing permanent sterilization. The coils cause the fallopian tubes’ tissue to swell, blocking sperm to egg fertilization.
Women looking for a simple sterilization method often choose Essure as an alternative to the complicated and invasive surgery that is tubal litigation. However, since Essure’s approval from the U.S. Food and Drug Administration (FDA), over 4,500 Essure adverse event reports have been received by the agency.
It has been remarked that the Essure birth control was approved through the FDA’s fast review process, causing many consumer advocates to strongly suggest the device’s being taken off the market. Bayer HealthCare allegedly was aware of these complications, but chose not to disclose them to protect their product’s market value.
Because of the alleged negligence of Bayer HealtCare, the Iowa couple have had their lives permanently altered by Essure complications. The husband states that the marriage has been severely impacted by the Essure injuries, and is filing for loss of consortium along with multiple counts of negligence, according to their Essure complications lawsuit.