The Food and Drug Administration (FDA) instructed the manufacturer of Essure birth control, Bayer, to conduct a new clinical study about the device. The aim of the study will be to gather more data about the health risk the device might pose in a “real world environment.”
Essure is a permanent, non-surgical option for birth control available to women. The device consists of flexible coils that are inserted into the fallopian tubes through the vagina and cervix. Once in place, scar tissue forms around the device, preventing sperm from fertilizing the egg.
Since gaining FDA approval in 2002, more than 5,000 women have filed grievances about the device with the agency. The women complain of unintended pregnancies, miscarriages, stillbirths, and intense pain and bleeding after placement of the device.
The FDA will use the results of the study conducted by Bayer to determine what, if any, measures are needed to be taken against the device to ensure public health. The company will be required to follow 2,000 women for at least three years. The study will not have to be limited to just women who choose Essure, but also to women who have chosen other sterilization methods, including surgery.
Bayer will be expected by the FDA to submit a study protocol within 30 days. The company is also required by law to begin the study within 15 months.
An independent investigator hired by Fitzpatrick had different findings than those the FDA reports. The investigation uncovered more than 10,558 adverse events. Of that number, 303 were linked to fetal death. In contrast, the FDA reports only 17 deaths related to the implantation of the Essure device. Only 5 of the 17 involved the death of a fetus.
New guidelines will require that women seeking to have the Essure device implanted be given a thorough checklist by their doctor. This checklist will ensure that the women are aware of any potential side effects that the device may cause. It will also require the woman promise to return to her doctor in three months to make sure that the device is implanted correctly.
If you have experienced an adverse health event due to the implantation of an Essure device, you may be entitled to compensation. Contact the “Strong Arm” attorneys at John Foy & Associates today. Our attorneys will work to get you the compensation you deserve. Contact us today.