Since the Essure sterilization device was approved in 2002 by the U.S. Food and Drug Administration (FDA), over 5,000 reports have been made about injuries stemming from the use of the device. In a recent NPR report, a representative from the National Center for Health Research indicated that Bayer, the manufacturer of Essure, may not have provided the FDA with all the information it had regarding the device’s potential complications at the time Bayer sought approval of the device. Some of this research indicates that the device may fail up to 10 percent of the time.
The pressure to address Essure’s complications heightened earlier this month when Congress drafted a bill calling for the FDA to remove the device from the market within 60 days after numerous women testified at a Congressional hearing about how the device had negatively affected them.
Recently, the FDA’s Obstetrics and Gynecology panel convened to discuss the device and how patients can best assure their safe use of the product. The device is particularly popular due to its status as the only non-surgical and permanent birth control method that the FDA has approved.
The device consists of a polyester and metal coil that is implanted into women who are seeking permanent birth control methods after having children. The device is inserted into the fallopian tube through the uterus. The tip of the device remains outside the organ in order to ensure visual confirmation of placement. Roughly three months after placement, the body grows tissue around the coils to create a natural barrier that prevents sperm from entering the uterus.
The complications associated with Essure can be severe and include depression, hair loss, chronic pain, heavy bleeding, psoriasis, migraines, perforation of the uterus, and fatigue. In some cases, the device does not stay where the doctors originally implanted it, causing the device to cut into nearby organs and requiring serious emergency surgical measures. Some doctors are even unwilling to operate on a patient who is having trouble with her Essure device, due to the complex complications that can arise after the device migrates.
The device is not ideal for all women, posing a heightened risk of complications in women whose fallopian tubes are not entirely straight, who have auto-immune disorders, or who have a history of abnormal uterine bleeding, hypersensitivity to nickel and other metals, chronic pelvic pain, or pelvic inflammatory diseases.
As a result of these complaints and complications, the panel recommended that Bayer, the manufacturer of the device, develop a new label for the product that provides more comprehensive instructions on how to insert and monitor the device. The panel also suggested that Bayer should increase its efforts to collect data on the device and promote patient education about Essure.
One of the panel’s more specific recommendations involved creating an informed consent form that patients must sign to indicate they are aware of the risks, benefits, and alternatives associated with Essure before implantation.
If you or someone you love has suffered injuries as the result of a dangerous medical device, you may be entitled to compensation. At Moll Law Group, we have helped many defective device victims investigate their claims and bring lawsuits against device manufacturers. Although no sum of money can ever truly compensate you for the pain and suffering that you have experienced, it can compensate you for your out-of-pocket expenses and help you and your family get back on your feet. Based in Chicago, our defective device lawyers represent clients across the nation, including in New York, California, and Florida. Call us now at 312-462-1700 or contact us online to set up your free consultation today.