FDA Updates Warning for Birth Control Device Essure
Essure is marketed as a form of permanent birth control device made of metals, including nickel and titanium. The device consists of two coils that are implanted into a woman’s fallopian tubes and are intended to remain there for the life of the patient blocking sperm from reaching the eggs. A number of risks have been associated with the device, including, but not limited to, pain following the procedure, a change in menstrual cycle, allergy-like symptoms, poking through the fallopian tubes or uterus during implant, and autoimmune type symptoms. However, the Food and Drug Administration (FDA) recently heightened the warnings on the Essure device to include a black box and a multi-page patient decision checklist. Following its investigation into the safety of the Essure device raised by patients and cited in Medical Device Reports (MDAs), the FDA also ordered Bayer (the manufacturer of the Essure device) to conduct postmarket surveillance study to obtain more data about the benefits and risks of Essure.
Women who have been implanted with the Essure device have reported to the FDA injuries from the device, including, but not limited to ectopic pregnancy, migration of the device out of the fallopian tubes into other parts of the body, chronic and persistent pain, abnormal and intractable bleeding, allergic or hypersensitivity reactions, and others requiring surgical removal of the device. The FDA’s action now requires Bayer to highlight these warnings and more in a black box and to detail them in a multi-page patient decision checklist.
Our own Erin Copeland is recognized as one of the leaders in the fight against Essure and is well-versed in its unreasonably dangerous side effects. Ms. Copeland has spoken at length about the dangers of Essure and was recently appointed Co-Chair of the newly formed Essure Litigation Group within the American Association for Justice. Fibich, Leebron, Copeland & Briggs is a Houston-based law firm that has a team of experienced personal injury lawyers who have represented injured clients across the country since 1992. We have over 100 years of combined legal experience in defending victims of product-related injuries and can help defend your rights if you have suffered injury from a potentially dangerous product.
Speak with one of our experienced injury attorneys today by calling us at 713-489-6566.