The U.S. Food and Drug Administration continues to advise women to carefully consider the benefits and risks associated with permanent birth control devices, like the FDA-approved Essure device, along with other birth control options. That's why FDA recently approved important labeling changes for Essure. Among other changes, Bayer, the company that makes Essure, will include a boxed warning and patient decision checklist in the labeling to help ensure that women receive and understand the benefits and risks of these permanent birth control devices. What does this mean? Bayer's new checklist in the patient information brochure summarizes key benefit and risk information about Essure. The checklist aims to encourage women to read the information brochure, understand Essure's benefits and risks, and discuss the information with their doctor before making an informed decision on whether to use this device. Here are some things to consider when choosing birth control. What Is Essure, and How Does It Work? Essure is a permanently implanted birth control device and is not intended to be removed. Its flexible coils are made of metals, including nickel and titanium. If you are sensitive or allergic to nickel or other metals, discuss this allergy with your health care provider. To implant Essure, a health care provider inserts the flexible coils into the fallopian tubes (the tubes that carry the eggs from the ovaries to the uterus). In about three months, tissue forms around the inserts, blocking sperm from reaching the eggs and preventing pregnancy. One of the most important things to know about Essure is that it's not immediately effective in preventing pregnancy. You'll need to use another form of birth control for at least three months after the device is implanted.