Hi, I am a 51 year old female with a PFO that was discovered about 4 and 1/2 years ago after I temporarily lost half of my vision and was unable to get thoughts and words together. I just went to bed that night and fortunately awoke ok. A cardiologist discovered a small PFO and warned me to make wise choices about how I live the remainder of my life. Another cardiologist who wanted to cut open my chest to fix it said that it is not if, but when I have a stroke. Have had declining cognitive issues over the last 6 months, but seem ok, now. I too, Amy, am allergic to nickel and cannot wear earings, jewelry, a watch, or any thing else with nickel. Have had headaches all of my life, including migraines but am terrified of this procedure. Is the Gore-Helix FDA approved? My insurance will only cover FDA approved devices. And what did your doctor say if you have an allergic reaction? The chicken bone and other side effects really concern me. I just don't know what to do ... Help!