I have been watching this very closely, and I am disappointed that it has not been approved. I had saline implants placed almost 5 years ago and after some early problems with constricture and leakage, they have been satisfactory in restoring form and function but have never been happy with the way they feel. I have rheumatoid arthritis and my rheumatologist did not feel comfortable giving me the green light for silicone until they were "prooven" safe and was FDA approved. My ps wouldn't consider them without the approval of my rheumatologist. I agree Candy, almost everything in medicine has risks associated with it. The medications I take for the arthritis have some potentially dangerous side effects. In fact Bextra is one of them and the FDA has recently recommended it be pulled from the market! This will probably result in switiching to another potentially dangerous drug that may not work as well as the Bextra did. Well, the opposition may have won this battle, but the war is far from over! Frayda