Email I sent to the FDA

I am writing to let you know how disgusted I along with many other women are on your decision to approve the silicone breast implants, what is very suspect is how this approval came down before the new senate and congress come in next January. I am asking if the FDA will in writing state the implants are safe for human insertion? Will the FDA agree to fund MRI's for the women who will not be able to afford the cost of them especially with silent ruptures. How could anyone at the FDA with a conscience state that the companies Inamed or Mentor provided adequate long term data? How could you play with the lives of so many women by agreeing to give them 10 years after the approval to do a long term study? How can anyone possibly believe that these manufacturers will provide data on any risks, problems with ruptures, re-operations, or disease, especially when nothing is in place to watch over them. They govern themselves they do there own tests, they hide what ever they feel is detrimental to them. We know this is how it works as Dow did the very thing I am afraid Mentor and Inamed will do and has done it. Health Agencies like yours and Canada need revamping, they need to not appear as if they are there for the self interests of the companies and physicians but there to protect American consumers from harm. Especially when this medical device is a non life threatening device. I hope that congress and other lawmakers look into this decision and look into changing the rules on approval for Americans well being and health not to mention even death from a product. How do you people sleep at night? How do you people look at yourselves in a mirror everyday knowing that the decision you made was not based on safety of a device but for the vested interests of plastic surgeons, Inamed and Mentor. Your decision left a lot of room for doubt on this device which I would assume makes your office feel it protects you from another tragedy down the road. Well congratulations on looking out for the big corporate greedy manufacturers, and the pockets of the plastic surgeons, I hope this is another situation where Americans wake up and see why the Republicans should not be voted in as the next president in 2009.

Sandra Laliberte