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April 25, 2008 Ophthalmic Panel Meeting PDF Print E-mail

Video Testimony on LASIK, Depression, and Suicide From the April 25th, 2008 Special Hearing of the FDA's Ophthalmic Devices Panel

"The FDA's capacity to oversee the refractive surgery industry is in my opinion no different than the doctors who have tarnished it. The FDA has been ineffective in overseeing investigational studies, ineffective in enforcing the policies mandated for the industry, and ineffective in providing thus far the protection that many of us here today should have had." - As stated in my presentation (below).

On April 25th, 2008, the FDA's Ophthalmic Panel held an open public meeting to address 'Quality of Life' issues after Refractive Surgery. Among the presenters were Gerry Dorrian, whose son took his own life in 2007 as a result of his complications. David Shell help up charts depicting his distorted vision.

The 'positive side' was shown as well. The military spoke stating this was one of the best procedures available for those in the field. Doctors brought in patients potraying lasik as a miracle.

The panel was made aware that refractive surgery had a complication rate of about 5%. Think about it: If 1 million people had the procedure done, then that means 50,000 (5%) were damaged. Majority rules though, so 50,000 doesn't mean anything to the FDA. What about 5 million? That would make 250,000 people with complications! When I hear that the FDA is influenced by financial interest, you get no argument, especially since I've seen how they work!!!

As the FDA wants information on quality of life, I say give it to them. Anyone who's had a complication from refractive surgery send them your story. Let them know what your life is like now. And if you're sending it to them, copy, paste, and send a copy to me because I simply don't trust them!

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