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Patients Call for Continued FDA Preemption Authority
Date:5/11/2009

ement surgery.

"I tried medicine, surgeries and even older technology without success. Thanks to continued research and innovation, I was able to receive a spinal cord stimulator that finally relieved my pain," said Roman, who uses his professional racing efforts to inform chronic pain sufferers that there is hope and they are not alone. "We need to preserve innovations for others like me."

Patients also expressed concern about turning the review of their complex medical devices, which can often take years of scientific and regulatory oversight, over to states and courtrooms that lack the necessary expertise and budgets.

"How does a lawyer or a judge or a jury know more than my doctor, the FDA or the engineers who invented and developed the medical device that gave me back my life?" said Adam Hammond, who is the first person in the world to be implanted with an Eon Mini neurostimulator.

"This legislation does not in any way improve patient safety," concluded Mr. Ubl. "It will only restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans. We can't let that happen."

The patients will remain in Washington for tomorrow's hearing and meet with their members of Congress about the importance of protecting access to safe and effective medical devices.

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to
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