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FDA Failing to Monitor Safety of Medical Devices: Report
Date:11/3/2010

f a recent embarrassment for the agency: In October, the FDA apologized for mistakenly approving the Menaflex knee implant over objections from its own scientists. In its announcement, the FDA admitted it caved to political pressure from New Jersey senators and a congressman. The FDA has now taken steps to rescind that approval.

"I have sympathy for the FDA, which is understaffed and underfunded in many areas," Brownlee said. "But there is no question that this agency had been captured by the very industries that it is supposed to regulate," she said.

Defending the VNS, Cyberonics chief financial officer Greg Browne said that "none of the approximately 900 deaths reported to the FDA were attributed to VNS therapy."

"Available data demonstrate that all-cause mortality rates for VNS therapy patients are less than half the rates in the comparable non-VNS epilepsy patient population," he added.

Dr. Jerry Avorn, professor of medicine at Harvard Medical School and author of an accompanying journal editorial, agreed with the article's authors that, "until recently the part of FDA that approves devices has been run in a much more loose manner than the part of FDA that approves drugs."

While the FDA has started to deal with some of these problems, "it's still more of a wild west environment than the drug side of FDA," he added.

The agency needs to look harder at the standards it uses when approving new devices, and should revamp its surveillance systems to spot people who have received faulty devices, he added.

"All government regulation is not a bad thing," Avorn said. "It can sometime be life-saving," he said.

More information

For more information on the FDA and medical devices, visit the U.S. Food and Drug Administration.

SOURCES: Shannon Brownlee, M.S., instructor, Dartmouth Institute for Health Policy and Cli
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