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At Senate hearing, critics slam FDA's device safety record

by Brendon Nafziger, DOTmed News Associate Editor | April 14, 2011
A woman on the verge of tears recounted how a defective hip implant might have ruined her chances at having children during a congressional hearing putting the Food and Drug Administration's medical device approval process in the crosshairs.

At the hearing Wednesday, convened by the Senate Special Committee on Aging, the Government Accountability Office also shared from a forthcoming report rapping the knuckles of the FDA for gaps in its postmarket surveillance process and for failing to reclassify nearly two dozen high-risk devices highlighted by the GAO in a January 2009 report.

The agency also took a drubbing from device industry representatives, who complained the process was too slow and was crippling America's competitiveness, with American patients getting devices sometimes four years later than European patients.
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The device industry then sparred with patient advocates over the correct figure for device recalls, in what a witness from the FDA dubbed the "war of numbers."

The hearing, "A Delicate Balance: FDA and the Reform of the Medical Device Approval Process," was called to judge how well the federal watchdog agency maintained the balance between safety and innovation of medical devices.

"This has been an extremely difficult assignment," committee chairman Sen. Herb. Kohl (D-Wis.) admitted at the start of the hearing.

The committee's ranking member, Sen. Bob Corker (R-Tenn.), agreed. "Nobody's particularly happy with the FDA. I don't know whether you consider that to be a success. A lot of times with legislation, if everybody's mad at you, you've kind of hit the sweet spot," he said.

In the hearing, a patient from Denver, Colo. said she was one of 96,000 people to receive an artificial hip implant made by Johnson & Johnson subsidiary DePuy Orthopedics. The metal-on-metal prosthetic made headlines last year when it was recalled in August after doctors found it could degrade and leak metal into the bloodstream.

"When I heard this news, I really didn't understand the implications of what I was told," Katie Korgaokar told the committee. "In my mind, recalls were for dishwashers and cars, not body parts."

Korgaokar said blood tests showed she had cobalt and chromium leaking from the implant, and was required to undergo a second surgery to replace the device with an older, safer model. She said the metal in her blood caused her to delay a pregnancy -- possibly ruining her chance to start a family.

She also said she discovered her doctor received $600,000 in consulting fees from DePuy. "This was never disclosed to me," she said.

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