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FDA Approving High Risk Medical Devices without Thorough Review of the Devices

Congressional investigators said yesterday that some medical devices for sensitive uses, from certain hip joints to a type of defibrillator, have won government approval without a close scientific review.

The Government Accountability Office said in a report that the Food and Drug Administration approved 228 medical devices without a full scale review from 2003-2007.

Some devices approved under the less rigorous process have been recalled because of malfunctions and other problems, according to the consumer group Public Citizen. One device was an external defibrillator to assist heart attack victims.

The report comes as the FDA's Center for Devices and Radiological Health is the subject of allegations that scientists were pressured to approve medical machinery against their professional judgment. Nine FDA scientists wrote the Obama transition team last week complaining that a "corrupted" review process is putting public health at risk.

Corporate pressure again is placing tens of thousands of Americans at risk.

For more information about dangerous and defective medical equipment, see the medical malpractice attorneys of Pennsylvania.