Tagged Articles

approval 25 articles

Metal-on-metal hip replacements ‘largest medical device failure ever’

Metal-on-metal hip replacement systems are becoming one of the nation’s largest medical device failures ever, according to a story on NBC Nightly News with Brian Williams. The special type of artificial hips are made with a metal ball that fits into a metal socket, and were designed to be stronger and last longer than traditional ceramic or plastic devices. But doctors and patients are now discovering the metal-on-metal hip implants are causing serious problems. In fact, nearly 11,000 complaints were logged by the Food and Drug Administration (FDA) this year alone, according to NBC Nightly News. Last fall, DePuy Orthopaedics, ... Read More

Medical device companies seek to discredit IOM on device approval process

Medical device companies are waging a campaign to discredit the recommendations of the Institute of Medicine (IOM) that include doing away with the Food and Drug Administration (FDA) accelerated approval process for moderate-risk medical devices. IOM is an independent, nonprofit institute that provides information and advice on issues concerning health and sciences. The FDA asked the institute more than two years ago to make recommendations on improving its 510(k) process, which is designed to get moderate-risk devices on the market faster. The process also greatly cuts down on the time it takes for medical device companies to begin selling and ... Read More

Many medical devices approved without human testing

About one percent of medical devices introduced in the United States market get recalled. It seems like a small number, but that number represents thousands of people who have died or been harmed by faulty medical devices. The clincher? Many of those devices were never tested on humans before they were approved for use. The process is called fast-tracking. Some categories of medical devices can be approved by the Food and Drug Administration (FDA) with little or no testing if they are similar to other devices already approved. Since 2009, 67 individual high-risk devices have been approved through this process ... Read More

FDA approval process flawed, warns Government Accountability Office

In January 2009, the Government Accountability Office prescribed some “immediate steps” federal regulators must take to improve its approval process and decrease the chance that dangerous drugs and medical devices are let loose on the public. But because nobody ever really listens to the GAO, it’s been business as usual for the U.S. Food and Drug Administration, which has fast-tracked the approval and sale of 67 medical devices since the GAO’s warning with the 510(k) program, allowing high-risk devices such as DePuy’s Acetabular and ASR Hip Resurfacing Systems to slip past a rigorous medical review. DePuy’s hip implants were sped ... Read More

BP seeks U.S. permission to drill in the Gulf again

BP officials have told federal regulators that their company is in a Catch-22. The federal government is pressing BP to pay more oil-spill claims faster, but the oil giant says that to meet those financial obligations, it must be allowed to drill in the Gulf of Mexico, which it is banned from doing. BP spilled 4.9 million barrels (206 million gallons) of oil in the Gulf of Mexico when its Deepwater Horizon rig exploded, killing 11 workers and triggering the biggest environmental catastrophe in U.S. history. As enormous quantities of oil spewed into the Gulf waters, the Obama Administration quickly ... Read More