Number of Medical Device Recalls Jumps 97 Percent From 2003 to 2012
According to the Minneapolis Star Tribune, the U.S. Food and Drug Administration (FDA) has revealed that the number of medical device recalls nationally doubled between 2003 and 2012.
The paper reported that the agency attributes the increase to “greater vigilance on the part of the industry and the agency to respond more quickly and decisively to problems with medical devices.”
Of the nearly 1,200 recalls in 2012, the FDA reported that 57 were Class 1 recalls, the type causing complications leading to injuries and/or death. Only seven Class 1 devices were recalled in 2003.
According to the FDA, Class 1 recalls represented only 1 percent of recalls in 2003, but comprised nearly 5 percent of total device recalls in 2012.
“The annual number of Class I recalls increased in part due to CDRH (the FDA’s Center for Devices and Radiological Health) and industry efforts to improve performance of devices historically associated with high numbers of device problems, such as ventilators, infusion pumps and external defibrillators,” the FDA said.
However, a cardiologist questioned the FDA’s conclusion that increased recalls were a sign of improved safety.
“The FDA suggests that the rise in the number of recalls reflects favorably on the regulatory process. I disagree,” Dr. Robert Hauser said in an e-mail, according to the Star Tribune. “A truly effective regulatory system would have prevented most recalled devices from being approved for use in the United States. The report also fails to measure the harm to patients and the cost to the health system.”
I Need a Defective Medical Device Attorney to Help Me
Defective medical devices can lead to horrific personal injuries and death.
One defective medical device involved in ongoing litigation is the DePuy ASR Hip Replacement. This device has been linked to death from revision surgery, myocardial infractions, stroke, pulmonary embolisms, and DVT.
If you have received one of the devices included in the DePuy hip implant recall, talk with our DePuy hip implant attorneys. Contact our metal-on-metal hip attorneys by calling toll-free (888)841-9623 today.
Zoll, Kranz & Borgess, LLC – Defective Medical Drug and Device Lawyers