A new report criticizes the FDA’s ability to keep dangerous and potentially defective medical devices out of the marketplace.
The report, published last week in the British Medical Journal, indicates that the FDA is currently unable to protect the public from harmful medical devices because it lacks the manpower, the budget and the authority to do so. It also suggests that the FDA has been co-opted by medical device manufacturers, political forces and other special interests.
The analysis comes a little more than two weeks after the FDA rescinded approval of the Menaflex Collagen Scaffold knee replacement device. The agency admitted that the medical device was approved without being properly researched due to political pressure and the overly flexible requirements of a program designed to fast-track certain devices through the approval process.
It also comes just three months after DePuy Orthopaedics issued a recall for 93,000 artificial hips, which had failure rates of 12% and 13%. Many individuals who received one of the defective hips are pursuing a DePuy hip lawsuit, alleging that doctors were expressing concerns to DePuy about a higher-than-expected failure rate for the metal hip system before the recall. The implants have been found to shed metal particles into the bloodstream, which could lead to cobalt toxicity.
The new report, written by Jeanne Lenzer, a medical investigative journalist, and Shannon Brownlee, an instructor at Dartmouth Institute for Health Policy and Clinical Practice, focuses on gaps in the FDA’s post-approval surveillance process. They focused, in particular, on the vagus nerve stimulator (VNS) by Cyberonics, which is designed to treat epilepsy through electrical impulses to the vagus nerve, which is located in the neck. It is also approved to treat depression.
The researchers said that since its approval 13 years ago the FDA has received reports of 900 deaths of people using the device. However the FDA has yet to require the company to determine the cause of death of those people, which the researchers say means that nobody knows if the VNS was tied to their deaths or not. The VNS is currently in use by about 60,000 patients, and Cyberonics is looking to expand its approval for the device to the treatment of stroke, traumatic brain injury and obesity.
In the case of the Menaflex, as well as a number of other medical devices that have turned out to be controversial, the products were approved through the FDA’s 510(k) approval process.
The 510(k) program allows quick approval of new medical devices if their manufacturers can show that they are functionally equivalent to devices already on the market. However critics say that the standards of the program and the definition of “functionally equivalent” have strayed over time.
A study by the Government Accountability Office (GAO) released in June 2009 found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identified gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.
As a result ofgrowing concerns, the FDA has proposed a more stringent application of the 510(k) process.