According to figures from the Institute of Medicine (IOM), 1.5 percent of all devices approved through the 510(k) process are recalled.
Ralph Hall, a professor at the University of Minnesota Law School, shared results from an analysis he performed that found the number of 510(k) devices that resulted in the FDA's most dangerous class of recall is even smaller — closer to 0.5%.
But a recent review by Dr. Steven Nissen of the Cleveland Clinic suggests recalls often involve devices approved through the 510(k) process. In Nissen's review of 113 urgent recalls from 2005 to 2009, more than 70 percent of the recalled devices were found to have been cleared via the 510(k) program — compared with 19 percent approved through the FDA's more rigorous premarket approval (PMA) system.
Diana Zuckerman, PhD, president of the National Research Center for Women and Families and one of the co-authors of Nissen's study, said the figures vary so much because the IOM figure doesn't include recalls for devices whose malfunction poses just a "moderate" risk of injury.
The panel heard from Katie Korgaokar, a Denver woman who was born with a disease that caused her extreme hip pain once she hit her 30s. She received a DePuy ASR prosthetic hip in 2006, but the hip was recalled in 2010 after it was found to malfunction at a much higher rate than expected. In Korgaokar's case, the metal implant's excessive wear and tear released levels of cobalt and chromium in her body that were 1000% higher than normal.
That recall was judged by the FDA to be just "moderate risk." But Korgaokar had to undergo additional painful surgeries to remove the hip, have a new one implanted, and she said the device malfunction may have caused her to miss her window to have children.
"It still blows me away that something that can go into someone's body doesn't have to be tested," Korgaokar said.
In January, the FDA released a list of 25 actions it is taking to improve the safety of the 510(k) process, but stopped short of weighing in on some of the more controversial recommendations made by the IOM, including giving the FDA authority to order postmarketing studies as part of the 510(k) process.
The agency receives upwards of 3,000 510(k) device applications annually, most of which are approved.
"FDA evaluates thousands of medical devices annually and the vast majority of these devices perform well and improve patients' health," Maisel said.