September 30, 2014 — JAMA Internal Medicine has published two studies raising concern about the lack of publicly-available evidence supporting the safety of low- to moderate-risk medical devices approved through the FDA’s 510(k) process.
The lead author on the study, Diana Zuckerman of the National Center for Health Research in Washington, D.C., said it is “shocking” how little information is available to the public. She warned:
“Let the buyer beware before getting an implant in their body, because there may be no evidence the implant is going to benefit them and no study done in case it might harm them.”
The FDA’s 510(k) approval process allows device-makers to introduce new products without requiring lengthy and expensive safety studies — so long as the new devices is “substantially equivalent” to a device that was previously approved. This system has allowed many dangerous products on the market, including metal-on-metal hip implants, vaginal mesh, and power morcellators.
The researchers reviewed 50 new devices that were approved with a 510(k) application between 2008 and 2012. Only eight (16%) had enough publicly-available evidence to support a “substantially equivalent” approval. Out of 1,105 devices that were previously approved, only 3% had enough available data.
The FDA responded by saying they review far more data on new devices than they make public. However, the Safe Medical Devices Act of 1990 requires companies to make evidence justifying the 510(k) clearance publicly available, according to the Wall Street Journal. This can include data from clinical trials, but it is not necessary.
The FDA has vowed to improve transparency in the approval process, but changes have been slow. By this month, most new moderate- and high-risk medical devices should have a unique code that will help the agency track outcomes. Even so, the United States lags behind countries like Australia and the U.K. in implementing a modern surveillance system for tracking new devices.
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